Dipeptidyl Peptidase-4 Inhibition on Glucagon-like Peptide-1 (GLP-1)

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-03-31

Brief Summary

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This research is being done to evaluate the effect of glucagon-like peptide-1 (GLP-1, a naturally occurring hormone) on insulin release and to examine whether there is extra insulin release when GLP-1 is not allowed to be rapidly inactivated.

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Detailed Description

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The purpose of the present proposal is to 1) examine the role of dipeptidyl peptidase (DPP-4) inhibition on insulin release during a hyperglycemic clamp while GLP-1 is being infused and, 2) further elucidate the role of the metabolite of GLP-1, that is GLP-1 9-36 amide (GLP-1m). During stable and very reproducible elevated plasma glucose levels the effect of increased active incretin levels with DPP-4 inhibitors should result in increased plasma insulin levels. Therefore the aim of this protocol is to document whether plasma insulin levels are increased following GLP-1 infusion in the presence or absence of DPP-4 inhibitors. Additionally, the investigators have shown that some improvement in glucose homeostasis during GLP-1 administration is due in part to the metabolite of GLP-1, i.e. GLP-1 (9-36) amide (GLP-1m). Therefore, the investigators will also test the role of the latter by infusing GLP-1m when the volunteers are being treated with DPP-4 inhibitors.

Conditions

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Glucose Homeostasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 tablet 100 mg once a day

Januvia

Group Type ACTIVE_COMPARATOR

Januvia

Intervention Type DRUG

1 tablet 100 mg once a day

Interventions

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Placebo

1 tablet 100 mg once a day

Intervention Type DRUG

Januvia

1 tablet 100 mg once a day

Intervention Type DRUG

Other Intervention Names

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Sugar pill Sitagliptin

Eligibility Criteria

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Inclusion Criteria

* Hct level of at least 34% for women and 36% for men
* Women of non-bearing potential and women of childbearing potential using adequate contraception
* Serum creatine level of less than 1.7 mg/dl
* Four groups:

* Age 21-45 (BMI between 18.50-24.99) \& (BMI between 30-35)
* Age greater than 65 years (BMI between 18.50-24.99) \& (BMI between 30-35)

* Serum creatine level greater than 1.8 mg/dl
* Age less than 21 and age between 46-64
* Diabetes mellitus
* BMI less than 18 and BMI greater than 35