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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glimepiride
Metformin
N,N-dimethylarginine
Anti-Arrhythmia Agents
Cardiovascular Agents
Enzyme Inhibitors
Hypoglycemic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014