drugset / Trial / NCT05390307

Obesity Treatment to Improve Diabetes

NCT05390307

Completed 60 enrolled Dasman Diabetes Institute
RandomizedParallel-groupOpen-labelTreatment

Summary

As the obesity pandemic continues unabated, one can expect to see an increase in the prevalence of TID/T2D and associated CKD. As a result, death will rise, preceded by an increase in kidney failure, requiring dialysis and renal transplantation. Innovative medical treatment may help prevent chronic kidney disease (CKD) across our healthcare system. The guideline of the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) suggest that patients with obesity, TID/ T2D, and CKD needed either glucagon-like peptide 1 receptor analogs (GLP1-RA) or sodium-glucose cotransport-2 inhibitors (SGLT2i). If neither achieve metabolic control, then the recommendation is to combine both drugs. The evidence base for combining GLP1RA and SGLT2i are not well developed, and hence the impact of the guidelines are limited. This study will provide evidence of discrete metabolic pathways by the GLP1RA/or SGLT2i alone or in combination contributed to metabolic control. The aim of this randomised control trial (RCT) is to test the impact of the combination of GLP1RA/SGLT2i on body weight and kidney damage, in patients with T1DM and CKD. In addition, we will explore associated changes in metabolic pathways with each of the treatments used in the RCT.

Timeline

Start
2023-04-01
Primary completion
2024-01-01
Completion
2024-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dapagliflozin Small molecule 5 mg
Subject Dapagliflozin Small molecule 10 mg
Subject Liraglutide Peptide 3 mg Subcutaneous
Subject Semaglutide Peptide 1 mg Subcutaneous