drugset / Trial / NCT04556760

Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults With Type 2 Diabetes

NCT04556760 ↗

Phase 2 Completed 46 enrolled AstraZeneca Parexel · collab
RandomizedCrossoverDouble-blindTreatment

Summary

The study is intended to assess the effect on glycaemic control of AZD9567, as measured by the glucose AUC(0-4) versus baseline following a standardised mixed meal tolerance test (MMTT), compared to prednisolone in adults with type 2 diabetes mellitus (T2DM). The study will also evaluate the safety, tolerability, and pharmacokinetics (PK) of AZD9567.

Timeline

Start
2020-11-26
Primary completion
2021-06-09
Completion
2021-06-09

Outcome

Mixed primary results

registry analysis (other test); Cohort 1; p = 0.036; Mean Difference (Final Values) -132.9528 (95% CI -256.5082 to -9.3973); Mixed Models Analysis NCT04556760 ↗

registry analysis (other test); Cohort 2; p = 0.432; Mean Difference (Final Values) -142.0330 (95% CI -554.8722 to 270.8061); Mixed Models Analysis NCT04556760 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject MIZACORAT Small molecule 40 mg Oral
Subject MIZACORAT Small molecule 72 mg Oral
Subject Prednisolone Other / unclassified 5 mg —
Subject Prednisolone Other / unclassified 20 mg —
Subject Prednisolone Other / unclassified 40 mg —