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A Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus
Plain-language guide to NCT04515849: phase 2 randomized trial of Semaglutide and Cotadutide, 248 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04515849
- Phase
- phase 2
- Status
- completed
- Start
- 2020-08-31
- Completion (planned or actual)
- 2022-03-08
- Participants
- 248 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Type 2 Diabetes Mellitus; Chronic Kidney Diseases
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Semaglutide and Cotadutide.
The registry classes the interventions as drug.
More on the Plan
The study plans to randomise approximately 225 subjects.
Japanese participants will not be randomised to the semaglutide arm.
Who Took Part
248 actual participants took part.
It was open to people of any sex aged from 18 years up to 79 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Receiving background standard of care treatment for renal disease and/or T2DM and being treated according to locally recognised guidelines, as appropriate. Body mass index \> 25 kg/m2 at screening or \> 23 kg/m2 for participants enrolled in Japan.
The full record lists 7 inclusion and 26 exclusion criteria; among the exclusions: receiving renal replacement therapy or expected to require it within 6 months of being randomised; renal transplant or on the waiting list for renal transplantation; received any of the following medications within the specified time frame prior to the start of the study (visit 2):.
How the Study Was Run
Design: randomized, parallel-group and double-blind.
The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2020-08-31 with completion listed for 2022-03-08.
It ran at 83 sites in Germany (15), Spain (15), Canada (13), Poland (13), Australia (9) and New Zealand (8).
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Semaglutide and Cotadutide in 248 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Semaglutide compound page and the Cotadutide compound page, all human trials.
Our Notes on the Compounds
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Cotadutide: A GLP-1/glucagon dual agonist from AstraZeneca studied in diabetes, fatty liver and kidney disease; development stopped in 2023.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.