---
title: Sitagliptin and Pioglitazone Mechanism of Action Study in Type 2 Diabetes Mellitus (0431-061)
nct_id: NCT00511108
overall_status: COMPLETED
phase: PHASE1
sponsor: Merck Sharp & Dohme LLC
study_type: INTERVENTIONAL
primary_condition: Type 2 Diabetes Mellitus (T2DM)
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00511108.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00511108"
ct_last_update_post_date: 2017-05-12
last_seen_at: "2026-05-12T06:01:05.580Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Sitagliptin and Pioglitazone Mechanism of Action Study in Type 2 Diabetes Mellitus (0431-061)

**Official Title:** A Phase I Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Study the Safety, Efficacy, and Mechanism of Action of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet and Exercise

**NCT ID:** [NCT00511108](https://clinicaltrials.gov/study/NCT00511108)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 211
- **Lead Sponsor:** Merck Sharp & Dohme LLC
- **Conditions:** Type 2 Diabetes Mellitus (T2DM)
- **Start Date:** 2007-07-11
- **Completion Date:** 2009-02-24
- **CT.gov Last Update:** 2017-05-12

## Brief Summary

A clinical study to determine the safety, efficacy and mechanism of action of sitagliptin alone and in combination with pioglitazone, in patients with type 2 diabetes mellitus who have inadequate glycemic (blood sugar) control.

## Eligibility

- **Minimum age:** 30 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patient has type 2 diabetes mellitus
* Male
* Female that is highly unlikely to become pregnant
* Patient is not on an antihyperglycemic agent (AHA) (hemoglobin A1c \[A1C\] 7-10%) or on oral single AHA or low-dose combination therapy (A1C 6.5-9.0%)

Exclusion Criteria:

* Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
* Patient has required insulin therapy within the past 12 weeks
* Patient is on or has been taking a Peroxisome Proliferator-Activated Receptor-gamma (PPAR -gamma) agent (i.e. Thiazolidinediones \[TZDs\]) within the prior 12 weeks of the screening visit.
```

## Arms

- **1** (EXPERIMENTAL) — Arm 1: drug
- **2** (ACTIVE_COMPARATOR) — Arm 2: active comparator
- **3** (EXPERIMENTAL) — Arm 3: drug + active comparator
- **4** (PLACEBO_COMPARATOR) — Arm 4: placebo comparator

## Interventions

- **Comparator: sitagliptin phosphate** (DRUG) — sitagliptin phosphate 100 mg as oral tablets. Each patient will be administered 1 tablet once daily.
- **Comparator: pioglitazone** (DRUG) — pioglitazone 30 mg will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
- **Comparator: placebo to pioglitazone** (DRUG) — pioglitazone 30 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
- **Comparator: placebo to sitagliptin** (DRUG) — sitagliptin phosphate 100 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.

## Primary Outcomes

- **Change From Baseline in Glucagon 3-hour Total Area Under the Curve (AUC) After 12 Weeks of Treatment** _(time frame: Baseline and 12 weeks)_ — Glucagon concentration was measured at 9 points during an Meal Tolerance Test (MTT), at times -10, 0, 10, 20, 30, 60, 90, 120, and 180 minutes. Total AUC was calculated over 3 hours including all sample points starting from 0 minutes using the trapezoid method. The change from baseline reflects Week 12 total AUC minus the Week 0 total AUC.
- **Percent Change From Baseline in Index of Static Beta-cell Sensitivity to Glucose After 12 Weeks of Treatment** _(time frame: Baseline and 12 weeks)_ — Static sensitivity is a measure of the effect of glucose on beta cell secretion and is the ratio between the insulin secretion rate and glucose concentration above the threshold level at steady state.

Percent change from baseline was calculated as the difference between index of static sensitivities at Week 12 and at baseline with respect to the index of static sensitivity at baseline times 100.

## Secondary Outcomes

- **Change From Baseline in Glucose 5-hour Total AUC After 12 Weeks of Treatment** _(time frame: Baseline and 12 weeks)_

## Recent Field Changes (last 30 days)

- `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)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — 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/NCT00511108.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00511108*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*