A Study to Assess the Safety and Efficacy of MK8245 in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK8245-005 AM2)

Study Overview
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Brief Summary
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A study to assess the safety and efficacy of MK8245 as monotherapy compared to placebo.

Official Title
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A Phase IIa, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK8245 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: MK8245 5 mg (twice a day) b.i.d.
* Drug: MK8245 50 mg b.i.d.
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have Type 2 Diabetes Mellitus 18 to 65 years of age Exclusion Criteria: History of Type 1 Diabetes or ketoacidosis Have been treated with lipid lowering medications 4 weeks before starting the study Have started on a weight loss program and not in the maintenance phase or have started weight loss medication within the last 12 weeks Have had surgery in the last 30 days History of active liver disease History of coronary heart disease or congestive heart failure Have had a stroke or transient ischemic neurological disorder in the past 6 months Are Human Immunodeficiency Virus (HIV) Positive

Ages Eligible for Study
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Minimum Age: 18 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: MK8245 5 mg b.i.d.<br>MK8245 | Drug: MK8245 5 mg (twice a day) b.i.d.<br>* All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily. Patients randomized to the 5 mg b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.<br>* Other names: MK8245;|
| Experimental: MK8245 50 mg b.i.d.<br>MK8245 | Drug: MK8245 50 mg b.i.d.<br>* All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily. Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.<br>* Other names: MK8245;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily. Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4 | The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A weighted rather than a simple mean is used to avoid overrepresentation of post-meal glucose values. Blood samples for glucose were to be collected immediately prior to (sample -10 minutes), and 0, 15, 30, 60, 90, 120, and 180 minutes after each meal, and overnight (at midnight, 3 AM, and 5 AM) and fasting at 7 AM. Patients were to be domiciled for approximately 26 hours at the site where standard meals were provided and physical activity monitored. | Baseline and Week 4 |