COMPARISON OF TWO THERAPEUTIC STRATEGIES FOR TREATING TYPE 2 DIABETIC PATIENTS POORLY CONTROLLED WITH BASAL INSULIN ASSOCIATED WITH ORAL ANTIDIABETIC DRUGS: 6-MONTH PROOF OF CONCEPT STUDY - BASAL PLUS

Phase 1

• Conditions: Type II diabetes mellitus; MedDRA version: 8.1 Level: LLT Classification code 10045242

• Registration Number: EUCTR2005-002614-38-GB
• Lead Sponsor: SANOFI AVENTIS GROUPE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-30
• Study Completion: 2008-08-20
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 196

Inclusion Criteria

1. Type 2 diabetic men or women
2. Aged 18 to 75 years
3. 25 < Body Mass Index (BMI) < 40 kg/m2
4. 7,5% = HbA1c = 9%
5. Treated with a basal insulin, and at least 1g metformin daily, for more than 3 months.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Type 1 diabetes mellitus
2. Treatment with OADs ( Oral Antidiabetic Drugs) only
3. Treatment with thiazolidinediones, with exenatide or with pramlintide
4. Treatment with an insulin other than basal insulin
5. Active proliferative diabetic retinopathy
6. Pregnancy
7. Breast-feeding
8. Treatment with systemic corticosteroids in the 3 months prior to study entry
9. Previous treatment with insulin glulisine
10. Impaired hepatic function at study entry
11. Impaired renal function at study entry

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified