Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272012
Status:
COMPLETED
Last Update Posted:
2009-12-07
First Post:
2006-01-02
Brief Title:
OPAL - Insulin Glulisine Diabetes Mellitus
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Efficacy and Safety of Insulin Glulisine Given as a Single Injection at Breakfast Insulin GlargineOAD Oral Antidiabetic Drug vs Insulin Glulisine Given as a Single Injection at Main MealInsulin GlargineOAD 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 70 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 70 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None