ClinicalTrials.Veeva

Menu

Initial Combination With Pioglitazone Study (0431-064)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.
Drug: sitagliptin 100 mg q.d./pioglitazone 30 mg q.d

Study type

Interventional

Funder types

Industry

Identifiers

NCT00397631
0431-064
MK0431-064
2006_531

Details and patient eligibility

About

A clinical study to evaluate the safety and efficacy of the initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes mellitus not on treatment with insulin or oral antihyperglycemic therapy.

Enrollment

520 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

General Inclusion Criteria:

  • Patients ≥18 years old with Type 2 Diabetes Mellitus (a specific type of diabetes)

General Exclusion Criteria:

  • Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
  • Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 4 months
  • Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 2 years

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

520 participants in 2 patient groups

1
Experimental group
Description:
sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.
Treatment:
Drug: sitagliptin 100 mg q.d./pioglitazone 30 mg q.d
2
Active Comparator group
Description:
sitagliptin 100 mg placebo q.d./pioglitazone 30 mg q.d.
Treatment:
Drug: Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems