A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)

NCT01034111 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-05-30

Study results available
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Summary

This study will assess, over a 4-week treatment period, the safety and efficacy of the addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who failed to achieve glycemic control on metformin monotherapy.

Conditions

Interventions

DRUG

Sitagliptin phosphate

Sitagliptin 100 mg tablet by mouth once daily for 4 weeks.

DRUG

Metformin

Stable dose of metformin tablet(s) by mouth (at least 1000 mg/day) for 4 weeks.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-01
Primary Completion
2010-10-04
Completion
2010-10-04

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Entities

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 NCT01034111 on ClinicalTrials.gov