Comparison of three therapeutic strategies for treating type 2 diabetes mellitus patients poorly controlled with basal insulin associated with oral antidiabetic drugs. - OSIRIS

Phase 1

• Conditions: Type 2 diabetes mellitus; MedDRA version: 8.1 Level: LLT Classification code 10045242

• Registration Number: EUCTR2004-002036-25-GB
• Lead Sponsor: sanofi aventis groupe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-17
• Study Completion: 2008-12-01
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 776

Inclusion Criteria

- Type 2 diabetic men or women
- Aged 18 to 75 years
- BMI =40 kg/m2
- HbA1c > 7%
- Treated with basal insulin (NPH, Insulin Zinc, insulin glargine or insulin detemir), and at least, two OAD including an insulin secretagogue (sulfonylurea or glinide, at any dosage) and metformin (at the maximum tolerated dosage), for more than 6 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

- Type 1 diabetes mellitus
- Treatment with OADs only
- Treatment with thiazolidinediones
- Treatment with an insulin other than basal insulin
- Active proliferative diabetic retinopathy
- Pregnancy
- Breast-feeding
- History of hypersensitivity to the study drug or to drugs with a similar chemical structure or to insulin glargine
- Treatment with systemic corticosteroids, irrespective of the dose of administration and irrespective of the prior or foreseeable treatment duration
- Treatment with any investigational product in the last 2 months before study entry, except for insulin glargine
- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol (see Section 6.2)
- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
- Impaired hepatic function at study entry
- Impaired renal function at study entry

Study & Design

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