Type 2 Diabetes MellitusPhase 3NCT00516074

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

A Phase 3 study testing exenatide in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: exenatide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 54 participants
Where: 6 sitesin 2 countries
Study dates: Sep 2007to Apr 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

6 sites in 2 countries.

Country

City, postcode or hospital

6 sites in 2 countries

Netherlands4 sites

Research Site
Etten-Leur
Research Site
Leiden
Research Site
Rotterdam
Research Site
Utrecht

Other trials in Netherlands

Canada2 sites

Research Site
Halifax, Nova Scotia
Research Site
Toronto, Ontario

Other trials in Canada

About this study

Conditions: Type 2 Diabetes Mellitus
Being tested: exenatide, placebo
Keywords: exenatide, Byetta, type 2 diabetes, heart rate, Amylin, Lilly
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

exenatideDrug
Also called Byetta, AC2993, LY2148568
subcutaneous injection, 5mcg or 10mcg, twice a day
placeboDrug
subcutaneous injection, volume equivalent to active, twice a day

Study groups in NCT00516074
Study group	Role	What they receive
Exenatide Arm	Experimental	This arm will receive 5mcg exenatide for 4 weeks, and then 10mcg exenatide for the remaining 8 weeks of the study. Receives: Drug: exenatide
Placebo Arm	Placebo comparator	This arm will receive placebo injection (volume equivalent to the exenatide injection in the experimental arm). Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Mean 24-hour Heart Rate From Baseline to Endpoint
Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor.
Measured: 12 weeks

Secondary outcomes (5)

Change in Daytime Heart Rate From Baseline to Endpoint
Change from baseline to endpoint in daytime heart rate as measured by an ambulatory blood pressure monitor
Measured: 12 weeks
Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint
Change from baseline to endpoint in nighttime (2400-0600) heart rate as measured by an ambulatory blood pressure monitor
Measured: 12 weeks
Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint
Change from baseline to endpoint in average systolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor
Measured: 12 weeks
Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint
Change from baseline to endpoint in average diastolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor
Measured: 12 weeks
Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
Change from baseline to endpoint in HbA1c
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Apr 2008

First posted14 Aug 2007 (estimated)
Study startSep 2007
Primary completionApr 2008
Study completionApr 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00516074
Sponsor's protocol ID: H8O-MC-GWCD
Status last verified: Mar 2015
First submitted: 10 Aug 2007
Last updated: 7 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 20109208

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00516074
Acronym / sponsor ID: H8O-MC-GWCD
Conditions: Type 2 Diabetes Mellitus
Keywords: exenatide, Byetta, type 2 diabetes, heart rate, Amylin, Lilly
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Sep 2007
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 14 Aug 2007 (estimated)
Results: Posted 12 Jun 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Exenatide Arm	Experimental	Drug: exenatideThis arm will receive 5mcg exenatide for 4 weeks, and then 10mcg exenatide for the remaining 8 weeks of the study.
Placebo Arm	Placebo comparator	Drug: placeboThis arm will receive placebo injection (volume equivalent to the exenatide injection in the experimental arm).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
exenatideAlso: Byetta, AC2993, LY2148568subcutaneous injection, 5mcg or 10mcg, twice a day	Drug	Exenatide Arm
placebosubcutaneous injection, volume equivalent to active, twice a day	Drug	Placebo Arm

Primary outcome

Change in Mean 24-hour Heart Rate From Baseline to Endpoint
Time frame: 12 weeks
Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor.

5 secondary outcomes

Change in Daytime Heart Rate From Baseline to Endpoint
Time frame: 12 weeks
Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint
Time frame: 12 weeks
Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint
Time frame: 12 weeks
Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint
Time frame: 12 weeks
Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
Time frame: 12 weeks

Results and safety

Results posted to the registry on 12 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exenatide BID	28	22
Placebo	26	23

Primary outcome: Change in Mean 24-hour Heart Rate From Baseline to Endpoint

Time frame: 12 weeks. Least squares mean (Standard Error). Unit: beats per minute

Measure	Exenatide BID n = 26	Placebo n = 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)

Exenatide BID vs Placebo: p = 0.1585, ANCOVA

Population analysed: Intent to treat; Last observation carried forward

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exenatide BID	1 of ?	18 of ?	Not reported
Placebo	1 of ?	21 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20109208Gill 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.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chief Medical Officer, MD study director

Eli Lilly and Company

6 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exenatide in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Netherlands, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mean 24-hour Heart Rate From Baseline to Endpoint (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00516074, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.