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

NCT ID: NCT01034111

Last Updated: 2017-05-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-01

Study Completion Date

2010-10-04

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sitagliptin

Sitagliptin as add-on therapy to a stable dose of metformin

Group Type EXPERIMENTAL

Sitagliptin phosphate

Intervention Type DRUG

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

Metformin

Intervention Type DRUG

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

Interventions

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Sitagliptin phosphate

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

Intervention Type DRUG

Metformin

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

Intervention Type DRUG

Other Intervention Names

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MK-0431 Januvia Glucophage

Eligibility Criteria

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Inclusion Criteria

* Participants with T2DM failing metformin monotherapy
* Between the ages of 18 and 79

Exclusion Criteria

* Participants has a history of type 1 Diabetes Mellitus or ketoacidosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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2009_705

Identifier Type: -

Identifier Source: secondary_id

0431-178

Identifier Type: -

Identifier Source: org_study_id

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