A Phase 2b, Multicentre, Randomised, Double-blind, Placebo-controlled, and Open-label Comparator Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus

Registration

Registration

NCT04515849

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE2

Masking

DOUBLE

Status

COMPLETED

Enrollment

248

Start

2020-08-31

Primary completion

2022-03-08

Lead sponsor

AstraZeneca

Conditions

Type 2 Diabetes Mellitus; Chronic Kidney Diseases

Interventions

DRUG:Cotadutide 100 micrograms; DRUG:Cotadutide 300 micrograms; DRUG:Cotadutide 600 micrograms; DRUG:Semaglutide; DRUG:Placebo

Results posted

TRUE

Individual participant data sharing

YES

Secondary identifiers

EUDRACT_NUMBER:2020-000255-12

Registered primary outcomes

• The Primary Endpoint Was Percentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 14 Weeks [Baseline to the end of 14 weeks of dosing]