A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245 (8245-004)(COMPLETED) - Full Text View

Purpose

A 2-period crossover study to assess the safety, tolerability and glucose-lowering effects of MK8245.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: MK8245 Drug: Comparator: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245

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:

Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs) [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
An LAE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A CAE is defined similarly but also includes changes in structure or function of the body.

Serious AEs are those occuring that result in one or more of the pre-specified outcome(s) that meet the criteria of seriousness, including death, life-threatening, significant disability, or hospitalization, etc.

Drug-relatedness was determined by the investigator based on clinical judgement.
Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14 [ Time Frame: Day 14 of each 14-day Treatment Period ] [ Designated as safety issue: No ]
Changes in HGP were determined during a euglycemic clamp procedure. HGP was evaluated as milligrams per kilogram of glucose produced per minute.

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

Arms	Assigned Interventions
Experimental: 1 MK8245	Drug: MK8245 MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken.
Placebo Comparator: 2 Placebo Comparator	Drug: Comparator: Placebo MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken.

Detailed Description:

Hypothesis: Multiple doses of MK-8245 are sufficiently safe and well tolerated in patients with Type 2 diabetes based on an assessment of clinical and laboratory adverse experiences (AEs), to permit continued clinical investigation.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has a diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or a single oral anti-hyperglycemic agent
Subject is willing to follow the weight-maintaining diet and exercise program or equivalent beginning 4 weeks before receiving study drug, throughout the study and until the post study visit
Subject has been a nonsmoker and/or has not used nicotine-containing products for at least approximately 6 months

Exclusion Criteria:

Subject has a history of stroke, chronic seizures, or major neurological disorder
Subject has a history of neoplastic disease (except non-melanomatous skin carcinoma, carcinoma in situ of the cervix, other malignancies successfully treated at least 10 years prior to screening, or malignancies deemed highly unlikely to recur.)
Subject has a history of Type 1 Diabetes Mellitus and/or history of ketoacidosis
Subject has a history of contact lens use within approximately the previous 6 months
Subject has been diagnosed with dry eye syndrome
Subject has used lipid-lowering therapies in the past 3 months (Subjects on a stable monotherapy dose of statins may be included)
Subject has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 4 weeks of starting in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790556

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00790556 History of Changes
Other Study ID Numbers:	MK-8245-004, 2008_582
Study First Received:	November 7, 2008
Results First Received:	September 10, 2010
Last Updated:	December 17, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 16, 2013