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

Efficacy and safety assessment of two schemes of oral administration of once-daily extended release metformin (metformin XR) in type 2 diabetic patients previously treated with metformin in combination with sulfonylurea. A 3-month, international, multicentre, randomised, double-blind, double-dummy, parallel group study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006054-82-CZ

Enrollment

250

Registered

2012-04-27

Start date

2012-06-29

Completion date

Unknown

Last updated

2016-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: GLUCOPHAGE SR Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: METFORMIN HYDROCHLORIDE CAS Number: 1115-70-4 Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 62

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Czech Republic, Hungary, Poland, Russian Federation, Slovakia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026