A Study to Assess the Safety and Efficacy of MK8245 in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00846391

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 Drug: Comparator: Placebo	Phase II

MedlinePlus related topics: Diabetes

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Merck:

Primary Outcome Measures:

Assess the effect of MK8245 compared to placebo on 24-hour Weighted Mean Glucose from baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Asses the safety and tolerability of MK8245 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	December 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MK8245	Drug: MK8245 All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily. Arm 1: MK8245 2.5 mg capsules twice daily. Arm 2: MK8245 25 mg capsules twice daily. Treatment period of 4 weeks.
2: Experimental MK8245	Drug: MK8245 All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily. Arm 1: MK8245 2.5 mg capsules twice daily. Arm 2: MK8245 25 mg capsules twice daily. Treatment period of 4 weeks.
3: Placebo Comparator Placebo	Drug: Comparator: Placebo All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily. Arm 3: Placebo capsules b.i.d. Treatment period of 4 weeks.

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 HIV Positive

Contacts and Locations

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

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, California
Call for Information	Recruiting
Walnut Creek, California, United States, 94598
United States, Florida
Call for Information	Recruiting
Orlando, Florida, United States, 32809
Call for Information	Recruiting
Miami, Florida, United States, 33169
United States, Kentucky
Call for Information	Recruiting
Louisville, Kentucky, United States, 40213
United States, North Carolina
Call for Information	Recruiting
Winston-Salem, North Carolina, United States, 27103-3914
United States, Texas
Call for Information	Recruiting
Irving, Texas, United States, 75039
United States, Washington
Call for Information	Recruiting
Renton, Washington, United States, 98057
Colombia, Cundinamarca
Frosst Laboratories Inc.	Recruiting
Bogota, Cundinamarca, Colombia
Contact: Felipe Arbelaez 57-1-592-4400
Lithuania, Lietuva
UAB Merck Sharp & Dohme	Recruiting
Vilnius, Lietuva, Lithuania
Contact: Andrius Bacevicius 3705 2 780 243
Norway
MSD (Norge) AS	Recruiting
Drammen, Norway, 3011
Contact: Gunnar Saeter 47 32 20 7460

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2009_541, MK8245-005
Study First Received:	February 17, 2009
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00846391 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 07, 2009