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Metformin in Overweight Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Era's Lucknow Medical College
ClinicalTrials.gov Identifier:
NCT00922194
First received: February 17, 2009
Last updated: March 15, 2010
Last verified: July 2009
History of Changes
  Purpose

The study included 102 overweight type 2 diabetes mellitus patients with a body mass index (BMI) of more than 25 in an open label study. They were advised intensive life style modification which was reinforced at each follow-up visit. In addition they were prescribed extended release metformin (XR) in a gradually increasing tolerable dose, starting with 0.5g twice a day after meals. In addition, hypertension and dyslipidemia, when present, were treated with appropriate recommended drugs. Those who completed a satisfactory regular follow-up for at least 12 months or more were then analyzed for changes in their anthropometric measurements and glycemic control.


Condition Intervention
Obesity
Type 2 Diabetes Mellitus
 Drug: Extended Release Metformin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metformin Monotherapy Significantly Improves Anthropometric and Glycemic Values in Overweight Type 2 Diabetes Mellitus: One Year or More Prospective Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Era's Lucknow Medical College:

Primary Outcome Measures:
  • Change in Weight From Baseline at 12 Months or More [ Time Frame: Initial and at the end of 12 months or more ] [ Designated as safety issue: No ]
    Change: Weight after 12 months of therapy or more - weight at baseline

  • Change in Body Mass Index (BMI) From Baseline at 12 Months or More [ Time Frame: Initial and at the end of 12 months or more ] [ Designated as safety issue: No ]
    Change: Body Mass Index (BMI) after 12 months of therapy or more - BMI at baseline

  • Change in Waist Circumference From Baseline at 12 Months or More [ Time Frame: Initial and at the end of 12 months or more ] [ Designated as safety issue: No ]
    Change: Waist circumference after 12 months or more of therapy - Waist circumference at baseline

  • Change in Waist Circumference (Cms)/Hip Circumference (Cms)From Baseline at 12 Months or More [ Time Frame: Initial and at the end of 12 months or more ] [ Designated as safety issue: No ]
    Change: Waist circumference/Hip circumference ratio after 12 months or more of therapy - Waist circumference/Hip circumference ratio at baseline

  • Change in Waist (Cms) /Height (Meters) Ratio From Baseline at 12 Months or More [ Time Frame: Initial and at the end of 12 months or more ] [ Designated as safety issue: No ]
    Change: Waist/Height ratio after 12 months or more of therapy - Waist/Height ratio at baseline

  • Change in Fasting Blood Glucose From Baseline at 12 Months or More [ Time Frame: Initial and at the end of 12 months or more ] [ Designated as safety issue: No ]
    Change: Fasting blood glucose after 12 months or more of therapy - Fasting blood glucose at baseline

  • Change in Glycosylated Haemoglobin (A1C) From Baseline at 12 Months or More [ Time Frame: Initial and at the end of 12 months or more ] [ Designated as safety issue: No ]
    Change: Glycosylated Haemoglobin after 12 months or more of therapy - Glycosylated Haemoglobin at baseline.


Enrollment: 102
Study Start Date: February 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Extended Release Metformin
    0.5g twice a day to 2g twice a day for at least 12 months or more
    Other Name: Bigsens XR® (Zydus CND)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes Mellitus
  • BMI more than 25

Exclusion Criteria:

  • Type 1 diabetes
  • pancreatic diabetes
  • presence of concomitant endocrinal disorder
  • non-overweight type 2 diabetes
  • type 2 diabetes with secondary failure to sulfonylurea and taking insulin
  • presence of proliferative retinopathy or chronic renal failure
  • known cirrhosis of liver
  • heavy alcoholic
  • presence of active tuberculosis
  • known HIV disease or any active infection
  • major mental illness
  • failure to comply with the exercise advice due to physical incapacity (e.g., severe osteoarthritis, hemiparesis or any other disabling neurological disease)
  • present pregnancy (or planning pregnancy)
  • lactating mothers
  • using any kind of hormones including oral contraceptives, systemic corticosteroids, nicotinic acid
  • use of anti-obesity drug within the past 3 months
  • chronic gastroparesis or chronic severe gastrointestinal symptoms
  • a history of gastric or duodenal ulcers
  • abdominal surgery within 1 year will not be included in the study
  • patients with congestive heart failure or overt nephropathy will also not be included, due to unreliability of anthropometric measurements in such subjects and the relative risk of lactic acidosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922194

Locations
India
Sircar Diabetes Clinic
Lucknow, UP, India, 226006
Sponsors and Collaborators
Era's Lucknow Medical College
Investigators
Principal Investigator: Amulya R Sircar, MD Sircar Diabetes Clinic
  More Information

No publications provided

Responsible Party: Amulya R Sircar, Sircar Diabetes Clinic
ClinicalTrials.gov Identifier: NCT00922194     History of Changes
Other Study ID Numbers: arsircar
Study First Received: February 17, 2009
Results First Received: February 17, 2009
Last Updated: March 15, 2010
Health Authority: India: Indian Council of Medical Research

Keywords provided by Era's Lucknow Medical College:
Type 2 diabetes
Obesity
Extended Release Metformin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013