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Sitagliptin Added-on to Insulin Study (0431-051)

NCT00395343 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 641

Last updated 2017-05-12

Study results available
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Summary

A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on insulin or insulin/metformin combination therapy.

Conditions

Interventions

DRUG

sitagliptin phosphate

sitagliptin 100 mg tablet qd for a 24-wk treatment period.

DRUG

Comparator : placebo (unspecified)

sitagliptin 100 mg Pbo tablet qd for a 24-wk treatment period.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-11
Primary Completion
2008-10-13
Completion
2008-10-13

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Entities

Diseases
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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 NCT00395343 on ClinicalTrials.gov