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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-09-02

Study results available
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Summary

This was a four-period crossover study to assess the glycemic effects of a single dose of oxyntomodulin (OXM) on the glucose levels in participants with Type 2 diabetes mellitus (T2DM). Participants were randomly assigned to 1 of 6 treatment sequences consisting of 4 treatment periods, with a 7-day wash-out between each treatment period. The primary hypothesis was that during graded glucose infusion (GGI) oxyntomodulin (OXM) is neutral or better than placebo (Pbo) at lowering ambient plasma glucose levels, and at significantly enhancing insulin secretion.

Conditions

Interventions

DRUG

Oxyntomodulin

3.0 pmol/kg/min as an intravenous (IV) infusion in the morning of the day of graded glucose infusion (GGI) (Day 1)

DRUG

Liraglutide 0.6 mg

Single subcutaneous dose in the evening of the day before the GGI (Day-1)

DRUG

Liraglutide 1.2 mg

Single subcutaneous dose in the evening of the day before the GGI (Day-1)

DRUG

Placebo for Oxyntomodulin

IV infusion in the morning of the day of GGI (Day 1)

DRUG

Placebo for Liraglutide

Single subcutaneous dose in the evening of the day before the GGI (Day-1)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-07-31
Completion
2011-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01373450 on ClinicalTrials.gov