Type2 DiabetesNCT03164187
Evaluation of Type 2 Diabetes Treatment
An observational study of Type2 Diabetes, run by Servier Affaires Médicales at 4 sites in Azerbaijan.
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Diabeton 60 MR
- Type of treatment
- Pill or oral medicine
- How many people
- 105 participants
- Where
- 4 sitesAzerbaijan
- Study dates
- 1 Sep 2016to 10 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Azerbaijan4 sites
Azerbaijan Republic Ministry of Health Republic Endocrinology Center
Baku, AZ 1/122
Azer-Turk Med clinic
Baku, AZ 1025
Hospital of oil workers, polyclinics and private clinics
Baku, AZ 1025
Medical Clinic of Azerbaijan Medical University
Baku, AZ-1078
About this study
Official title: 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.
- Conditions
- Type2 Diabetes
- Being tested
- Diabeton 60 MR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabeton 60 MRDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Diabeton MR 60 | Not described Receives: Drug: Diabeton 60 MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in HbA1c
Measured: over 4 months
Percentage of patients achieving HbA1c level ≤ 7 %
Measured: week 16.
Secondary outcomes (2)
number of hypoglycemia episodes
Measured: Week 0, 2, 4, 6, 8 and week 16.
Mean daily dosage of Diabeton MR
Measured: Week 2, 4, 6, 8 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start1 Sep 2016
- Primary completion15 May 2017
- Study completion10 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servier Affaires Médicales
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164187
- Sponsor's protocol ID
- EDIAZER
- Status last verified
- Jul 2024
- First submitted
- 12 Apr 2017
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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 Sep-Dec;11(3):175-182. doi: 10.4103/JOD.JOD_5_20
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Type 2 Diabetes Treatment in AZERbaijan
- ClinicalTrials.gov ID
- NCT03164187
- Acronym / sponsor ID
- EDIAZER
- Conditions
- Type2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Servier Affaires MédicalesIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 10 Jun 2017 (actual)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabeton MR 60 | – | Drug: Diabeton 60 MR |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabeton 60 MRAdminister 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. | Drug | Diabeton MR 60 |
Primary outcome
Decrease in HbA1c
Time frame: over 4 months
Percentage of patients achieving HbA1c level ≤ 7 %
Time frame: week 16.
2 secondary outcomes
number of hypoglycemia episodes
Time frame: Week 0, 2, 4, 6, 8 and week 16.
Mean daily dosage of Diabeton MR
Time frame: Week 2, 4, 6, 8 and 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- BackgroundMirzazada 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
- Scientific publicationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2 Diabetes, run by Servier Affaires Médicales at 4 sites in Azerbaijan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Azerbaijan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in HbA1c (time frame: over 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03164187, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.