Effects of DPP-4 Inhibition on Triglycerides

April 5, 2023 updated by: P. Barton Duell, M.D., Oregon Health and Science University

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • BP < 140/85
  • Normal serum TSH and free T4 concentrations (hypothyroid subjects taking a stable replacement dose of levothyroxine will be allowed if they are biochemically euthyroid)
  • Subjects will otherwise be healthy
  • Women of child-bearing potential must be willing to use reliable contraception, as defined by our IRB, throughout the study (There are currently no FDA recommended restrictions on the use of saxagliptin in sexually active men, or requirements for contraception in their wives or sexual partners)
  • Able and willing to complete study procedures

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
  • Pregnancy or lactation
  • A current diagnosis of active non-dermatologic cancer
  • Other life-threatening illness
  • History of small bowel resection or gastric bypass surgery
  • Use of glucocorticoid medications, beta blockers, thiazide diuretics, excess alcohol intake (beta-blockers and thiazide diuretic will be allowed, if necessary, if the dose has been stable for > 12 weeks prior to study entry and the dose will remain stable throughout the study. Complete exclusion of these drugs would exclude a substantial proportion of diabetic patients)
  • Use of systemic cytochrome P450 3A4 (CYP 3A4/5) inhibitors such as ketaconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir and telithromycin.
  • Current enrollment in another research study or use of any investigational drug within 90 days of study entry
  • Other medical conditions that may interfere with participation in the study, in the opinion of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo arm
Drug: Saxagliptin
5 mg daily
Other Names:
  • Onglyza
Experimental: Saxagliptin
Active drug arm
Drug: Saxagliptin
5 mg daily
Other Names:
  • Onglyza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fasting and postprandial triglyceride concentrations
Time Frame: baseline, 6 weeks
Comparison of 6 weeks of placebo vs 6 weeks of saxagliptin
baseline, 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in glycemia
Time Frame: baseline, 6 weeks
Comparison of 6 weeks of placebo vs 6 weeks of saxagliptin
baseline, 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

  • Principal Investigator: P Barton Duell, MD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

January 31, 2012

First Submitted That Met QC Criteria

February 6, 2012

First Posted (Estimate)

February 7, 2012

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 5, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV181-142

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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