# A Study of the Efficacy and Safety of MK-0431D (a Fixed-dose Combination of Sitagliptin and Simvastatin) for the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-266)

> **NCT01678820** · PHASE3 · TERMINATED · sponsor: **Merck Sharp & Dohme LLC** · enrollment: 299 (actual)

## Conditions studied

- Type 2 Diabetes Mellitus

## Interventions

- **DRUG:** Sitagliptin/Simvastatin FDC
- **DRUG:** Sitagliptin
- **DRUG:** Simvastatin
- **DRUG:** Placebo to sitagliptin
- **DRUG:** Placebo to simvastatin
- **DRUG:** Placebo to Sitagliptin/Simvastatin FDC
- **DRUG:** Metformin
- **DRUG:** Glimepiride

## Key facts

- **NCT ID:** NCT01678820
- **Lead sponsor:** Merck Sharp & Dohme LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2012-10-10
- **Primary completion:** 2013-11-01
- **Final completion:** 2013-11-01
- **Target enrollment:** 299 (ACTUAL)
- **Why stopped:** Merck terminated the study for business reasons in November 2013.
- **Last updated:** 2018-08-24


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01678820

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01678820, "A Study of the Efficacy and Safety of MK-0431D (a Fixed-dose Combination of Sitagliptin and Simvastatin) for the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-266)". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT01678820. Licensed CC0.

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