Insulin Glargine in Type 2 Diabetes

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00268645
• Lead Sponsor: Sanofi

Brief Summary

The aim of this project is to confirm the efficacy and safety profile of Insulin glargine in daily practice and to improve the physicians' knowledge and experience concerning Insulin glargine

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-12-21
• Study First Submitted QC: 2005-12-21
• Study First Posted: 2005-12-22
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-10
• Last Update Posted: 2011-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 534

Inclusion Criteria

• Type 2 Diabetes Mellitus patients,
• Diabetic patients receiving insulin or patients who are insulin-naive and whose glycemic control cannot be sufficiently maintained with single or combined oral antidiabetic agents,
• Patients with HbA1C>8
• Patients able to self-measure its blood glucose levels.

Exclusion Criteria

• According to package insert information (Summary of Product Characteristics)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
For efficacy: FBG (Fasting Blood Glucose), HbA1c

Secondary Outcome Measures

Name	Time	Method
For safety: ICA (Insulin Cell Antibody)

Trial Locations

Locations (1)

Sanofi-Aventis; 🇹🇷 Istanbul, Turkey