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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00516074
Recruitment Status : Completed
First Posted : August 14, 2007
Results First Posted : June 12, 2009
Last Update Posted : April 7, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: exenatide Drug: placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes
Study Start Date : September 2007
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Exenatide Arm
This arm will receive 5mcg exenatide for 4 weeks, and then 10mcg exenatide for the remaining 8 weeks of the study.
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
Other Names:
  • Byetta
  • AC2993
  • LY2148568
Placebo Comparator: Placebo Arm
This arm will receive placebo injection (volume equivalent to the exenatide injection in the experimental arm).
Drug: placebo
subcutaneous injection, volume equivalent to active, twice a day


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516074


Locations
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada
Canada, Ontario
Research Site
Toronto, Ontario, Canada
Netherlands
Research Site
Etten-Leur, Netherlands
Research Site
Leiden, Netherlands
Research Site
Rotterdam, Netherlands
Research Site
Utrecht, Netherlands
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
Study Director: Chief Medical Officer, MD Eli Lilly and Company
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00516074     History of Changes
Other Study ID Numbers: H8O-MC-GWCD
First Posted: August 14, 2007    Key Record Dates
Results First Posted: June 12, 2009
Last Update Posted: April 7, 2015
Last Verified: March 2015

Keywords provided by AstraZeneca:
exenatide
Byetta
type 2 diabetes
heart rate
Amylin
Lilly

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists