Long term double blind comparison of gliclazide MR (30 to 120 mg daily per os) and rosiglitazone (4 to 8 mg daily per os) given in combination with metformin in type 2 diabetic patients.A 2-year international, multicentre, randomised, double-blind, parallel-group study followed by a 2-year double blind extension. - ENDORSE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001240-30-BE

Enrollment

2500

Registered

2006-08-08

Start date

2006-10-31

Completion date

Unknown

Last updated

2012-05-29

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

Conditions

Diabetes mellitus non insulino dependant MedDRA version: 9.0 Level: PT Classification code 10027433

Interventions

Trade Name: DIAMICRON 30 mg Product Name: S05702 Product Code: S05702 Pharmaceutical Form: Modified-release tablet INN or Proposed INN: gliclazide Current Sponsor code: S05702 Concentration unit: mg m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Type 2 diabetic outpatients, - Male or female aged > 35 years inclusive, - BMI 24-38 kg/m2 inclusive, - Treated in monotherapy with metformin, - not optimally controlled with HbA1c in the range [7.5-9.0%] inclusive. 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

Exclusion criteria: - Type 1 diabetes, - Patient with frequent changes in his/her eating behaviour and having had weight fluctuations or patient intending to deeply modify his/her eating behaviour during the study, - Contra-indication to gliclazide, rosiglitazone or metformin, - Recent major cardiovascular events.

Design outcomes

Primary

Measure	Time frame
Main Objective: Compare the efficacy of the two bitherapies administered at optimal dosage on mean weighted HbA1c.;Secondary Objective: Compare the two bitherapies on: other metabolic efficacy criteria, pancreatic b cell function, cardiovascular risk profile, safety profile, health status of the patients, economic outcomes. Evaluate the additional benefit of tritherapy when bitherapy fails. ;Primary end point(s): HbA1c at different periods.	—

Measure

Time frame

Main Objective: Compare the efficacy of the two bitherapies administered at optimal dosage on mean weighted HbA1c.;Secondary Objective: Compare the two bitherapies on: other metabolic efficacy criteria, pancreatic b cell function, cardiovascular risk profile, safety profile, health status of the patients, economic outcomes. Evaluate the additional benefit of tritherapy when bitherapy fails. ;Primary end point(s): HbA1c at different periods.

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Countries

Austria, Belgium, Czech Republic, Germany, Hungary, Latvia, Lithuania, Netherlands, Portugal, Slovenia, Spain, United Kingdom

Outcome results

None listed

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