OPAL - Insulin Glulisine, Diabetes Mellitus
- Conditions
- Diabetes Mellitus Type 2
- Registration Number
- NCT00272012
- Lead Sponsor
- Sanofi
- Brief Summary
Primary objective:
The primary study objective is to compare efficacy of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of change in HbA1c, from baseline to endpoint for the individual patient. The aim of the study is to demonstrate two-sided equivalence between the two therapy regimens receiving two different injection timing of Insulin glulisine.
Secondary objective:
Secondary study objectives are to compare efficacy and safety of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of:
* Change of fasting-, pre-/2h-postprandial-, mean daily and nocturnal blood glucose (baseline to endpoint)
* Change of fasting plasma glucose (baseline to endpoint)
* Response rate: Responders will be those patients with HbA1c smaller than 7.0% at study endpoint
* Insulin dose (rapid-acting, basal and total daily doses)
* Weight, body-mass index
* Hypoglycemic events
* Adverse events
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 396
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in HbA1c. from baseline to study endpoint.
- Secondary Outcome Measures
Name Time Method Change of pre-, 2 h postprandial and nocturnal blood glucose values 8-point profile Fasting blood glucose 8-point blood glucose profile values Responder rate HbA1c smaller 7 % at study endpoint Insulin dose rapid-acting, basal and total daily doses Weight, BMI study follow-up Hypoglycemic events study follow-up Adverse events. study follow-up
Trial Locations
- Locations (1)
Sanofi-Aventis
🇩🇪Berlin, Germany