A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015)

Study Overview
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Brief Summary
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This study will test the effectiveness and safety of treatment with MK-0893 in combination with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.

Official Title
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A Phase IIa, Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of MK0893 in Combination With Sitagliptin or in Combination With Metformin 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: MK-0893
* Drug: Sitagliptin
* Drug: Metformin
* Drug: Placebo for MK-0893
* Drug: Placebo for Sitagliptin
* Drug: Placebo for Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants 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: Participants have a history of Type 1 Diabetes Mellitus Participants taking insulin or thiazolidinediones (TZDs: peroxisome proliferator-activated receptor [PPAR]-gamma agonists) Participants who have a contraindication to metformin or sitagliptin

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 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: MK-0893 + Sitagliptin<br> | Drug: MK-0893<br>* Initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period (4 weeks).<br>Drug: Sitagliptin<br>* Sitagliptin Phosphate administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).<br>* Other names: MK0431;Drug: Placebo for Metformin<br>* Metformin-matched placebo taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin-matched placebo then administered throughout the double-blind treatment period (4 weeks).<br>|
| Experimental: MK-0893 + Metformin<br> | Drug: MK-0893<br>* Initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period (4 weeks).<br>Drug: Metformin<br>* Metformin taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin then administered throughout the double-blind treatment period (4 weeks).<br>* Other names: GLUCOPHAGE®;Drug: Placebo for Sitagliptin<br>* Matching placebo for Sitagliptin (100 mg) administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).<br>|
| Active Comparator: Sitagliptin + Metformin<br> | Drug: Sitagliptin<br>* Sitagliptin Phosphate administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).<br>* Other names: MK0431;Drug: Metformin<br>* Metformin taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin then administered throughout the double-blind treatment period (4 weeks).<br>* Other names: GLUCOPHAGE®;Drug: Placebo for MK-0893<br>* Matching placebo for MK-0893 was orally administered for the loading dose (200 mg) and for the following daily treatment (40 mg) over the 4 week double blind treatment period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels |  | BL, 4 weeks (end of double-blind treatment period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From BL to Week 4 in Fasting Plasma Glucose (FPG) |  | BL, 4 weeks (end of double-blind treatment period) | 
| Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC) |  | BL, 4 weeks (end of double-blind treatment period) | 
| Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC | Glucagon-Like Peptide-1 (GLP-1) is an incretin hormone that acts as a potent insulin secretegogue in response to nutrient ingestion and stimulates glucose disposition. The total AUC of Total GLP-1 levels was calculated from blood sample data measured after the morning meal. | BL, 4 weeks (end of double-blind treatment period) | 
| Change From BL to Week 4 in the 2-Hour Active GLP-1 Total AUC | GLP-1 is cleaved from proglucagon to form the active peptide GLP-1. The active form promotes suppression of glucagon secretion. The total AUC of Active GLP-1 levels was calculated from blood sample data measured after the morning meal. | BL, 4 weeks (end of double-blind treatment period) |