A Phase IV, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Assess the Effect of 12-week Treatment With the Glucagon-like Peptide-1 Receptor Agonist (GLP-1RA) Liraglutide or Dipeptidyl Peptidase-4 Inhibitor (DPP-4i) Sitagliptin on the Cardiovascular, Renal and Gastrointestinal System in Insulin-naive Patients With Type 2 Diabetes (T2DM).
Phase of Trial: Phase IV
Latest Information Update: 01 Jan 2017
At a glance
- Drugs Exenatide (Primary) ; Liraglutide (Primary) ; Sitagliptin (Primary)
- Indications Type 2 diabetes mellitus
- Focus Pharmacodynamics
- Acronyms SAFEGUARD
- 10 Jun 2017 Biomarkers information updated
- 20 Dec 2016 Primary endpoint has been met. (Changes from baseline following 12-week treatment with DPP-4i Sitagliptin or GLP-1RA liraglutide (long-term effects) on pancreatic exocrine function (chymotrypsin)) as per article published in the Diabetes Care.
- 20 Dec 2016 Primary endpoint has not been met. (Changes from baseline following 12-week treatment with GLP-1RA liraglutide or DPP-4i Sitagliptin (long-term effects) on pancreatic exocrine function, (lipase activity measured as cumulative13C recovery)) as per article published in the Diabetes Care.