A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-04-30

Brief Summary

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This study will explore the effect of exenatide (given twice a day) versus placebo (given twice a day) treatment on change in mean 24-hour heart rate over a 12 week period of drug exposure in patients with type 2 diabetes.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Exenatide Arm

This arm will receive 5mcg exenatide for 4 weeks, and then 10mcg exenatide for the remaining 8 weeks of the study.

Group Type EXPERIMENTAL

exenatide

Intervention Type DRUG

subcutaneous injection, 5mcg or 10mcg, twice a day

Placebo Arm

This arm will receive placebo injection (volume equivalent to the exenatide injection in the experimental arm).

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

subcutaneous injection, volume equivalent to active, twice a day

Interventions

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exenatide

subcutaneous injection, 5mcg or 10mcg, twice a day

Intervention Type DRUG

placebo

subcutaneous injection, volume equivalent to active, twice a day

Intervention Type DRUG

Other Intervention Names

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Byetta AC2993 LY2148568

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with type 2 diabetes.
* Treated with metformin and/or a thiazolidinedione.
* HbA1c between 6.5% and 9.5%, inclusive.
* Body Mass Index (BMI) \> 25 kg/m\^2 and \< 40 kg/m\^2.

Exclusion Criteria

* Have previously received exenatide or glucagon-like peptide-1 analogs.
* Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
* Receiving beta blockers.
* Receiving treatment with a drug directly affecting gastrointestinal motility, including but not limited to Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.
* Have received treatment with systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route within 6 weeks of screening, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption or bronchodilators.
* Have been treated with drugs that promote weight loss (for example, Adipex® \[phentermine\], Acomplia® \[rimonabant\], Xenical® \[orlistat\], Meridia® \[sibutramine\], Acutrim® \[phenylpropanolamine\], or similar over-the-counter medications) within 3 months of screening.
* Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: \*Insulin; \*Alpha-glucosidase inhibitors (for example, Glyset® \[miglitol\] or Precose® \[acarbose\]); \*Meglitinides (for example, Prandin® \[repaglinide\] or Starlix® \[nateglinide\]); \*Sulfonylureas (for example, Glucotrol® \[glipizide\] or Micronase® \[glyburide\]); \*Dipeptidyl peptidase IV (DPP-IV) inhibitors (for example, Januvia™ \[sitagliptin\])
* Have donated blood within 60 days of screening.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No