Phase 3 · Exenatide

NCT00516074 trial results

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

Participants
54
Status
completed
Completed
2008-04
Sponsor
AstraZeneca

As posted on ClinicalTrials.gov (NCT00516074), updated at source Apr 7, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT00516074 measured first

Change in Mean 24-hour Heart Rate From Baseline to Endpointbeats per minute · 12 weeks · least squares mean
MeasureExenatide BIDn=26Placebon=25
Baseline (Week 0)74.83(2.04)74.47(2.08)
Change at endpoint (Week 12)2.14(1.39)-0.71(1.42)
Side effects by arm

Side effects in NCT00516074

Percent of participants affected. The most common events the registry lists.

EventExenatide BIDPlacebo
Nausea35.7%19.2%
Influenza17.9%26.9%
Hyperglycemia3.6%19.2%
Headache17.9%15.4%
Vomiting7.1%7.7%
Dizziness3.6%7.7%
Depression0%7.7%
Migraine0%7.7%
Restlessness0%7.7%
Cough7.1%0%
Pharyngolaryngeal pain7.1%3.8%
Secondary outcomes

What else it measured

Change in Daytime Heart Rate From Baseline to Endpointbeats per minute · 12 weeks · least squares mean
MeasureExenatide BIDn=26Placebon=25
Baseline (Week 0)75.97(2.22)75.37(2.26)
Change at endpoint (Week 12)2.35(1.59)-0.87(1.62)
Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpointbeats per minute · 12 weeks · least squares mean
MeasureExenatide BIDn=26Placebon=25
Baseline (Week 0)71.54(2.12)71.77(2.16)
Change at endpoint (Week 12)1.43(1.79)-0.28(1.83)
Change in Mean 24 Hour Systolic Blood Pressure From Baseline to EndpointmmHg · 12 weeks · least squares mean
MeasureExenatide BIDn=26Placebon=25
Baseline (Week 0)126.61(3.04)119.93(3.10)
Change at endpoint (Week 12)-0.81(2.67)-0.34(2.72)
Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to EndpointmmHg · 12 weeks · least squares mean
MeasureExenatide BIDn=26Placebon=25
Baseline (Week 0)75.70(2.05)70.54(2.09)
Change at endpoint (Week 12)-0.60(1.49)-2.34(1.52)
Change in Hemoglobin A1c (HbA1c) From Baseline to Endpointpercent · 12 weeks · least squares mean
MeasureExenatide BIDn=27Placebon=25
Baseline (Week 0)7.50(0.16)7.11(0.17)
Change at endpoint (Week 12)-0.15(0.16)0.12(0.17)
The trial

How NCT00516074 was run

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.

  • Exenatide Arm: This arm will receive 5mcg exenatide for 4 weeks, and then 10mcg exenatide for the remaining 8 weeks of the study.
  • Placebo Arm: This arm will receive placebo injection (volume equivalent to the exenatide injection in the experimental arm).
Who could join the trial

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.

Published papers

Papers from NCT00516074

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.