Metformin in Overweight Type 2 Diabetes Mellitus

NCT00922194 | Completed Results DMC

• 1 other identifier: arsircar
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes; Obesity; Extended Release Metformin

Outcome Measures

Primary Outcomes (7)

• Change in Weight From Baseline at 12 Months or More

  Change: Weight after 12 months of therapy or more - weight at baseline

  Initial and at the end of 12 months or more

• Change in Body Mass Index (BMI) From Baseline at 12 Months or More

  Change: Body Mass Index (BMI) after 12 months of therapy or more - BMI at baseline

  Initial and at the end of 12 months or more

• Change in Waist Circumference From Baseline at 12 Months or More

  Change: Waist circumference after 12 months or more of therapy - Waist circumference at baseline

  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

  Change: Waist circumference/Hip circumference ratio after 12 months or more of therapy - Waist circumference/Hip circumference ratio at baseline

  Initial and at the end of 12 months or more

• Change in Waist (Cms) /Height (Meters) Ratio From Baseline at 12 Months or More

  Change: Waist/Height ratio after 12 months or more of therapy - Waist/Height ratio at baseline

  Initial and at the end of 12 months or more

• Change in Fasting Blood Glucose From Baseline at 12 Months or More

  Change: Fasting blood glucose after 12 months or more of therapy - Fasting blood glucose at baseline

  Initial and at the end of 12 months or more

• Change in Glycosylated Haemoglobin (A1C) From Baseline at 12 Months or More

  Change: Glycosylated Haemoglobin after 12 months or more of therapy - Glycosylated Haemoglobin at baseline.

  Initial and at the end of 12 months or more

Interventions

Extended Release Metformin DRUG

0.5g twice a day to 2g twice a day for at least 12 months or more

Also known as: Bigsens XR® (Zydus CND)

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 Diabetes Mellitus
• BMI more than 25

You may not qualify if:

• 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

Sponsors & Collaborators

• Era's Lucknow Medical College: lead

Study Sites (1)

Sircar Diabetes Clinic

Lucknow, Uttar Pradesh, 226006, India

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Amulya R Sircar
• Organization: Sircar Diabetes Clinic

arsircar@yahoo.com

+ 91 (522) 2324747

Study Officials

• Amulya R Sircar, MD

  Sircar Diabetes Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: June 17, 2009
• Study Start: February 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 23, 2010
• Results First Posted: June 17, 2009

Record last verified: 2009-07

Locations

IN (1)