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

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: MK8245

• Registration Number: NCT00790556
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-07
• Study First Submitted QC: 2008-11-11
• Study First Posted: 2008-11-13
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2010-09-10
• Results First Submitted QC: 2010-12-17
• Results First Posted: 2011-01-20
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

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

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	MK8245	MK8245

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs)	56 days	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	Day 14 of each 14-day Treatment Period	Changes in HGP were determined during a euglycemic clamp procedure. HGP was evaluated as milligrams per kilogram of glucose produced per minute.