Metformin in Overweight Type 2 Diabetes Mellitus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00922194
• Date of registration: 17/02/2009
• Prospective Registration: No
• Primary sponsor: Era's Lucknow Medical College
• Public title: Metformin in Overweight Type 2 Diabetes Mellitus
• Scientific title: Metformin Monotherapy Significantly Improves Anthropometric and Glycemic Values in Overweight Type 2 Diabetes Mellitus: One Year or More Prospective Study.
• Date of first enrolment: February 2006
• Target sample size: 102
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00922194
• Study type: Interventional
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Amulya R Sircar, MD
• Affiliation: Sircar Diabetes Clinic

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Obesity

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Extended Release Metformin

Primary Outcome(s)

Change in Waist Circumference From Baseline at 12 Months or More [Time Frame: Initial and at the end of 12 months or more]

Change in Fasting Blood Glucose From Baseline at 12 Months or More [Time Frame: Initial and at the end of 12 months or more]

Change in Glycosylated Haemoglobin (A1C) From Baseline at 12 Months or More [Time Frame: Initial and at the end of 12 months or more]

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]

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]

Change in Weight From Baseline at 12 Months or More [Time Frame: Initial and at the end of 12 months or more]

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]

Secondary ID(s)

arsircar

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/06/2009
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00922194