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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Glucoregulatory Effects of Glucagon-like Peptide-1 Receptor (GLP-1 Receptor) Activation in Participants With Type 2 Diabetes Mellitus (MK-0000-222)

NCT01373450

Type 2 Diabetes Mellitus

COMPLETED PHASE1

Incretin Regulation of Insulin Secretion in Monogenic Diabetes

NCT01795144

Monogenic Diabetes

COMPLETED PHASE1

Incretin Hormones in Type 1 Diabetes Mellitus;Effect of Metformin Treatment

NCT04177303

Type 1 Diabetes Mellitus

UNKNOWN PHASE3

Effects of Glucagon Administration on Energy Expenditure

NCT02237053

Hyperglucagonemia Obesity

COMPLETED PHASE1

Effect of GLP-1 on Glucose Metabolism in CNS Assessed by PET

NCT01185119

Healthy

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment sequence 1

OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min - Placebo

Group Type EXPERIMENTAL

Oxyntomodulin (OXM)

Intervention Type DRUG

Single infusion of OXM 3.0 pmol/kg/min by IV

Comparator: Oxyntomodulin (OXM)

Intervention Type DRUG

Single infusion of OXM 0.6 pmol/kg/min by IV

Comparator: Placebo [ hemaccel-containing saline]

Intervention Type DRUG

Single Placebo infusion of hemaccel-containing saline by IV

Treatment sequence 2

OXM 0.6 pmol/kg/min - Placebo - OXM 3.0 pmol/kg/min

Group Type EXPERIMENTAL

Oxyntomodulin (OXM)

Intervention Type DRUG

Single infusion of OXM 3.0 pmol/kg/min by IV

Comparator: Oxyntomodulin (OXM)

Intervention Type DRUG

Single infusion of OXM 0.6 pmol/kg/min by IV

Comparator: Placebo [ hemaccel-containing saline]

Intervention Type DRUG

Single Placebo infusion of hemaccel-containing saline by IV

Treatment sequence 3

Placebo - OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min

Group Type EXPERIMENTAL

Oxyntomodulin (OXM)

Intervention Type DRUG

Single infusion of OXM 3.0 pmol/kg/min by IV

Comparator: Oxyntomodulin (OXM)

Intervention Type DRUG

Single infusion of OXM 0.6 pmol/kg/min by IV

Comparator: Placebo [ hemaccel-containing saline]

Intervention Type DRUG

Single Placebo infusion of hemaccel-containing saline by IV

Treatment sequence 4

OXM 3.0 pmol/kg/min - Placebo - OXM 0.6 pmol/kg/min

Group Type EXPERIMENTAL

Oxyntomodulin (OXM)

Intervention Type DRUG

Single infusion of OXM 3.0 pmol/kg/min by IV

Comparator: Oxyntomodulin (OXM)

Intervention Type DRUG

Single infusion of OXM 0.6 pmol/kg/min by IV

Comparator: Placebo [ hemaccel-containing saline]

Intervention Type DRUG

Single Placebo infusion of hemaccel-containing saline by IV

Treatment sequence 5

Placebo - OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min

Group Type EXPERIMENTAL

Oxyntomodulin (OXM)

Intervention Type DRUG

Single infusion of OXM 3.0 pmol/kg/min by IV

Comparator: Oxyntomodulin (OXM)

Intervention Type DRUG

Single infusion of OXM 0.6 pmol/kg/min by IV

Comparator: Placebo [ hemaccel-containing saline]

Intervention Type DRUG

Single Placebo infusion of hemaccel-containing saline by IV

Treatment sequence 6

OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min - Placebo

Group Type EXPERIMENTAL

Oxyntomodulin (OXM)

Intervention Type DRUG

Single infusion of OXM 3.0 pmol/kg/min by IV

Comparator: Oxyntomodulin (OXM)

Intervention Type DRUG

Single infusion of OXM 0.6 pmol/kg/min by IV

Comparator: Placebo [ hemaccel-containing saline]

Intervention Type DRUG

Single Placebo infusion of hemaccel-containing saline by IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oxyntomodulin (OXM)

Single infusion of OXM 3.0 pmol/kg/min by IV

Intervention Type DRUG

Comparator: Oxyntomodulin (OXM)

Single infusion of OXM 0.6 pmol/kg/min by IV

Intervention Type DRUG

Comparator: Placebo [ hemaccel-containing saline]

Single Placebo infusion of hemaccel-containing saline by IV

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes