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Sitagliptin and Pioglitazone Mechanism of Action Study in Type 2 Diabetes Mellitus (0431-061)

NCT00511108 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2017-05-12

Study results available
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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.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

DRUG

Comparator: sitagliptin phosphate

sitagliptin phosphate 100 mg as oral tablets. Each patient will be administered 1 tablet once daily.

DRUG

Comparator: pioglitazone

pioglitazone 30 mg will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.

DRUG

Comparator: placebo to pioglitazone

pioglitazone 30 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.

DRUG

Comparator: placebo to sitagliptin

sitagliptin phosphate 100 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-11
Primary Completion
2009-02-24
Completion
2009-02-24

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00511108 on ClinicalTrials.gov