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Completed

NCT Number: NCT01204580

ADIponectin and Asymmetric Dimethylarginine (ADMA) Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Jakarta, Indonesia

About this study

The clinical trial will consist of 2 weeks of selection followed by a 12 weeks (3 months) of treatment period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GLIMEPIRIDE + METFORMIN

Drug

Pharmaceutical form: film coated tablet Route of administration: oral Dose regimen: 1 tablet of 1/250 mg per day

Other names: Amaryl-M

Primary outcomes

  1. Adiponectin and Asymmetric Dimethylarginine (ADMA) plasma level changes

    Time frame: from baseline to end of Clinical Trial (12 weeks)

Secondary outcomes

  1. Change in adiponectin and Asymmetric Dimethylarginine (ADMA) plasma levels

    Time frame: at week 8

  2. Pulse Wave Velocity (PWV) change

    Time frame: at week 8 and week 12

  3. Change in Fasting Blood Glucose (FBG)

    Time frame: At week 2, 4, 8 and 12

  4. Change in glycosylated hemoglobin (HbA1c)

    Time frame: at week 12

  5. Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Homeostatic Model Assessment (HOMA-β)

    Time frame: At week 12

  6. Change of Tumor Necrosis Factor- Alfa (TNF-Alfa)

    Time frame: At week 12

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

ADIponectin and ADMA Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination (Amaryl-M)

Acronym: DIAGRAM

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 17, 2010
Registry last updated
Apr 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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