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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Sitagliptin phosphate; Drug: Metformin

• Registration Number: NCT01034111
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-17
• Study Start: 2010-03-01
• Primary Completion: 2010-10-04
• Study Completion: 2010-10-04
• Results First Submitted: 2011-10-03
• Results First Submitted QC: 2011-10-03
• Results First Posted: 2011-11-06
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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Exclusion Criteria

• Participants has a history of type 1 Diabetes Mellitus or ketoacidosis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sitagliptin	Sitagliptin phosphate	Sitagliptin as add-on therapy to a stable dose of metformin
Sitagliptin	Metformin	Sitagliptin as add-on therapy to a stable dose of metformin

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment	4 weeks	Safety \& tolerability were measured in terms of the # of participants with \>=1 adverse event (AE), \>=1 drug-related AE, \>=1 serious AE (SAE), or discontinued treatment due to an AE. SAEs included events occurring after initiation of glycemic rescue therapy. AE is defined as any unfavorable/unintended change in structure, function, or chemistry of the body temporally associated with the use of SPONSOR's product. SAE is defined as any AE that results in death, is life-threatening, an overdose, causes or prolongs in-patient hospitalization, or considered medically significant by the investigator.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose at Week 4	Baseline and Week 4	Calculated as the mean change from baseline in fasting plasma glucose at Week 4.