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A Study to Compare Methodologies for Assessing Glucose-Dependent Insulin Secretion (0000-104)(COMPLETED)

NCT ID: NCT00782418

Last Updated: 2016-12-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-03-31

Brief Summary

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This study will compare graded glucose infusion (GGI) to the hyperglycemic clamp (HGC) for assessment of glucose-dependent insulin secretion (GDIS) using exenatide as a probe.

Detailed Description

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Conditions

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The Methodology Assessment of Glucose Dependent Insulin Secretion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

exenatide 5mcg

Group Type ACTIVE_COMPARATOR

Comparator: exenatide

Intervention Type DRUG

exenatide in two 5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 5mcg doses will be administered, followed by HCG or GGI.

2

exenatide 1.5mcg

Group Type ACTIVE_COMPARATOR

Comparator: exenatide

Intervention Type DRUG

exenatide in two 1.5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 1.5mcg doses will be administered, followed by HCG or GGI.

3

Placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type DRUG

5% osmitrol in two 60 mcL subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 60 mcL doses will be administered, followed by HCG or GGI.

Interventions

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Comparator: exenatide

exenatide in two 5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 5mcg doses will be administered, followed by HCG or GGI.

Intervention Type DRUG

Comparator: exenatide

exenatide in two 1.5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 1.5mcg doses will be administered, followed by HCG or GGI.

Intervention Type DRUG

Comparator: Placebo

5% osmitrol in two 60 mcL subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 60 mcL doses will be administered, followed by HCG or GGI.

Intervention Type DRUG

Other Intervention Names

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Byetta Byetta

Eligibility Criteria

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Inclusion Criteria

* Subject has a Body Mass Index (BMI) of less than or equal to 26 kg/m2 at screening
* Subject is judged to be in good health
* Subject has been a nonsmoker for at least 3 months
* Subject is willing to avoid strenuous physical activity for the duration of the study

Exclusion Criteria

* Subject has a history of high blood pressure requiring treatment
* Subject has a history of diabetes or a family history of diabetes mellitus
* Subject is unable to discontinue all prescription and non-prescription drugs for duration of study
* Subject consumes more than 3 alcoholic beverages per day
* Subject consumes more than 6 servings of caffeinated beverages per day (1 serving = 120mg caffeine)
* Subject has had major surgery or has donated or loss 1 unit of blood within 4 weeks of screening
* Subject has multiple and/or severe allergies to foods or drugs
* Subject is a regular user of illegal drugs
* Subject is unwilling or unable to consume the standardized meals during the study and/or is on a carbohydrate restricted diet
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Countries

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Belgium

References

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Shankar SS, Shankar RR, Mixson LA, Miller DL, Chung C, Cilissen C, Beals CR, Stoch SA, Steinberg HO, Kelley DE. Linearity of beta-cell response across the metabolic spectrum and to pharmacology: insights from a graded glucose infusion-based investigation series. Am J Physiol Endocrinol Metab. 2016 Jun 1;310(11):E865-73. doi: 10.1152/ajpendo.00527.2015. Epub 2016 Apr 12.

Reference Type RESULT
PMID: 27072496 (View on PubMed)

Other Identifiers

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2008_568

Identifier Type: -

Identifier Source: secondary_id

0000-104

Identifier Type: -

Identifier Source: org_study_id