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: 7.0Level: LLTClassification code 10012601

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-11
• Study Completion: 2008-12-01
• Last Update Posted: 7 September 2021

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 ³ 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 (Premix, rapid insulin, fast-acting insulin analogue)
- Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (confirmed by an optic fundus performed in the 2 years prior study entry)
- Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and effective contraception)
- Breast-feeding
- 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
- 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 as shown by ALT and/or AST greater than three times the upper limit of normal at study entry
- Impaired renal function as shown by serum creatinine >135 µmol/l in men and > 110 µmol/l in women at study entry
- History of drug or alcohol abuse

Study & Design

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