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

This study has been terminated.

(Study was terminated due to inability to recruit patients.)

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00846391

First received: February 17, 2009

Last updated: June 3, 2011

Last verified: June 2011

Purpose

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

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: MK8245 5 mg (twice a day) b.i.d. Drug: MK8245 50 mg b.i.d. Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
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.

Enrollment:	14
Study Start Date:	December 2008
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: MK8245
Placebo Comparator: Placebo 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.

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846391

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00846391 History of Changes
Other Study ID Numbers:	MK8245-005, 2009_541
Study First Received:	February 17, 2009
Results First Received:	August 26, 2010
Last Updated:	June 3, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 26, 2012