A Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose (0000-099)(COMPLETED)

NCT01021527 | Completed Phase 1

• 3 other identifiers: 0000-0990992009_697
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

A four-period study to evaluate if the grade glucose infusion procedure will be able to detect an increase in beta-cell glucose sensitivity from exenatide compared to no treatment in healthy subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose)

  0-160 minutes after start of infusion

Secondary Outcomes (1)

• safety and tolerability of a graded glucose infusion procedure measured by the number of clinical adverse experiences

  11 weeks

Study Arms (6)

Treatment Sequence 1

EXPERIMENTAL

A-B-C-C

Other: Comparator: Treatment A; Drug: Comparator: Treatment B; Drug: Comparator: Treatment C; Procedure: Comparator: graded glucose infusion

Treatment Sequence 2

EXPERIMENTAL

B-C-A-C

Other: Comparator: Treatment A; Drug: Comparator: Treatment B; Drug: Comparator: Treatment C; Procedure: Comparator: graded glucose infusion

Treatment Sequence 3

EXPERIMENTAL

C-A-B-C

Other: Comparator: Treatment A; Drug: Comparator: Treatment B; Drug: Comparator: Treatment C; Procedure: Comparator: graded glucose infusion

Treatment Sequence 4

EXPERIMENTAL

A-C-B-C

Other: Comparator: Treatment A; Drug: Comparator: Treatment B; Drug: Comparator: Treatment C; Procedure: Comparator: graded glucose infusion

Treatment Sequence 5

EXPERIMENTAL

B-A-C-C

Other: Comparator: Treatment A; Drug: Comparator: Treatment B; Drug: Comparator: Treatment C; Procedure: Comparator: graded glucose infusion

Treatment Sequence 6

EXPERIMENTAL

C-B-A-C

Other: Comparator: Treatment A; Drug: Comparator: Treatment B; Drug: Comparator: Treatment C; Procedure: Comparator: graded glucose infusion

Interventions

Comparator: Treatment A OTHER

No Treatment

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4; Treatment Sequence 5; Treatment Sequence 6

Comparator: Treatment B DRUG

single dose administration of exenatide 5ug by subcutaneous injection

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4; Treatment Sequence 5; Treatment Sequence 6

Comparator: Treatment C DRUG

single dose administration of exenatide 10ug by subcutaneous injection

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4; Treatment Sequence 5; Treatment Sequence 6

Comparator: graded glucose infusion PROCEDURE

A stepwise graded infusion of glucose (20% dextrose \[D20\]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods.

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4; Treatment Sequence 5; Treatment Sequence 6

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is in good health
• Subject is a non-smoker

You may not qualify if:

• Subject has irritable bowel disease
• Subject has a history of cancer
• Subject has a history of hypertension requiring treatment
• Subject is unable to refrain from the use of any prescription or non-prescription medication
• Subject consumes excessive amounts of alcohol or caffeine
• Subject has had major surgery, donated blood or participated in another investigational study in the past 4 weeks

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2009
• First Posted: November 30, 2009
• Study Start: February 1, 2008
• Primary Completion: March 1, 2008
• Study Completion: April 1, 2008
• Last Updated: April 28, 2015

Record last verified: 2015-04