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

Study Overview
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Brief Summary
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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).

Detailed Description
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The duration of treatment is 104 weeks.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: sitagliptin (MK0431)
* Drug: Comparator: glipizide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are at least 18 years of age and not older than 78 with type 2 diabetes mellitus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitagliptin 100 mg<br>Sitagliptin 100 mg oral tablets of sitagliptin once daily. | Drug: sitagliptin (MK0431)<br>* Sitagliptin 100 mg oral tablets of sitagliptin once daily.<br>* Other names: MK0431;|
| Active Comparator: Glipizide<br>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. | Drug: Comparator: glipizide<br>* 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.<br>* Other names: Glipizide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c at 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 | 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 | 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 | Change from baseline at Week 104 is defined as Week 104 minus Week 0. | Baseline and Week 104 | 
| Hypoglycemic Events at 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |