Skip to main content
OpenTrials
Completed

NCT Number: NCT00516074

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Halifax, Nova Scotia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

exenatide

Drug

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

Other names: Byetta, AC2993, LY2148568

Placebo

Drug

subcutaneous injection, volume equivalent to active, twice a day

Primary outcomes

  1. Change in Mean 24-hour Heart Rate From Baseline to Endpoint

    Time frame: 12 weeks

    Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor.

Secondary outcomes

  1. Change in Daytime Heart Rate From Baseline to Endpoint

    Time frame: 12 weeks

    Change from baseline to endpoint in daytime heart rate as measured by an ambulatory blood pressure monitor

  2. Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint

    Time frame: 12 weeks

    Change from baseline to endpoint in nighttime (2400-0600) heart rate as measured by an ambulatory blood pressure monitor

  3. Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint

    Time frame: 12 weeks

    Change from baseline to endpoint in average systolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor

  4. Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint

    Time frame: 12 weeks

    Change from baseline to endpoint in average diastolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor

  5. Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint

    Time frame: 12 weeks

    Change from baseline to endpoint in HbA1c

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 14, 2007
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.