Trial Outcomes & Findings for Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes (NCT NCT02023918)

NCT ID: NCT02023918

Last Updated: 2017-04-24

Results Overview

Investigators will measure insulin sensitivity via hyperinsulinemic euglycemic clamp prior to the initiation of the study medication and then again at the end of the 28 days to evaluate the effect of pegvisomant on insulin sensitivity and reported as HOMA-IR. HOMA-IR was derived from fasting insulin and fasting glucose by the calculation: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2017-04-24

Participant Flow

Participant milestones

Measure	Pegvisomant Arm Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject. pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes

Baseline characteristics by cohort

Measure	Pegvisomant Arm n=6 Participants pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	56.5 years STANDARD_DEVIATION 3.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Patients were compared after treatment to their own baseline

Investigators will measure insulin sensitivity via hyperinsulinemic euglycemic clamp prior to the initiation of the study medication and then again at the end of the 28 days to evaluate the effect of pegvisomant on insulin sensitivity and reported as HOMA-IR.

HOMA-IR was derived from fasting insulin and fasting glucose by the calculation: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5

Outcome measures

Measure	Pegvisomant Arm n=6 Participants Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.
Insulin Sensitivity Baseline HOMA-IR	3.06 units on a scale Standard Deviation 1.46
Insulin Sensitivity HOMA-IR after 28 days of treatment	3.33 units on a scale Standard Deviation 2.76

SECONDARY outcome

Timeframe: 28 days

Population: Ra glycerol reported

Treatment with pegvisomant is expected to alter lipolysis. To assess this investigators will do fasting and steady state stable isotope measurements prior to treatment with pegvisomant and at day 28 after treatment with pegvisomant.

Outcome measures

Measure	Pegvisomant Arm n=6 Participants Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.
Lipolysis Ra glycerol fasting state baseline	0.20 mg/kg/min Standard Deviation 0.07
Lipolysis Ra glycerol fasting state after 28 days of peg	0.21 mg/kg/min Standard Deviation 0.02
Lipolysis Ra glycerol steady state baseline	-0.01 mg/kg/min Standard Deviation 0.2
Lipolysis Ra glycerol steady state treatment 28 days peg	0.4 mg/kg/min Standard Deviation 0.2

Adverse Events

Pegvisomant Arm

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. Ethan Weiss

UCSF

Phone: 4155140819

Email: ethan.weiss@ucsf.edu

Results disclosure agreements

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