Clinical trial NCT00516074: A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes
Official title: A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: exenatide
Byetta
type 2 diabetes
heart rate
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2007-08-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in Mean 24-hour Heart Rate From Baseline to Endpoint
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Daytime Heart Rate From Baseline to Endpoint
timeFrame: 12 weeks
measure: Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint
timeFrame: 12 weeks
measure: Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint
timeFrame: 12 weeks
measure: Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint
timeFrame: 12 weeks
measure: Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Etten-Leur
country: Netherlands
facility: Research Site
city: Leiden
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Utrecht
country: Netherlands
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: Chief Medical Officer, MD
role: STUDY_DIRECTOR
References:
citation: Gill A, Hoogwerf BJ, Burger J, Bruce S, Macconell L, Yan P, Braun D, Giaconia J, Malone J. Effect of exenatide on heart rate and blood pressure in subjects with type 2 diabetes mellitus: a double-blind, placebo-controlled, randomized pilot study. Cardiovasc Diabetol. 2010 Jan 28;9:6. doi: 10.1186/1475-2840-9-6.