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sitagliptin q.d./metformin ≥ /day

Phase 3

Type 2 Diabetes Mellitus (T2DM) | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: May 12, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment190

FDA Designations

No designations recorded

Clinical trial landscape

sitagliptin q.d./metformin ≥ /day · 1 trial · 1 indication

Phase 3 1
NCT00337610Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)
COMPLETED190 Analytics
PHASE3COMPLETED
Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM)Unlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in A1C at Week 18
Baseline and Week 18

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

Secondary Endpoints

Change From Baseline in FPG at Week 18
Baseline and Week 18
Change From Baseline in 2 Hr-PMG at Week 18
Baseline and Week 18
Change From Baseline in A1C at Week 30
Baseline and Week 30
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
sitagliptin 100 mg once a day (q.d.)/metformin ≥1500 mg a dayEXPERIMENTAL -
sitagliptin 100 mg placebo q.d./ metformin ≥ 1500 mg/dayPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
sitagliptin 100 mg q.d./metformin ≥ 1500 mg/dayDRUGPatients will receive blinded sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.
comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/dayDRUGPatients will receive placebo to match sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.
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Eligibility Criteria

Age Range18 Years to 78 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patient has type 2 diabetes mellitus * Males * Females who are highly unlikely to become pregnant * Patients poorly controlled while taking one or two oral antidiabetic medications Exclusion Criteria: * Patient has a history of type 1 diabetes mellitus or history of ketoacid...

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Frequently asked questions about sitagliptin q.d./metformin ≥ /day

What is Sitagliptin q.d.+ Pioglitazone q.d used for?

Sitagliptin q.d.+ Pioglitazone q.d is an investigational combination of two small-molecule drugs being studied for the treatment of Type 2 Diabetes Mellitus (T2DM). It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 3 clinical development.

Who makes Sitagliptin q.d.+ Pioglitazone q.d?

Sitagliptin q.d.+ Pioglitazone q.d is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting Phase 3 clinical trials to evaluate this combination therapy for Type 2 Diabetes Mellitus.

What phase is Sitagliptin q.d.+ Pioglitazone q.d in?

Sitagliptin q.d.+ Pioglitazone q.d is in Phase 3 clinical development. It is an investigational combination therapy for Type 2 Diabetes Mellitus and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, with a total enrollment of 837 patients.

What clinical trials is Sitagliptin q.d.+ Pioglitazone q.d in?

Sitagliptin q.d.+ Pioglitazone q.d has been studied in three completed Phase 3 trials: NCT00337610, NCT00397631, and NCT01028391. These trials evaluated the combination in patients with Type 2 Diabetes Mellitus, with enrollments of 190, 520, and 317 patients respectively.

Is Sitagliptin q.d.+ Pioglitazone q.d the same as sitagliptin and pioglitazone?

Sitagliptin q.d.+ Pioglitazone q.d is a combination therapy that includes sitagliptin and pioglitazone, administered once daily. It is being studied as a fixed-dose combination for Type 2 Diabetes Mellitus, distinct from the individual drugs used separately.