A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM)

Phase 1 Completed 30 enrolled AstraZeneca

RandomizedCrossoverTriple-blindBasic science

Summary

A study to assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated Doses for 3 days in Subjects with Type 2 Diabetes Mellitus

Timeline

Start: 2015-03
Primary completion: 2015-05
Completion: 2015-05

Outcome

Mixed primary results

registry analysis (superiority or other test); AZD1981 vs Placebo; p = 0.02; Geometric LS Mean Ratio 0.94 (80% CI 0.90 to 0.98) NCT02367066 ↗

registry analysis (superiority or other test); AZD1981 vs Placebo; p = 0.06; Geometric LS Mean Ratio 0.96 (80% CI 0.92 to 0.99) NCT02367066 ↗

registry analysis (superiority or other test); AZD1981 vs Placebo; p = 0.41; Geometric LS Mean Ratio 0.99 (80% CI 0.96 to 1.03) NCT02367066 ↗

Publications

Skrtic S, Tyrberg B, Broberg M, Ericsson H, Schnecke V, Kjaer M, Hompesch M, Andersson EM, Ryberg E, Aivazidis A, Wennberg Huldt C, Lofgren L, Morrow L, Parkinson J, Ryden-Bergsten T, Watkins E, Sorhede Winzell M. Exploring the insulin secretory properties of the PGD2-GPR44/DP2 axis in vitro and in a randomized phase-1 trial of type 2 diabetes patients. PLoS One. 2018 Dec 17;13(12):e0208998. doi: 10.1371/journal.pone.0208998. eCollection 2018.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AR-C165395XX	Unknown	—	Oral