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Comparator: graded infusion of glucose

Phase 1

Healthy | Unknown | Other |Merck & Company, Inc.|Last Updated: Jul 30, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01021462A Study to Evaluate the Use of a Graded Infusion of Intravenous Glucose in the Assessment of Insulin Secretion Rates (MK-0000-078)PHASE1 COMPLETED 12Aug 1, 2007Sep 1, 2007Jul 30, 2015 -
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Study Endpoints
Primary Endpoints
proper implementation and tolerability of a grade glucose infusion using D20 intravenous infusion measured by glucose, insulin and C-peptide levels
0-160 minutes after start of infusion
Secondary Endpoints
beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose)
0-160 minutes after start of infusion
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Period 1 + Period 2EXPERIMENTALgraded infusion of intravenous glucose
Interventions
NameTypeDescription
Comparator: graded infusion of intravenous glucosePROCEDUREA stepwise graded infusion of glucose (20% dextrose \[D20\]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12mg/kg/min. Procedure will be identical in Period 1 and Period 2.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Subject is in good health * Subject is a non-smoker Exclusion Criteria: * Subject has a history of hypertension requiring treatment * Subject has a history of cancer * Subject's parents of siblings have a history of type 2 diabetes * Subject is unable to refrain from the use...

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