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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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00516074
First received: August 10, 2007
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: exenatide
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in Mean 24-hour Heart Rate From Baseline to Endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor.


Secondary Outcome Measures:
  • Change in Daytime Heart Rate From Baseline to Endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline to endpoint in daytime heart rate as measured by an ambulatory blood pressure monitor

  • Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline to endpoint in nighttime (2400-0600) heart rate as measured by an ambulatory blood pressure monitor

  • Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline to endpoint in average systolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor

  • Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline to endpoint in average diastolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor

  • Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline to endpoint in HbA1c


Enrollment: 54
Study Start Date: September 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by AstraZeneca

Additional 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
Study First Received: August 10, 2007
Results First Received: April 24, 2009
Last Updated: June 6, 2014
Health Authority: Canada: Health Canada
Netherlands: Dutch Health Care Inspectorate

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

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

ClinicalTrials.gov processed this record on November 24, 2014