Evaluation of Type 2 Diabetes Treatment

NCT ID: NCT03164187

Last Updated: 2024-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-01

Study Completion Date

2017-06-10

Brief Summary

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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.

Detailed Description

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Conditions

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Type2 Diabetes

Study Groups

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Diabeton MR 60

Diabeton 60 MR

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Servier Affaires Médicales

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Azerbaijan Republic Ministry of Health Republic Endocrinology Center

Baku, , Azerbaijan

Site Status

Azer-Turk Med clinic

Baku, , Azerbaijan

Site Status

Hospital of oil workers, polyclinics and private clinics

Baku, , Azerbaijan

Site Status

Medical Clinic of Azerbaijan Medical University

Baku, , Azerbaijan

Site Status

Countries

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Azerbaijan

References

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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

Reference Type BACKGROUND

Related Links

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Other Identifiers

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EDIAZER

Identifier Type: -

Identifier Source: org_study_id

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