A Study That Will Evaluate Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects (MK-0000-159)(COMPLETED)

Phase 1

Completed

• Conditions: Obesity
• Interventions: Drug: Oxyntomodulin (OXM)

• Registration Number: NCT01055340
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study will test the hypotheses that a single dose of oxyntomodulin (OXM) will be neutral or better than placebo in lowering ambient glucose levels during a graded glucose infusion (GGI) and that a single dose of OXM will lead to a statistically significant increase in the sum of the plasma βOHB + AcAc levels compared to placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-22
• Study First Submitted QC: 2010-01-22
• Study First Posted: 2010-01-25
• Study Start: 2010-04
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Subject is judged to be in good health based on medical history, physical examination, and laboratory safety tests
• Subject has a Body Mass Index of ≥27 kg/m^2 and ≤35 kg/m^2 and weighs ≥70 kg at the prestudy (screening) visit
• Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
• Subject is willing to avoid strenuous physical activity (weight lifting, running, bicycling, etc.) for the duration of the study

Exclusion Criteria

• Subject is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit
• Subject has a history of stroke, chronic seizures, or major neurological disorder
• Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
• Subject has irritable bowel disease, or recurrent occurrences of nausea, vomiting, diarrhea, or abdominal pain
• Subject has a history of hypertension requiring treatment
• Subject has a history of cancer
• Subject has history of diabetes, or family history of diabetes mellitus
• Subject has a history of hypersensitivity to OXM or hemaccel

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment sequence 3	Oxyntomodulin (OXM)	Placebo - OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min
Treatment sequence 4	Oxyntomodulin (OXM)	OXM 3.0 pmol/kg/min - Placebo - OXM 0.6 pmol/kg/min
Treatment sequence 5	Oxyntomodulin (OXM)	Placebo - OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min
Treatment sequence 6	Oxyntomodulin (OXM)	OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min - Placebo
Treatment sequence 1	Oxyntomodulin (OXM)	OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min - Placebo
Treatment sequence 2	Oxyntomodulin (OXM)	OXM 0.6 pmol/kg/min - Placebo - OXM 3.0 pmol/kg/min

Primary Outcome Measures

Name	Time	Method
Ambient plasma glucose concentration during the GGI	Last 160 minutes of OXM/placebo infusion
plasma βOHB + AcAc concentrations	First 300 minutes of OXM/placebo infusion