ADIponectin and Asymmetric Dimethylarginine (ADMA) Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination (DIAGRAM)
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01204580
First received: September 16, 2010
Last updated: April 2, 2012
Last verified: April 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: GLIMEPIRIDE + METFORMIN |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Adiponectin and Asymmetric Dimethylarginine (ADMA) plasma level changes [ Time Frame: from baseline to end of Clinical Trial (12 weeks) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in adiponectin and Asymmetric Dimethylarginine (ADMA) plasma levels [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
- Pulse Wave Velocity (PWV) change [ Time Frame: at week 8 and week 12 ] [ Designated as safety issue: No ]
- Change in Fasting Blood Glucose (FBG) [ Time Frame: At week 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
- Change in glycosylated hemoglobin (HbA1c) [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
- Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Homeostatic Model Assessment (HOMA-β) [ Time Frame: At week 12 ] [ Designated as safety issue: No ]
- Change of Tumor Necrosis Factor- Alfa (TNF-Alfa) [ Time Frame: At week 12 ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | December 2010 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Amaryl-M (Glimepiride + Metformin)
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. |
Drug: GLIMEPIRIDE + METFORMIN
Pharmaceutical form: film coated tablet Route of administration: oral Dose regimen: 1 tablet of 1/250 mg per day
Other Name: Amaryl-M
|
Detailed Description:
The clinical trial will consist of 2 weeks of selection followed by a 12 weeks (3 months) of treatment period.
Eligibility| Ages Eligible for Study: | 40 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Type 2 diabetes mellitus patients
- Patients with HbA1c >or= 7.0% and < 10.0%
- Patients not currently treated with any oral antidiabetic drugs (OADs)
Exclusion criteria:
- 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
- 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01204580 History of Changes |
| Other Study ID Numbers: | GLMET_L_04735, U1111-1116-8173 |
| Study First Received: | September 16, 2010 |
| Last Updated: | April 2, 2012 |
| Health Authority: | Indonesia: Departement Kesehatan (Department of Health) |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glimepiride Metformin N,N-dimethylarginine Hypoglycemic Agents |
Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013