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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01683266
Other study ID # EFC12456
Secondary ID 2012-001524-35U1
Status Completed
Phase Phase 3
First received September 7, 2012
Last updated May 28, 2015
Start date September 2012
Est. completion date March 2014

Study information

Verified date May 2015
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Primary Objective:

- To compare the efficacy of a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus

Secondary Objective:

- To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of:

- Change of HbA1c from baseline to endpoint (scheduled Month 6)

- Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM)

- Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia)

- Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative)

- Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period


Description:

The maximum study duration was up to approximately 54 weeks per participants:

- Up to 2-week screening period

- 6-month open-label comparative efficacy and safety treatment period

- 6-month open-label comparative safety extension period

- 48-hour post-treatment safety follow-up period


Recruitment information / eligibility

Status Completed
Enrollment 549
Est. completion date March 2014
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

- Adult participants with type 1 diabetes mellitus

Exclusion criteria:

- HbA1c less than (<) 7.0% (53 mmol/mol) or greater than (>) 10% (86 mmol/mol) at screening

- Less than 1 year on any basal plus mealtime insulin and self-monitoring of blood glucose before screening visit

- Participants not on stable insulin dose (+/-20 percent total basal insulin dose) in the last 30 days prior to screening visit

- Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit

- Use of an insulin pump in the last 6 months before screening visit and no plan to switch to insulin pump in the next 12 months

- Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening;

- Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit

- Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (example laser, surgical treatment or injectable drugs) during the study period

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
HOE901-U300 (Insulin glargine new formulation)

Lantus (Insulin glargine)


Locations

Country Name City State
Canada Investigational Site Number 124110 Coquitlam
Canada Investigational Site Number 124104 Laval
Canada Investigational Site Number 124108 Mirabel
Canada Investigational Site Number 124109 Montreal
Canada Investigational Site Number 124105 Thornhill
Canada Investigational Site Number 124101 Toronto
Czech Republic Investigational Site Number 203102 Brno
Czech Republic Investigational Site Number 203104 Praha 10
Czech Republic Investigational Site Number 203103 Praha 8
Denmark Investigational Site Number 208102 Ålborg
Denmark Investigational Site Number 208103 Esbjerg
Denmark Investigational Site Number 208105 Gentofte
Denmark Investigational Site Number 208104 København Nv
Denmark Investigational Site Number 208107 Køge
Estonia Investigational Site Number 233104 Pärnu
Estonia Investigational Site Number 233105 Tallinn
Estonia Investigational Site Number 233101 Tartu
Estonia Investigational Site Number 233106 Tartu
Estonia Investigational Site Number 233103 Viljandimaa
Finland Investigational Site Number 246102 Kokkola
Finland Investigational Site Number 246101 Kuopio
Finland Investigational Site Number 246106 Loimaa
Finland Investigational Site Number 246105 Oulu
Finland Investigational Site Number 246103 Tampere
Hungary Investigational Site Number 348103 Budapest
Hungary Investigational Site Number 348107 Budapest
Hungary Investigational Site Number 348108 Budapest
Hungary Investigational Site Number 348106 Debrecen
Hungary Investigational Site Number 348102 Gyula
Hungary Investigational Site Number 348101 Urhida
Japan Investigational Site Number 392110 Aisai-Shi
Japan Investigational Site Number 392105 Ise-Shi
Japan Investigational Site Number 392104 Karatsu-Shi
Japan Investigational Site Number 392111 Kitakyushu-Shi
Japan Investigational Site Number 392112 Matsumoto-Shi
Japan Investigational Site Number 392108 Matumoto
Japan Investigational Site Number 392103 Midori-Shi
Japan Investigational Site Number 392107 Mito-Shi
Japan Investigational Site Number 392101 Sakai-Shi
Japan Investigational Site Number 392102 Tomishiro
Japan Investigational Site Number 392106 Yamagata-Shi
Latvia Investigational Site Number 428106 Limbazi
Latvia Investigational Site Number 428103 Riga
Latvia Investigational Site Number 428105 Riga
Latvia Investigational Site Number 428102 Sigulda
Latvia Investigational Site Number 428101 Ventspils
Netherlands Investigational Site Number 528101 Almere
Netherlands Investigational Site Number 528103 Beek
Netherlands Investigational Site Number 528105 Nijmegen
Netherlands Investigational Site Number 528104 Venlo
Netherlands Investigational Site Number 528102 Zwijndrecht
Puerto Rico Investigational Site Number 840602 Ponce
Romania Investigational Site Number 642107 Bacau
Romania Investigational Site Number 642103 Brasov
Romania Investigational Site Number 642109 Oradea
Romania Investigational Site Number 642106 Resita
Romania Investigational Site Number 642104 Sibiu
Romania Investigational Site Number 642101 Targu Mures
Romania Investigational Site Number 642102 Targu Mures
Romania Investigational Site Number 642105 Timisoara
Romania Investigational Site Number 642108 Timisoara
Sweden Investigational Site Number 752103 Goteborg
Sweden Investigational Site Number 752105 Kristianstad
Sweden Investigational Site Number 752101 Stockholm
Sweden Investigational Site Number 752104 Vällingby
United States Investigational Site Number 840151 Albuquerque New Mexico
United States Investigational Site Number 840133 Asheville North Carolina
United States Investigational Site Number 840195 Atlanta Georgia
United States Investigational Site Number 840109 Austin Texas
United States Investigational Site Number 840157 Austin Texas
United States Investigational Site Number 840172 Avon Indiana
United States Investigational Site Number 840104 Baltimore Maryland
United States Investigational Site Number 840430 Bell Gardens California
United States Investigational Site Number 840112 Bend Oregon
United States Investigational Site Number 840113 Bradenton Florida
United States Investigational Site Number 840125 Burke Virginia
United States Investigational Site Number 840156 Chandler Arizona
United States Investigational Site Number 840175 Chapel Hill North Carolina
United States Investigational Site Number 840144 Chattanooga Tennessee
United States Investigational Site Number 840427 Chesapeake Virginia
United States Investigational Site Number 840122 Dakota Dunes South Dakota
United States Investigational Site Number 840150 Dallas Texas
United States Investigational Site Number 840412 Dallas Texas
United States Investigational Site Number 840160 Denver Colorado
United States Investigational Site Number 840188 Denver Colorado
United States Investigational Site Number 840108 Des Moines Iowa
United States Investigational Site Number 840408 Detroit Michigan
United States Investigational Site Number 840131 Escondido California
United States Investigational Site Number 840140 Fresno California
United States Investigational Site Number 840107 Greenbrae California
United States Investigational Site Number 840136 Greer South Carolina
United States Investigational Site Number 840137 Haverhill Massachusetts
United States Investigational Site Number 840102 Hialeah Florida
United States Investigational Site Number 840134 Hollywood Florida
United States Investigational Site Number 840124 Honolulu Hawaii
United States Investigational Site Number 840130 Houston Texas
United States Investigational Site Number 840141 Houston Texas
United States Investigational Site Number 840149 Huntington Beach California
United States Investigational Site Number 840167 Idaho Falls Idaho
United States Investigational Site Number 840197 Indianapolis Indiana
United States Investigational Site Number 840407 Iowa City Iowa
United States Investigational Site Number 840116 Jacksonville Florida
United States Investigational Site Number 840185 Jacksonville Florida
United States Investigational Site Number 840120 La Jolla California
United States Investigational Site Number 840123 La Mesa California
United States Investigational Site Number 840159 La Mesa California
United States Investigational Site Number 840139 Las Vegas Nevada
United States Investigational Site Number 840421 Lexington Kentucky
United States Investigational Site Number 840177 Little Rock Arkansas
United States Investigational Site Number 840114 Long Beach California
United States Investigational Site Number 840153 Madison Heights Michigan
United States Investigational Site Number 840103 Manassas Virginia
United States Investigational Site Number 840169 Mentor Ohio
United States Investigational Site Number 840426 Metairie Louisiana
United States Investigational Site Number 840126 Miami Florida
United States Investigational Site Number 840179 Miami Florida
United States Investigational Site Number 840411 Milwaukee Wisconsin
United States Investigational Site Number 840189 Mission Hills California
United States Investigational Site Number 840161 Morganton North Carolina
United States Investigational Site Number 840101 Murray Utah
United States Investigational Site Number 840163 Nampa Idaho
United States Investigational Site Number 840187 Nashville Tennessee
United States Investigational Site Number 840196 New Haven Connecticut
United States Investigational Site Number 840191 New Hyde Park New York
United States Investigational Site Number 840117 New Port Richey Florida
United States Investigational Site Number 840119 Norman Oklahoma
United States Investigational Site Number 840106 Omaha Nebraska
United States Investigational Site Number 840145 Omaha Nebraska
United States Investigational Site Number 840174 Orlando Florida
United States Investigational Site Number 840110 Oviedo Florida
United States Investigational Site Number 840178 Palm Harbor Florida
United States Investigational Site Number 840132 Renton Washington
United States Investigational Site Number 840180 Rockville Maryland
United States Investigational Site Number 840166 San Antonio Texas
United States Investigational Site Number 840403 Seattle Washington
United States Investigational Site Number 840402 Spokane Washington
United States Investigational Site Number 840162 Springfield Illinois
United States Investigational Site Number 840184 St Louis Missouri
United States Investigational Site Number 840171 St Louis Park Minnesota
United States Investigational Site Number 840173 Syracuse New York
United States Investigational Site Number 840127 Tacoma Washington
United States Investigational Site Number 840181 Tampa Florida
United States Investigational Site Number 840105 Temecula California
United States Investigational Site Number 840170 Topeka Kansas
United States Investigational Site Number 840155 Tustin California
United States Investigational Site Number 840115 Walnut Creek California
United States Investigational Site Number 840420 West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Denmark,  Estonia,  Finland,  Hungary,  Japan,  Latvia,  Netherlands,  Puerto Rico,  Romania,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change In HbA1c From Baseline to Month 6 Endpoint Baseline, Month 6 No
Secondary Percentage of Participants With HbA1c <7% at Month 6 Endpoint Month 6 No
Secondary Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint Month 6 No
Secondary Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Baseline, Month 6 No
Secondary Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Baseline, Month 6 No
Secondary Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint Baseline, Month 6 No
Secondary Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6 Month 6 No
Secondary Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint Month 6 No
Secondary Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Baseline, Month 6 No
Secondary Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint Baseline, Month 6 No
Secondary Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Baseline, Month 6 No
Secondary Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L). Up to Month 12 Yes
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