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Type 2 Diabetes MellitusPhase 4NCT01181986

The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and Prediabetes

A Phase 4 study testing Exenatide SC, Exenatide IV and Exendin-9 in people with Type 2 Diabetes Mellitus, run by Carl T. Hayden VA Medical Center at 1 site in United States.

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

The purpose of this investigation is to evaluate whether exenatide, a type 2 diabetes medication, will improve the function of the innermost part of the arterial wall called the endothelium after a fat-enriched meal and to determine how this occurs. Read more about this study

Who is it for?
Ages 35 to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Exenatide SC, Exenatide IV and Exendin-9
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
1 siteUnited States
Study dates
Aug 2010to Dec 2012
Phase
Phase 4
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 35 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • US Veterans
  • type 2 diabetes mellitus (T2D) diagnosed within 3 years with good glycemic control on diet, metformin, or sulfonylurea agents or combinations of these agents (HbA1c ≤8.0%)
  • T2D diagnosed ≥ 5 years prior to study enrollment
  • Impaired glucose tolerance

Who cannot join

  • T2D not meeting inclusion above criteria for duration of diabetes or HbA1c values
  • known or suspected T1D (early onset age, low body mass index, lack of family history)
  • TZD use in the prior 3 months
  • prior regular use of insulin
  • Creatinine >2.0 mg/dl or other laboratory or clinical evidence of kidney disease
  • anemia
Show all 12Show fewer
  • known active liver disease or hepatic enzyme elevation two-and-a half times above normal
  • acute bacterial or viral illness or evidence of other active infection in the past 4 weeks
  • stable or unstable angina or other major illness in the past 6 months
  • Raynaud's disease or any rheumatic disease affecting fingers
  • current regular use of anti-inflammatory medications or antioxidants, including over the counter medications and high dose salicylates (>1 g/day);
  • subjects receiving lipid lowering or anti-hypertension medications must be on stable doses for at least 2 months prior to participation.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Phoenix VA Medical Center

    Phoenix, Arizona, 85012

Other trials in United States

About this study

Official title: Exenatide and Postprandial Endothelial Dysfunction: Effects and Mechanisms

The purpose of this investigation is to evaluate whether exenatide, a type 2 diabetes medication, will improve the function of the innermost part of the arterial wall called the endothelium after a fat-enriched meal and to determine how this occurs. The results of this study will help to determine and understand a novel action of this group of diabetes medications based on the action of naturally occuring gut substances called incretins. This may have a significant impact on cardiovascular health in patients with early and longstanding diabetes.

Read the detailed description

Two independent, double-blinded, crossover substudies will be conducted to test the effect of exenatide on daylong post-meal and fasting endothelial function. We will measure endothelial function measured by peripheral arterial tonometry (EndoPAT2000, Itamar Inc.). Patients with recent onset (<3 years) or established (>5 years, Substudy 1 only) diabetes and impaired sugar tolerance (Substudy 2 only) will be studied. The plan is to complete studies in 75 patients (40 in Substudy 1 and 35 in Substudy 2).

In Substudy 1 patients will get twice a day a skin injection of exenatide (Byetta) or identically looking placebo for 10 days, separated by 14-day period. On the next day after each treatemnt period (day 11), they get just one injection and eat a fat-enriched breakfast. A fatty lunch of similar caloric content will be given 4 hours following the breakfast. Endothelial function will be measured just prior to the injection and every 2 hours for total 8 hours.

In Substudy 2, patients on 3 different days will get infusion of exenatide withg or without a blocking drug exendin-9, and a control test with placebo without exendin-9. Endothelial function will be measured before the infusion and 2 hours later during the final 15 minutes of the infusion cocktails. Patients will not eat any meal during the test visits.

Being tested
Exenatide SC, Exenatide IV, Placebo SC, Exendin-9, Placebo IV
Keywords
Type 2 diabetes mellitus, Impaired glucose tolerance
Medical subject headings
Diabetes Mellitus, Type 2, Glucose Intolerance

What participants receive

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

  • Exenatide SCDrug

    Also called Byetta, exendin-4

    Exenatide 5-10 ug sc BID/10 days

  • Exenatide IVDrug

    Also called exendin-4, Byetta

    50 ng/min intravenously for 45 minutes on 2 out of 3 study visits separated by 5-10 days

  • Placebo SCDrug

    Also called placebo

    Placebo sc BID/10days

  • Exendin-9Drug

    Also called exendin-(9-39)

    Primed (6,000 pM/kg), continuous (600 pM/kg) intravenous infusion for 75 minutes on 1 out of 3 study visits.

  • Placebo IVDrug

    Also called placebo

    Intravenous infusion for 45 minutes on 1 out of 3 visits

Study groups in NCT01181986
Study groupRoleWhat they receive
Exenatide SC (Sub-study 1)ExperimentalStudy groups will be individuals with recent onset (<3 years) or established (>5 years) T2D. The plan is to achieve 40 complete studies of subcutaneous injection of exenatide BID (Byetta®, 5 or 10 µg) or identically looking Placebo SC for 10 days, separated by 14-day washout period. On the next day after each treatment phase, a single dose of the assigned medication will be injected just before a fat-enriched breakfast meal. A lunch meal of similar caloric and nutrient content will be administered 4 hours following the breakfast meal. Endothelial function will be measured just prior to the injection and every 2 hours during 8-hour post-breakfast period.
Receives: Drug: Exenatide SC; Drug: Placebo SC
Exenatide IV (Sub-study 2)ExperimentalStudy group will be individuals with recent onset (<1 year) T2D on diet and impaired glucose tolerance. The plan is to achieve 35 complete studies. The intervention will include 3 randomly ordered visits with intravenous infusion of exenatide in the presence (v1) or absence (v2) of GLP-1 receptor inhibitor exendin-9, and a control test with Placebo IV without exendin-9 (v3). Endothelial function will be measured at baseline and 2 hours later during the final 15 minutes of the infusion cocktails. Study participants will remain fasting during the test visit (3 hours total).
Receives: Drug: Exenatide IV; Drug: Exendin-9; Drug: Placebo IV

What is being measured

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

  1. Reactive Hyperemia Index (RHI)

    Greater RHI reflects greater endothelial function. It is calculated as average post-ischemia pulse magnitude divided by average pre-ischemia pulse magnitude. Results are expressed as least-square means of ANCOVA models.

    Measured: 0, 2, 4, 6 and 8 hours on Day 11 (Sub-study 1); 0 and 120 minutes on test Days 1, 2 & 3 (Sub-study 2)

Secondary outcomes (2)

  1. Plasma Triglycerides

    Triglycerides concentrations were measured before and 2, 4, 6 and 8 hours following study drug. Results are expressed as least-square means of ANCOVA models adjusted for sampling time and intervention sequence.

    Measured: 0, 2, 4, 6 and 8 hours post-study drug on day 11

  2. Plasma Glucose

    Plasma glucose was measured before and 2, 4, 6 and 8 hours following study drug administration. Results are expressed as least-square means of ANCOVA models adjusted for sampling time and intervention sequence.

    Measured: 0, 2, 4, 6, and 8 hours post-study drug on day 11

Timeline

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

  1. First posted16 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01181986
Sponsor's protocol ID
1-10-CT-31
Status last verified
May 2014
First submitted
13 Aug 2010
Last updated
20 May 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Exenatide SC, Exenatide IV and Exendin-9 in people with Type 2 Diabetes Mellitus, run by Carl T. Hayden VA Medical Center 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 4 inclusion and 12 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 20 May 2014. 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. 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?

Yes. Results are posted in the registry (first posted 28 Apr 2014). 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?

Reactive Hyperemia Index (RHI) (time frame: 0, 2, 4, 6 and 8 hours on Day 11 (Sub-study 1); 0 and 120 minutes on test Days 1, 2 & 3 (Sub-study 2)). 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 NCT01181986.

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 20 May 2014.

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