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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
248
Cotadutide 100 micrograms administered subcutaneously
Cotadutide 300 micrograms administered subcutaneously
Cotadutide 600 micrograms administered subcutaneously
The Primary Endpoint Was Percentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 14 Weeks
Percentage change in UACR of cotadutide at different dose levels compared to placebo after 14 weeks. Efficacy endpoints for cotadutide vs. semaglutide are exploratory and are therefore excluded.
Time frame: Baseline to the end of 14 weeks of dosing
Percentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 26 Weeks
Percentage change in UACR of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks. Efficacy endpoints for cotadutide vs. semaglutide are exploratory and are therefore excluded.
Time frame: Baseline to end of 26 weeks of dosing
Percent Change in Body Weight of Cotatudide at Different Dose Levels Versus Placebo From Baseline to End of 14 Weeks of Dosing
Percentage change in body weight of cotadutide at different dose levels compared to placebo from baseline to end of 14 weeks of dosing.
Time frame: Baseline to end of 14 weeks of dosing
Percentage Change in Body Weight of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 26 Weeks of Dosing
Percentage change in body weight of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks of dosing
Time frame: Baseline to end of 26 weeks of dosing
Percent Change in HbA1c of Cotadutide at Different Dose Levels Versus Placebo From Baseline to the End of 14 of Dosing
Percentage change in HbA1c of cotadutide at different dose levels compared to placebo from baseline to end of 14 weeks of dosing
Time frame: Baseline to end of 14 weeks of dosing
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Semaglutide 1.0 miligrams administered subcutaneously
Placebo administered subcutaneously
Research Site
Box Hill, Australia
Research Site
Elizabeth Vale, Australia
Research Site
Fitzroy, Australia
Research Site
Heidelberg, Australia
Research Site
Melbourne, Australia
Research Site
Merewether, Australia
Research Site
Oaklands Park, Australia
Research Site
Wollongong, Australia
Research Site
Woolloongabba, Australia
Research Site
Vancouver, British Columbia, Canada
...and 73 more locations
Percent Change in HbA1c of Cotadutide at Different Dose Levels Versus Placebo From Baseline to the End of 26 of Dosing
Percentage change in HbA1c of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks of dosing
Time frame: Baseline to end of 26 weeks of dosing
Change in Fasting Glucose of Cotadutide at Different Dose Levels From Baseline Versus Placebo After 14 Weeks of Dosing
Absolute change in fasting glucose of cotadutide at different dose levels compared to placebo from baseline to end of 14 weeks
Time frame: Baseline to end of 14 weeks of dosing
Change in Fasting Glucose of Cotadutide at Different Dose Levels From Baseline Versus Placebo After 26 Weeks of Dosing
Absolute change in fasting glucose of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks
Time frame: Baseline to end of 26 weeks of dosing
Change in 10-day Average Glucose Levels of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 14 Weeks of Dosing
Absolute change in 10-day average glucose of cotadutide at different dose levels compared to placebo from baseline to end of 14 weeks of dosing
Time frame: Baseline to end of 14 weeks of dosing
Change in 10-day Average Glucose Levels of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 26 Weeks of Dosing
Absolute change in 10-day average glucose of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks of dosing
Time frame: Baseline to end of 26 weeks of dosing
Change in Percentage Time Spent in Hyperglycaemia Over 10 Days of Cotadutide at Different Dose Levels Compared to Placebo After 14 Weeks of Dosing
Percentage change in 10-day percentage time spent in hyperglycaemia of cotadutide at different dose levels compared to placebo from baseline to end of 14 weeks
Time frame: Baseline to 14 weeks of dosing
Change in Percentage Time Spent in Hyperglycaemia Over 10 Days of Cotadutide at Different Dose Levels Compared to Placebo After 26 Weeks of Dosing
Percentage change in 10-day percentage time spent in hyperglycaemia of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks
Time frame: Baseline to 26 weeks of dosing