An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)

August 25, 2016 updated by: Merck Sharp & Dohme LLC

A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK0431 Compared With Sulfonylurea Therapy in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy

The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).

Study Overview

Detailed Description

The duration of treatment is 104 weeks.

Study Type

Interventional

Enrollment (Actual)

1172

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are at least 18 years of age and not older than 78 with type 2 diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sitagliptin 100 mg
Sitagliptin 100 mg oral tablets of sitagliptin once daily.
Sitagliptin 100 mg oral tablets of sitagliptin once daily.
Other Names:
  • MK0431
Active Comparator: Glipizide
Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
Other Names:
  • Glipizide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c at Week 52
Time Frame: Baseline and Week 52
HbA1c is measured as percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent.
Baseline and Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c at Week 104
Time Frame: Baseline and Week 104
HbA1c is measured as percent. Thus, this change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.
Baseline and Week 104
Change From Baseline in Body Weight at Week 52
Time Frame: Baseline and Week 52
Change from baseline at Week 52 is defined as Week 52 minus Week 0.
Baseline and Week 52
Change From Baseline in Body Weight at Week 104
Time Frame: Baseline and Week 104
Change from baseline at Week 104 is defined as Week 104 minus Week 0.
Baseline and Week 104
Hypoglycemic Events at Week 52
Time Frame: Baseline to Week 52
Number of participants who reported 1 or more episodes of the adverse experience (AEs) of hypoglycemia.
Baseline to Week 52
Hypoglycemic Events at Week 104
Time Frame: Baseline to Week 104
Number of participants who reported 1 or more episodes of the adverse experience of hypoglycemia.
Baseline to Week 104
Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104
Time Frame: Baseline to Week 104
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Baseline to Week 104
Number of Participants With Serious CAEs at Week 104
Time Frame: Baseline to Week 104
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose.
Baseline to Week 104
Number of Participants With Drug-related CAEs at Week 104
Time Frame: Baseline to Week 104
Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.
Baseline to Week 104
Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104
Time Frame: Baseline to Week 104
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Baseline to Week 104
Number of Participants With Serious LAEs at Week 104
Time Frame: Baseline to Week 104
Serious LAEs are any LAEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Baseline to Week 104
Number of Participants With Drug-related LAEs at Week 104
Time Frame: Baseline to Week 104
Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs.
Baseline to Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

October 22, 2004

First Submitted That Met QC Criteria

October 22, 2004

First Posted (Estimate)

October 25, 2004

Study Record Updates

Last Update Posted (Estimate)

August 26, 2016

Last Update Submitted That Met QC Criteria

August 25, 2016

Last Verified

August 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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