Type2 Diabetes
Conditions
Brief summary
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.
Interventions
DRUGDiabeton 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.
Sponsors
Servier Affaires Médicales
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in HbA1c | over 4 months |
| Percentage of patients achieving HbA1c level ≤ 7 % | week 16. |
Secondary
| Measure | 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 |
Countries
Azerbaijan
Outcome results
None listed