NCT02536248

Sitagliptin Therapy and Kinetics of Inflammatory Markers

Completed Phase 3 Results posted Last updated 13 May 2020

What this trial tests

Phase 3 trial testing Sitagliptin in Type 2 Diabetes Mellitus in 20 participants. Completed in 31 October 2017.

Timeline

1 August 2015

Primary endpoint
30 September 2017

31 October 2017

Quick facts

Lead sponsor	Laval University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	20
Start date	1 August 2015
Primary completion	30 September 2017
Estimated completion	31 October 2017
Sites	1 location across Canada

Drugs / interventions tested

• Sitagliptin (SITAGLIPTIN) — full drug profile →
• Placebo

Conditions studied

• Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Laval University

Who can join

Adults 18 to 65, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Measurement of Serum Amyloid A Production Rate With Stable Isotope During Postprandial Period Secondary · 6 weeks

Group	Value	95% CI
Sitagliptin	0.039	± 0.030
Placebo	0.049	± 0.047

Sponsor's own description

Inflammatory processes are increasingly being recognized as a critical step in the pathogenesis of both diabetes and heart disease and may constitute a biological link between the two diseases. Inflammatory cytokines increase vascular permeability, change vasoregulatory responses, increase leukocyte adhesion to endothelium, and facilitate thrombus formation by inducing procoagulant activity, inhibiting anticoagulant pathways, and impairing fibrinolysis. Leukocyte adhesion to arterial endothelial cells is thought to be an important step in the development of atherosclerosis, and adhesion molecules, such as intercellular adhesion molecule-1 (ICAM-1) and L-selectin, play key roles in this process. Therefore, identifying novel therapeutic approaches that would favorably affect inflammation, endothelial function, and glucose is of significant interest. Investigators have recently demonstrated that, relative to placebo, sitagliptin treatment resulted in a significant reduction in plasma levels of various inflammatory markers and cell adhesion molecules. The results also suggest that the beneficial effects of sitagliptin on both inflammation and endothelial function are most likely mediated by an elevation in plasma GLP-1 levels and global improvement of the glucose-insulin homeostasis. However, the mechanisms underlying the beneficial effects of sitagliptin on these markers remain to be fully elucidated. The proposed study will address this key issue.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.