Phase 4
Completed N=76
The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and Prediabetes
Source: ClinicalTrials.gov NCT01181986 ↗Enrolled (actual)
76
Serious AEs
0.6%
Results posted
Apr 2014
Primary outcomePrimary: Reactive Hyperemia Index (RHI) — 1.90; 1.79; 2.24; 1.95 ratio — p=<0.0001
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. 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reactive Hyperemia Index (RHI) |
1.90; 1.79; 2.24; 1.95; 1.99 | <0.0001 sig |
| SECONDARY Plasma Triglycerides |
175; 230 | <0.0001 sig |
| SECONDARY Plasma Glucose |
115; 136 | <0.0001 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01181986). 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.