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

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

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

Study Overview

• Status: Terminated
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: MK8245 5 mg (twice a day) b.i.d.; Drug: MK8245 50 mg b.i.d.; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 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.
Experimental: MK8245 5 mg b.i.d.; MK8245	Drug: MK8245 5 mg (twice a day) b.i.d.; 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.; Other Names: MK8245
Experimental: MK8245 50 mg b.i.d.; MK8245	Drug: MK8245 50 mg b.i.d.; 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.; Other Names: MK8245

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: February 17, 2009
• First Submitted That Met QC Criteria: February 17, 2009
• First Posted (Estimate): February 18, 2009

Study Record Updates

• Last Update Posted (Estimate): February 5, 2016
• Last Update Submitted That Met QC Criteria: February 4, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 8245-005; 2009_541

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No