Phase 3
Completed N=317
30-Week Extension to an Initial Combination Study (24 Weeks in Duration) of Sitagliptin With Pioglitazone (0431-064)
Source: ClinicalTrials.gov NCT01028391 ↗Enrolled (actual)
317
Serious AEs
2.5%
Results posted
Feb 2010
Primary outcomePrimary: Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Hemoglobin A1c (HbA1c) at Week 54 — -2.37; -1.86 Percent HbA1c
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Hemoglobin A1c (HbA1c) at Week 54 |
-2.37; -1.86 | — |
| SECONDARY Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Fasting Plasma Glucose (FPG) at Week 54 |
-61.3; -52.8 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01028391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.