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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01021527

099

0000-099

2009_697

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 6 patient groups

Treatment Sequence 1

Experimental group

Description:

A-B-C-C

Treatment:

Drug: Comparator: Treatment B

Other: Comparator: Treatment A

Drug: Comparator: Treatment C

Procedure: Comparator: graded glucose infusion

Treatment Sequence 2

Experimental group

Description:

B-C-A-C

Treatment:

Drug: Comparator: Treatment B

Other: Comparator: Treatment A

Drug: Comparator: Treatment C

Procedure: Comparator: graded glucose infusion

Treatment Sequence 3

Experimental group

Description:

C-A-B-C

Treatment:

Drug: Comparator: Treatment B

Other: Comparator: Treatment A

Drug: Comparator: Treatment C

Procedure: Comparator: graded glucose infusion

Treatment Sequence 4

Experimental group

Description:

A-C-B-C

Treatment:

Drug: Comparator: Treatment B

Other: Comparator: Treatment A

Drug: Comparator: Treatment C

Procedure: Comparator: graded glucose infusion

Treatment Sequence 5

Experimental group

Description:

B-A-C-C

Treatment:

Drug: Comparator: Treatment B

Other: Comparator: Treatment A

Drug: Comparator: Treatment C

Procedure: Comparator: graded glucose infusion

Treatment Sequence 6

Experimental group

Description:

C-B-A-C

Treatment:

Drug: Comparator: Treatment B

Other: Comparator: Treatment A

Drug: Comparator: Treatment C

Procedure: Comparator: graded glucose infusion