Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00405418
Status:
COMPLETED
Last Update Posted:
2009-09-15
First Post:
2006-11-29
Brief Title:
Lantus Versus Levemir Treat-To-Target
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Target Glycemic Control and the Incidence of Documented Symptomatic Hypoglycemia in Insulin naïve Subjects With Type 2 Diabetes Failing on Oral Hypoglycemic Agents and Treated With Insulin Glargine or Insulin Detemir
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:
L2T3
Brief Summary:
Primary objective
To demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in term of percentage of patients who reach the target of HbA1c 7 at the end of the treatment period and do not experience symptomatic hypoglycemia confirmed by plasma glucose PG 56 mgdL 31 mmolL
Secondary objectives
To compare between the 2 treatment groups the percentage of patients who reach the target of HbA1c 7 and 65 at the end of the treatment period
To compare the changes in HbA1c and fasting plasma glucose FPG
To compare the evolution of blood glucose profiles
To compare the day to day FPG variability the insulin doses
To determine in each treatment group the biochemical and patient-related determinants of failure to reach HbA1c targets
To compare the overall incidence and rate of symptomatic hypoglycemia and nocturnal symptomatic hypoglycemia confirmed by PG 56 mgdL 31 mmolL
To compare over the treatment period the overall incidence and rate of symptomatic hypoglycemia and symptomatic nocturnal hypoglycemia with PG 70 mgdL 39 mmolL of symptomatic day-time hypoglycemia with PG 70 mgdL and with PG 56 mgdL of severe hypoglycemia of asymptomatic hypoglycemia with PG 56 mgdL
To compare the overall safety incidence of adverse events including serious hypoglycemia and local tolerance at injection site change in body weight in waist circumference and in waist hip ratio
To assess the quality of life and treatment satisfaction
To demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in term of percentage of patients who reach the target of HbA1c 7 at the end of the treatment period and do not experience symptomatic hypoglycemia confirmed by plasma glucose PG 56 mgdL 31 mmolL
Secondary objectives
To compare between the 2 treatment groups the percentage of patients who reach the target of HbA1c 7 and 65 at the end of the treatment period
To compare the changes in HbA1c and fasting plasma glucose FPG
To compare the evolution of blood glucose profiles
To compare the day to day FPG variability the insulin doses
To determine in each treatment group the biochemical and patient-related determinants of failure to reach HbA1c targets
To compare the overall incidence and rate of symptomatic hypoglycemia and nocturnal symptomatic hypoglycemia confirmed by PG 56 mgdL 31 mmolL
To compare over the treatment period the overall incidence and rate of symptomatic hypoglycemia and symptomatic nocturnal hypoglycemia with PG 70 mgdL 39 mmolL of symptomatic day-time hypoglycemia with PG 70 mgdL and with PG 56 mgdL of severe hypoglycemia of asymptomatic hypoglycemia with PG 56 mgdL
To compare the overall safety incidence of adverse events including serious hypoglycemia and local tolerance at injection site change in body weight in waist circumference and in waist hip ratio
To assess the quality of life 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 2006-000324-13 | None | None | None |