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MK-8245

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Sep 10, 2018

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00972322Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012)PHASE1 COMPLETED 56Aug 24, 2009Jan 26, 2010Sep 10, 2018 -
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Study Endpoints
Primary Endpoints
Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)
Baseline and Day 28

The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A "weighted" rather than a "simple" mean is used to avoid overrepresentation of post-meal glucose values. Blood samples for glucose were collected immediately prior to, and after each meal, and overnight and fasting one hour pre-dose.

Number of Participants Who Experienced Serious or Non-serious Adverse Events
Up to Day 31

An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. A serious AE is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Number of Participants Discontinuing Study Drug Due to an AE
Up to Day 28

An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MK-8245 50 mgEXPERIMENTALMK-8245, 50 mg, twice daily for 28 days
PlaceboPLACEBO_COMPARATORPlacebo to MK-8245, 50 mg, twice daily
Interventions
NameTypeDescription
MK-8245DRUGMK-8245 50 mg twice daily for 28 days
Comparator: placeboDRUGmatching placebo to MK-8245 twice daily for 28 days
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subject has a diagnosis of type 2 diabetes and is being treated with diet and exercise alone, a single oral anti-hyperglycemic agent or a combination of two oral anti-hyperglycemic agents * Subject is willing to follow a weight-maintaining diet and exercise program during the ...

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