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

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.