---
title: MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)
nct_id: NCT00532935
overall_status: COMPLETED
phase: PHASE3
sponsor: Merck Sharp & Dohme LLC
study_type: INTERVENTIONAL
primary_condition: Type 2 Diabetes Mellitus
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00532935.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00532935"
ct_last_update_post_date: 2017-06-09
last_seen_at: "2026-05-12T06:00:35.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)

**Official Title:** A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of the MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus

**NCT ID:** [NCT00532935](https://clinicaltrials.gov/study/NCT00532935)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 517
- **Lead Sponsor:** Merck Sharp & Dohme LLC
- **Conditions:** Type 2 Diabetes Mellitus
- **Start Date:** 2008-01-26
- **Completion Date:** 2009-10-23
- **CT.gov Last Update:** 2017-06-09

## Brief Summary

A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 78 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
General Inclusion Criteria:

* Patient has type 2 diabetes mellitus
* Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

General Exclusion Criteria:

* Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
* Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 12 weeks
* Patient was on \>4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 3 years
```

## Arms

- **1** (EXPERIMENTAL) — Sitagliptin phosphate (+) metformin hydrochloride
- **2** (ACTIVE_COMPARATOR) — pioglitazone

## Interventions

- **sitagliptin phosphate (+) metformin hydrochloride** (DRUG) — sitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an \~32 wk treatment period
- **Comparator: pioglitazone** (DRUG) — pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an \~32-wk treatment period.

## Primary Outcomes

- **Change From Baseline in A1C at Week 32** _(time frame: Baseline and Week 32)_ — A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent

## Secondary Outcomes

- **Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1** _(time frame: Baseline and Week 1)_
- **Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32** _(time frame: Baseline and Week 32)_
- **Change From Baseline in FPG at Week 32** _(time frame: Baseline and Week 32)_
- **Percent of Participants With A1C <7.0% at Week 32** _(time frame: Week 32)_

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00532935.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00532935*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*