Diabetes Mellitus, Type 2Phase 4DIAGRAMNCT01204580
ADIponectin and Asymmetric Dimethylarginine (ADMA) Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination
A Phase 4 study testing GLIMEPIRIDE + METFORMIN in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Indonesia.
Trial summary
Primary Objective: To evaluate the change in plasma levels of adiponectin and Asymmetric Dimethylarginine (ADMA) in type 2 diabetes patients after 12 weeks of treatment with Amaryl-M Secondary Objectives: 1. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- GLIMEPIRIDE + METFORMIN
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- Dec 2010to Mar 2012
- Phase
- Phase 4
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 2 diabetes mellitus patients
- Patients with HbA1c >or= 7.0% and < 10.0%
- Patients not currently treated with any oral antidiabetic drugs (OADs)
Who cannot join
- Participation in other investigational Clinical Trial
- Current temporary insulin treatment: gestational diabetes, pancreas cancer, surgery etc.
- Women who are pregnant and lactating
- Type 1 diabetes mellitus patients
- Treatment with antihypertensive Angiotensin-Converting Enzyme (ACE)-Inhibitors and/or Angiotensin II Receptor Blocker (ARB) or has just stopped treatment for less than two months
- Treatment with lipid lowering agent statins or has just stopped treatment for less than two months
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- Known hypersensitive to any of the excipients of Amaryl-M, sulphonylureas, sulfonamides or biguanide
- Patients with active smoking or history of smoking cessation less than 2 months
- Patients with history of severe hepatic dysfunction
- Patients with serum creatinine >or= 1.5 mg/dL (male) and >or= 1.4 mg/dL (female)
- Patients with congestive heart failure requiring pharmacologic treatment
- Treatment with antifungal agent especially Miconazole
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ADIponectin and ADMA Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination (Amaryl-M)
Primary Objective:
To evaluate the change in plasma levels of adiponectin and Asymmetric Dimethylarginine (ADMA) in type 2 diabetes patients after 12 weeks of treatment with Amaryl-M
Read more
Secondary Objectives:
- To assess the role of Amaryl-M in the change of plasma levels of adiponectin and ADMA in type 2 diabetes patients after 8 weeks of therapy
- To evaluate the brachial-ankle pulse wave velocity (baPWV) change after 8 and 12 weeks of therapy with Amaryl-M
- To evaluate the efficacy of Amaryl-M in the improvement of patients glycemic level (Fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c))
- To evaluate the change of Tumor Necrosis Factor - Alfa (TNF-Alfa) after 12 weeks of therapy with Amaryl-M
- To evaluate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) change after 12 weeks of therapy with Amaryl-M
- To evaluate the HOMA-β change after 12 weeks of therapy with Amaryl-M
- To evaluate the relationship between adiponectin and ADMA level with FBG or HbA1c level
Read the detailed description
The clinical trial will consist of 2 weeks of selection followed by a 12 weeks (3 months) of treatment period.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- GLIMEPIRIDE + METFORMIN
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLIMEPIRIDE + METFORMINDrug
Also called Amaryl-M
Pharmaceutical form: film coated tablet Route of administration: oral Dose regimen: 1 tablet of 1/250 mg per day
| Study group | Role | What they receive |
|---|---|---|
| Amaryl-M (Glimepiride + Metformin) | Experimental | Glimepiride 1 mg and metformin 250 mg are the active ingredients of Amaryl-M 1/250 mg film coated tablets.
Starting dosage is 1 tablet per day, then dosage titration will be based on the result of patient FBG test. Receives: Drug: GLIMEPIRIDE + METFORMIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adiponectin and Asymmetric Dimethylarginine (ADMA) plasma level changes
Measured: from baseline to end of Clinical Trial (12 weeks)
Secondary outcomes (6)
Change in adiponectin and Asymmetric Dimethylarginine (ADMA) plasma levels
Measured: at week 8
Pulse Wave Velocity (PWV) change
Measured: at week 8 and week 12
Change in Fasting Blood Glucose (FBG)
Measured: At week 2, 4, 8 and 12
Change in glycosylated hemoglobin (HbA1c)
Measured: at week 12
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Homeostatic Model Assessment (HOMA-β)
Measured: At week 12
Change of Tumor Necrosis Factor- Alfa (TNF-Alfa)
Measured: At week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startDec 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204580
- Sponsor's protocol ID
- GLMET_L_04735
- Other IDs
- U1111-1116-8173
- Acronym
- DIAGRAM
- Status last verified
- Apr 2012
- First submitted
- 16 Sep 2010
- Last updated
- 3 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADIponectin and ADMA Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination (Amaryl-M)
- ClinicalTrials.gov ID
- NCT01204580
- Acronym / sponsor ID
- DIAGRAM / GLMET_L_04735
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 17 Sep 2010 (estimated)
- 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.
Primary Objective:
To evaluate the change in plasma levels of adiponectin and Asymmetric Dimethylarginine (ADMA) in type 2 diabetes patients after 12 weeks of treatment with Amaryl-M
Secondary Objectives:
- To assess the role of Amaryl-M in the change of plasma levels of adiponectin and ADMA in type 2 diabetes patients after 8 weeks of therapy
- To evaluate the brachial-ankle pulse wave velocity (baPWV) change after 8 and 12 weeks of therapy with Amaryl-M
- To evaluate the efficacy of Amaryl-M in the improvement of patients glycemic level (Fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c))
- To evaluate the change of Tumor Necrosis Factor - Alfa (TNF-Alfa) after 12 weeks of therapy with Amaryl-M
- To evaluate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) change after 12 weeks of therapy with Amaryl-M
- To evaluate the HOMA-β change after 12 weeks of therapy with Amaryl-M
- To evaluate the relationship between adiponectin and ADMA level with FBG or HbA1c level
Detailed description
The clinical trial will consist of 2 weeks of selection followed by a 12 weeks (3 months) of treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amaryl-M (Glimepiride + Metformin) | Experimental | Drug: GLIMEPIRIDE + METFORMINGlimepiride 1 mg and metformin 250 mg are the active ingredients of Amaryl-M 1/250 mg film coated tablets. Starting dosage is 1 tablet per day, then dosage titration will be based on the result of patient FBG test. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus patients
- Patients with HbA1c >or= 7.0% and < 10.0%
- Patients not currently treated with any oral antidiabetic drugs (OADs)
Key exclusion criteria (13 listed)
- Participation in other investigational Clinical Trial
- Current temporary insulin treatment: gestational diabetes, pancreas cancer, surgery etc.
- Women who are pregnant and lactating
- Type 1 diabetes mellitus patients
- Treatment with antihypertensive Angiotensin-Converting Enzyme (ACE)-Inhibitors and/or Angiotensin II Receptor Blocker (ARB) or has just stopped treatment for less than two months
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 |
|---|---|---|
| GLIMEPIRIDE + METFORMINAlso: Amaryl-MPharmaceutical form: film coated tablet Route of administration: oral Dose regimen: 1 tablet of 1/250 mg per day | Drug | Amaryl-M (Glimepiride + Metformin) |
Primary outcome
Adiponectin and Asymmetric Dimethylarginine (ADMA) plasma level changes
Time frame: from baseline to end of Clinical Trial (12 weeks)
6 secondary outcomes
Change in adiponectin and Asymmetric Dimethylarginine (ADMA) plasma levels
Time frame: at week 8
Pulse Wave Velocity (PWV) change
Time frame: at week 8 and week 12
Change in Fasting Blood Glucose (FBG)
Time frame: At week 2, 4, 8 and 12
Change in glycosylated hemoglobin (HbA1c)
Time frame: at week 12
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Homeostatic Model Assessment (HOMA-β)
Time frame: At week 12
Change of Tumor Necrosis Factor- Alfa (TNF-Alfa)
Time frame: At week 12
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 3 Apr 2012.
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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.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GLIMEPIRIDE + METFORMIN in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Indonesia.
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 3 inclusion and 13 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 3 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adiponectin and Asymmetric Dimethylarginine (ADMA) plasma level changes (time frame: from baseline to end of Clinical Trial (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2012.