Phase 4
Completed N=38
Effects of Sitagliptin on Endothelial Function in Type 2 Diabetes on Background Metformin Therapy
Source: ClinicalTrials.gov NCT01859793 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Brachial Artery Flow Mediated Dilation — 5.2; 5.6; 5.6; 6.3 %FMD — p=<0.05
◆ Published Evidence
Established
30citations · ~3 / year
Impact of DPP-4 inhibition on acute and chronic endothelial function in humans with type 2 diabetes on background metformin therapy.
Summary
The study is being performed to determine whether sitagliptin, a dipeptidyl peptidase-4 inhibitor, both acutely and chronically improves blood vessel function. Patients with type 2 diabetes who are on metformin will be enrolled in this study for up to 22 weeks in this double blinded cross over study where they will receive a sitagliptin pill once a day for 8 weeks and during a separate 8 weeks receive a matching placebo pill. The treatment periods are divided by a 4 week period. Blood vessel function will be measured by ultrasound before and after a single dose of sitagliptin and placebo, as well as after 8 weeks of treatment with each. Blood will also be taken to measure blood markers of inflammation at each time the ultrasounds are performed.
Linked Publications
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Impact of DPP-4 inhibition on acute and chronic endothelial function in humans with type 2 diabetes on background metformin therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brachial Artery Flow Mediated Dilation |
5.2; 5.6; 5.6; 6.3; 6.0; 5.8 | <0.05 sig |
| SECONDARY Circulating Inflammatory Marker ICAM-1 |
226; 223; 216; 211; 228; 232 | <0.05 sig |
| SECONDARY Circulating Inflammatory Markers VCAM-1 |
584; 608; 575; 574; 620; 620 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Adult age 21-70 years of age.
- Diagnosis of type 2 diabetes by a physician as defined by the American Diabetes Association standard criteria: 1) Fasting Plasma glucose at or above 126 mg/dL 2) a two-hour value in an oral glucose tolerance test at or above 200 mg/dL, or 3) a random plasma glucose concentration 200 mg/dL in the presence of symptoms, or 4) glycosylated hemoglobin greater than or equal to 6.5%.
- On stable metformin therapy for at least 6 weeks prior to enrollment.
- Glycosylated Hemoglobin ≥6.2% and ≤ 9.5%.
Exclusion Criteria
- History of stroke, peripheral arterial disease, or coronary artery disease (as defined by the presence of at least one coronary stenosis ≥ 50% on angiography or by confirmed history of myocardial infarction by standard criteria.)
- Evidence of other evident major illness including chronic renal insufficiency (creatinine clearance less than 60 mL/min),chronic liver disease (AST or ALT greater than 2.5 x normal), or cancer currently undergoing systemic therapy or had systemic therapy for cancer within 1 year of enrollment.
- Pregnancy as determined by urinary beta-HCG test
- Illicit drug use (heroin, cocaine etc) in the past 1 year.
- Alcohol abuse, defined as the equivalent of 14 beers/week for a man or 7 beers/week for a woman
- History of allergy to DPP-4 inhibitors at the time of screening/enrollment
- Prior history of pancreatitis
- Patients currently on insulin or sulfonylurea therapy.
- Patients currently on digoxin.
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Data sourced from ClinicalTrials.gov (NCT01859793) and the linked publication. 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.