Trial Outcomes & Findings for Effects of Pioglitazone on Insulin and Glucose Metabolism in Women With Polycystic Ovary Syndrome (PCOS) (NCT NCT00868140)

Last Updated: 2016-06-10

Results Overview

Change in the Area Under the Curve DCI-IPG measurements in blood samples taken at 15 minute intervals during the 2 hour OGTT before treatment with pioglitazone or placebo. Values reported as a percentage of bioactivity measured at time 0. Negative values indicate a decrease relative to the time 0 measurement.

Recruitment status

TERMINATED

Study phase

Target enrollment

51 participants

Primary outcome timeframe

Baseline

Results posted on

2016-06-10

Participant Flow

Participant milestones

Participant milestones
Measure	1/Pioglitazaone Treated Pioglitazone treated subjects pioglitazone: pioglitazone 45 mg	2/Placebo Placebo control to arm 1 Placebo: placebo daily
Overall Study STARTED	26	25
Overall Study COMPLETED	26	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Pioglitazone on Insulin and Glucose Metabolism in Women With Polycystic Ovary Syndrome (PCOS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1/Pioglitazaone Treated n=16 Participants Pioglitazone treated subjects pioglitazone: pioglitazone 45 mg	2/Placebo n=16 Participants Placebo control to arm 1 Placebo: placebo daily	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Females	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Venezuela	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	1/Pioglitazaone Treated n=16 Participants Pioglitazone pioglitazone: pioglitazone 45 mg	2/Placebo n=16 Participants control to arm 1 Placebo: placebo daily
AUC DCI-IPG (%/Min)	13162.06 % bioactivity at time 0 of OGTT Standard Error 1240.6	14054.17 % bioactivity at time 0 of OGTT Standard Error 1373.1

PRIMARY outcome

Timeframe: 6 months

Change in the Area Under the Curve DCI-IPG measurements in blood samples taken at 15 minute intervals during the 2 hour OGTT following 6 months of treatment with pioglitazone or placebo. Values reported as a percentage of bioactivity measured at time 0. Negative values indicate a decrease relative to the time 0 measurement.

Outcome measures

Outcome measures
Measure	1/Pioglitazaone Treated n=16 Participants Pioglitazone pioglitazone: pioglitazone 45 mg	2/Placebo n=16 Participants control to arm 1 Placebo: placebo daily
AUC DCI-IPG (%/Min)	-412.22 % bioactivity at time 0 of OGTT Standard Error 1295.7	-699.45 % bioactivity at time 0 of OGTT Standard Error 1890.71

PRIMARY outcome

Timeframe: baseline

Fasting serum insulin (uIU.min/ml) measured at 0, 60 and 120 minutes of a 2 hour OGTT before treatment with either pioglitazone or placebo

Outcome measures

Outcome measures
Measure	1/Pioglitazaone Treated n=16 Participants Pioglitazone pioglitazone: pioglitazone 45 mg	2/Placebo n=16 Participants control to arm 1 Placebo: placebo daily
Fasting Serum Insulin	15.04 uIU.min/ml Standard Error 1.23	15.91 uIU.min/ml Standard Error 1.32

PRIMARY outcome

Timeframe: 6 months

Fasting serum insulin (uIU.min/ml) measured at 0, 60 and 120 minutes of a 2 hour OGTT following 6 months treatment with either pioglitazone or placebo

Outcome measures

Outcome measures
Measure	1/Pioglitazaone Treated n=16 Participants Pioglitazone pioglitazone: pioglitazone 45 mg	2/Placebo n=16 Participants control to arm 1 Placebo: placebo daily
Fasting Serum Insulin (uIU/ml)	-8.69 uIU.min/ml Standard Error 1.23	-0.24 uIU.min/ml Standard Error 1.50

SECONDARY outcome

Timeframe: Baseline

Whole body insulin sensitivity as determined by the Matsuda Index as calculated using the following formula: 10,000 divided by the square root of (FPI\* FPG) \* (xGPC\* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load. Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher scores indicating better insulin sensitivity. A value of 2.5 or less is indicative of insulin resistance.

Outcome measures

Outcome measures
Measure	1/Pioglitazaone Treated n=16 Participants Pioglitazone pioglitazone: pioglitazone 45 mg	2/Placebo n=16 Participants control to arm 1 Placebo: placebo daily
Matsuda Index	3.36 units on a scale Standard Error 0.18	3.05 units on a scale Standard Error 0.15

SECONDARY outcome

Timeframe: 6 months

Whole body insulin sensitivity as determined by the Matsuda Index

Outcome measures

Outcome measures
Measure	1/Pioglitazaone Treated n=16 Participants Pioglitazone pioglitazone: pioglitazone 45 mg	2/Placebo n=16 Participants control to arm 1 Placebo: placebo daily
Matsuda Index	4.29 units on a scale Standard Error 0.36	0.29 units on a scale Standard Error 0.17

Adverse Events

1/Pioglitazone

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

2/Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	1/Pioglitazone n=26 participants at risk Pioglitazone in pill form at 45mg twice per day for 6 months pioglitazone: pioglitazone 45 mg	2/Placebo n=25 participants at risk Placebo control to arm 1 in pill form identical to treatment form also twice per day for 6 months Placebo: placebo daily
General disorders Edema	11.5% 3/26 • Number of events 3 • 6 months	0.00% 0/25 • 6 months

Additional Information

Dr. John Nestler

Virginia Commonwealth University

Phone: (804) 828-3389

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place