Evaluation of Type 2 Diabetes Treatment

Evaluation of Type 2 Diabetes Treatment in AZERbaijan

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.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Drug: Diabeton 60 MR

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Azerbaijan
  • Baku, Azerbaijan, AZ 1/122
    • Azerbaijan Republic Ministry of Health Republic Endocrinology Center
  • Baku, Azerbaijan, AZ 1025
    • Azer-Turk Med clinic
  • Baku, Azerbaijan, AZ 1025
    • Hospital of oil workers, polyclinics and private clinics
  • Baku, Azerbaijan, AZ-1078
    • Medical Clinic of Azerbaijan Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diabeton MR 60	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decrease in HbA1c	over 4 months
Percentage of patients achieving HbA1c level ≤ 7 %	week 16.

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Servier Affaires Médicales

Publications and helpful links

General Publications

• 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

Helpful Links

• Scientific publication

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): May 15, 2017
• Study Completion (Actual): June 10, 2017

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (Actual): May 23, 2017

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: EDIAZER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

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:

• submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
• Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

• IPD Sharing Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No