Study assessing two timing of administration of metformin XR, breakfast vs dinner, in type 2 diabetic patients previously treated with the combination metformin-sulfonylurea.

Phase 1

• Conditions: Type 2 diabetes; MedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-006054-82-CZ
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-27
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

- Type 2 diabetic outpatients diagnosed for at least 6 months according to WHO criteria
- Caucasian male or female aged > or = 35 years
- BMI within the range [22-40 kg/m2] inclusive
- Currently treated with metformin at a daily dose between [850-2000 mg] in combination with a sulfonylurea at stable dose of both drugs for at least 3 months prior to selection optimally or sub-optimally controlled with HbA1c < 8% (or between [6.5-8%[ if metformin daily dose is 850 or 1700 mg)
- used to take regular meals (well balanced repartition of food intake between meals as recommended in type 2 diabetes) with substantial breakfast including solid food
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 188
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 62

Exclusion Criteria

- Type 1 diabetes
- Type 2 diabetes requiring a change of the current oral antidiabetic treatment
- History of repeated non severe hypoglycaemia
- ASAT, ALAT, GGT > 3xULN, total alkaline phosphatase > 2xULN
- Creatinine clearance < 60 mL/min according to Cockroft formula
- Haemoglobin < 12 g/dL (males) or 11 g/dL (females)

Study & Design

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