Evaluation of Type 2 Diabetes Treatment

Type2 Diabetes Clinical Trial

Official title:

Evaluation of Type 2 Diabetes Treatment in AZERbaijan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03164187
• Other study ID #: EDIAZER
• Status: Completed
• Start date: September 1, 2016
• Est. completion date: June 10, 2017

Study information

• Verified date: September 2020
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 10, 2017
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Azerbaijan	Azer-Turk Med clinic	Baku
Azerbaijan	Azerbaijan Republic Ministry of Health Republic Endocrinology Center	Baku
Azerbaijan	Hospital of oil workers, polyclinics and private clinics	Baku
Azerbaijan	Medical Clinic of Azerbaijan Medical University	Baku

Sponsors (1)

Lead Sponsor	Collaborator
Servier Affaires Médicales

Country where clinical trial is conducted

Azerbaijan, 

References & Publications (1)

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;11:175-182

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in HbA1c		over 4 months
Primary	Percentage of patients achieving HbA1c level = 7 %		week 16.
Secondary	number of hypoglycemia episodes		Week 0, 2, 4, 6, 8 and week 16.
Secondary	Mean daily dosage of Diabeton MR		Week 2, 4, 6, 8 and 16

External Links

•   Scientific publication