Trial Outcomes & Findings for Metformin in Overweight Type 2 Diabetes Mellitus (NCT NCT00922194)

NCT ID: NCT00922194

Last Updated: 2010-03-23

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

102 participants

Primary outcome timeframe

Initial and at the end of 12 months or more

Results posted on

2010-03-23

Participant Flow

February 2006 to December 2008; Sircar Diabetes Clinic

Participant milestones

Participant milestones
Measure	Overweight Type 2 Diabetes Mellitus One arm study in Overweight Type 2 Diabetes Mellitus
Metformin in Maximum Tolerated Dose STARTED	102
Metformin in Maximum Tolerated Dose COMPLETED	102
Metformin in Maximum Tolerated Dose NOT COMPLETED	0
Metformin for 12 Months or More STARTED	102
Metformin for 12 Months or More COMPLETED	102
Metformin for 12 Months or More NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Metformin in Overweight Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overweight Type 2 Diabetes Mellitus n=102 Participants One arm study in Overweight Type 2 Diabetes Mellitus
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	92 Participants n=39 Participants
Age, Categorical >=65 years	10 Participants n=39 Participants
Age Continuous	51.16 years STANDARD_DEVIATION 9.75 • n=39 Participants
Sex: Female, Male Female	41 Participants n=39 Participants
Sex: Female, Male Male	61 Participants n=39 Participants
Region of Enrollment India	102 participants n=39 Participants

PRIMARY outcome

Timeframe: Initial and at the end of 12 months or more

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

Outcome measures

Outcome measures
Measure	Overweight Type 2 Diabetes Mellitus n=102 Participants One arm study in Overweight Type 2 Diabetes Mellitus
Change in Weight From Baseline at 12 Months or More	-8.37 Kg Interval -9.03 to -7.72

PRIMARY outcome

Timeframe: Initial and at the end of 12 months or more

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

Outcome measures

Outcome measures
Measure	Overweight Type 2 Diabetes Mellitus n=102 Participants One arm study in Overweight Type 2 Diabetes Mellitus
Change in Body Mass Index (BMI) From Baseline at 12 Months or More	-3.28 kg/m2 Interval -3.5 to -3.0

PRIMARY outcome

Timeframe: Initial and at the end of 12 months or more

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

Outcome measures

Outcome measures
Measure	Overweight Type 2 Diabetes Mellitus n=102 Participants One arm study in Overweight Type 2 Diabetes Mellitus
Change in Waist Circumference From Baseline at 12 Months or More	-7.41 Centimeters Interval -8.37 to -6.47

PRIMARY outcome

Timeframe: Initial and at the end of 12 months or more

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

Outcome measures

Outcome measures
Measure	Overweight Type 2 Diabetes Mellitus n=102 Participants One arm study in Overweight Type 2 Diabetes Mellitus
Change in Waist Circumference (Cms)/Hip Circumference (Cms)From Baseline at 12 Months or More	-0.014 Ratio Interval -0.02 to 0.001

PRIMARY outcome

Timeframe: Initial and at the end of 12 months or more

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

Outcome measures

Outcome measures
Measure	Overweight Type 2 Diabetes Mellitus n=102 Participants One arm study in Overweight Type 2 Diabetes Mellitus
Change in Waist (Cms) /Height (Meters) Ratio From Baseline at 12 Months or More	-4.61 Ratio Interval -5.2 to -3.8

PRIMARY outcome

Timeframe: Initial and at the end of 12 months or more

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

Outcome measures

Outcome measures
Measure	Overweight Type 2 Diabetes Mellitus n=102 Participants One arm study in Overweight Type 2 Diabetes Mellitus
Change in Fasting Blood Glucose From Baseline at 12 Months or More	-2.97 mmol/L Interval -3.57 to -2.38

PRIMARY outcome

Timeframe: Initial and at the end of 12 months or more

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

Outcome measures

Outcome measures
Measure	Overweight Type 2 Diabetes Mellitus n=102 Participants One arm study in Overweight Type 2 Diabetes Mellitus
Change in Glycosylated Haemoglobin (A1C) From Baseline at 12 Months or More	-2.37 Percentage of HbA1c Interval -2.65 to -2.08

Adverse Events

Overweight Type 2 Diabetes Mellitus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amulya R Sircar

Sircar Diabetes Clinic

Phone: + 91 (522) 2324747

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place