Trials / Completed
CompletedNCT04515849
A Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 248 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 79 Years
- Healthy volunteers
- Not accepted
Summary
A Phase 2b, study to measure the effect of Cotadutide at different doses versus placebo or comparator (semaglutide) in participants who have Chronic Kidney Disease with Type 2 Diabetes Mellitus.
Detailed description
A Phase 2b randomised, double-blind, placebo-controlled and open-label active comparator study to evaluate the effect of Cotadutide at 100, 300 or 600 micrograms in participants who have Chronic Kidney Disease with Type 2 Diabetes Mellitus. The study plans to randomise approximately 225 subjects. Subjects will be randomised to receive double-blind Cotadutide or placebo at 100, 300 or 600 micrograms once daily for 26 weeks, or open-label semaglutide at 1.0 miligrams once a week for 26 weeks. Japanese participants will not be randomised to the semaglutide arm.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cotadutide 100 micrograms | Cotadutide 100 micrograms administered subcutaneously |
| DRUG | Cotadutide 300 micrograms | Cotadutide 300 micrograms administered subcutaneously |
| DRUG | Cotadutide 600 micrograms | Cotadutide 600 micrograms administered subcutaneously |
| DRUG | Semaglutide | Semaglutide 1.0 miligrams administered subcutaneously |
| DRUG | Placebo | Placebo administered subcutaneously |
Timeline
- Start date
- 2020-08-31
- Primary completion
- 2022-03-08
- Completion
- 2022-03-08
- First posted
- 2020-08-17
- Last updated
- 2025-01-17
- Results posted
- 2025-01-17
Locations
83 sites across 8 countries: Australia, Canada, Germany, Japan, New Zealand, Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT04515849. Inclusion in this directory is not an endorsement.