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Phase 4 Completed N=40 Randomized Double-blind Treatment

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

Source: ClinicalTrials.gov NCT02372630 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcomePrimary: JNK-1 Protein in MNC — 0.943; 0.801; 1.106; 0.789 Arbitrary Units
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
JNK-1 Protein in MNC
0.943; 0.801; 1.106; 0.789; 1.933; 0.702
SECONDARY
IL-1β mRNA Levels
0.768; 1.276; 0.885; 1.166; 0.736; 1.063
SECONDARY
Oxidative Stress (as ROS Generation Level)
102; 91; 95; 85; 94; 81
SECONDARY
Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp
123; 137; 119; 141

Eligibility Criteria

Inclusion Criteria

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%

Exclusion Criteria

  • 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02372630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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