Effects of DPP-4 Inhibition on Triglycerides

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01527747
Recruitment Status : Unknown
Verified October 2015 by P. Barton Duell, M.D., Oregon Health and Science University.
Recruitment status was:  Recruiting
First Posted : February 7, 2012
Last Update Posted : October 15, 2015
Information provided by (Responsible Party):
P. Barton Duell, M.D., Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Hypertriglyceridemia Drug: Saxagliptin Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Dipeptidyl Peptidase-4 Inhibition With Saxagliptin on Fasting and Postprandial Triglyceride Concentrations
Study Start Date : January 2012
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides
Drug Information available for: Saxagliptin
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo arm
Drug: Saxagliptin
5 mg daily
Other Name: Onglyza
Experimental: Saxagliptin
Active drug arm
Drug: Saxagliptin
5 mg daily
Other Name: Onglyza

Primary Outcome Measures :
  1. Change in fasting and postprandial triglyceride concentrations [ Time Frame: baseline, 6 weeks ]
    Comparison of 6 weeks of placebo vs 6 weeks of saxagliptin

Secondary Outcome Measures :
  1. Changes in glycemia [ Time Frame: baseline, 6 weeks ]
    Comparison of 6 weeks of placebo vs 6 weeks of saxagliptin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01527747

Contact: Duell P. Barton, MD

United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Paul Duell, MD    503-494-8311   
Principal Investigator: Paul B Duell, MD         
Sponsors and Collaborators
Oregon Health and Science University
Principal Investigator: P Barton Duell, MD Oregon Health and Science University

Responsible Party: P. Barton Duell, M.D., Director, Lipid-Atherosclerosis Laboratory, Oregon Health and Science University Identifier: NCT01527747     History of Changes
Other Study ID Numbers: CV181-142
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: October 15, 2015
Last Verified: October 2015

Keywords provided by P. Barton Duell, M.D., Oregon Health and Science University:
Type 2 Diabetes
dipeptidyl peptidase-4 (DPP-4)
glucagon-like peptide-1 (glp-1)

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents