Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
105 participants
OBSERVATIONAL
2016-09-01
2017-06-10
Brief Summary
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Detailed Description
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Conditions
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Study Groups
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Diabeton MR 60
Diabeton 60 MR
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.
Interventions
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Diabeton 60 MR
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
35 Years
ALL
No
Sponsors
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Servier Affaires Médicales
INDUSTRY
Responsible Party
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Locations
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Azerbaijan Republic Ministry of Health Republic Endocrinology Center
Baku, , Azerbaijan
Azer-Turk Med clinic
Baku, , Azerbaijan
Hospital of oil workers, polyclinics and private clinics
Baku, , Azerbaijan
Medical Clinic of Azerbaijan Medical University
Baku, , Azerbaijan
Countries
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References
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Mirzazada VA, Huseynova RA, Mustafayeva SA, Gasimova FN, Ahmadova U, Ismayilova N, Kerimova V, Mehdiyeva H, Suleymanova R, Maharramova Z, Iskandarli G, Gurbanova O, Aghayeva S, Malikova S, Ismayilova K, Salimkhanova K. Evaluation of Type 2 Diabetes Treatment with Gliclazide Modified Release in Azerbaijan (the EdiAzer study): Results from a 16-Week Observational Clinical Study. J Diabetol. 2020 Sep-Dec;11(3):175-182. doi: 10.4103/JOD.JOD_5_20
Related Links
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Other Identifiers
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EDIAZER
Identifier Type: -
Identifier Source: org_study_id
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