Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2025-12-25 @ 11:20 PM
Study NCT ID:
NCT01204593
Status:
COMPLETED
Last Update Posted:
2014-03-17
First Post:
2010-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
Phase IV, Multicenter, International, Non-comparative, Open Label Study of Efficacy and Safety of Basal Bolus Therapy (Insulin Glargine + Insulin Glulisine) in Patients With T1 Diabetes Previously Uncontrolled on Any Insulin Regimen.
Status:
COMPLETED
Status Verified Date:
2014-03
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:
SUBSTITUTE
Brief Summary:
Primary Objective:
To evaluate the efficacy of the association Lantus (once-a-day, od) Apidra (thrice-a-day, tid) in terms of change HbA1c from baseline to end of study (week 24), in patients with Type 1 Diabetes Mellitus (T1DM).
Secondary Objectives:
To evaluate:
* The change of hemoglobin A1c (HbA1c) from baseline to week 12
* The percentage of patients with HbA1c \< 7% at week 12 and week 24
* The FBG and the 7-point self monitoring of blood glucose (SMBG) at baseline, week 12 and week 24
* The daily dose for both insulin glulisine insulin glargine at baseline, week 12 and week 24
* The incidence of symptomatic hypoglycemias
* Adverse events
To evaluate the efficacy of the association Lantus (once-a-day, od) Apidra (thrice-a-day, tid) in terms of change HbA1c from baseline to end of study (week 24), in patients with Type 1 Diabetes Mellitus (T1DM).
Secondary Objectives:
To evaluate:
* The change of hemoglobin A1c (HbA1c) from baseline to week 12
* The percentage of patients with HbA1c \< 7% at week 12 and week 24
* The FBG and the 7-point self monitoring of blood glucose (SMBG) at baseline, week 12 and week 24
* The daily dose for both insulin glulisine insulin glargine at baseline, week 12 and week 24
* The incidence of symptomatic hypoglycemias
* Adverse events
Detailed Description:
After a two-week run-in period patients will enter a six-month treatment period.
Estimated study duration per patient : 26 weeks (including a 2-week run-in period).
Estimated study duration per patient : 26 weeks (including a 2-week run-in period).
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1116-3450 | OTHER | WHO | View |