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: 8.1Level: LLTClassification code 10045242

• Registration Number: EUCTR2004-002036-25-GR
• Lead Sponsor: ABORATOIRE AVENTIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-11-13
• Study Completion: 2008-12-01
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 776

Inclusion Criteria

- Type 2 diabetic men or women
- Aged 18 to 75 years
- BMI =40 kg/m2
- 7% < HbA1c = 11%
- Treated with basal insulin (NPH, Insulin Zinc, insulin glargine or insulin detemir), and at least, two OAD including a sulfonylurea (at a dosage = 50% of the maximum recommended 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 or glinides
- 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