Sitagliptin Treatment in Patients With Type 2 DM After Kidney Transplant

Status Completed

Clinical Trial Summary

This study is designed to look at the effect sitagliptin has on tacrolimus and sirolimus drug levels in kidney transplant patients. It is also designed to look at the side effects experienced in the transplant population.

Clinical Trial Description

Within the last six months, the FDA has approved sitagliptin phosphate as an oral drug that potentiates the effect of native GLP-1 through inhibition of DPP-4. It is approved for treatment of type 2 diabetes in adults as monotherapy or in combination with metformin or a TZD. It has several advantages over extenatide when considering its use in kidney transplant recipients:

1. It is administered orally once a day

2. Nausea occurred at a rate of only 1.4%

3. Its potential of hypoglycemia is low

However, it may not be as potent, in terms of HbA1C with % change in HbA1C<1%. In addition there is not a lot of information on gastric emptying, although this is probably not as severe as exenatide, with fewer symptoms of nausea reported.

We propose to conduct a pilot study for using sitagliptin in patients who have both type 2 diabetes and who have received a kidney transplant. Our objectives are to study the effect of sitagliptin administration on side effect profiles, change in HbA1C, and the percentage of patients who require discontinuation of the drug as a result of major changes in immunosuppressant drug levels. The data will be used as preliminary data for a larger study that attempts to prevent or delay the onset of PTDM in kidney transplant recipients. We anticipate treating patients with both impaired fasting glucose and normoglycemia, given the high frequency of PTDM in the post-kidney transplant population. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00466518
Study type	Interventional
Source	University of Oklahoma
Contact
Status	Completed
Phase	N/A
Start date	April 2007
Completion date	January 2011

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05219994` - Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum	N/A
Completed	`NCT04056208` - Pistachios Blood Sugar Control, Heart and Gut Health	Phase 2
Completed	`NCT02284893` - Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone	Phase 3
Completed	`NCT04274660` - Evaluation of Diabetes and WELLbeing Programme	N/A
Active, not recruiting	`NCT05887817` - Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)	Phase 4
Active, not recruiting	`NCT05566847` - Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes	N/A
Recruiting	`NCT06007404` - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Completed	`NCT04965506` - A Study of IBI362 in Chinese Patients With Type 2 Diabetes	Phase 2
Recruiting	`NCT06115265` - Ketogenic Diet and Diabetes Demonstration Project	N/A
Active, not recruiting	`NCT03982381` - SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes	Phase 4
Completed	`NCT04971317` - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages	N/A
Completed	`NCT04496154` - Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood	N/A
Completed	`NCT04023539` - Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes	N/A
Recruiting	`NCT05572814` - Transform: Teaching, Technology, and Teams	N/A
Enrolling by invitation	`NCT05530356` - Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
Completed	`NCT03960424` - Diabetes Management Program for Hispanic/Latino	N/A
Completed	`NCT04097600` - A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets	Phase 1
Completed	`NCT05378282` - Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
Active, not recruiting	`NCT06010004` - A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes	Phase 3
Completed	`NCT03653091` - Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes	N/A