Evaluation of Type 2 Diabetes Treatment

Servier

Status: Completed

Conditions: Type2 Diabetes

Treatments: Drug: Diabeton 60 MR

Study type: Observational

Funder types: Industry

Identifiers

NCT03164187

EDIAZER

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

105 participants in 1 patient group

Diabeton MR 60

Treatment:

Drug: Diabeton 60 MR