Primary outcomeLeast squares mean· 12 weeks
Change in Mean 24-hour Heart Rate From Baseline to Endpoint
| Group | Value (beats per minute) | Spread |
|---|---|---|
| Exenatide BID | 74.83 | 2.04 |
| Placebo | 74.47 | 2.08 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes
NCTNCT00516074 (opens ClinicalTrials.gov in a new tab)Other idH8O-MC-GWCD
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 54 participants (actual)
- Sponsor
- AstraZeneca · Industry
- Design
- Randomized · Double masking
- Countries
2 countries
Canada, Netherlands
- Start
- Sept 2007
- Primary completion
- Apr 2008
- Completion
- Apr 2008
- First posted
- 14 Aug 2007 (estimated)
- Last update posted
- 7 Apr 2015 (estimated)
- Conditions
- Type 2 Diabetes Mellitus
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200720082009
- Ph 3
A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes
NCT00516074Sept 2007 to Apr 2008
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- exenatideDrug
- placeboDrug
Arms2
Experimental
Exenatide Arm
This arm will receive 5mcg exenatide for 4 weeks, and then 10mcg exenatide for the remaining 8 weeks of the study.
Placebo comparator
Placebo Arm
This arm will receive placebo injection (volume equivalent to the exenatide injection in the experimental arm).
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in Mean 24-hour Heart Rate From Baseline to Endpoint
Time frame · 12 weeks
Registry description
Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor.
Secondary outcomes(5)
Change in Daytime Heart Rate From Baseline to Endpoint
Time frame · 12 weeks
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
Change from baseline to endpoint in HbA1c
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(5)
Secondary outcomeLeast squares mean· 12 weeks
Change in Daytime Heart Rate From Baseline to Endpoint
| Group | Value (beats per minute) | Spread |
|---|---|---|
| Exenatide BID | 75.97 | 2.22 |
| Placebo | 75.37 | 2.26 |
Secondary outcomeLeast squares mean· 12 weeks
Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint
| Group | Value (beats per minute) | Spread |
|---|---|---|
| Exenatide BID | 71.54 | 2.12 |
| Placebo | 71.77 | 2.16 |
Secondary outcomeLeast squares mean· 12 weeks
Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint
| Group | Value (mmHg) | Spread |
|---|---|---|
| Exenatide BID | 126.61 | 3.04 |
| Placebo | 119.93 | 3.10 |
Secondary outcomeLeast squares mean· 12 weeks
Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint
| Group | Value (mmHg) | Spread |
|---|---|---|
| Exenatide BID | 75.70 | 2.05 |
| Placebo | 70.54 | 2.09 |
Secondary outcomeLeast squares mean· 12 weeks
Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
| Group | Value (percent) | Spread |
|---|---|---|
| Exenatide BID | 7.50 | 0.16 |
| Placebo | 7.11 | 0.17 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide BID5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study. | – | 1 / ? | 18 / ? |
| PlaceboPlacebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm). | – | 1 / ? | 21 / ? |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2010
6 results
Effect of exenatide on heart rate and blood pressure in subjects with type 2 diabetes mellitus: a double-blind, placebo-controlled, randomized pilot study.
Gill et al. 2010Cardiovascular diabetologycited by 105
PMID 20109208PMC2823663DOI 10.1186/1475-2840-9-6PUB-20109208
CC BY6 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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