Effects of DPP-4 Inhibition on Triglycerides

NCT01527747 | Suspended Phase 4

• 1 other identifier: CV181-142
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Hypertriglyceridemia

Keywords

Type 2 Diabetes; Hypertriglyceridemia; dipeptidyl peptidase-4 (DPP-4); glucagon-like peptide-1 (glp-1)

Outcome Measures

Primary Outcomes (1)

• Change in fasting and postprandial triglyceride concentrations

  Comparison of 6 weeks of placebo vs 6 weeks of saxagliptin

  baseline, 6 weeks

Secondary Outcomes (1)

• Changes in glycemia

  baseline, 6 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo arm

Drug: Saxagliptin

Saxagliptin

EXPERIMENTAL

Active drug arm

Drug: Saxagliptin

Interventions

Saxagliptin DRUG

5 mg daily

Also known as: Onglyza

Placebo; Saxagliptin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 systemic cytochrome P450 3A4 (CYP 3A4/5) inhibitors such as ketaconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir and telithromycin.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertriglyceridemia

Interventions

saxagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• P Barton Duell, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Lipid-Atherosclerosis Laboratory

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: February 7, 2012
• Study Start: January 1, 2012
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)