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sitagliptin metformin

Phase 3

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Jun 9, 2017

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment1,763
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00532935MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)PHASE3 COMPLETED 517Jan 26, 2008Oct 23, 2009Jun 9, 2017 -
NCT00482729MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)PHASE3 COMPLETED 1,246Jun 19, 2007Apr 27, 2009Jun 9, 2017 -
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Study Endpoints
Primary Endpoints
Change From Baseline in A1C at Week 32
Baseline and Week 32

A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent

Change From Baseline in Hemoglobin A1c (A1C) at Week 18
Baseline and Week 18

A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.

Secondary Endpoints
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1
Baseline and Week 1
Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32
Baseline and Week 32
Change From Baseline in FPG at Week 32
Baseline and Week 32
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALSitagliptin phosphate (+) metformin hydrochloride
2ACTIVE_COMPARATORpioglitazone
Interventions
NameTypeDescription
sitagliptin phosphate (+) metformin hydrochlorideDRUGsitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an \~32 wk treatment period
Comparator: pioglitazoneDRUGpioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an \~32-wk treatment period.
metforminDRUGmetformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period
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Eligibility Criteria
Age Range18 Years — 78 Years
SexALL
Healthy VolunteersNo

General Inclusion Criteria: * Patient has type 2 diabetes mellitus * Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy General Exclusion Criteria: * Patient has a history of type 1 diabetes mellitus or history of ketoacidosis * Patient was on a...

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