Multicenter, Open, Non-randomised Phase III Clinical Study of Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine

Insulin Glulisine, Diabetes Mellitus Type 1

Sponsors

Lead sponsor: Sanofi

Source Sanofi
Brief Summary

To provide local data on efficacy and safety of insulin glulisine in patients with Type 1 Diabetes Mellitus receiving insulin glargine as basic insulin therapy

Overall Status Completed
Start Date January 2005
Primary Completion Date December 2007
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
HbA1c 52 weeks
Secondary Outcome
Measure Time Frame
HbA1c 26 weeks
Fasting Blood Glucose 26 weeks
Fasting Blood Glucose 52 weeks
Post-prandial glycemia (2 hour after breakfast) 26 weeks
Post-prandial glycemia (2 hour after breakfast) 52 weeks
Enrollment 104
Condition
Intervention

Intervention type: Drug

Intervention name: Insulin glulisine

Arm group label: Insulin Glulisine

Eligibility

Criteria:

Inclusion Criteria:

- Diabetes mellitus, Type 1

- HbA1c 6.5-11.0%

- BMI <35 kg/m²

Exclusion Criteria:

- Diabetes mellitus, Type 2

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Marina Atarshchikova, MD Study Director Sanofi
Location
facility
Sanofi-Aventis
Location Countries

Russian Federation

Verification Date

May 2009

Responsible Party

Name title: Medical Affairs Study Director

Organization: sanofi-aventis

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Insulin Glulisine

Arm group type: Experimental

Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov