A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Randomized, Open-label, Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes of Toujeo Compared to Commercially Available Basal Insulins for Initiation of Therapy in Insulin-naive Patients With Uncontrolled Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02451137
• Other study ID #: LPS14347
• Secondary ID: U1111-1168-0354
• Status: Completed
• Phase: Phase 4
• Start date: June 16, 2015
• Est. completion date: August 9, 2018

Study information

• Verified date: August 2019
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

Demonstrate clinical benefit of Toujeo in achieving individualized Healthcare Effectiveness Data and Information Set (HEDIS) glycated hemoglobin (HbA1c) targets (<8% if age >=65 years or with defined comorbidities or otherwise <7%) at 6 months without documented symptomatic (Blood Glucose <=70 mg/deciliter [mg/dL]) and/or severe hypoglycemia at any time of day from baseline to 6 months in uncontrolled insulin naive participants with type 2 diabetes initiating basal insulin therapy in a real world setting.

Secondary Objectives:

Compare Toujeo to other commercially available basal insulins at 6 months after initiating insulin therapy in a real world setting in terms of:

• Participant persistence with assigned basal insulin therapy.

• Risk of hypoglycemia including the incidence and rate of documented symptomatic and severe hypoglycemia.

• Changes in HbA1c, fasting plasma glucose, body weight

• Differences in participant and provider- reported outcomes (including Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs) and (DTSQc), Hypoglycemia Patient Questionnaire, and participant and provider reported Global Effectiveness Scale (GES).

• Healthcare resource utilization including hospitalizations and emergency department or other provider visits and healthcare costs.

Description:

The total study duration per patient will be up to 53 weeks, consisting of a 1-week screening period at the site, a 26-week treatment period, and a 26-week extension period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3304
• Est. completion date: August 9, 2018
• Est. primary completion date: March 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria :

• Participants with Type 2 Diabetes Mellitus (T2DM), as defined by the American Diabetes Association/World Health Organization, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled after at least 1 year of treatment with 2 or more of the following: oral agents (metformin, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 (DPP4) inhibitors, or sodium-glucose cotransporter 2 (SGLT2) inhibitors) or glucagon-like peptide-1 (GLP-1) receptor agonists approved for daily use with insulin (Victoza, Byetta, Adlyxin).

• Adult patients who have signed an Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form.

Exclusion criteria:

• HbA1c <8.0% or >11.0%.

• Males or females <18 years of age.

• Type 1 diabetes mellitus.

• Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the participant's successful participation for the duration of the study.

• Use of any product containing insulin (Lantus, Levemir, Humulin, Novolin, Humalog, Novolog, Apidra, or Afrezza) since the time of diagnosis with T2DM other than temporary use during pregnancy or hospitalization, or short-term use during acute event.

• Use of oral hypoglycemic agents other than those noted in the inclusion criteria, GLP-1 receptor agonists for weekly use, or any investigational agent (drug, biologic, or device) within 3 months prior to the time of screening.

• All contraindications to commercially available insulin therapy or warnings/precautions of use as displayed in the respective national product labeling for these products.

• Pregnancy or lactation.

• Women of childbearing potential with no effective contraceptive method.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin glargine, 300 U/ml
Pharmaceutical form: solution Route of administration: subcutaneous
• Insulin glargine, 100 U/ml
Pharmaceutical form: solution Route of administration: subcutaneous
• Insulin detemir
Pharmaceutical form: solution Route of administration: subcutaneous
• Background Therapy
Anti-diabetic drugs at investigator discretion and consistent with local labeling guidelines for use with insulin.

Locations

Country	Name	City	State
Canada	Investigational Site Number 124002	Barrie
Canada	Investigational Site Number 124001	Brampton
Canada	Investigational Site Number 124005	Brampton
Canada	Investigational Site Number 124030	Burlington
Canada	Investigational Site Number 124017	Calgary
Canada	Investigational Site Number 124013	Concord
Canada	Investigational Site Number 124014	Etobicoke
Canada	Investigational Site Number 124018	Etobicoke
Canada	Investigational Site Number 124026	Guelph
Canada	Investigational Site Number 124008	Hamilton
Canada	Investigational Site Number 124027	Hamilton
Canada	Investigational Site Number 124010	London
Canada	Investigational Site Number 124015	Markham
Canada	Investigational Site Number 124020	Montreal
Canada	Investigational Site Number 124016	Newmarket
Canada	Investigational Site Number 124024	Oakville
Canada	Investigational Site Number 124029	Saint-Laurent
Canada	Investigational Site Number 124007	Surrey
Canada	Investigational Site Number 124003	Toronto
Canada	Investigational Site Number 124025	Vancouver
United States	Investigational Site Number 840481	Albany	New York
United States	Investigational Site Number 840117	Alpena	Michigan
United States	Investigational Site Number 840292	Altoona	Pennsylvania
United States	Investigational Site Number 840213	Amarillo	Texas
United States	Investigational Site Number 840772	Amityville	New York
United States	Investigational Site Number 840491	Anderson	South Carolina
United States	Investigational Site Number 840214	Asheville	North Carolina
United States	Investigational Site Number 840801	Ashland	Kentucky
United States	Investigational Site Number 840232	Atlanta	Georgia
United States	Investigational Site Number 840261	Atlanta	Georgia
United States	Investigational Site Number 840411	Aurora	Colorado
United States	Investigational Site Number 840643	Aventura	Florida
United States	Investigational Site Number 840125	Avon	Indiana
United States	Investigational Site Number 840746	Babylon	New York
United States	Investigational Site Number 840337	Bakersfield	California
United States	Investigational Site Number 840534	Baltimore	Maryland
United States	Investigational Site Number 840387	Bangor	Maine
United States	Investigational Site Number 840009	Beaver	Pennsylvania
United States	Investigational Site Number 840103	Bend	Oregon
United States	Investigational Site Number 840754	Benton	Kentucky
United States	Investigational Site Number 840753	Billings	Montana
United States	Investigational Site Number 840305	Birmingham	Alabama
United States	Investigational Site Number 840731	Birmingham	Alabama
United States	Investigational Site Number 840811	Birmingham	Alabama
United States	Investigational Site Number 840400	Blackfoot	Idaho
United States	Investigational Site Number 840129	Blue Ridge	Georgia
United States	Investigational Site Number 840652	Boca Raton	Florida
United States	Investigational Site Number 840764	Boise	Idaho
United States	Investigational Site Number 840423	Boston	Massachusetts
United States	Investigational Site Number 840449	Bradenton	Florida
United States	Investigational Site Number 840302	Bridgeton	Missouri
United States	Investigational Site Number 840717	Bristol	Tennessee
United States	Investigational Site Number 840136	Brooklyn	New York
United States	Investigational Site Number 840355	Brooklyn	New York
United States	Investigational Site Number 840344	Brownsburg	Indiana
United States	Investigational Site Number 840237	Burlington	North Carolina
United States	Investigational Site Number 840714	Burlington	North Carolina
United States	Investigational Site Number 840603	Butte	Montana
United States	Investigational Site Number 840077	Canal Fulton	Ohio
United States	Investigational Site Number 840738	Canton	Ohio
United States	Investigational Site Number 840455	Catonsville	Maryland
United States	Investigational Site Number 840658	Charleston	West Virginia
United States	Investigational Site Number 840456	Charlotte	North Carolina
United States	Investigational Site Number 840580	Chatham	Virginia
United States	Investigational Site Number 840160	Chattanooga	Tennessee
United States	Investigational Site Number 840590	Chesapeake	Virginia
United States	Investigational Site Number 840693	Chesterfield	Missouri
United States	Investigational Site Number 840005	Chicago	Illinois
United States	Investigational Site Number 840399	Chicago	Illinois
United States	Investigational Site Number 840064	Cincinnati	Ohio
United States	Investigational Site Number 840701	Cincinnati	Ohio
United States	Investigational Site Number 840779	Cleveland	Ohio
United States	Investigational Site Number 840392	Clinton	Utah
United States	Investigational Site Number 840063	Columbus	Ohio
United States	Investigational Site Number 840191	Columbus	Ohio
United States	Investigational Site Number 840339	Columbus	Ohio
United States	Investigational Site Number 840380	Columbus	Ohio
United States	Investigational Site Number 840752	Columbus	Ohio
United States	Investigational Site Number 840820	Columbus	Georgia
United States	Investigational Site Number 840312	Concord	North Carolina
United States	Investigational Site Number 840725	Conway	Arkansas
United States	Investigational Site Number 840081	Cooper City	Florida
United States	Investigational Site Number 840027	Coral Gables	Florida
United States	Investigational Site Number 840446	Coral Gables	Florida
United States	Investigational Site Number 840157	Corpus Christi	Texas
United States	Investigational Site Number 840686	Council Bluffs	Iowa
United States	Investigational Site Number 840342	Covington	Kentucky
United States	Investigational Site Number 840592	Covington	Louisiana
United States	Investigational Site Number 840744	Covington	Louisiana
United States	Investigational Site Number 840532	Crowley	Louisiana
United States	Investigational Site Number 840407	Cutler Bay	Florida
United States	Investigational Site Number 840011	Dallas	Texas
United States	Investigational Site Number 840013	Dallas	Texas
United States	Investigational Site Number 840034	Dallas	Texas
United States	Investigational Site Number 840313	Dallas	Texas
United States	Investigational Site Number 840333	Dallas	Texas
United States	Investigational Site Number 840405	Dallas	Texas
United States	Investigational Site Number 840706	Danville	Virginia
United States	Investigational Site Number 840736	Danville	Virginia
United States	Investigational Site Number 840788	Danville	Virginia
United States	Investigational Site Number 840767	Decatur	Georgia
United States	Investigational Site Number 840812	Decatur	Georgia
United States	Investigational Site Number 840170	Denver	Colorado
United States	Investigational Site Number 840596	Denver	Colorado
United States	Investigational Site Number 840175	Des Moines	Iowa
United States	Investigational Site Number 840289	Detroit	Michigan
United States	Investigational Site Number 840083	Doral	Florida
United States	Investigational Site Number 840059	Downingtown	Pennsylvania
United States	Investigational Site Number 840700	Dunwoody	Georgia
United States	Investigational Site Number 840648	East Point	Georgia
United States	Investigational Site Number 840799	Edison	New Jersey
United States	Investigational Site Number 840262	Edmond	Oklahoma
United States	Investigational Site Number 840089	El Cajon	California
United States	Investigational Site Number 840330	El Paso	Texas
United States	Investigational Site Number 840301	Elgin	Illinois
United States	Investigational Site Number 840713	Elizabethtown	Kentucky
United States	Investigational Site Number 840264	Elkhorn	Nebraska
United States	Investigational Site Number 840684	Elyria	Ohio
United States	Investigational Site Number 840188	Englewood	Colorado
United States	Investigational Site Number 840024	Escondido	California
United States	Investigational Site Number 840053	Essexville	Michigan
United States	Investigational Site Number 840007	Evansville	Indiana
United States	Investigational Site Number 840164	Evansville	Indiana
United States	Investigational Site Number 840324	Evansville	Indiana
United States	Investigational Site Number 840709	Everett	Washington
United States	Investigational Site Number 840545	Fargo	North Dakota
United States	Investigational Site Number 840238	Federal Way	Washington
United States	Investigational Site Number 840663	Findlay	Ohio
United States	Investigational Site Number 840181	Fleetwood	Pennsylvania
United States	Investigational Site Number 840141	Fleming Island	Florida
United States	Investigational Site Number 840150	Flint	Michigan
United States	Investigational Site Number 840184	Flint	Michigan
United States	Investigational Site Number 840734	Forest Hills	New York
United States	Investigational Site Number 840035	Fort Lauderdale	Florida
United States	Investigational Site Number 840068	Fort Lauderdale	Florida
United States	Investigational Site Number 840307	Fort Worth	Texas
United States	Investigational Site Number 840022	Franklin	Indiana
United States	Investigational Site Number 840379	Franklin	Ohio
United States	Investigational Site Number 840794	Franklin	Tennessee
United States	Investigational Site Number 840575	Fredericksburg	Virginia
United States	Investigational Site Number 840020	Fresno	California
United States	Investigational Site Number 840126	Gallipolis	Ohio
United States	Investigational Site Number 840659	Great Neck	New York
United States	Investigational Site Number 840536	Greenfield	Indiana
United States	Investigational Site Number 840611	Greensboro	North Carolina
United States	Investigational Site Number 840763	Greensboro	North Carolina
United States	Investigational Site Number 840776	Greensboro	North Carolina
United States	Investigational Site Number 840743	Greensburg	Pennsylvania
United States	Investigational Site Number 840361	Greenville	North Carolina
United States	Investigational Site Number 840732	Greenville	South Carolina
United States	Investigational Site Number 840043	Greer	South Carolina
United States	Investigational Site Number 840218	Gulf Shores	Alabama
United States	Investigational Site Number 840739	Guntersville	Alabama
United States	Investigational Site Number 840760	Hammond	Louisiana
United States	Investigational Site Number 840662	Hampton	Virginia
United States	Investigational Site Number 840087	Henderson	Nevada
United States	Investigational Site Number 840294	Henderson	Nevada
United States	Investigational Site Number 840145	Hialeah	Florida
United States	Investigational Site Number 840705	High Point	North Carolina
United States	Investigational Site Number 840644	Holbrook	New York
United States	Investigational Site Number 840681	Hopkinsville	Kentucky
United States	Investigational Site Number 840137	Houston	Texas
United States	Investigational Site Number 840182	Houston	Texas
United States	Investigational Site Number 840211	Houston	Texas
United States	Investigational Site Number 840306	Houston	Texas
United States	Investigational Site Number 840323	Houston	Texas
United States	Investigational Site Number 840366	Houston	Texas
United States	Investigational Site Number 840377	Houston	Texas
United States	Investigational Site Number 840502	Houston	Texas
United States	Investigational Site Number 840513	Houston	Texas
United States	Investigational Site Number 840521	Houston	Texas
United States	Investigational Site Number 840533	Houston	Texas
United States	Investigational Site Number 840608	Houston	Texas
United States	Investigational Site Number 840260	Humble	Texas
United States	Investigational Site Number 840479	Huntingdon Valley	Pennsylvania
United States	Investigational Site Number 840367	Huntsville	Alabama
United States	Investigational Site Number 840470	Imperial	California
United States	Investigational Site Number 840712	Indiana	Pennsylvania
United States	Investigational Site Number 840582	Indianapolis	Indiana
United States	Investigational Site Number 840155	Inglewood	California
United States	Investigational Site Number 840161	Inglewood	California
United States	Investigational Site Number 840403	Irving	Texas
United States	Investigational Site Number 840171	Jackson	Tennessee
United States	Investigational Site Number 840550	Jackson	Tennessee
United States	Investigational Site Number 840142	Jacksonville	Florida
United States	Investigational Site Number 840352	Jacksonville	Florida
United States	Investigational Site Number 840159	Jamaica	New York
United States	Investigational Site Number 840041	Jefferson City	Missouri
United States	Investigational Site Number 840402	Joliet	Illinois
United States	Investigational Site Number 840790	Jonesboro	Arkansas
United States	Investigational Site Number 840021	Jupiter	Florida
United States	Investigational Site Number 840236	Kalamazoo	Michigan
United States	Investigational Site Number 840771	Kettering	Ohio
United States	Investigational Site Number 840132	Kingsport	Tennessee
United States	Investigational Site Number 840639	Kissimmee	Florida
United States	Investigational Site Number 840640	Kissimmee	Florida
United States	Investigational Site Number 840140	Knoxville	Tennessee
United States	Investigational Site Number 840194	Laguna Hills	California
United States	Investigational Site Number 840710	Laguna Hills	California
United States	Investigational Site Number 840463	Lake Charles	Louisiana
United States	Investigational Site Number 840777	Lake Clarke Shores	Florida
United States	Investigational Site Number 840148	Lake Success	New York
United States	Investigational Site Number 840382	Lampasas	Texas
United States	Investigational Site Number 840204	Lancaster	California
United States	Investigational Site Number 840257	Lancaster	Ohio
United States	Investigational Site Number 840523	Lansdale	Pennsylvania
United States	Investigational Site Number 840108	Las Vegas	Nevada
United States	Investigational Site Number 840412	Las Vegas	Nevada
United States	Investigational Site Number 840638	Las Vegas	Nevada
United States	Investigational Site Number 840656	Las Vegas	Nevada
United States	Investigational Site Number 840664	Las Vegas	Nevada
United States	Investigational Site Number 840750	Las Vegas	Nevada
United States	Investigational Site Number 840815	Las Vegas	Nevada
United States	Investigational Site Number 840253	Laurelton	New York
United States	Investigational Site Number 840110	Lawrenceville	Georgia
United States	Investigational Site Number 840766	Levittown	Pennsylvania
United States	Investigational Site Number 840595	Lewisburg	West Virginia
United States	Investigational Site Number 840755	Lexington	North Carolina
United States	Investigational Site Number 840167	Linden	New Jersey
United States	Investigational Site Number 840528	Little Rock	Arkansas
United States	Investigational Site Number 840699	Little Rock	Arkansas
United States	Investigational Site Number 840329	Littleton	Colorado
United States	Investigational Site Number 840728	Littleton	Colorado
United States	Investigational Site Number 840310	Los Angeles	California
United States	Investigational Site Number 840340	Los Angeles	California
United States	Investigational Site Number 840371	Los Angeles	California
United States	Investigational Site Number 840504	Los Angeles	California
United States	Investigational Site Number 840309	Los Gatos	California
United States	Investigational Site Number 840578	Louisville	Kentucky
United States	Investigational Site Number 840680	Lubbock	Texas
United States	Investigational Site Number 840795	Lynchburg	Virginia
United States	Investigational Site Number 840584	Lyndhurst	Ohio
United States	Investigational Site Number 840444	Macon	Georgia
United States	Investigational Site Number 840362	Margate	Florida
United States	Investigational Site Number 840003	Marietta	Georgia
United States	Investigational Site Number 840165	Marion	Ohio
United States	Investigational Site Number 840675	Marrero	Louisiana
United States	Investigational Site Number 840605	Martinsville	Virginia
United States	Investigational Site Number 840308	McAllen	Texas
United States	Investigational Site Number 840625	Memphis	Tennessee
United States	Investigational Site Number 840789	Merrick	New York
United States	Investigational Site Number 840549	Mesquite	Texas
United States	Investigational Site Number 840133	Metairie	Louisiana
United States	Investigational Site Number 840002	Miami	Florida
United States	Investigational Site Number 840012	Miami	Florida
United States	Investigational Site Number 840014	Miami	Florida
United States	Investigational Site Number 840102	Miami	Florida
United States	Investigational Site Number 840128	Miami	Florida
United States	Investigational Site Number 840143	Miami	Florida
United States	Investigational Site Number 840197	Miami	Florida
United States	Investigational Site Number 840209	Miami	Florida
United States	Investigational Site Number 840349	Miami	Florida
United States	Investigational Site Number 840414	Miami	Florida
United States	Investigational Site Number 840415	Miami	Florida
United States	Investigational Site Number 840690	Miami	Florida
United States	Investigational Site Number 840698	Miami	Florida
United States	Investigational Site Number 840758	Miami	Florida
United States	Investigational Site Number 840221	Miami Lakes	Florida
United States	Investigational Site Number 840303	Miami Lakes	Florida
United States	Investigational Site Number 840800	Miamisburg	Ohio
United States	Investigational Site Number 840694	Michigan City	Indiana
United States	Investigational Site Number 840360	Midwest City	Oklahoma
United States	Investigational Site Number 840351	Missouri City	Texas
United States	Investigational Site Number 840622	Monroe	Louisiana
United States	Investigational Site Number 840130	Montgomery	Alabama
United States	Investigational Site Number 840729	Montgomery	Alabama
United States	Investigational Site Number 840688	Mooresville	North Carolina
United States	Investigational Site Number 840747	Mooresville	North Carolina
United States	Investigational Site Number 840296	Morganton	North Carolina
United States	Investigational Site Number 840226	Morton	Illinois
United States	Investigational Site Number 840052	Muncie	Indiana
United States	Investigational Site Number 840109	Murrells Inlet	South Carolina
United States	Investigational Site Number 840144	Nashua	New Hampshire
United States	Investigational Site Number 840299	Nashville	Tennessee
United States	Investigational Site Number 840147	Natchitoches	Louisiana
United States	Investigational Site Number 840060	Neptune	New Jersey
United States	Investigational Site Number 840716	Nesconset	New York
United States	Investigational Site Number 840786	New Albany	Indiana
United States	Investigational Site Number 840573	New Bern	North Carolina
United States	Investigational Site Number 840072	New Hyde Park	New York
United States	Investigational Site Number 840810	New Hyde Park	New York
United States	Investigational Site Number 840609	New Orleans	Louisiana
United States	Investigational Site Number 840381	New Tazewell	Tennessee
United States	Investigational Site Number 840674	New Windsor	New York
United States	Investigational Site Number 840586	New York	New York
United States	Investigational Site Number 840626	New York	New York
United States	Investigational Site Number 840620	Newport News	Virginia
United States	Investigational Site Number 840088	Norfolk	Virginia
United States	Investigational Site Number 840247	North Chesterfield	Virginia
United States	Investigational Site Number 840256	North Hollywood	California
United States	Investigational Site Number 840044	North Massapequa	New York
United States	Investigational Site Number 840327	North Myrtle Beach	South Carolina
United States	Investigational Site Number 840687	Northglenn	Colorado
United States	Investigational Site Number 840015	Northridge	California
United States	Investigational Site Number 840056	Norwalk	California
United States	Investigational Site Number 840508	Ocala	Florida
United States	Investigational Site Number 840092	Ocoee	Florida
United States	Investigational Site Number 840363	Oklahoma City	Oklahoma
United States	Investigational Site Number 840556	Oklahoma City	Oklahoma
United States	Investigational Site Number 840033	Olive Branch	Mississippi
United States	Investigational Site Number 840742	Omaha	Nebraska
United States	Investigational Site Number 840090	Orange	California
United States	Investigational Site Number 840478	Owensboro	Kentucky
United States	Investigational Site Number 840576	Owensboro	Kentucky
United States	Investigational Site Number 840819	Owensboro	Kentucky
United States	Investigational Site Number 840373	Palestine	Texas
United States	Investigational Site Number 840118	Palm Harbor	Florida
United States	Investigational Site Number 840078	Palm Springs	California
United States	Investigational Site Number 840791	Palmdale	California
United States	Investigational Site Number 840080	Panama City	Florida
United States	Investigational Site Number 840216	Paramount	California
United States	Investigational Site Number 840645	Paris	Kentucky
United States	Investigational Site Number 840032	Penndel	Pennsylvania
United States	Investigational Site Number 840730	Pennington Gap	Virginia
United States	Investigational Site Number 840318	Peoria	Illinois
United States	Investigational Site Number 840365	Pharr	Texas
United States	Investigational Site Number 840067	Philadelphia	Pennsylvania
United States	Investigational Site Number 840174	Philadelphia	Pennsylvania
United States	Investigational Site Number 840277	Philadelphia	Pennsylvania
United States	Investigational Site Number 840561	Philadelphia	Pennsylvania
United States	Investigational Site Number 840173	Phoenix	Arizona
United States	Investigational Site Number 840555	Phoenix	Arizona
United States	Investigational Site Number 840348	Pittsburgh	Pennsylvania
United States	Investigational Site Number 840439	Plano	Texas
United States	Investigational Site Number 840372	Plantation	Florida
United States	Investigational Site Number 840413	Pomona	California
United States	Investigational Site Number 840707	Port Arthur	Texas
United States	Investigational Site Number 840199	Port Charlotte	Florida
United States	Investigational Site Number 840244	Port Hueneme	California
United States	Investigational Site Number 840689	Portland	Maine
United States	Investigational Site Number 840669	Pottstown	Pennsylvania
United States	Investigational Site Number 840378	Providence	Rhode Island
United States	Investigational Site Number 840761	Reno	Nevada
United States	Investigational Site Number 840179	Richmond	Virginia
United States	Investigational Site Number 840692	Richmond	Texas
United States	Investigational Site Number 840393	Rockville	Maryland
United States	Investigational Site Number 840189	Saint George	Utah
United States	Investigational Site Number 840711	Saint Louis	Missouri
United States	Investigational Site Number 840076	Salem	Virginia
United States	Investigational Site Number 840096	Salisbury	North Carolina
United States	Investigational Site Number 840228	Salt Lake City	Utah
United States	Investigational Site Number 840018	San Antonio	Texas
United States	Investigational Site Number 840074	San Antonio	Texas
United States	Investigational Site Number 840135	San Antonio	Texas
United States	Investigational Site Number 840176	San Antonio	Texas
United States	Investigational Site Number 840390	San Antonio	Texas
United States	Investigational Site Number 840431	San Antonio	Texas
United States	Investigational Site Number 840434	San Antonio	Texas
United States	Investigational Site Number 840691	San Antonio	Texas
United States	Investigational Site Number 840028	San Diego	California
United States	Investigational Site Number 840162	San Diego	California
United States	Investigational Site Number 840383	San Dimas	California
United States	Investigational Site Number 840627	San Jose	California
United States	Investigational Site Number 840120	San Ramon	California
United States	Investigational Site Number 840632	Sandersville	Georgia
United States	Investigational Site Number 840156	Santa Ana	California
United States	Investigational Site Number 840281	Saraland	Alabama
United States	Investigational Site Number 840591	Savannah	Georgia
United States	Investigational Site Number 840616	Savannah	Georgia
United States	Investigational Site Number 840748	Sayre	Pennsylvania
United States	Investigational Site Number 840207	Schertz	Texas
United States	Investigational Site Number 840615	Sealy	Texas
United States	Investigational Site Number 840079	Searcy	Arkansas
United States	Investigational Site Number 840613	Sheffield	Alabama
United States	Investigational Site Number 840634	Sheffield	Alabama
United States	Investigational Site Number 840654	Sheffield	Alabama
United States	Investigational Site Number 840697	Shelby	North Carolina
United States	Investigational Site Number 840266	Sherman Oaks	California
United States	Investigational Site Number 840311	Shreveport	Louisiana
United States	Investigational Site Number 840679	Sicklerville	New Jersey
United States	Investigational Site Number 840759	Simpsonville	South Carolina
United States	Investigational Site Number 840619	Slidell	Louisiana
United States	Investigational Site Number 840187	Smithfield	Pennsylvania
United States	Investigational Site Number 840587	Smithtown	New York
United States	Investigational Site Number 840727	Smyrna	Georgia
United States	Investigational Site Number 840520	Snellville	Georgia
United States	Investigational Site Number 840210	Southfield	Michigan
United States	Investigational Site Number 840577	Staten Island	New York
United States	Investigational Site Number 840163	Statesboro	Georgia
United States	Investigational Site Number 840258	Stevensville	Michigan
United States	Investigational Site Number 840297	Stockbridge	Georgia
United States	Investigational Site Number 840097	Sugar Land	Texas
United States	Investigational Site Number 840460	Sugar Land	Texas
United States	Investigational Site Number 840514	Sugar Land	Texas
United States	Investigational Site Number 840530	Sugar Land	Texas
United States	Investigational Site Number 840628	Summerville	South Carolina
United States	Investigational Site Number 840805	Sun City	Arizona
United States	Investigational Site Number 840091	Sylmar	California
United States	Investigational Site Number 840773	Syosset	New York
United States	Investigational Site Number 840560	Tallmadge	Ohio
United States	Investigational Site Number 840559	Teaneck	New Jersey
United States	Investigational Site Number 840715	Thomson	Georgia
United States	Investigational Site Number 840208	Thousand Oaks	California
United States	Investigational Site Number 840515	Toledo	Ohio
United States	Investigational Site Number 840134	Topeka	Kansas
United States	Investigational Site Number 840115	Torrance	California
United States	Investigational Site Number 840792	Torrance	California
United States	Investigational Site Number 840158	Troy	Michigan
United States	Investigational Site Number 840524	Troy	Michigan
United States	Investigational Site Number 840612	Tulare	California
United States	Investigational Site Number 840287	Uniontown	Pennsylvania
United States	Investigational Site Number 840341	Uniontown	Pennsylvania
United States	Investigational Site Number 840467	Upland	California
United States	Investigational Site Number 840588	Vancouver	Washington
United States	Investigational Site Number 840797	Vandalia	Ohio
United States	Investigational Site Number 840741	Versailles	Kentucky
United States	Investigational Site Number 840354	Virginia Beach	Virginia
United States	Investigational Site Number 840185	Vista	California
United States	Investigational Site Number 840008	Waco	Texas
United States	Investigational Site Number 840593	Waco	Texas
United States	Investigational Site Number 840192	Wadsworth	Ohio
United States	Investigational Site Number 840084	Walla Walla	Washington
United States	Investigational Site Number 840809	Waxahachie	Texas
United States	Investigational Site Number 840651	Webster	Texas
United States	Investigational Site Number 840466	West Des Moines	Iowa
United States	Investigational Site Number 840765	West Jordan	Utah
United States	Investigational Site Number 840806	West Jordan	Utah
United States	Investigational Site Number 840472	Whittier	California
United States	Investigational Site Number 840389	Willoughby Hills	Ohio
United States	Investigational Site Number 840636	Wilmington	North Carolina
United States	Investigational Site Number 840195	Wilson	North Carolina
United States	Investigational Site Number 840704	Winchester	Virginia
United States	Investigational Site Number 840315	Winston-Salem	North Carolina
United States	Investigational Site Number 840538	Winter Haven	Florida
United States	Investigational Site Number 840751	Wooster	Ohio
United States	Investigational Site Number 840047	Yonkers	New York
United States	Investigational Site Number 840673	Zachary	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Individualized Glycated Hemoglobin Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria Without Documented Symptomatic(Blood Glucose <=70 mg/dL [<=3.9 mmol/L]) and/or Severe Hypoglycemia	HEDIS criteria: Individualized HbA1c target <8% if age >= 65 years or presence of medical comorbidities, or otherwise <7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <=70 milligrams per deciliter (mg/dL) (<=3.9 millimoles per litre [mmol/L]). Analysis was performed using all post-baseline data available on the 6 month randomized period (defined as time from randomization up to Day 180 or discontinuation date, whichever comes earlier).	Baseline to Month 6
Secondary	Change From Baseline in HbA1c at Month 6 and Month 12	Change in HbA1c was calculated by subtracting baseline value from Month 6 and Month 12 values. Adjusted Least Squares (LS) means and Standard Errors (SE) were obtained using Mixed Effect Model with Repeated Measures (MMRM ) with fixed categorical effects of treatment arm, visit, treatment arm-by-visit interaction, randomization strata of HbA1c target (<8% / <7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline HbA1c (as continuous) and baseline HbA1c-by-visit interaction.	Baseline, Month 6, Month 12
Secondary	Treatment Persistence Measured by Medication Possession Ratio (MPR)	Treatment persistence was determined based on vendor claims database that would be responsible for managing and administration of the study drugs. Medication use was assessed by MPR and persistence measures based on data collected by the smart card vendor (date of fill or refill and quantity of medication dispensed for 30-day supply). The MPR was assessed based on total number of days of supply divided by the total number of days in 6 or 12 months period.	At Month 6 and Month 12
Secondary	Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <3.0 mmol/L (<54 mg/dL) and/or Severe Hypoglycemia During the 6-Month Randomized Period	HEDIS criteria for Individualized HbA1c target: <8% if age >= 65 years or presence of medical comorbidities, or otherwise <7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <54 mg/dL (3.0 mmol/L).	Baseline to Month 6
Secondary	Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <=3.9 mmol/L (<= 70 mg/dL) and <3.0 mmol/L (< 54 mg/dL) and/or Severe Hypoglycemia During the 12-Month Randomized Period	HEDIS criteria for Individualized HbA1c target: <8% if age >= 65 years or presence of medical comorbidities, or otherwise <7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (<=70 mg/dL) and < 3.0 mmol/L (< 54 mg/dL).	Baseline to Month 12
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 and Month 12	Change in FPG was calculated by subtracting baseline value from Month 6 and Month 12 values. Adjusted LS means and SE were obtained using MMRM model with fixed categorical effects of treatment arm, randomization strata of HbA1c target (<8% / <7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline FPG (as continuous) and baseline FPG-by-visit interaction.	Baseline, Month 6, Month 12
Secondary	Change From Baseline in Body Weight at Month 6 and Month 12	Adjusted LS means and SE were obtained using MMRM model with fixed categorical effects of treatment arm, visit, treatment arm-by-visit interaction, randomization strata of HbA1c target (<8% / <7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline weight (as continuous) and baseline weight-by-visit interaction.	Baseline, Month 6, Month 12
Secondary	Change From Baseline in Basal Insulin Dose at Month 6 and Month 12	Change in basal insulin dose was calculated by subtracting baseline value from Month 6 and Month 12 values.	Baseline, Month 6, Month 12
Secondary	Percentage of Responders (Participants and Provider) Who Reported "Excellent" or "Good" Responses to Global Effectiveness Scale (GES) Question at Month 6, and Month 12	Participant and Physician (Provider) reported GES for this diabetes study. The GES assessed impact of treatment on scale ranges as: excellent (complete control of diabetes), good (marked improvement of diabetes), moderate (discernible, but limited improvement in diabetes), poor (no appreciable change in diabetes), or worsening of condition (worsening of diabetes). There was no score expressed by numbers and no change measured over the time of the study. Percentage of participants and providers who reported "excellent" or "good" on the GES at Month 6 and Month 12 are reported here.	At Month 6, Month 12
Secondary	Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) at Baseline, Month 6, Month 12	DTSQs is a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consists of 8 items, each answered on a Likert scale of 0 to 6. Responses of 6 questions (Items 1, 4, 5, 6, 7 and 8) were summarized to derive total treatment satisfaction score, such that a higher score was indicative of better satisfaction. Total treatment satisfaction score is the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (improvement in treatment satisfaction). Item 2 and Item 3 scores were used for hyperglycemia perception and hypoglycemia perception respectively, where lower scores indicated better health outcome. Perceived frequency of hyperglycemia score (Item 2) and perceived frequency of hypoglycemia score (Item 3) range from 0 (none of the time) to 6 (most of time), where lower scores indicated more satisfaction/better health outcome.	At Baseline, Month 6, Month 12
Secondary	Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Change Version (DTSQc) at Month 12	DTSQc version evaluates the change in treatment satisfaction at Month 12 as compared to the start of the study . It consists of 8 items, each answered on a Likert scale from -3 to +3. The sum of treatment satisfaction scores (items 1, 4, 5, 6, 7,and 8) ranged from score -18 (deterioration in treatment satisfaction) to +18 (improvement in treatment satisfaction). Perceived frequency of hypoglycemia and perceived frequency of hyperglycemia score ranges from score -3 (fewer problems) to +3 (more problems).	At Month 12
Secondary	Percentage of Participants With Hospitalizations, Emergency Rooms and Specialty Visits From Baseline to Month 6 and Month 12	Percentage of participants with hospitalizations, emergency room visits, and specialty visits during the 6-month and 12-month randomized period were reported. The 12-month randomized period was defined as the time from randomization up to Day 365 or discontinuation date, whichever comes earlier.	From Baseline to Month 6 and Month 12
Secondary	Percentage of Participants With at Least One Treatment-Emergent Hypoglycemia Event (Any Time of the Day, Nocturnal) Per Type of Hypoglycaemia During the Month 6 and Month 12 on Treatment Period	Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (<=3.9 mmol/L) or <54 mg/dL (3.0 mmol/L).	Up to Month 6 and Month 12