Trial Outcomes & Findings for Insulin Resistance and Testosterone in Women (NCT NCT00123110)

NCT ID: NCT00123110

Last Updated: 2019-05-23

Results Overview

Percent change in free T by equilibrium dialysis between baseline and 12 weeks

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 35 participants
• Primary outcome timeframe: Baseline to 12 weeks
• Results posted on: 2019-05-23

Participant Flow

The participants were recruited beginning 8/11/05 and continued until the last patient was consented on 4/8/08.

Participant milestones

Measure	Metformin metformin plus leuprolide placebo (LP) injection	Leuprolide leuprolide plus metformin placebo (MP) pill	Placebo MP placebo pill plus LP placebo injection
Overall Study STARTED	12	12	11
Overall Study COMPLETED	12	12	11
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Insulin Resistance and Testosterone in Women

Baseline characteristics by cohort

Measure	Metformin n=12 Participants metformin plus leuprolide placebo (LP) injection	Leuprolide n=12 Participants leuprolide plus metformin placebo (MP) pill	Placebo n=11 Participants MP placebo pill plus LP placebo injection	Total n=35 Participants Total of all reporting groups
Age, Continuous	56 years STANDARD_DEVIATION 4 • n=5 Participants	58 years STANDARD_DEVIATION 7 • n=7 Participants	62 years STANDARD_DEVIATION 7 • n=5 Participants	58 years STANDARD_DEVIATION 7 • n=4 Participants
Sex/Gender, Customized Female	12 participants n=5 Participants	12 participants n=7 Participants	11 participants n=5 Participants	35 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Percent change in free T by equilibrium dialysis between baseline and 12 weeks

Outcome measures

Measure	Metformin n=12 Participants Randomized to metformin plus leuprolide placebo, treating insulin resistance	Leuprolide n=12 Participants Randomized to leuprolide plus metformin placebo, pharmacologic lowering of testosterone	Placebo n=11 Participants Placebo metformin plus placebo leuprolide
Percent Change in Free Testosterone (T)	-6.9 percent change Standard Deviation 22.8	-35.8 percent change Standard Deviation 31.8	12.1 percent change Standard Deviation 17.8

PRIMARY outcome

Timeframe: baseline and 12 weeks

Change in insulin sensitivity (mg/kg/min) calculated from hyperinsulinemic euglycemic clamp

Outcome measures

Measure	Metformin n=12 Participants Randomized to metformin plus leuprolide placebo, treating insulin resistance	Leuprolide n=12 Participants Randomized to leuprolide plus metformin placebo, pharmacologic lowering of testosterone	Placebo n=11 Participants Placebo metformin plus placebo leuprolide
Change in Insulin Sensitivity	0.44 mg/kg/min Standard Deviation 0.80	0.04 mg/kg/min Standard Deviation 0.81	-0.08 mg/kg/min Standard Deviation 0.73

SECONDARY outcome

Timeframe: baseline and 12 weeks

Outcome measures

Measure	Metformin n=12 Participants Randomized to metformin plus leuprolide placebo, treating insulin resistance	Leuprolide n=12 Participants Randomized to leuprolide plus metformin placebo, pharmacologic lowering of testosterone	Placebo n=11 Participants Placebo metformin plus placebo leuprolide
Percent Change in Luteinizing Hormone (LH) From Baseline	4.6 percent change Interval -5.6 to 9.8	-96.5 percent change Interval -210.2 to -46.3	-1.2 percent change Interval -3.9 to 6.6

SECONDARY outcome

Timeframe: baseline and 12 weeks

Insulin resistance calculated from homeostasis model assessment of insulin resistance (HOMA-IR) equation: fasting insulin x fasting glucose / 405. Higher values indicate more insulin resistance.

Outcome measures

Measure	Metformin n=12 Participants Randomized to metformin plus leuprolide placebo, treating insulin resistance	Leuprolide n=12 Participants Randomized to leuprolide plus metformin placebo, pharmacologic lowering of testosterone	Placebo n=11 Participants Placebo metformin plus placebo leuprolide
Percent Change in Homeostasis Model Assessment Index of Insulin Resistance (HOMA-IR)	-31.0 percent change Standard Deviation 24.39	-8.18 percent change Standard Deviation 35.3	4.67 percent change Standard Deviation 38.16

SECONDARY outcome

Timeframe: baseline and 12 weeks

Outcome measures

Measure	Metformin n=12 Participants Randomized to metformin plus leuprolide placebo, treating insulin resistance	Leuprolide n=12 Participants Randomized to leuprolide plus metformin placebo, pharmacologic lowering of testosterone	Placebo n=11 Participants Placebo metformin plus placebo leuprolide
Percent Change in Low Density Lipoprotein (LDL)	-10.8 percent change Standard Deviation 22.2	5.3 percent change Standard Deviation 19.3	25.3 percent change Standard Deviation 50.8

SECONDARY outcome

Timeframe: baseline and 12 weeks

Outcome measures

Measure	Metformin n=12 Participants Randomized to metformin plus leuprolide placebo, treating insulin resistance	Leuprolide n=12 Participants Randomized to leuprolide plus metformin placebo, pharmacologic lowering of testosterone	Placebo n=11 Participants Placebo metformin plus placebo leuprolide
Percent Change in Systolic Blood Pressure	-4.2 percent change Standard Deviation 8.6	4.0 percent change Standard Deviation 13.6	-0.3 percent change Standard Deviation 8.6

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: Data were not collected and the outcome will never be analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 12 weeks

Outcome measures

Measure	Metformin n=12 Participants Randomized to metformin plus leuprolide placebo, treating insulin resistance	Leuprolide n=12 Participants Randomized to leuprolide plus metformin placebo, pharmacologic lowering of testosterone	Placebo n=11 Participants Placebo metformin plus placebo leuprolide
Dehydroepiandrosterone Sulfate (DHEA-S)	2.6 percent change Interval -10.5 to 18.4	0.9 percent change Interval -15.5 to 21.1	-2.9 percent change Interval -17.2 to 8.8

SECONDARY outcome

Timeframe: baseline and 12 weeks

Outcome measures

Measure	Metformin n=12 Participants Randomized to metformin plus leuprolide placebo, treating insulin resistance	Leuprolide n=12 Participants Randomized to leuprolide plus metformin placebo, pharmacologic lowering of testosterone	Placebo n=11 Participants Placebo metformin plus placebo leuprolide
Body Mass Index (BMI)	-1.3 percent change Standard Deviation 3.2	0.1 percent change Standard Deviation 1.5	0.3 percent change Standard Deviation 1.1

Adverse Events

Metformin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Leuprolide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Adverse event data not reported

Additional Information

Anne R. Cappola, M.D., ScM

University of Pennsylvania, School of Medicine

Phone: (215) 573-5359

Email: ACappola@mail.med.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place