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

Phase 2

Terminated

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: MK8245 5 mg (twice a day) b.i.d.; Drug: MK8245 50 mg b.i.d.; Drug: Placebo

• Registration Number: NCT00846391
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

A study to assess the safety and efficacy of MK8245 as monotherapy compared to placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-18
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2010-08-26
• Results First Submitted QC: 2010-08-26
• Results First Posted: 2010-09-21
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Have Type 2 Diabetes Mellitus
• 18 to 65 years of age

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MK8245 5 mg b.i.d.	MK8245 5 mg (twice a day) b.i.d.	MK8245
MK8245 50 mg b.i.d.	MK8245 50 mg b.i.d.	MK8245
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4	Baseline and 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.