Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)

Study Overview
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Brief Summary
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The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Official Title
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A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of MK0431 Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Sitagliptin (MK0431)
* Drug: Sitagliptin
* Drug: Placebo
* Drug: Placebo
* Drug: Metformin - Rescue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with type 2 diabetes mellitus Patient is not pregnant or breastfeeding Male or female patient unlikely to conceive Patient not on an antihyperglycemic drug Exclusion Criteria: Patient has history of type 1 diabetes mellitus Patient has history of ketoacidosis Patient requires insulin within 8 weeks prior to start of study Patient on weight loss program and is not in maintenance phase Patient taking weight loss medication within 8 weeks prior to start of study Patient on or likely to require = 14 days or repeated courses of corticosteroids Patient taking immunosuppressive/immunomodulating medication Patient taking digoxin or other cardiac medication Patient has undergone surgical general anesthesia within 30 days prior to start of study Patient taking investigational drug within 8 weeks prior to start of study Patient is diagnosed with liver disease Patient has chronic myopathy, progressive neurological/neuromuscular disorder Patient has with severe cardiac conditions within the last 6 months Patient is Human immunodeficiency virus (HIV) positive Patient has hematological disorder Patient has history of malignancy Patient has history of alcohol or drug abuse within the past 3 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Active Comparator: Sitagliptin 100 mg/100 mg<br>Phase A and B: Oral tablets of sitagliptin 100 mg Once a Day (q.d ) | Drug: Sitagliptin (MK0431)<br>* Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.<br>* Other names: Januvia;Drug: Metformin - Rescue<br>* Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.<br>* Other names: Riomet;|
| Active Comparator: Sitagliptin 200 mg/200 mg<br>Phase A and B: Oral tablets of sitagliptin 200 mg q.d | Drug: Sitagliptin<br>* Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.<br>* Other names: Januvia;Drug: Metformin - Rescue<br>* Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.<br>* Other names: Riomet;|
| Placebo Comparator: Placebo/Sitagliptin 100 mg<br>Phase A: Oral tablets of placebo matching sitagliptin 100 mg q.d. Phase B: Oral tablets of sitagliptin 100 mg q.d. | Drug: Placebo<br>* Phase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.<br>Drug: Metformin - Rescue<br>* Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.<br>* Other names: Riomet;|
| Placebo Comparator: Placebo/Sitagliptin 200 mg<br>Phase A: Oral tablets of placebo matching sitagliptin 200 mg q.d. Phase B: Oral tablets of sitagliptin 200 mg q.d. | Drug: Placebo<br>* Phase A: Placebo matching Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.<br>Drug: Metformin - Rescue<br>* Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.<br>* Other names: Riomet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in A1C at Week 24 | A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. | Weeks 0-24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in FPG at Week 24 | Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG. | Weeks 0-24 | 
| Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24 | Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG. | Weeks 0-24 | 
| Change From Baseline in A1C at Week 104 | A1C is measured as a percent. Thus, this change from baseline reflects the Week 104 A1C percent minus the Week 0 A1C percent. | Weeks 0-104 | 
| Change From Baseline in FPG at Week 104 | Change from baseline at Week 104 is defined as Week 104 FPG minus Week 0 FPG. | Weeks 0-104 | 
| Change From Baseline in 2-hr PMG at Week 104 | Change from baseline at Week 104 is defined as Week 104 2-hr PMG minus Week 0 2-hr PMG. | Weeks 0-104 |