EUCTR2010-023769-23-DEActive, not recruitingNot Applicable
6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both plus Mealtime Insulin in Patients with Type 2 Diabetes Mellitus with a 6-month Safety Extension Period
sanofi-aventis recherche & développement0 sites800 target enrollmentStarted: February 3, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 800
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Patients with type 2 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 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
Exclusion Criteria
- •Age <18 years;
- •HbA1c <7.0% or >10% at screening;
- •Diabetes other than type 2 diabetes mellitus;
- •Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose;
- •Any contraindication to use of insulin glargine as defined in the national product label;
- •Patients using human regular insulin as mealtime insulin in the last 3 months before screening visit;
- •Use of an insulin pump in the last 6 months before screening visit;
- •Initiation of new glucose-lowering agents and/or weight loss drugs in the last 3 months before screening visit;
- •History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period;
- •Pregnant or breast-feeding women or women who intend to become pregnant during the study period.
Investigators
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