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

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-PL

Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary: Not available

Detailed Description: Not available

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess efficacy and safety of metformin XR at 2 different daily time of administration - breakfast vs dinner time- in type 2 daibetic patients in combination with sulfonylurea.;Secondary Objective: Assess efficacy on fasting plasma glucose and safety profile;Primary end point(s): HbA1c;Timepoint(s) of evaluation of this end point: At baseline (M0), M2 and study end (M3)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Fasting plasma glucose <br><br>and safety measurements:<br>- Adverse events (AE),<br>- Laboratory analyses<br>- Physical examination and body weight<br>- Vital signs<br>;Timepoint(s) of evaluation of this end point: All over the study