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Comparator: Hyperinsulinemic Euglycemic Clamp

Phase 1

Healthy | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Oct 2, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01115712Effects of Pioglitazone on Insulin Sensitivity in Healthy Overweight and Obese Males (MK-0000-170)PHASE1 COMPLETED 35 — — May 1, 2010Sep 1, 2010Oct 2, 2015 - —
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Study Endpoints
Primary Endpoints
Change from baseline in glucose infusion rate (M) during the high dose portion of the hyperinsulinemic euglycemic clamp after 28 days of dosing.
Baseline and 28 days
Change from baseline in glucose infusion rate (M) during the high dose portion of the hyperinsulinemic euglycemic clamp after 14 days of dosing
Baseline and 14 days
Secondary Endpoints
Change from baseline in glucose infusion rate (M) during the low dose portion of the hyperinsulinemic euglycemic clamp after 28 days of dosing.
Baseline and 28 days
Change from baseline in glucose infusion rate (M) during the low dose portion of the hyperinsulinemic euglycemic clamp after 14 days of dosing
Baseline and 14 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Pioglitazone 30 mgACTIVE_COMPARATORPioglitazone 30 mg
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
PlaceboDRUGPlacebo (to match pioglitazone 30 mg) once daily
Comparator: PioglitazoneDRUGPioglitazone 30 mg once daily
Comparator: Hyperinsulinemic Euglycemic ClampDRUGInfusion of Glucose (20% dextrose) to achieve a glucose concentration of 90mg/dL; Infusion of Insulin at a rate of 10 mU/m2/minute from 0 to 180 minutes and at a rate of 40 mU/m2/minute from 180 to 360 minutes; Saline infusion at 60 minutes before the insulin and glucose infusions to keep the antecubital vein open.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Subject has a BMI of greater than 28 kg/m\^2 and less than or equal to 38 kg/m\^2 * Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months * Subject is willing to avoid major dietary changes for the duratio...

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