Comparison of a new formulation of insulin glargine with Lantus in patients with type 1 diabetes mellitus

• Conditions: Type 1 diabetes mellitus; MedDRA version: 14.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-001524-35-SE
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-27
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 577

Inclusion Criteria

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

Exclusion Criteria

- 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