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 - CKD

AstraZeneca AB0 sites225 target enrollmentOctober 1, 2020

ConditionsChronic Kidney Disease with Type 2 Diabetes Mellitus MedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

DrugsOZEMPIC® (0.25mg)OZEMPIC® (0.5mg)OZEMPIC® (1.0mg)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic Kidney Disease with Type 2 Diabetes Mellitus
Sponsor: AstraZeneca AB
Enrollment: 225
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 1, 2020

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

AstraZeneca AB

Eligibility Criteria

Inclusion Criteria

•1/ Male and female subjects \= 18 and \= 79 years of age at the time of signing the informed consent.
•2/ Estimated glomerular filtration rate \= 20 to \< 90 mL/min/1\.73 m2 determined at the screening visit or a documented occurrence in their medical history at least 3 months prior to randomisation.
•3/ Receiving background standard of care treatment for renal disease and/or T2DM and being treated according to locally recognised guidelines, as appropriate.
•4/ Receiving optimised and stable treatment with an angiotensin\-converting\-enzyme (ACE) inhibitor or an angiotensin II receptor antagonist for \= 3 months at screening at the maximum tolerated dose (MTD) unless contraindicated, not tolerated, or in the opinion of the investigator, not practically available or suitable.
•5/ Micro\- or macroalbuminuria as defined by UACR \> 50 mg/g or 5\.7 mg/mmol.
•6/ Diagnosed with T2DM with glucose control managed with any insulin and/or any oral therapy combination
•7/ Haemoglobin A1c range of 6\.5 % to 12\.5% (inclusive) at screening
•8/ Body mass index \> 25 kg/m^2 at screening or \> 23 kg/m^2 for participants enrolled in Japan
•9/ Negative pregnancy test at screening (serum only) and randomisation (serum or urine) for female participants of childbearing potential and must not be breastfeeding.
•10/ Female participants of childbearing potential must use one highly effective form of birth control. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. They should have been stable on their chosen method of birth control for a minimum of 3 months before entering the study to 5 weeks after the last dose.

Exclusion Criteria

•1/ History or presence of significant medical or psychological conditions, including significant abnormalities in laboratory parameters or vital signs
•2/ Receiving renal replacement therapy or expected to require it within 6 months of being randomised
•3/ Renal transplant or on the waiting list for renal transplantation
•4/ Received a GLP\-1 analogue\-containing preparation within the last 30 days or 5 half\-lives of the drug, if known (whichever is longer), at the time of Visit 2
•5/ Received any of the following medications within the specified time frame prior to the start of the study (Visit 2\):
•(a) Aspirin (acetylsalicylic acid) at a dose greater than 150 mg once daily and within the last 3 days prior to the start of the run\-in period (Visit 2\)
•(b) Paracetamol (acetaminophen) or paracetamol\-containing preparations at a total daily dose of greater than 3000 mg and within the last 3 days prior to the start of the run\-in period (Visit 2\)
•(c) Ascorbic acid (vitamin C) supplements at a total daily dose of greater than 1000 mg and within the last 3 days prior to the start of the run\-in period (Visit 2\)
•6/ Participation in another clinical study with an investigational product administered in the last 30 days or 5 half\-lives of the drug, if known (whichever is longer)
•7/ Participants with a known severe allergy/hypersensitivity to any of the proposed study interventions or excipients of the product.