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Assessment of blood glucose profile in type 2 diabetic patients after a one-week treatment with gliclazide 60 mg MR using both the glycaemic Holter method and multiple blood glucose samples. A double-blind, randomized, parallel group, placebo-controlled, exploratory study.

Assessment of blood glucose profile in type 2 diabetic patients after a one-week treatment with gliclazide 60 mg MR using both the glycaemic Holter method and multiple blood glucose samples. A double-blind, randomized, parallel group, placebo-controlled, exploratory study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-002647-16-GB
Enrollment
Unknown
Registered
2008-11-04
Start date
2009-02-05
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Type 2 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus

Interventions

Product Name: S05762 Product Code: S05762 Pharmaceutical Form: Modified-release tablet INN or Proposed INN: Gliclazide Current Sponsor code: S05762 Concentration unit: mg milligram(s) Concentration ty

Sponsors

Institut de Recherches Internationales Servier
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: . Type 2 diabetic patients . Between 35 and 70 years of age inclusive, . Diagnosed with diabetes for at least 3 months, . Body Mass Index (BMI) between 24 and 38 kg/m2 inclusive, . Currently treated with metformin alone. 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: · Pregnancy, breast-feeding or female of childbearing potential not using appropriate contraception, · Special diet or substantial changes in eating habits in the last 3 months, . Type 1 diabetes.

Design outcomes

Primary

MeasureTime frame
Main Objective: · To study the glycaemic Holter and the multiple venous blood glucose samples methods to assess the blood glucose profile over 24 hours in type 2 diabetic patients after 7-day repeated oral dose administration with gliclazide;Secondary Objective: · To assess the short-term treatment effect of gliclazide versus placebo, on top of metformin, based on glucose profile over 24 hours using the glycaemic Holter and the multiple venous blood glucose samples methods · To optimise the duration of the glycaemic Holter recording · To provide information on the plasma pharmacokinetic profile of gliclazide in type 2 diabetic patients ;Primary end point(s): Blood glucose profile using glycaemic Holter and method of multiple venous blood glucose samples—

Countries

United Kingdom

Outcome results

None listed

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