Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT00272012
Status:
COMPLETED
Last Update Posted:
2009-12-07
First Post:
2006-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OPAL - Insulin Glulisine, Diabetes Mellitus
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
Efficacy and Safety of Insulin Glulisine Given as a Single Injection at Breakfast + Insulin Glargine+OAD (Oral Antidiabetic Drug) vs Insulin Glulisine Given as a Single Injection at Main Meal+Insulin Glargine+OAD in Type 2 Diabetic Patients for Which Glycemic Control is Suboptimal Using Insulin Glargine+ OAD Alone
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: