Type 2 DiabetesPhase 4NCT02162550
Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus
A Phase 4 study testing Bydureon in people with Type 2 Diabetes, run by Phoenix VA Health Care System at 1 site in United States.
Trial summary
Investigators will be determining whether a once weekly injectable medication Bydureon versus placebo is able to reduce the development of atherosclerosis. Investigators are testing the overall hypothesis that 18 months of Bydureon treatment will improve cardiovascular risk factors, endothelial function and retard… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Bydureon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Sep 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males and females of any race and ethnicity with T2DM, HbA1c of ≥6.5% and ≤10.0% on diet only
- take stable doses of oral antihyperglycemic agents with or without long-acting insulin
- must have a regular primary care provider (PCP) that is amenable to patient study participation and will facilitate (blinded to the treatment) the research team's study protocol efforts
Who cannot join
- type 1 diabetes mellitus (T1DM)
- current or recent glucagon-like peptide 1 receptor (GLP-1R) agonist use
- contraindications to MRI (e.g., claustrophobia, ferromagnetic materials, body habitus inappropriate for MRI exam)
- screening carotid ultrasound plaque thickness of <0.75 mm, prior or anticipated carotid stenting or endarterectomy
- recent CVD (past 6 months) or other major illness or conditions affecting risk (e.g., pancreatitis, severe renal disease) or personal or family history of medullary thyroid carcinoma
- patients with Multiple Endocrine Neoplasia syndrome type 2
- serious hypersensitivity to exenatide or any product components
- severe gastrointestinal disease, or pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Phoenix VA Health Care System
Phoenix, Arizona, 85012
About this study
Official title: Effect of Bydureon on Carotid Atherosclerosis Progression in T2DM
Investigators will be determining whether a once weekly injectable medication Bydureon versus placebo is able to reduce the development of atherosclerosis.
Investigators are testing the overall hypothesis that 18 months of Bydureon treatment will improve cardiovascular risk factors, endothelial function and retard carotid atherosclerosis plaque progression in type 2 diabetes mellitus (T2DM). Investigators anticipate these studies will provide novel information about the temporal relationship between Bydureon induced changes in risk factors, endothelial function and atherosclerosis progression.
Read the detailed description
148 typical T2DM patients (ages 21-75) will participate in a rolling recruitment over approximately 2.25 years and be randomly allocated for 18 months to Bydureon (2 mg/week) or matching placebo subcutaneous injections 1x/week in a 2:1 ratio. Participants are expected to have a wide range of cardiovascular (CVD) risk and will therefore allow us to explore the importance of disease extent at baseline as a predictor of response. Blocked randomization will be used to ensure equal distribution of gender and CVD history. Carotid plaque MRI assessments will be performed at baseline, 9 and 18 months.
- Conditions
- Type 2 Diabetes
- Being tested
- Bydureon, placebo
- Keywords
- Type 2 Diabetes, Cardiovascular Disease, Hyperglycemia, Carotid Plaque, Endothelial function, Incretins, Atherosclerosis
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Hyperglycemia, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BydureonDrug
Also called long-acting exenatide
once weekly injection
placeboDrug
Also called inactive agent
once weekly injection
| Study group | Role | What they receive |
|---|---|---|
| Bydureon | Experimental | injectable medication Bydureon Receives: Drug: Bydureon |
| Placebo | Placebo comparator | a similar looking injectable Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in carotid plaque volume
To determine the difference in change in carotid plaque volume, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.
Measured: 18 months
Secondary outcomes (2)
Change in reactive hyperemic index
To determine the effects of long-term Bydureon therapy on vascular function as measured by the difference in fasting and post prandial reactive hyperemic index using peripheral artery tonometry.
Measured: 18 months
Change in carotid plaque composition
To determine the difference in change in carotid plaque composition, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phoenix VA Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Peter Reaven, Phoenix VA Health Care System
- Investigators
- Peter D Reaven, MD, Principal investigator, Carl T. Hayden Medical Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162550
- Sponsor's protocol ID
- 1026
- Status last verified
- Jun 2018
- First submitted
- 27 May 2014
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Subject to VA regulation.
Publications
Koska J, Migrino RQ, Chan KC, Cooper-Cox K, Reaven PD. The Effect of Exenatide Once Weekly on Carotid Atherosclerosis in Individuals With Type 2 Diabetes: An 18-Month Randomized Placebo-Controlled Study. Diabetes Care. 2021 Jun;44(6):1385-1392. doi: 10.2337/dc20-2014. Epub 2021 Jan 25.
PubMed 33495294
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bydureon on Carotid Atherosclerosis Progression in T2DM
- ClinicalTrials.gov ID
- NCT02162550
- Acronym / sponsor ID
- 1026
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Cardiovascular Disease, Hyperglycemia, Carotid Plaque, Endothelial function, Incretins, Atherosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Phoenix VA Health Care SystemUS federal agency
- Study start
- Jun 2014
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 12 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators will be determining whether a once weekly injectable medication Bydureon versus placebo is able to reduce the development of atherosclerosis.
Investigators are testing the overall hypothesis that 18 months of Bydureon treatment will improve cardiovascular risk factors, endothelial function and retard carotid atherosclerosis plaque progression in type 2 diabetes mellitus (T2DM). Investigators anticipate these studies will provide novel information about the temporal relationship between Bydureon induced changes in risk factors, endothelial function and atherosclerosis progression.
Detailed description
148 typical T2DM patients (ages 21-75) will participate in a rolling recruitment over approximately 2.25 years and be randomly allocated for 18 months to Bydureon (2 mg/week) or matching placebo subcutaneous injections 1x/week in a 2:1 ratio. Participants are expected to have a wide range of cardiovascular (CVD) risk and will therefore allow us to explore the importance of disease extent at baseline as a predictor of response. Blocked randomization will be used to ensure equal distribution of gender and CVD history. Carotid plaque MRI assessments will be performed at baseline, 9 and 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bydureon | Experimental | Drug: Bydureoninjectable medication Bydureon |
| Placebo | Placebo comparator | Drug: placeboa similar looking injectable |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- males and females of any race and ethnicity with T2DM, HbA1c of ≥6.5% and ≤10.0% on diet only
- take stable doses of oral antihyperglycemic agents with or without long-acting insulin
- must have a regular primary care provider (PCP) that is amenable to patient study participation and will facilitate (blinded to the treatment) the research team's study protocol efforts
Key exclusion criteria (8 listed)
- type 1 diabetes mellitus (T1DM)
- current or recent glucagon-like peptide 1 receptor (GLP-1R) agonist use
- contraindications to MRI (e.g., claustrophobia, ferromagnetic materials, body habitus inappropriate for MRI exam)
- screening carotid ultrasound plaque thickness of <0.75 mm, prior or anticipated carotid stenting or endarterectomy
- recent CVD (past 6 months) or other major illness or conditions affecting risk (e.g., pancreatitis, severe renal disease) or personal or family history of medullary thyroid carcinoma
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 |
|---|---|---|
| BydureonAlso: long-acting exenatideonce weekly injection | Drug | Bydureon |
| placeboAlso: inactive agentonce weekly injection | Drug | Placebo |
Primary outcome
Change in carotid plaque volume
Time frame: 18 months
To determine the difference in change in carotid plaque volume, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.
2 secondary outcomes
Change in reactive hyperemic index
Time frame: 18 months
Change in carotid plaque composition
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- Derived from this study: PubMed 33495294Koska J, Migrino RQ, Chan KC, Cooper-Cox K, Reaven PD. The Effect of Exenatide Once Weekly on Carotid Atherosclerosis in Individuals With Type 2 Diabetes: An 18-Month Randomized Placebo-Controlled Study. Diabetes Care. 2021 Jun;44(6):1385-1392. doi: 10.2337/dc20-2014. Epub 2021 Jan 25.
- Individual participant dataSharing planned: No. Subject to VA regulation.
Related trials for Type 2 Diabetes
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
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Peter D Reaven, MD principal investigator
Carl T. Hayden Medical Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bydureon in people with Type 2 Diabetes, run by Phoenix VA Health Care System at 1 site in United States.
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 3 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: status not confirmed, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 carotid plaque volume (time frame: 18 months). 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 NCT02162550, 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 14 Jun 2018.