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Completed

NCT Number: NCT03164187

Evaluation of Type 2 Diabetes Treatment

The aim of this study is to analyze the efficacy of Diabeton 60 MR as intensive sugar-lowering therapy into routine clinical practice, in patients for whom the treating physician has already decided to prescribe this medication. This concerns untreated newly diagnosed patients uncontrolled by diet, and patients uncontrolled by metformin.

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Key information

Conditions

Type2 Diabetes

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azer-Turk Med clinic, Baku, Azerbaijan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes patients:
  • Males and females, aged over 35
  • Currently treated: with diet only, or with metformin therapy for at least 3 months prior to inclusion
  • Who have not been able to achieve target level of glycaemia, with glycated hemoglobin (HbA1c) level exceeding 7%.

Exclusion criteria

Patients with at least one of the following criteria are not included in the study:

  • Type 1 diabetes
  • Severe liver (ALT and AST levels 2.5 times as high as upper level of normal range) or renal insufficiency (creatinin plasma level above 140 µmole/L)
  • Patients who are on insulin therapy, or at risk to receive an insulin treatment in the next 4 months, according to physician judgment.
  • Intolerance to Gliclazide if such prescription was done in the past
  • Pregnancy and breast-feeding
  • Night workers or patients able to skip meals
  • Presence of any contraindication listed in the SmPC.

Treatment and study plan

Diabeton 60 MR

Drug

Administer Diabeton MR 60 mg 1/2 tablet. Increasing dosage of Diabeton MR 60 mg by ½ tablet is recommended if fasting glucose level exceeds 6 mmol/L.

Primary outcomes

  1. Decrease in HbA1c

    Time frame: over 4 months

  2. Percentage of patients achieving HbA1c level ≤ 7 %

    Time frame: week 16.

Secondary outcomes

  1. number of hypoglycemia episodes

    Time frame: Week 0, 2, 4, 6, 8 and week 16.

  2. Mean daily dosage of Diabeton MR

    Time frame: Week 2, 4, 6, 8 and 16

Sponsors and collaborators

Lead sponsor

Servier Affaires Médicales

Industry

Registry information

Official study title

Evaluation of Type 2 Diabetes Treatment in AZERbaijan

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 23, 2017
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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