Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174642
Status:
COMPLETED
Last Update Posted:
2009-09-15
First Post:
2005-09-09
Brief Title:
Opposing Step-by-step Insulin Reinforcement to Intensified Strategy
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Comparison of Three Therapeutic Strategies for Treating Type 2 Diabetes Mellitus Patients Poorly Controlled With Basal Insulin Associated With Oral Antidiabetic Drugs
Status:
COMPLETED
Status Verified Date:
2009-09
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:
OSIRIS
Brief Summary:
Primary objectives
To show the non inferiority in terms of efficacy HbA1c of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively Arm 2 compared with insulin glargine plus metformin combined with 3 bolus of insulin glulisine Arm 1 in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs
To show the non inferiority in terms of efficacy HbA1c of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively Arm 2 compared with insulin glargine plus metformin and insulin secretagogue sulfonylurea or glinide combined with 1 to 3 bolus of insulin glulisine introduced progressively Arm 3 in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs
Secondary objectives
To compare between the 3 treatment groups evolution of HbA1c over time percentage of subjects with HbA1c 7 at the end of the study evolution of blood glucose profiles incidence of hypoglycemia insulin doses evolution of body weight and treatment satisfaction
To show the non inferiority in terms of efficacy HbA1c of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively Arm 2 compared with insulin glargine plus metformin combined with 3 bolus of insulin glulisine Arm 1 in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs
To show the non inferiority in terms of efficacy HbA1c of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively Arm 2 compared with insulin glargine plus metformin and insulin secretagogue sulfonylurea or glinide combined with 1 to 3 bolus of insulin glulisine introduced progressively Arm 3 in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs
Secondary objectives
To compare between the 3 treatment groups evolution of HbA1c over time percentage of subjects with HbA1c 7 at the end of the study evolution of blood glucose profiles incidence of hypoglycemia insulin doses evolution of body weight and treatment satisfaction
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT 2004-002036-25 | None | None | None |