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

• Register: ISRCTN
• Last refreshed on: 21 May 2018
• Main ID: ISRCTN00943368
• Date of registration: 25/02/2013
• Prospective Registration: No
• Primary sponsor: Institut de Recherches Internationales Servier (France)
• Public title: 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
• Scientific title: ObsErvationAl Study to analYse titration of Diamicron MR 60 mg in daily clinical practice in a large population with uncontrolled type 2 diabetes
• Date of first enrolment: 01/07/2011
• Target sample size: 5000
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN00943368
• Study type: Observational
• Study design: Multicenter open-label observational study (Other)
• Phase: Not Applicable

Countries of recruitment

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

Contacts

• Name: Lawrence Leiter

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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. Previously diagnosed patients will be switched to gliclazide MR 60 mg or receive it added on to their current treatment.

The starting dose of gliclazide MR 60 mg will be defined according to the judgment of the investigators and the Summary of Product Characteristics.

Dose increases will be made at each study visit (1, 2, and 3 months) according to fasting plasma glucose and patient characteristics (especially regarding elderly patients or those with renal insufficiency), up to a maximal dose of 120 mg (2 tablets) per day in a single intake at breakfast, before adding any other oral antidiabetic drug.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

DME-5702-149

Source(s) of Monetary Support

Institut de Recherches Internationales Servier (France)

Ethics review

Status:
Approval date:
Contact:

Slovenian National Medical Ethics Committee, 19/10/2011 All other centres will seek ethics approval before recruiting participants

Results

• Results available: Yes
• Date Completed: 31/10/2013