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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabeton MR 60 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in HbA1c | over 4 months | |
| Percentage of patients achieving HbA1c level ≤ 7 % | week 16. |
| Measure | Description | Time Frame |
|---|---|---|
| number of hypoglycemia episodes | Week 0, 2, 4, 6, 8 and week 16. | |
| Mean daily dosage of Diabeton MR | Week 2, 4, 6, 8 and 16 |
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Inclusion Criteria:
- Type 2 diabetes patients:
Exclusion Criteria:
Patients with at least one of the following criteria are not included in the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azerbaijan Republic Ministry of Health Republic Endocrinology Center | Baku | AZ 1/122 | Azerbaijan | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 |
| Label | URL |
|---|---|
| Scientific publication | View source |
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Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).
They can ask all interventional clinical studies:
After Marketing Authorisation in EEA or US if the study is used for the approval.
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
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| Azer-Turk Med clinic |
| Baku |
| AZ 1025 |
| Azerbaijan |
| Hospital of oil workers, polyclinics and private clinics | Baku | AZ 1025 | Azerbaijan |
| Medical Clinic of Azerbaijan Medical University | Baku | AZ-1078 | Azerbaijan |