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:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01204580
First received: September 16, 2010
Last updated: April 2, 2012
Last verified: April 2012
  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:

  1. 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
  2. To evaluate the brachial-ankle pulse wave velocity (baPWV) change after 8 and 12 weeks of therapy with Amaryl-M
  3. To evaluate the efficacy of Amaryl-M in the improvement of patients glycemic level (Fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c))
  4. To evaluate the change of Tumor Necrosis Factor - Alfa (TNF-Alfa) after 12 weeks of therapy with Amaryl-M
  5. To evaluate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) change after 12 weeks of therapy with Amaryl-M
  6. To evaluate the HOMA-β change after 12 weeks of therapy with Amaryl-M
  7. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204580

Locations
Indonesia
Sanofi-Aventis Administrative Office
Jakarta, Indonesia
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  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 April 14, 2014