A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus (MK0431-074)

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT00813995
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-09
• Study First Submitted: 2008-12-19
• Study First Submitted QC: 2008-12-22
• Study First Posted: 2008-12-23
• Primary Completion: 2010-08-09
• Study Completion: 2010-08-09
• Results First Submitted: 2011-08-09
• Results First Submitted QC: 2011-08-09
• Results First Posted: 2011-09-13
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 395

Inclusion Criteria

• 18 - 78 years of age
• Currently on metformin monotherapy

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Exclusion Criteria

• History of Type 1 diabetes mellitus or ketoacidosis
• Currently on a weight loss program and not in the maintenance phase or has started on a weight loss medication within the last 8 weeks
• Has undergone surgery requiring general anesthesia within the past 4 weeks or has planned major surgery
• Currently participating in a study or has participated in a study with or without an investigational compound or device within the past 12 weeks
• History of active liver disease such as chronic active hepatitis B or C, cirrhosis or symptomatic gallbladder disease
• HIV positive
• Pregnant, breast-feeding or planning to become pregnant during the study
• User of recreational or illicit drugs or has a recent history (within the past year) of drug or alcohol abuse or dependence

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c (A1C) at Week 24	Baseline and Week 24	A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1000 mg/Day	Baseline and Week 24	A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1700 mg/Day	Baseline and Week 24	A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24	Baseline and Week 24	Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Baseline and Week 24	Change from baseline at Week 24 is defined as Week 24 minus Week 0.