Multiple Ascending Doses of Globalagliatin Hydrochloride in Type 2 Diabetes Mellitus

Phase 1 Completed 24 enrolled Yabao Pharmaceutical Group

RandomizedParallel-groupSingle-blindTreatment

Summary

This is a phase I placebo-controlled study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of Globalagliatin Hydrochloride (SY-004) after Multiple Ascending Doses in patients with Type 2 Diabetes Mellitus (T2DM).

Timeline

Start: 2018-01-03
Primary completion: 2019-01-04
Completion: 2019-12-01

Publications

Zheng S, Shao F, Ding Y, Fu Z, Fu Q, Ding S, Xie L, Chen J, Zhou S, Zhang H, Zhou H, Chen Y, Sun C, Zhu J, Zheng X, Yang T. Safety, Pharmacokinetics, and Pharmacodynamics of Globalagliatin, a Glucokinase Activator, in Chinese Patients with Type 2 Diabetes Mellitus: A Randomized, Phase Ib, 28-day Ascending Dose Study. Clin Drug Investig. 2020 Dec;40(12):1155-1166. doi: 10.1007/s40261-020-00971-x. Epub 2020 Oct 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LY2608204	Small molecule	20 mg	Oral
Subject	LY2608204	Small molecule	40 mg	Oral
Subject	LY2608204	Small molecule	80 mg	Oral
Subject	LY2608204	Small molecule	120 mg	Oral
Subject	LY2608204	Small molecule	160 mg	Oral
Subject	LY2608204	Small molecule	240 mg	Oral
Subject	LY2608204	Small molecule	320 mg	Oral

Multiple Ascending Doses of Globalagliatin Hydrochloride in Type 2 Diabetes Mellitus

Summary

Timeline

Publications

Drugs

Indications