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Evaluation of Type 2 Diabetes Treatment

Primary Purpose

Type2 Diabetes

Status
Completed
Phase
Locations
Azerbaijan
Study Type
Observational
Intervention
Diabeton 60 MR
Sponsored by
Servier Affaires Médicales
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Type2 Diabetes

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Azerbaijan Republic Ministry of Health Republic Endocrinology Center
  • Azer-Turk Med clinic
  • Hospital of oil workers, polyclinics and private clinics
  • Medical Clinic of Azerbaijan Medical University

Arms of the Study

Arm 1

Arm Type

Arm Label

Diabeton MR 60

Arm Description

Outcomes

Primary Outcome Measures

Decrease in HbA1c
Percentage of patients achieving HbA1c level ≤ 7 %

Secondary Outcome Measures

number of hypoglycemia episodes
Mean daily dosage of Diabeton MR

Full Information

First Posted
April 12, 2017
Last Updated
September 15, 2020
Sponsor
Servier Affaires Médicales
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1. Study Identification

Unique Protocol Identification Number
NCT03164187
Brief Title
Evaluation of Type 2 Diabetes Treatment
Official Title
Evaluation of Type 2 Diabetes Treatment in AZERbaijan
Study Type
Observational

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
May 15, 2017 (Actual)
Study Completion Date
June 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Servier Affaires Médicales

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes

7. Study Design

Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diabeton MR 60
Intervention Type
Drug
Intervention Name(s)
Diabeton 60 MR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decrease in HbA1c
Time Frame
over 4 months
Title
Percentage of patients achieving HbA1c level ≤ 7 %
Time Frame
week 16.
Secondary Outcome Measure Information:
Title
number of hypoglycemia episodes
Time Frame
Week 0, 2, 4, 6, 8 and week 16.
Title
Mean daily dosage of Diabeton MR
Time Frame
Week 2, 4, 6, 8 and 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Azerbaijan Republic Ministry of Health Republic Endocrinology Center
City
Baku
ZIP/Postal Code
AZ 1/122
Country
Azerbaijan
Facility Name
Azer-Turk Med clinic
City
Baku
ZIP/Postal Code
AZ 1025
Country
Azerbaijan
Facility Name
Hospital of oil workers, polyclinics and private clinics
City
Baku
ZIP/Postal Code
AZ 1025
Country
Azerbaijan
Facility Name
Medical Clinic of Azerbaijan Medical University
City
Baku
ZIP/Postal Code
AZ-1078
Country
Azerbaijan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://clinicaltrials.servier.com
Citations:
Citation
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
Results Reference
background
Links:
URL
http://www.journalofdiabetology.org/article.asp?issn=2078-7685;year=2020;volume=11;issue=3;spage=175;epage=182;aulast=Mirzazada;type=0
Description
Scientific publication

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Evaluation of Type 2 Diabetes Treatment

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