Comparison of a new formulation of insulin glargine with Lantus in patients with type 1 diabetes mellitus
- Conditions
- Type 1 diabetes mellitusMedDRA version: 15.0Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2012-001524-35-LV
- Lead Sponsor
- sanofi-aventis recherche & développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 577
Adult Patients with type 1 diabetes mellitus
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 550
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
- HbA1c <7.0% (53 mmol/mol) or >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;
- Patients not on stable insulin dose (±20% total basal insulin dose) in the last 30 days prior to screening visit;
- Patients 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 (eg, laser, surgical treatment or injectable drugs) during the study period
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled month 6) in patients with type 1 diabetes mellitus;Secondary Objective: To compare a new formulation of insulin glargine and Lantus in terms of change in fasting plasma glucose, pre-injection plasma glucose, 8-point self-measured plasma glucose profile;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: Baseline, 6 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Change in Pre-injection plasma glucose<br>- Change in Fasting plasma glucose<br>- Change in 8-point self-monitored plasma glucose profile<br>- Hypoglycemia;Timepoint(s) of evaluation of this end point: Baseline, 6 months for :<br>- Change in Pre-injection plasma glucose<br>- Change in Fasting plasma glucose<br>- Change in 8-point self-monitored plasma glucose profile<br><br>6 months for :<br>- Hypoglycemia