Dose-Range Finding Study for MK0893 (0893-008)

Study Overview
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Brief Summary
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A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus).

Official Title
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A Multicenter, Double-Blind, Randomized, Placebo and Active Comparator Controlled Dose-Range Finding Study of MK0893 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: MK0893
* Drug: Metformin
* Drug: Placebo to MK0893
* Drug: Placebo to Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy Exclusion Criteria: Patients have a history of Type 1 Diabetes Mellitus Patients taking insulin or thiazolidinedione (TZD, a peroxisome proliferator-activated receptor [PPAR]-gamma agonist) Patients who have a contraindication to metformin

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 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: MK0893 80 mg<br>MK0893 tablets totaling 80 mg once daily. | Drug: MK0893<br>* MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.<br>Drug: Placebo to MK0893<br>* Dose-matched placebo tablets to MK0893; taken orally once daily.<br>Drug: Placebo to Metformin<br>* Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.<br>|
| Experimental: MK0893 60 mg<br>MK0893 tablets totaling 60 mg once daily. | Drug: MK0893<br>* MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.<br>Drug: Placebo to MK0893<br>* Dose-matched placebo tablets to MK0893; taken orally once daily.<br>Drug: Placebo to Metformin<br>* Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.<br>|
| Experimental: MK0893 40 mg<br>MK0893 40 mg tablet once daily. | Drug: MK0893<br>* MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.<br>Drug: Placebo to MK0893<br>* Dose-matched placebo tablets to MK0893; taken orally once daily.<br>Drug: Placebo to Metformin<br>* Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.<br>|
| Experimental: MK0893 20 mg<br>MK0893 20 mg tablet once daily. | Drug: MK0893<br>* MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.<br>Drug: Placebo to MK0893<br>* Dose-matched placebo tablets to MK0893; taken orally once daily.<br>Drug: Placebo to Metformin<br>* Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.<br>|
| Active Comparator: Metformin<br>Metformin HCL 500 mg tablet twice daily BID titrating up to 1000 mg twice daily over 3 weeks. | Drug: Metformin<br>* Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks.<br>Drug: Placebo to MK0893<br>* Dose-matched placebo tablets to MK0893; taken orally once daily.<br>|
| Placebo Comparator: Placebo<br>PLA tablets. 12 week treatment period. | Drug: Placebo to MK0893<br>* Dose-matched placebo tablets to MK0893; taken orally once daily.<br>Drug: Placebo to Metformin<br>* Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) |  | Week 12 | 
| Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG) |  | Week 12 |