Effects of DPP-4 Inhibition on Triglycerides

• Register: ClinicalTrials.gov
• Last refreshed on: 17 April 2023
• Main ID: NCT01527747
• Date of registration: 31/01/2012
• Prospective Registration: No
• Primary sponsor: Oregon Health and Science University
• Public title: Effects of DPP-4 Inhibition on Triglycerides
• Scientific title: Effects of Dipeptidyl Peptidase-4 Inhibition With Saxagliptin on Fasting and Postprandial Triglyceride Concentrations
• Date of first enrolment: January 2012
• Target sample size: 15
• Recruitment status: Suspended
• URL: https://clinicaltrials.gov/show/NCT01527747
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: P Barton Duell, MD
• Affiliation: Oregon Health and Science University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes

Hypertriglyceridemia

Intervention(s)

Drug: Saxagliptin

Primary Outcome(s)

Change in fasting and postprandial triglyceride concentrations [Time Frame: baseline, 6 weeks]

Secondary Outcome(s)

Changes in glycemia [Time Frame: baseline, 6 weeks]

Secondary ID(s)

CV181-142

Source(s) of Monetary Support

Please refer to primary and secondary sponsors