drugset / Trial / NCT02244164
Pathophysiological Study of the Increase in Pancreatic Volume in Type 2 Diabetes Treatments.
Non-randomizedParallel-groupOpen-labelPrevention
Summary
Incretinomimetics and inhibitors of dipeptidyl peptidase-4 (DPP-4) are new treatments for diabetes. Previous retrospective studies have shown that these treatments induced an increase in pancreatic mass with potentially a risk for pancreatitis and development of precancerous lesions. The aim of our study is to provide a better understanding of the pathophysiological mechanisms of increased volume and / or pancreatic exocrine secretion when exposed to certain treatment of type 2 diabetes.
Timeline
- Start
- 2014-10
- Primary completion
- 2023-02-13
- Completion
- 2023-02-13
Publications
- Results Drucker DJ, Nauck MA. The incretin system: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes. Lancet. 2006 Nov 11;368(9548):1696-705. doi: 10.1016/S0140-6736(06)69705-5.
- Results Amori RE, Lau J, Pittas AG. Efficacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis. JAMA. 2007 Jul 11;298(2):194-206. doi: 10.1001/jama.298.2.194.
- Results Butler AE, Campbell-Thompson M, Gurlo T, Dawson DW, Atkinson M, Butler PC. Marked expansion of exocrine and endocrine pancreas with incretin therapy in humans with increased exocrine pancreas dysplasia and the potential for glucagon-producing neuroendocrine tumors. Diabetes. 2013 Jul;62(7):2595-604. doi: 10.2337/db12-1686. Epub 2013 Mar 22.
- Results Butler PC, Elashoff M, Elashoff R, Gale EA. A critical analysis of the clinical use of incretin-based therapies: Are the GLP-1 therapies safe? Diabetes Care. 2013 Jul;36(7):2118-25. doi: 10.2337/dc12-2713. Epub 2013 May 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Exenatide | Peptide | — | — |
| Comparator | Linagliptin | Small molecule | — | — |
| Comparator | Liraglutide | Peptide | — | — |
| Comparator | Lixisenatide | Peptide | — | — |
| Comparator | SAXAGLIPTIN ANHYDROUS | Small molecule | — | — |
| Comparator | Sitagliptin | Small molecule | — | — |
| Comparator | Vildagliptin | Other / unclassified | — | — |