Recent Updates
Recently added Catalysts

MK-0893

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Jan 2, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment146
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00631488A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015)PHASE2 COMPLETED 146Feb 1, 2008Jan 1, 2009Jan 2, 2017 -
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels
BL, 4 weeks (end of double-blind treatment period)
Secondary Endpoints
Change From BL to Week 4 in Fasting Plasma Glucose (FPG)
BL, 4 weeks (end of double-blind treatment period)
Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC)
BL, 4 weeks (end of double-blind treatment period)
Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC
BL, 4 weeks (end of double-blind treatment period)
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MK-0893 + SitagliptinEXPERIMENTAL -
MK-0893 + MetforminEXPERIMENTAL -
Sitagliptin + MetforminACTIVE_COMPARATOR -
Interventions
NameTypeDescription
MK-0893DRUGInitial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period (4 weeks).
SitagliptinDRUGSitagliptin Phosphate administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).
MetforminDRUGMetformin taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin then administered throughout the double-blind treatment period (4 weeks).
Placebo for MK-0893DRUGMatching placebo for MK-0893 was orally administered for the loading dose (200 mg) and for the following daily treatment (40 mg) over the 4 week double blind treatment period.
Placebo for SitagliptinDRUGMatching placebo for Sitagliptin (100 mg) administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).
Placebo for MetforminDRUGMetformin-matched placebo taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin-matched placebo then administered throughout the double-blind treatment period (4 weeks).
Unlock Study Design Details
Eligibility Criteria
Age Range21 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Participants who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy Exclusion Criteria: * Participants have a history of Type 1 Diabetes Mellitus * Par...

Unlock Eligibility Criteria