Effects of Dipeptidyl Peptidase-4 Inhibition With Saxagliptin on Fasting and Postprandial Triglyceride Concentrations

Oregon Health and Science University1 site in 1 country15 target enrollmentJanuary 2012

ConditionsType 2 Diabetes Hypertriglyceridemia

InterventionsSaxagliptin

DrugsSaxagliptin

Overview

Phase: Phase 4
Intervention: Saxagliptin
Conditions: Type 2 Diabetes
Sponsor: Oregon Health and Science University
Enrollment: 15
Locations: 1
Primary Endpoint: Change in fasting and postprandial triglyceride concentrations
Status: Suspended
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to test the effects of saxagliptin, a treatment for diabetes, on fasting and post-meal blood triglyceride (blood fat) levels.

Detailed Description

This study is designed to help us understand the effects of DPP-4 inhibition on triglyceride levels before and after eating.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

December 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Oregon Health and Science University

Responsible Party

Principal Investigator

P. Barton Duell, M.D.

Director, Lipid-Atherosclerosis Laboratory

Oregon Health and Science University

Eligibility Criteria

Inclusion Criteria

•Willing to provide signed written informed consent
•Men and women aged 18-80 years
•Type 2 diabetes (as defined by the ADA - see reference 18)
•Baseline HgbA1c between 6.5% and 8%; HgbA1c 7.5-8.0% among subjects taking sulfonylureas
•Baseline plasma triglyceride concentration between 200 and 700 mg/dl
•Stable diabetes medication regimen for at least 12 weeks prior to study entry
•Taking a statin for at least 8 weeks, unless statin therapy is contraindicated or intolerable
•Treatment with other lipid-lowering medications only if the dose has been stable for \> 8 weeks.
•Non-smoker
•Body mass index \< 45.0 kg/m2

Exclusion Criteria

•Transaminase concentrations \> 2 times the ULN. (Mild elevations of AST and ALT will be allowed up to 2x ULN at baseline if there is no evidence of viral hepatitis or intrinsic liver disease. Since many of these subjects may have some degree of hepatic steatosis, a key intervention is the implementation of treatment to lower glucose and triglycerides)
•Estimated creatinine clearance \< 60 ml/min
•Microalbumin-creatinine ratio \> 120
•Alcohol consumption \> 1 drink daily in women and \> 2 drinks daily in men
•Pancreatitis within the preceding 6 months
•Type 1 diabetes
•History of diabetic ketoacidosis (DKA)
•Cardiovascular disease (CAD, stroke, PVD)
•Known human immunodeficiency virus (HIV) infection
•Viral hepatitis