The Effect of LINAGLIPTIN on Inflammation, Oxidative Stress and Insulin Resistance in Obese Type 2 Diabetes Subjects

Completed · Phase 4 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

This is a single center, prospective randomized double blind, parallel and placebo controlled study to evaluate oxidative stress and inflammation before and after treatment with linagliptin for 12 weeks. We will also, testing whether Linagliptin is an insulin sensitizer.

Key facts

Study ID

NCT02372630

Run by

University at Buffalo

People needed

40

Starts

2014-05-23

Expected to finish

2018-05-01

Last updated by the study team

2023-02-21

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 20-80 years inclusive. Type 2 diabetes BMI ≥30 kg/m2 Subjects on statins, ACE inhibitors, thiazolidinediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the course of study.
• HbA1c ≤ 8.0%

You may not qualify if…

• Use of GLP-1 agonists or DPP-IV therapy in the last 3 months. History of Pancreatitis. Risk for pancreatitis, i.e., history of gallstones, alcohol abuse, and hypertriglyceridemia.
• Subjects who are taking antiplatelet or anticoagulant medications will be excluded from the fat biopsy portion of the study.
• Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks Hepatic disease (liver function tests more than 3 times the upper limit of normal) Renal impairment (serum eGFR <30 ml/min) Any other life-threatening, non-cardiac disease Uncontrolled hypertension (BP > 160/100 mm of Hg) Congestive Heart Failure class III or IV. Use of an investigational agent or therapeutic regimen within 30 days of study Participation in any other concurrent clinical trial

Where it is running

• ECMC Ambulatory Center, 3rd Floor — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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