N/A N=102 Treatment

Metformin in Overweight Type 2 Diabetes Mellitus

Obesity · Type 2 Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT00922194 ↗

Enrolled (actual)

102

Serious AEs

—

Results posted

Jun 2009

Primary outcome: Primary: Change in Weight From Baseline at 12 Months or More — -8.37 Kg — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Extended Release Metformin (Drug)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: Era's Lucknow Medical College
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Weight From Baseline at 12 Months or More	-8.37	<0.05 sig
PRIMARY Change in Body Mass Index (BMI) From Baseline at 12 Months or More	-3.28	<0.05 sig
PRIMARY Change in Waist Circumference From Baseline at 12 Months or More	-7.41	<0.05 sig
PRIMARY Change in Waist Circumference (Cms)/Hip Circumference (Cms)From Baseline at 12 Months or More	-0.014	<0.05 sig
PRIMARY Change in Waist (Cms) /Height (Meters) Ratio From Baseline at 12 Months or More	-4.61	<0.05 sig
PRIMARY Change in Fasting Blood Glucose From Baseline at 12 Months or More	-2.97	<0.05 sig
PRIMARY Change in Glycosylated Haemoglobin (A1C) From Baseline at 12 Months or More	-2.37	<0.05 sig

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00922194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.