Protective Effects of Saxagliptin (And Vitamin D3) on β Cell Function in Adult-onset Latent Autoimmune Diabetes

Phase 4 Completed 300 enrolled Second Xiangya Hospital of Central South University Beijing Hospital · collab First Affiliated Hospital of Chongqing Medical University · collab The First Affiliated Hospital of Henan University of Science and Technology · collab The First Affiliated Hospital with Nanjing Medical University · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to evaluate whether saxagliptin or (and vitamin D3) with metformin (and insulin) therapy can better protect islet β cell function than metformin(and insulin) .

Timeline

Start: 2015-03
Primary completion: 2020-12-30
Completion: 2020-12-31

Outcome

Missed primary endpoint

paper The primary endpoint was not achieved in saxagliptin plus vitamin D group (P = 0.18) and saxagliptin group (P = 0.26). PMID 37076476 ↗

Publications

Yan X, Li X, Liu B, Huang J, Xiang Y, Hu Y, Tang X, Zhang Z, Huang G, Xie Z, Zhou H, Liu Z, Wang X, Leslie RD, Zhou Z. Combination therapy with saxagliptin and vitamin D for the preservation of beta-cell function in adult-onset type 1 diabetes: a multi-center, randomized, controlled trial. Signal Transduct Target Ther. 2023 Apr 20;8(1):158. doi: 10.1038/s41392-023-01369-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cholecalciferol	Other / unclassified	2000 iu	Oral
Subject	SAXAGLIPTIN ANHYDROUS	Small molecule	5 mg	Oral
Background	Insulin	Protein / enzyme biologic	—	—
Background	Metformin	Small molecule	1.5 g	Oral