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

NCT02372630 | Completed Phase 4 Results DMC

• 1 other identifier: 514091
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• JNK-1 Protein in MNC

  JNK-1 protein in MNC before and after linagliptin use as compared to placebo.

  Week 0, Week 2, Week 4, Week 12

Secondary Outcomes (3)

• IL-1β mRNA Levels

  Week 0, Week 2, Week 4, Week 12

• Oxidative Stress (as ROS Generation Level)

  Week 0, Week 2, Week 4, Week 12

• Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp

  At baseline and week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients will be treated for 12 weeks with placebo once daily

Drug: Placebo

Linagliptin 5mg per day

ACTIVE COMPARATOR

Patients will be treated for 12 weeks with Linagliptin 5mg once daily.

Drug: Linagliptin

Interventions

Linagliptin DRUG

5 mg daily oral tablets of linagliptin

Also known as: TRADJENTA

Linagliptin 5mg per day

Placebo DRUG

matching placebo giving orally daily

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University at Buffalo: lead
• Kaleida Health: collaborator

Study Sites (1)

ECMC Ambulatory Center, 3rd Floor

Buffalo, New York, 14215, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Results Point of Contact

• Title: Paresh Dandona, B.Sc., M.B. B.S., D.Phil., F.R.C.P
• Organization: State University of NY at Buffalo

dandona@buffalo.edu

71653518520

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: February 26, 2015
• Study Start: May 23, 2014
• Primary Completion: February 1, 2018
• Study Completion: May 1, 2018
• Last Updated: February 21, 2023
• Results First Posted: February 21, 2023

Record last verified: 2023-01

Locations

US (1)