Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus

Completed · Phase 3

Conditions studied: Type 1 Diabetes Mellitus

In brief

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

Key facts

Study ID: NCT01683266
Run by: Sanofi
People needed: 549
Starts: 2012-09-01
Expected to finish: 2014-03-01
Last updated by the study team: 2015-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adult participants with type 1 diabetes mellitus

You may not qualify if…

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.

Where it is running

Investigational Site Number 840177 — Little Rock, Arkansas, United States
Investigational Site Number 840430 — Bell Gardens, California, 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 840149 — Huntington Beach, California, 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 840114 — Long Beach, California, United States
Investigational Site Number 840189 — Mission Hills, California, United States
Investigational Site Number 840105 — Temecula, California, United States
Investigational Site Number 840155 — Tustin, California, United States
Investigational Site Number 840115 — Walnut Creek, California, United States
Investigational Site Number 840160 — Denver, Colorado, United States
Investigational Site Number 840188 — Denver, Colorado, United States
Investigational Site Number 840196 — New Haven, Connecticut, United States
Investigational Site Number 840113 — Bradenton, Florida, United States
Investigational Site Number 840102 — Hialeah, Florida, United States
Investigational Site Number 840134 — Hollywood, Florida, United States
Investigational Site Number 840185 — Jacksonville, Florida, United States
Investigational Site Number 840116 — Jacksonville, Florida, United States
Investigational Site Number 840126 — Miami, Florida, United States
Investigational Site Number 840179 — Miami, Florida, United States
Investigational Site Number 840156 — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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