Back to resultsThe Effect of LINAGLIPTIN on Inflammation, Oxidative Stress and Insulin Resistance in Obese Type 2 Diabetes Subjects (1971)
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Linagliptin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
Age 20-80 years inclusive. Type 2 diabetes BMI ≥30 kg/m2 Subjects on statins, ACE inhibitors, thiazolidenediones 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 <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
Sites / Locations
- ECMC Ambulatory Center, 3rd Floor
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Linagliptin 5mg per day
Arm Description
Patients will be treated for 12 weeks with placebo once daily
Patients will be treated for 12 weeks with Linagliptin 5mg once daily.
Outcomes
Primary Outcome Measures
JNK-1 Protein in MNC
JNK-1 protein in MNC before and after linagliptin use as compared to placebo.
Secondary Outcome Measures
IL-1β mRNA Levels
Comparing IL-1B between Linagliptin group and placebo group based on the PCR test, between week 0 and week 12.
Oxidative Stress (as ROS Generation Level)
oxidative stress (ROS generation level) following linagliptin. ROS generation measurement by chemiluminescence of PMN cells
Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp
Insulin sensitivity is measured with HE clamp. Glucose Infusion Rate was titrated to maintain blood glucose concentration at the fasting glucose level. Plasma samples for glucose was obtained at 10-minute intervals starting 30 minutes before the clamp, to quantitate rates of whole-body glucose disposal. Difference from baseline at 12 weeks is calculated and compared to placebo arm
Full Information
NCT ID
NCT02372630
First Posted
February 20, 2015
Last Updated
January 24, 2023
Sponsor
University at Buffalo
Collaborators
Kaleida Health
1. Study Identification
Unique Protocol Identification Number
NCT02372630
Brief Title
The Effect of LINAGLIPTIN on Inflammation, Oxidative Stress and Insulin Resistance in Obese Type 2 Diabetes Subjects
Acronym
1971
Official Title
The Effect of TRADJENTA ® (LINAGLIPTIN) on Inflammation, Oxidative Stress and Insulin Resistance in Obese Type 2 Diabetes Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 23, 2014 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University at Buffalo
Collaborators
Kaleida Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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. The study enrolls type 2 patients with diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will be treated for 12 weeks with placebo once daily
Arm Title
Linagliptin 5mg per day
Arm Type
Active Comparator
Arm Description
Patients will be treated for 12 weeks with Linagliptin 5mg once daily.
Intervention Type
Drug
Intervention Name(s)
Linagliptin
Other Intervention Name(s)
TRADJENTA
Intervention Description
5 mg daily oral tablets of linagliptin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo giving orally daily
Primary Outcome Measure Information:
Title
JNK-1 Protein in MNC
Description
JNK-1 protein in MNC before and after linagliptin use as compared to placebo.
Time Frame
Week 0, Week 2, Week 4, Week 12
Secondary Outcome Measure Information:
Title
IL-1β mRNA Levels
Description
Comparing IL-1B between Linagliptin group and placebo group based on the PCR test, between week 0 and week 12.
Time Frame
Week 0, Week 2, Week 4, Week 12
Title
Oxidative Stress (as ROS Generation Level)
Description
oxidative stress (ROS generation level) following linagliptin. ROS generation measurement by chemiluminescence of PMN cells
Time Frame
Week 0, Week 2, Week 4, Week 12
Title
Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp
Description
Insulin sensitivity is measured with HE clamp. Glucose Infusion Rate was titrated to maintain blood glucose concentration at the fasting glucose level. Plasma samples for glucose was obtained at 10-minute intervals starting 30 minutes before the clamp, to quantitate rates of whole-body glucose disposal. Difference from baseline at 12 weeks is calculated and compared to placebo arm
Time Frame
At baseline and week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 <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
Facility Information:
Facility Name
ECMC Ambulatory Center, 3rd Floor
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of LINAGLIPTIN on Inflammation, Oxidative Stress and Insulin Resistance in Obese Type 2 Diabetes Subjects
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