Effects of DPP-4 Inhibition on Triglycerides

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
P. Barton Duell, M.D., Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01527747
First received: January 31, 2012
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Type 2 Diabetes
Hypertriglyceridemia
Drug: Saxagliptin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Dipeptidyl Peptidase-4 Inhibition With Saxagliptin on Fasting and Postprandial Triglyceride Concentrations

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Change in fasting and postprandial triglyceride concentrations [ Time Frame: baseline, 6 weeks ] [ Designated as safety issue: No ]
    Comparison of 6 weeks of placebo vs 6 weeks of saxagliptin


Secondary Outcome Measures:
  • Changes in glycemia [ Time Frame: baseline, 6 weeks ] [ Designated as safety issue: No ]
    Comparison of 6 weeks of placebo vs 6 weeks of saxagliptin


Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Saxagliptin
5 mg daily
Experimental: Saxagliptin Drug: Saxagliptin
5 mg daily

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527747

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Paul Duell, MD    503-494-8311    duellb@ohsu.edu   
Principal Investigator: Paul B Duell, MD         
Sponsors and Collaborators
Oregon Health and Science University
Bristol-Myers Squibb
  More Information

No publications provided

Responsible Party: P. Barton Duell, M.D., Director, Lipid-Atherosclerosis Laboratory, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01527747     History of Changes
Other Study ID Numbers: CV181-142
Study First Received: January 31, 2012
Last Updated: February 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Type 2 Diabetes
Hypertriglyceridemia
dipeptidyl peptidase-4 (DPP-4)
glucagon-like peptide-1 (glp-1)

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

ClinicalTrials.gov processed this record on October 01, 2014