Phase 3
Completed N=54
A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00516074 ↗Enrolled (actual)
54
Serious AEs
—
Results posted
Jun 2009
Primary outcomePrimary: Change in Mean 24-hour Heart Rate From Baseline to Endpoint — 74.83; 74.47; 2.14; -0.71 beats per minute — p=0.1585
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean 24-hour Heart Rate From Baseline to Endpoint |
74.83; 74.47; 2.14; -0.71 | 0.1585 |
| SECONDARY Change in Daytime Heart Rate From Baseline to Endpoint |
75.97; 75.37; 2.35; -0.87 | 0.1624 |
| SECONDARY Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint |
71.54; 71.77; 1.43; -0.28 | 0.5077 |
| SECONDARY Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint |
126.61; 119.93; -0.81; -0.34 | 0.9034 |
| SECONDARY Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint |
75.70; 70.54; -0.60; -2.34 | 0.4270 |
| SECONDARY Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint |
7.50; 7.11; -0.15; 0.12 | 0.2600 |
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.
Data sourced from ClinicalTrials.gov (NCT00516074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.