Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT01181986Other id1-10-CT-31

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 76 participants (actual)
Sponsor: Carl T. Hayden VA Medical Center · Fed
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: Aug 2010
Primary completion: Dec 2012
Completion: Dec 2012
First posted: 16 Aug 2010 (estimated)
Last update posted: 20 May 2014 (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

2010201120122013

Ph 4
The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and Prediabetes
NCT01181986
Aug 2010 to Dec 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Exenatide SCDrug
Exenatide IVDrug
Placebo SCDrug
Exendin-9Drug
Placebo IVDrug

Arms2

Experimental
Exenatide SC (Sub-study 1)
Study 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.
Experimental
Exenatide IV (Sub-study 2)
Study 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).

Primary outcomes1

Outcomes the sponsor listed as primary.

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)
Registry description
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.

Secondary outcomes(2)

Plasma Triglycerides
Time frame · 0, 2, 4, 6 and 8 hours post-study drug on day 11
Registry description
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.
Plasma Glucose
Time frame · 0, 2, 4, 6, and 8 hours post-study drug on day 11
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· 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)

Reactive Hyperemia Index (RHI)

Group	Value (ratio)	Spread
Exenatide (Subs-study 1)	1.90	0.005
Placebo (Sub-study 1)	1.79	0.05
Saline+Exenatide (Sub-study 2)	2.24	0.07
Saline+Placebo (Sub-study 2)	1.95	0.07
Exendin-9+Exenatide (Sub-study 2)	1.99	0.07

Secondary and other outcome results(2)

Secondary outcomeLeast squares mean· 0, 2, 4, 6 and 8 hours post-study drug on day 11

Plasma Triglycerides

Group	Value (mg/dl)	Spread
Exenatide (Sub-study 1)	175	14
Placebo (Sub-study 1)	230	14

Secondary outcomeLeast squares mean· 0, 2, 4, 6, and 8 hours post-study drug on day 11

Plasma Glucose

Group	Value (mg/dl)	Spread
Exenatide (Sub-study 1)	115	5
Placebo (Sub-study 1)	136	5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Exenatide SC (Sub-study 1)Exenatide 5-10 ug sc BID/10 days, AM dose and meal test on day 11	–	0 / 41	16 / 41
Placebo SC (Sub-study 1)Placebo sc BID/10days, AM dose and meal test on day 11	–	0 / 41	3 / 41
Saline+Exenatide IV (Sub-study 2)Intravenous infusion of saline (min 0-75), added intravenous infusion of exenatide (min30-75)	–	0 / 32	0 / 32
Saline+Placebo (Sub-study 2)Intravenous infusion of saline (min 0-75), added intravenous infusion of placebo (min30-75)	–	1 / 33	0 / 33
Exendin-9+Exenatide IV (Sub-study 2)Intravenous infusion of exendin-9 (min 0-75), added intravenous infusion of placebo (min30-75)	–	0 / 33	0 / 33

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 35 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.

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