Phase 4 Completed N=53 Randomized Treatment

The Effect of Exenatide Compared to Lantus Insulin on Vascular Function in Type 2 Diabetes

Source: ClinicalTrials.gov NCT00353834 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2018

Primary outcomePrimary: The Primary Endpoint Was the Change in FMD at the End of the Study Compared to Baseline Measurements in Subjects Treated With Exenatide Compared to Subjects Treated With Lantus. — 5.0; 4.7 Percentage dilation

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

The main goals of the study are to evaluate the effect of Exenatide on endothelial-dependent vasodilation, as measured by flow mediated dilation (FMD), to evaluate the effect on endothelial-independent vasodilation, as measured by nitroglycerin (TNG) response, and to evaluate the effect on arterial stiffness, as measured by pulse wave analysis (PWA). We will also measure the effects on various markers of endothelial function, subclinical inflammation, fibrinolysis, and oxidative stress. The control group for the study will receive Lantus insulin, with a goal of similar glycemic control between the treatment and control groups. Specific Aims We will test the following hypotheses: 1. Treatment of patients with type 2 diabetes who are inadequately controlled by monotherapy with a Sulfonylurea (SU) or Metformin, or on combination therapy of a SU and Metformin with Exenatide (GLP-1 mimetic) will result in improved endothelial dependent vasodilation, as measured by FMD, as compared to the control group, who will be treated with Lantus insulin to achieve comparable HbA1c levels. 2. Treatment with Exenatide (GLP-1 mimetic) will result in improved arterial stiffness, as measured by AI by PWA, as compared to the control group, who will be treated with Lantus insulin to achieve comparable HbA1c levels. 3. Endothelial dependent vasodilation, as measured by FMD, and arterial stiffness, as measured by AI, measured in the postprandial state (following a standard test meal) will be improved following treatment with Exenatide as compared to treatment with once daily basal insulin (Lantus). 4. Treatment will result in no improvement in endothelial-independent vasodilation, as measured by a response to TNG, as compared to the control group, who will be treated with Lantus insulin to achieve comparable HbA1c levels. 5. Treatment with Exenatide, compared with treatment with Lantus, will result in a reduction in various plasma markers of inflammation (CRP, TNFA, IL6), endothelial activation (ICAM, VCAM, endothelin 1), fibrinolysis (PAI-1 protein, PAI-1 activity), and oxidative stress (FOX2).

Outcome Measures

Outcome	Result	p-value
PRIMARY The Primary Endpoint Was the Change in FMD at the End of the Study Compared to Baseline Measurements in Subjects Treated With Exenatide Compared to Subjects Treated With Lantus.	5.0; 4.7	—
SECONDARY First Will be the Changes in TNG Stimulated Arterial Dilation (Endothelial-independent) in Subjects Treated With Exenatide Compared With Subjects Treated With Lantus at the End of the Study Compared to Baseline Measurements	10.7; 11.3	—
SECONDARY Second Will be the Change in Arterial Stiffness, as Measured by PWA, in Subjects Treated With Exenatide Compared With Subjects Treated With Lantus at the End of the Study Compared to Baseline Measurements.	—	—
SECONDARY Third Will be the Changes in Markers of Endothelial Function, Inflammation, Fibrinolysis, and Oxidative Stress in Subjects Treated With Exenatide Compared With Subjects Treated With Lantus at the End of the Study Compared to Baseline	—	—
SECONDARY Fourth Will be Changes in Insulin, Glucose, C-peptide, Lipids, and FFA Responses Following the MTT in Subjects Treated With Exenatide Compared With Subjects Treated With Lantus at the End of the Study Compared to Baseline Measurement	—	—

Eligibility Criteria

Inclusion Criteria

age 18-75
Type 2 Diabetes (diagnosed at least 3 months prior to study)
HbA1c: above 7.0 and less than or equal to 10.0
At least one HbA1c over preceding 3-6 months, and HbA1c at screening, with less than 1% difference between lowest and highest values
Stable doses of antidiabetic medications (SU and/or Metformin) for 3 months
reproductive age females must have negative urine HCG at screening, and be using appropriate contraception during the study or be surgically sterile
postmenopausal woman
stable weight for 3 months prior to study (+/- 2kg)
willingness to participate in the study

Exclusion Criteria

Type 1 diabetes
Type 2 diabetes less than 3 months in duration
HbA1c less than 7.0 or greater than 10
age less than 18 or greater than 75
pregnant or planning to become pregnant during study period
current insulin therapy or insulin within 6 months prior to study
current use of Thiazolidinedione or within 6 months prior to study
current use of Nateglinide or Repaglinide
current use of an Alpha-glucosidase Inhibitor
current weight loss program
active smoker, or quit smoking within preceding 6 months
creatinine greater than 2.0 mg/dL
total cholesterol greater than 300 mg/dL
triglycerides greater than 600 mg/dL
blood pressure greater than 160/105 mmHg
ALT/AST greater than twice the upper limit of normal
any other medical condition that may interfere with trial participation or trial results
if on Statin: Statin therapy for less than 3 months or dose change within preceding 3 months
if on ACE Inhibitor: ACE Inhibitor therapy for less than 3 months or dose change within preceding 3 months
current use of any medication that is known to alter gastric motility

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00353834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.