CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
AZD9567 +2 moredrug
Likely dose
AZD9567 72 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04556760
NCT04556760Phase 2Completed

A Phase 2a Randomised, Double Blind, Multi-centre Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults With Type 2 Diabetes

AstraZeneca·interventional·Posted Sep 21, 2020·Updated Jul 18, 2024

In Brief

A Phase 2 clinical trial evaluating AZD9567, Prednisolone, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 46 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
CollaboratorsParexel

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedSep 21, 2020
Enrollment StartNov 26, 2020
Primary CompletionJun 9, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.8 years ago

Interventions

AZD9567drug

Participants will receive 72 mg/day (oral suspension) of AZD9567 for 3 consecutive days of each treatment period in Cohort 1 and 40 mg/day for 3 consecutive days of each treatment period in Cohort 2.

Prednisolonedrug

Participants will receive 40 mg/day of prednisolone for 3 consecutive days of each treatment period in Cohort 1, 20 mg/day of prednisolone for 3 consecutive days of each treatment period in Cohort 2, and 5 mg/day prednisolone for 3 consecutive days of each treatment period in Cohort 3.

Placeboother

Participants will receive placebo for 3 consecutive days of each treatment period in Cohort 3.