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| Name | Class |
|---|---|
| Kaleida Health | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients will be treated for 12 weeks with placebo once daily |
|
| Linagliptin 5mg per day | Active Comparator | Patients will be treated for 12 weeks with Linagliptin 5mg once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linagliptin | Drug | 5 mg daily oral tablets of linagliptin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| IL-1β mRNA Levels | Comparing IL-1B between Linagliptin group and placebo group based on the PCR test, between week 0 and week 12. | Week 0, Week 2, Week 4, Week 12 |
| Oxidative Stress (as ROS Generation Level) |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ECMC Ambulatory Center, 3rd Floor | Buffalo | New York | 14215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients will be treated for 12 weeks with placebo once daily Placebo |
| FG001 | Linagliptin 5mg Per Day | Patients will be treated for 12 weeks with Linagliptin 5mg once daily. Linagliptin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients will be treated for 12 weeks with placebo once daily Placebo |
| BG001 | Linagliptin 5mg Per Day | Patients will be treated for 12 weeks with Linagliptin 5mg once daily. Linagliptin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | JNK-1 Protein in MNC | JNK-1 protein in MNC before and after linagliptin use as compared to placebo. | Posted | Mean | Standard Error | Arbitrary Units | Week 0, Week 2, Week 4, Week 12 |
|
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patients will be treated for 12 weeks with placebo once daily Placebo |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paresh Dandona, B.Sc., M.B. B.S., D.Phil., F.R.C.P | State University of NY at Buffalo | 71653518520 | dandona@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2014 | Oct 31, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | matching placebo giving orally daily |
|
oxidative stress (ROS generation level) following linagliptin. ROS generation measurement by chemiluminescence of PMN cells
| Week 0, Week 2, Week 4, Week 12 |
| 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 | At baseline and week 12 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m² |
|
| Participants |
|
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| Secondary | IL-1β mRNA Levels | Comparing IL-1B between Linagliptin group and placebo group based on the PCR test, between week 0 and week 12. | Posted | Mean | Standard Error | Arbitrary Units | Week 0, Week 2, Week 4, Week 12 |
|
|
|
| Secondary | Oxidative Stress (as ROS Generation Level) | oxidative stress (ROS generation level) following linagliptin. ROS generation measurement by chemiluminescence of PMN cells | Posted | Mean | Standard Error | mV | Week 0, Week 2, Week 4, Week 12 |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Error | mL/hr | At baseline and week 12 |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Linagliptin 5mg Per Day | Patients will be treated for 12 weeks with Linagliptin 5mg once daily. Linagliptin | 0 | 17 | 0 | 17 | 0 | 17 |
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| D004700 | Endocrine System Diseases |
| D011799 | Quinazolines |
| Week 4 |
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| Week 12 |
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| Week 4 |
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| Week 12 |
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