Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus
Phase 3
Completed
- Conditions
- Diabetes Mellitus
- Interventions
- Registration Number
- NCT00467376
- Lead Sponsor
- Sanofi
- Brief Summary
Primary:
* To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects with type 1 or type 2 diabetes mellitus.
* To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro.
Secondary:
* To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks 12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with type 1 or type 2 diabetes mellitus
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 485
Inclusion Criteria
- Type 1 or type 2 diabetic patients
- Measure HbA1c 6.5% to 11.0% at visit 1
- More than 3 months of continuous insulin treatment immediately prior to study entry
Exclusion Criteria
- Pregnant women
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Insulin Glulisine Administration of Insulin Glulisine 2 Lispro Administration of Lispro 1 Insulin Glargine Administration of Insulin Glulisine 2 Insulin Glargine Administration of Lispro
- Primary Outcome Measures
Name Time Method Hypoglycemic episodes From the beginning to end of the study Change in HbA1c From baseline to endpoint Adverse events From the beginning to the end of study
- Secondary Outcome Measures
Name Time Method Change in HbA1c From baseline to weeks 12 blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and Lantus. from baseline to week 12
Trial Locations
- Locations (1)
Sanofi-Aventis
🇨🇳Beijing, China