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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00516074
• Other study ID #: H8O-MC-GWCD
• Status: Completed
• Phase: Phase 3
• First received: August 10, 2007
• Last updated: March 19, 2015
• Start date: September 2007
• Est. completion date: April 2008

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaNetherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
• placebo
subcutaneous injection, volume equivalent to active, twice a day

Locations

Country	Name	City	State
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Toronto	Ontario
Netherlands	Research Site	Etten-Leur
Netherlands	Research Site	Leiden
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Countries where clinical trial is conducted

Canada,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean 24-hour Heart Rate From Baseline to Endpoint	Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor.	12 weeks	No
Secondary	Change in Daytime Heart Rate From Baseline to Endpoint	Change from baseline to endpoint in daytime heart rate as measured by an ambulatory blood pressure monitor	12 weeks	No
Secondary	Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint	Change from baseline to endpoint in nighttime (2400-0600) heart rate as measured by an ambulatory blood pressure monitor	12 weeks	No
Secondary	Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint	Change from baseline to endpoint in average systolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor	12 weeks	No
Secondary	Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint	Change from baseline to endpoint in average diastolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor	12 weeks	No
Secondary	Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint	Change from baseline to endpoint in HbA1c	12 weeks	No