ObsErvationAl Study to analYse titration of the new Diamicron MR 60 mg formulation in daily clinical practice in a large population with uncontrolled type 2 diabetes

ObsErvationAl Study to analYse titration of Diamicron MR 60 mg in daily clinical practice in a large population with uncontrolled type 2 diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN00943368

Enrollment

5000

Registered

2013-02-25

Start date

2011-07-01

Completion date

Unknown

Last updated

2018-05-21

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

Conditions

Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

This observational study is performed in patients receiving gliclazide MR 60 mg as the basis of their treatment strategy: 1. Newly diagnosed patients will be initiated on gliclazide MR 60 mg. 2. Previ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female patients with type 2 diabetes, aged 35 years or older, not optimally controlled (HbA1c 7.5% or higher, according to patient profile), including: 1. Newly diagnosed patients, in whom lifestyle recommendations have failed 2. Previously diagnosed patients, who are intolerant or have contraindication to current treatment, or in whom previous treatment has failed.

Exclusion criteria

Exclusion criteria: 1. Requirement for insulin therapy 2. Severe liver or renal failure 3. Contraindication to gliclazide 4. Pregnancy or breast feeding 5. Treatment with miconazole

Design outcomes

Primary

Measure	Time frame
Time to reach the efficient dose that provides optimal glycemic control, according to the investigator's judgment	—

Secondary

Measure	Time frame
1. Average daily dose of gliclazide MR 60 mg at the end of the study 2. Compliance assessed by a qualitative questionnaire (addressed to the investigators) 3. Treatment doses: repartition of each dose level in the population over time 4. Efficacy parameters (HbA1c and fasting plasma glucose): change versus baseline; percentage of patients achieving an HbA1c level 6.5% or lower, and 7% or lower 5. Safety parameters 6. Treatment acceptability with assessment of body weight change	—

Measure

Time frame

1. Average daily dose of gliclazide MR 60 mg at the end of the study 2. Compliance assessed by a qualitative questionnaire (addressed to the investigators) 3. Treatment doses: repartition of each dose level in the population over time 4. Efficacy parameters (HbA1c and fasting plasma glucose): change versus baseline; percentage of patients achieving an HbA1c level 6.5% or lower, and 7% or lower 5. Safety parameters 6. Treatment acceptability with assessment of body weight change

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Countries

Armenia, Bangladesh, Georgia, Lebanon, Malaysia, Russian Federation, Slovenia, Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026