GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone

Diabetes Mellitus Type 2 Clinical Trial

— GETGOAL-P  

Official title:

A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Main Treatment Period and an Extension Assessing the Efficacy and Safety of AVE0010 on Top of Pioglitazone in Patients With Type 2 Diabetes Not Adequately Controlled With Pioglitazone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763815
• Other study ID #: EFC6017
• Secondary ID: EudraCT: 2007-00
• Status: Completed
• Phase: Phase 3
• First received: September 30, 2008
• Last updated: February 26, 2014
• Start date: September 2008
• Est. completion date: June 2011

Study information

• Verified date: February 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to pioglitazone with or without metformin, over a period of 24 weeks of treatment, followed by an extension.

The primary objective is to assess the effects of lixisenatide when added to pioglitazone on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.

Secondary objectives are to assess the effects of lixisenatide when added to pioglitazone on the percentage of patients reaching HbA1c less than 7 percent (%) and less than or equal to 6.5%, fasting plasma glucose (FPG), body weight, beta-cell function (assessed by homeostatic model assessment of beta-cell function [HOMA-beta]), and on fasting plasma insulin (FPI), to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

Description:

Patients who complete the 24-week main double-blind treatment would undergo a variable double-blind extension treatment, which ends for all patients at approximately the schedule date of Week 76 visit (Visit 25) for the last randomized patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type 2 diabetes mellitus, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with pioglitazone

Exclusion Criteria:

• HbA1c less than (<) 7 percent (%) or greater than (>) 10% at screening

• At the time of screening age <legal age of majority

• Pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control

• Type 1 diabetes mellitus

• Pioglitazone not at a stable dose of at least 30 milligram per day (mg/day) for at least 3 months prior to screening

• If treatment with metformin, no stable dose of at least 1.5 gram per day (g/day) for at least 3 months prior to screening visit

• FPG at screening >250 milligram per deciliter (mg/dL) (>13.9 millimole per liter [mmol/L])

• Body mass index less than or equal to (<=) 20 kilogram per square meter (kg/m^2)

• Weight change of more than 5 kg during the 3 months preceding the screening visit

• History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, or inflammatory bowel disease

• History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening

• Hemoglobinopathy or hemolytic anemia, or receipt of blood or plasma products within3 months prior to the time of screening

• History of myocardial infarction or stroke within the last 6 months prior to screening

• Known history of drug or alcohol abuse within 6 months prior to the time of screening

• Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period

• Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic blood pressure or diastolic blood pressure (DBP) >180 millimeter of mercury (mmHg) or >95 mmHg, respectively

• Laboratory findings at the time of screening: aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP): >2 times upper limit of normal (ULN) laboratory range; amylase and/or lipase: >3 times ULN; total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome); Hemoglobin <11 gram/deciliter and/or neutrophils <1500 per cubic millimeter (mm^3) and/or platelets <100 000/mm^3; positive test for Hepatitis B surface antigen (HBsAg) and/or Hepatitis C antibody (HCAb); positive serum pregnancy test in females of childbearing potential

• Any clinically significant abnormality identified on physical examination, laboratory tests, electrocardiogram (ECG), or vital signs at the time of screening that, in the judgment of the investigator or any sub-investigator, precludes safe completion of the study or constrains efficacy assessment

• Patients who are considered by the investigator or any sub-investigator as inappropriate for this study for any reason (for example, impossibility to meet specific protocol requirements [such as scheduled visits, being able to do self-injections]; likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol; investigator or any sub-investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol)

• Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin or pioglitazone (for example, sulfonylurea, alpha-glucosidase inhibitor, other thiazolidinediones, rimonabant, exenatide, dipeptidyl peptidase-4 [DPP-4] inhibitors, insulin) within 3 months prior to the time of screening

• Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to the time of screening

• Use of any investigational drug within 3 months prior to study

• Any previous treatment with lixisenatide or participation in a previous study with lixisenatide

• Renal impairment defined with creatinine >1.4 mg/dL in women and creatinine >1.5 mg/dL in men (applicable only for patients with metformin treatment)

• Patients with cardiac failure or history of cardiac failure (New York Heart Association class I to IV)

• End-stage renal disease defined by a serum creatinine clearance of <15 milliliter per minute (mL/min) (calculated by the Cockcroft and Gault formula) and/or patients on dialysis, if no treatment with metformin

• Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to, gastroparesis and gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening

• Allergic reaction to any glucagon like peptide-1 (GLP-1) agonist in the past (for example,exenatide, liraglutide) or to metacresol

• Additional exclusion criteria at the end of the run-in phase: informed consent withdrawal; lack of compliance during the single-blind placebo run-in phase (>2 injections missed); and patient with any adverse event which precludes the inclusion in the study, as assessed by the investigator

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Lixisenatide (AVE0010)
Self-administered by subcutaneous injections once daily within the hour preceding breakfast.
• Placebo
Self-administered by subcutaneous injections once daily within the hour preceding breakfast.

Device:
• Pen auto-injector

Drug:
• Pioglitazone
Dose to be kept stable.
• Metformin
Metformin, if given to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.

Locations

Country	Name	City	State
Austria	Sanofi-Aventis Investigational Site Number 040706	Graz
Austria	Sanofi-Aventis Investigational Site Number 040704	Vienna
Austria	Sanofi-Aventis Investigational Site Number 040707	Wels
Austria	Sanofi-Aventis Investigational Site Number 040701	Wien
Austria	Sanofi-Aventis Investigational Site Number 040702	Wien
Austria	Sanofi-Aventis Investigational Site Number 040705	Wien
Canada	Sanofi-Aventis Investigational Site Number 124710	London
Canada	Sanofi-Aventis Investigational Site Number 124712	Mirabel
Canada	Sanofi-Aventis Investigational Site Number 124703	Saskatoon
Canada	Sanofi-Aventis Investigational Site Number 124713	Scarborough
Canada	Sanofi-Aventis Investigational Site Number 124711	Sherbrooke
Canada	Sanofi-Aventis Investigational Site Number 124704	Smiths Falls
Canada	Sanofi-Aventis Investigational Site Number 124705	St-Romuald
Canada	Sanofi-Aventis Investigational Site Number 124716	Sudbury
Canada	Sanofi-Aventis Investigational Site Number 124701	Thornhill
Canada	Sanofi-Aventis Investigational Site Number 124708	Vancouver
France	Sanofi-Aventis Investigational Site Number 250704	Armentieres
France	Sanofi-Aventis Investigational Site Number 250707	La Rochelle Cedex
France	Sanofi-Aventis Investigational Site Number 250705	Labarthe Sur Leze
France	Sanofi-Aventis Investigational Site Number 250702	Le Creusot
France	Sanofi-Aventis Investigational Site Number 250701	Strasbourg
Germany	Sanofi-Aventis Investigational Site Number 276708	Asslar
Germany	Sanofi-Aventis Investigational Site Number 276704	Berlin
Germany	Sanofi-Aventis Investigational Site Number 276703	Künzing
Germany	Sanofi-Aventis Investigational Site Number 276706	Leipzig
Germany	Sanofi-Aventis Investigational Site Number 276707	Pirna
Germany	Sanofi-Aventis Investigational Site Number 276702	Sulzbach-Rosenberg
Germany	Sanofi-Aventis Investigational Site Number 276701	Würzburg
Greece	Sanofi-Aventis Investigational Site Number 300703	Athens
Greece	Sanofi-Aventis Investigational Site Number 300704	Athens
Greece	Sanofi-Aventis Investigational Site Number 300705	Athens
Greece	Sanofi-Aventis Investigational Site Number 300701	Thessaloniki
Guatemala	Sanofi-Aventis Investigational Site Number 320701	Guatemala
Guatemala	Sanofi-Aventis Investigational Site Number 320702	Guatemala
Guatemala	Sanofi-Aventis Investigational Site Number 320703	Guatemala
Guatemala	Sanofi-Aventis Investigational Site Number 320704	Guatemala
India	Sanofi-Aventis Investigational Site Number 356701	Bangalore
India	Sanofi-Aventis Investigational Site Number 356703	Bangalore
India	Sanofi-Aventis Investigational Site Number 356702	Hyderabad
India	Sanofi-Aventis Investigational Site Number 356704	Nagpur
Mexico	Sanofi-Aventis Investigational Site Number 484703	Merida
Mexico	Sanofi-Aventis Investigational Site Number 484701	Tlalnepantla
Mexico	Sanofi-Aventis Investigational Site Number 484704	Zapopan
Peru	Sanofi-Aventis Investigational Site Number 604701	Lima
Peru	Sanofi-Aventis Investigational Site Number 604702	Lima
Peru	Sanofi-Aventis Investigational Site Number 604703	Lima
Peru	Sanofi-Aventis Investigational Site Number 604705	Lima
Puerto Rico	Sanofi-Aventis Investigational Site Number 630714	Carolina
Puerto Rico	Sanofi-Aventis Investigational Site Number 630715	Carolina
Romania	Sanofi-Aventis Investigational Site Number 642711	Alba Iulia
Romania	Sanofi-Aventis Investigational Site Number 642702	Bacau
Romania	Sanofi-Aventis Investigational Site Number 642709	Baia Mare
Romania	Sanofi-Aventis Investigational Site Number 642701	Brasov
Romania	Sanofi-Aventis Investigational Site Number 642712	Bucuresti
Romania	Sanofi-Aventis Investigational Site Number 642714	Bucuresti
Romania	Sanofi-Aventis Investigational Site Number 642705	Constanta
Romania	Sanofi-Aventis Investigational Site Number 642707	Galati
Romania	Sanofi-Aventis Investigational Site Number 642703	Ploiesti
Romania	Sanofi-Aventis Investigational Site Number 642713	Resita
Romania	Sanofi-Aventis Investigational Site Number 642708	Satu Mare
Romania	Sanofi-Aventis Investigational Site Number 642706	Targu Mures
Romania	Sanofi-Aventis Investigational Site Number 642710	Timisoara
Romania	Sanofi-Aventis Investigational Site Number 642715	Timisoara
Turkey	Sanofi-Aventis Investigational Site Number 792702	Erzurum
Turkey	Sanofi-Aventis Investigational Site Number 792705	Istanbul
United States	Sanofi-Aventis Investigational Site Number 840795	Artesia	California
United States	Sanofi-Aventis Investigational Site Number 840777	Athens	Ohio
United States	Sanofi-Aventis Investigational Site Number 840857	Augusta	Georgia
United States	Sanofi-Aventis Investigational Site Number 840738	Avon	Indiana
United States	Sanofi-Aventis Investigational Site Number 840862	Baton Rouge	Louisiana
United States	Sanofi-Aventis Investigational Site Number 840751	Beaver	Pennsylvania
United States	Sanofi-Aventis Investigational Site Number 840720	Birmingham	Alabama
United States	Sanofi-Aventis Investigational Site Number 840723	Birmingham	Alabama
United States	Sanofi-Aventis Investigational Site Number 840744	Birmingham	Alabama
United States	Sanofi-Aventis Investigational Site Number 840867	Birmingham	Alabama
United States	Sanofi-Aventis Investigational Site Number 840780	Bismarck	North Dakota
United States	Sanofi-Aventis Investigational Site Number 840774	Bloomington	Minnesota
United States	Sanofi-Aventis Investigational Site Number 840711	Bristol	Tennessee
United States	Sanofi-Aventis Investigational Site Number 840747	Burlington	North Carolina
United States	Sanofi-Aventis Investigational Site Number 840775	Chandler	Arizona
United States	Sanofi-Aventis Investigational Site Number 840791	Chicago	Illinois
United States	Sanofi-Aventis Investigational Site Number 840782	Chino	California
United States	Sanofi-Aventis Investigational Site Number 840741	Cleveland	Ohio
United States	Sanofi-Aventis Investigational Site Number 840796	Clinton	Utah
United States	Sanofi-Aventis Investigational Site Number 840853	Colleyville	Texas
United States	Sanofi-Aventis Investigational Site Number 840868	Colorado Springs	Colorado
United States	Sanofi-Aventis Investigational Site Number 840872	Colorado Springs	Colorado
United States	Sanofi-Aventis Investigational Site Number 840792	Columbia	South Carolina
United States	Sanofi-Aventis Investigational Site Number 840851	Dartmouth	Massachusetts
United States	Sanofi-Aventis Investigational Site Number 840728	Dayton	Ohio
United States	Sanofi-Aventis Investigational Site Number 840704	Eagan	Minnesota
United States	Sanofi-Aventis Investigational Site Number 840877	Fargo	North Dakota
United States	Sanofi-Aventis Investigational Site Number 840760	Greensboro	North Carolina
United States	Sanofi-Aventis Investigational Site Number 840729	Harrisburg	Arkansas
United States	Sanofi-Aventis Investigational Site Number 840712	High Point	North Carolina
United States	Sanofi-Aventis Investigational Site Number 840730	Houston	Texas
United States	Sanofi-Aventis Investigational Site Number 840785	Huntington Beach	California
United States	Sanofi-Aventis Investigational Site Number 840764	Hyattsville	Maryland
United States	Sanofi-Aventis Investigational Site Number 840724	Idaho Falls	Idaho
United States	Sanofi-Aventis Investigational Site Number 840794	Indianapolis	Indiana
United States	Sanofi-Aventis Investigational Site Number 840727	Jacksonville	Florida
United States	Sanofi-Aventis Investigational Site Number 840708	Kalamazoo	Michigan
United States	Sanofi-Aventis Investigational Site Number 840767	Kansas City	Kansas
United States	Sanofi-Aventis Investigational Site Number 840858	La Jolla	California
United States	Sanofi-Aventis Investigational Site Number 840779	Lansing	Kansas
United States	Sanofi-Aventis Investigational Site Number 840875	Las Vegas	Nevada
United States	Sanofi-Aventis Investigational Site Number 840789	Lexington	Kentucky
United States	Sanofi-Aventis Investigational Site Number 840850	Lexington	Kentucky
United States	Sanofi-Aventis Investigational Site Number 840784	Los Banos	California
United States	Sanofi-Aventis Investigational Site Number 840701	Medford	Oregon
United States	Sanofi-Aventis Investigational Site Number 840709	Mentor	Ohio
United States	Sanofi-Aventis Investigational Site Number 840722	Mesa	Arizona
United States	Sanofi-Aventis Investigational Site Number 840773	Mission Hills	California
United States	Sanofi-Aventis Investigational Site Number 840707	Mission Viejo	California
United States	Sanofi-Aventis Investigational Site Number 840855	Mobile	Alabama
United States	Sanofi-Aventis Investigational Site Number 840863	Mobile	Alabama
United States	Sanofi-Aventis Investigational Site Number 840776	Mountain Home	Arkansas
United States	Sanofi-Aventis Investigational Site Number 840745	New Port Richey	Florida
United States	Sanofi-Aventis Investigational Site Number 840865	New York	New York
United States	Sanofi-Aventis Investigational Site Number 840766	New York City	New York
United States	Sanofi-Aventis Investigational Site Number 840753	Norfolk	Virginia
United States	Sanofi-Aventis Investigational Site Number 840770	Norfolk	Virginia
United States	Sanofi-Aventis Investigational Site Number 840716	Norman	Oklahoma
United States	Sanofi-Aventis Investigational Site Number 840733	Northridge	California
United States	Sanofi-Aventis Investigational Site Number 840761	Oviedo	Florida
United States	Sanofi-Aventis Investigational Site Number 840866	Pahrump	Nevada
United States	Sanofi-Aventis Investigational Site Number 840769	Phoenix	Arizona
United States	Sanofi-Aventis Investigational Site Number 840717	Picayune	Mississippi
United States	Sanofi-Aventis Investigational Site Number 840798	Red Lion	Pennsylvania
United States	Sanofi-Aventis Investigational Site Number 840752	Richmond	Virginia
United States	Sanofi-Aventis Investigational Site Number 840871	Rockville	Maryland
United States	Sanofi-Aventis Investigational Site Number 840864	Roseville	California
United States	Sanofi-Aventis Investigational Site Number 840755	Salt Lake City	Utah
United States	Sanofi-Aventis Investigational Site Number 840756	Salt Lake City	Utah
United States	Sanofi-Aventis Investigational Site Number 840758	Salt Lake City	Utah
United States	Sanofi-Aventis Investigational Site Number 840854	San Antonio	Texas
United States	Sanofi-Aventis Investigational Site Number 840772	San Diego	California
United States	Sanofi-Aventis Investigational Site Number 840743	San Mateo	California
United States	Sanofi-Aventis Investigational Site Number 840879	Shreveport	Louisiana
United States	Sanofi-Aventis Investigational Site Number 840740	Simpsonville	South Carolina
United States	Sanofi-Aventis Investigational Site Number 840735	Spokane	Washington
United States	Sanofi-Aventis Investigational Site Number 840765	St Louis	Missouri
United States	Sanofi-Aventis Investigational Site Number 840874	Staten Island	New York
United States	Sanofi-Aventis Investigational Site Number 840721	Stockton	California
United States	Sanofi-Aventis Investigational Site Number 840726	Taylors	South Carolina
United States	Sanofi-Aventis Investigational Site Number 840757	Virginia Beach	Virginia
United States	Sanofi-Aventis Investigational Site Number 840799	Wellington	Florida
United States	Sanofi-Aventis Investigational Site Number 840763	West Hills	California
United States	Sanofi-Aventis Investigational Site Number 840762	West Seneca	New York
United States	Sanofi-Aventis Investigational Site Number 840739	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Austria,  Canada,  France,  Germany,  Greece,  Guatemala,  India,  Mexico,  Peru,  Puerto Rico,  Romania,  Turkey, 

References & Publications (1)

Pinget M, Goldenberg R, Niemoeller E, Muehlen-Bartmer I, Guo H, Aronson R. Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P). Diabetes Obes Metab. 2013 Nov;15(11):1000-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24	The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.	Baseline, Week 24	No
Other	Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia	Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.	First dose of study drug up to 3 days after the last dose administration	Yes
Primary	Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24	Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.	Baseline, Week 24	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.	Baseline, Week 24	No
Secondary	Change From Baseline in Body Weight at Week 24	Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.	Baseline, Week 24	No
Secondary	Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24	Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.	Baseline, Week 24	No
Secondary	Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24	The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.	Week 24	No
Secondary	Percentage of Patients With HbA1c Level Less Than or Equal to 6.5% at Week 24	The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.	Week 24	No
Secondary	Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24	Beta cell function was assessed by HOMA-beta. HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (fasting plasma glucose [mmol/L] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.	Baseline, Week 24	No
Secondary	Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period	Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.	Baseline up to Week 24	No