30-Week Extension to an Initial Combination Study (24 Weeks in Duration) of Sitagliptin With Pioglitazone (0431-064)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Pioglitazone 45 mg q.d. + Sitagliptin 100 mg placebo q.d.
Drug: Sitagliptin 100 mg q.d.+ Pioglitazone 45 mg q.d.
Drug: Metformin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01028391
MK0431-064-10
0431-064-10
2009_003

Details and patient eligibility

About

A 30-week extension to a 24-week study assessing the hemoglobin A1c (HbA1c)- and fasting plasma glucose (FPG)-lowering efficacy of the combination of sitagliptin and pioglitazone in patients with type 2 diabetes mellitus (T2DM) with inadequate glycemic control.

Enrollment

317 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Patients must complete the double-blind base study (MK-0431-064-00)(NCT00397631) and have at least 75% compliance with study medication during the base study treatment period. Women of childbearing potential must continue to comply with the protocol-specified contraceptive methods

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

317 participants in 2 patient groups

Sitagliptin + Pioglitazone
Experimental group
Treatment:
Drug: Metformin
Drug: Sitagliptin 100 mg q.d.+ Pioglitazone 45 mg q.d.
Pioglitazone + Placebo
Active Comparator group
Treatment:
Drug: Metformin
Drug: Pioglitazone 45 mg q.d. + Sitagliptin 100 mg placebo q.d.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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