Evaluation of Type 2 Diabetes Treatment

NCT03164187 | Completed

• 1 other identifier: EDIAZER
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 4

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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Decrease in HbA1c

  over 4 months

• Percentage of patients achieving HbA1c level ≤ 7 %

  week 16.

Secondary Outcomes (2)

• 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

Study Arms (1)

Diabeton MR 60

Drug: Diabeton 60 MR

Interventions

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.

Diabeton MR 60

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Type 2 diabetes patients:
• Males and females, aged over 35
• Who have not been able to achieve target level of glycaemia, with glycated hemoglobin (HbA1c) level exceeding 7%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Servier Affaires Médicales: lead

Study Sites (4)

Azerbaijan Republic Ministry of Health Republic Endocrinology Center

Baku, AZ 1/122, Azerbaijan

Location

Azer-Turk Med clinic

Baku, AZ 1025, Azerbaijan

Location

Hospital of oil workers, polyclinics and private clinics

Baku, AZ 1025, Azerbaijan

Location

Medical Clinic of Azerbaijan Medical University

Baku, AZ-1078, Azerbaijan

Location

Related 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 Sep-Dec;11(3):175-182. doi: 10.4103/JOD.JOD_5_20

  BACKGROUND

Related Links

• Scientific publication

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: May 23, 2017
• Study Start: September 1, 2016
• Primary Completion: May 15, 2017
• Study Completion: June 10, 2017
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
• 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.

Locations

AZ (4)