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 A, Hoogwerf BJ, Burger J, Bruce S, Macconell L, Yan P, Braun D, Giaconia J, Malone J

Cardiovascular diabetology28 Jan 2010Cited by 105 (Europe PMC)

PMID20109208PMCIDPMC2823663DOI10.1186/1475-2840-9-6PepBankPUB-20109208

Summary

BackgroundCardiovascular effects of glucose-lowering agents are of increasing interest. Our aim was to assess the effects of the glucagon-like peptide-1 receptor agonist exenatide on heart rate (HR) and blood pressure (BP) in subjects with type 2 diabetes mellitus (T2DM).MethodsIn this double-blind, placebo-controlled trial, subjects with T2DM on metformin and/or a thiazolidinedione were randomized to receive exenatide (5 microg for 4 weeks followed by 10 microg) or placebo BID for 12 weeks. Heart rate and BP were assessed with 24-hour ambulatory BP monitoring. The primary measure was change from baseline in mean 24-hour HR.ResultsFifty-four subjects (28 exenatide, 26 placebo) were randomized and comprised the intent-to-treat population. Baseline values (exenatide and placebo) were (mean +/- SE) 74.4 +/- 2.1 and 74.5 +/- 1.9 beats/minute for HR, 126.4 +/- 3.2 and 119.9 +/- 2.8 mm Hg for systolic BP (SBP), and 75.2 +/- 2.1 and 70.5 +/- 2.0 mm Hg for diastolic BP (DBP). At 12 weeks, no significant change from baseline in 24-hour HR was observed with exenatide or placebo (LS mean +/- SE, 2.1 +/- 1.4 versus -0.7 +/- 1.4 beats/minute, respectively; between treatments, p = 0.16). Exenatide therapy was associated with trends toward lower 24-hour, daytime, and nighttime SBP; changes in DBP were similar between groups. No changes in daytime or nighttime rate pressure product were observed. With exenatide, body weight decreased from baseline by -1.8 +/- 0.4 kg (p < 0.0001; treatment difference -1.5 +/- 0.6 kg, p < 0.05). The most frequently reported adverse event with exenatide was mild to moderate nausea.ConclusionsExenatide demonstrated no clinically meaningful effects on HR over 12 weeks of treatment in subjects with T2DM. The observed trends toward lower SBP with exenatide warrant future investigation.Trial registrationNCT00516074.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In subjects with type 2 diabetes, exenatide did not significantly change heart rate versus placebo.
In plain wordsIn people with diabetes, exenatide did not significantly change heart rate compared with placebo.
Peptide
Exenatide (exendin-4)
Outcome
No significant change24-hour heart rate
Study
n = 54
Comparator
placebo
Analysis
Primary
Outcome group
Heart function · Cardiovascular
Studied dose
5 microg BID for 4 weeks followed by 10 microg BID · 12 weeksAs given in this study (human).
Measurements
Change in 24-hour heart rate
2.1 beats/minute
exenatide
Change in 24-hour heart rate
−0.7 beats/minute
placebo
Source sentences
Summary
At 12 weeks, no significant change from baseline in 24-hour HR was observed with exenatide or placebo (LS mean +/- SE, 2.1 +/- 1.4 versus -0.7 +/- 1.4 beats/minute, respectively; between treatments, p = 0.16).
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled trial, subjects with T2DM on metformin and/or a thiazolidinedione were randomized to receive exenatide (5 microg for 4 weeks followed by 10 microg) or placebo BID for 12 weeks.
Show in the study text Report a problemFND-2010920801
02HumanRandomized controlled trialEfficacy outcome
In subjects with type 2 diabetes, exenatide showed trends toward lower 24-hour, daytime, and nighttime systolic pressure.
In plain wordsIn people with diabetes, exenatide showed trends toward lower systolic blood pressure compared with placebo.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeSystolic blood pressure
Study
n = 54
Comparator
placebo
Outcome group
Blood pressure · Cardiovascular
Studied dose
5 microg BID for 4 weeks followed by 10 microg BID · 12 weeksAs given in this study (human).
Source sentences
Summary
Exenatide therapy was associated with trends toward lower 24-hour, daytime, and nighttime SBP; changes in DBP were similar between groups.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled trial, subjects with T2DM on metformin and/or a thiazolidinedione were randomized to receive exenatide (5 microg for 4 weeks followed by 10 microg) or placebo BID for 12 weeks.
Show in the study text Report a problemFND-2010920802
03HumanRandomized controlled trialEfficacy outcome
In subjects with type 2 diabetes, diastolic pressure changes were similar with exenatide and placebo.
In plain wordsIn people with diabetes, diastolic pressure changed similarly with exenatide and placebo.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeDiastolic blood pressure
Study
n = 54
Comparator
placebo
Outcome group
Blood pressure · Cardiovascular
Studied dose
5 microg BID for 4 weeks followed by 10 microg BID · 12 weeksAs given in this study (human).
Source sentences
Summary
Exenatide therapy was associated with trends toward lower 24-hour, daytime, and nighttime SBP; changes in DBP were similar between groups.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled trial, subjects with T2DM on metformin and/or a thiazolidinedione were randomized to receive exenatide (5 microg for 4 weeks followed by 10 microg) or placebo BID for 12 weeks.
Show in the study text Report a problemFND-2010920803
04HumanRandomized controlled trialEfficacy outcome
In participants with type 2 diabetes, no daytime or nighttime rate pressure product changes occurred in the exenatide-placebo trial.
In plain wordsIn people with diabetes, daytime and nighttime rate pressure product did not change in the exenatide-placebo trial.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeRate pressure product
Study
n = 54
Outcome group
Heart function · Cardiovascular
Studied dose
5 microg BID for 4 weeks followed by 10 microg BID · 12 weeksAs given in this study (human).
Source sentences
Summary
No changes in daytime or nighttime rate pressure product were observed.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled trial, subjects with T2DM on metformin and/or a thiazolidinedione were randomized to receive exenatide (5 microg for 4 weeks followed by 10 microg) or placebo BID for 12 weeks.
Show in the study text Report a problemFND-2010920804
05HumanRandomized controlled trialEfficacy outcome
In subjects with type 2 diabetes, exenatide reduced body weight more than placebo.
In plain wordsIn people with diabetes, exenatide reduced body weight more than placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseBody weight
Study
n = 54
Comparator
placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
5 microg BID for 4 weeks followed by 10 microg BID · 12 weeksAs given in this study (human).
Measurements
Weight treatment difference
−1.5 kg
exenatide versus placebo
Weight change
−1.8 kg
exenatide
Source sentences
Summary
With exenatide, body weight decreased from baseline by -1.8 +/- 0.4 kg (p < 0.0001; treatment difference -1.5 +/- 0.6 kg, p < 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled trial, subjects with T2DM on metformin and/or a thiazolidinedione were randomized to receive exenatide (5 microg for 4 weeks followed by 10 microg) or placebo BID for 12 weeks.
Show in the study text Report a problemFND-2010920805
06HumanRandomized controlled trialSafety outcome
In subjects with type 2 diabetes, mild to moderate nausea was the most frequent adverse event with exenatide.
In plain wordsIn people with diabetes, mild to moderate nausea was the most frequent adverse event with exenatide.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableNausea
Study
n = 28
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
5 microg BID for 4 weeks followed by 10 microg BID · 12 weeksAs given in this study (human).
Source sentences
Summary
The most frequently reported adverse event with exenatide was mild to moderate nausea.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled trial, subjects with T2DM on metformin and/or a thiazolidinedione were randomized to receive exenatide (5 microg for 4 weeks followed by 10 microg) or placebo BID for 12 weeks.
Show in the study text Report a problemFND-2010920806

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00516074

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

AstraZenecan = 54Sept 2007 to Apr 2008

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 7 Apr 2015

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

MeSH terms

PepBank is a research reference. Talk to a doctor before you use any peptide.