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

> **NCT01028391** · PHASE3 · COMPLETED · sponsor: **Merck Sharp & Dohme LLC** · enrollment: 317 (actual)

## Conditions studied

- Type 2 Diabetes Mellitus

## Interventions

- **DRUG:** Sitagliptin 100 mg q.d.+ Pioglitazone 45 mg q.d.
- **DRUG:** Pioglitazone 45 mg q.d. + Sitagliptin 100 mg placebo q.d.
- **DRUG:** Metformin

## Key facts

- **NCT ID:** NCT01028391
- **Lead sponsor:** Merck Sharp & Dohme LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2007-09-01
- **Primary completion:** 2009-01-01
- **Final completion:** 2009-01-01
- **Target enrollment:** 317 (ACTUAL)
- **Last updated:** 2017-05-12


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01028391

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01028391, "30-Week Extension to an Initial Combination Study (24 Weeks in Duration) of Sitagliptin With Pioglitazone (0431-064)". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT01028391. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
