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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04515849
Registration number
NCT04515849
Ethics application status
Date submitted
6/07/2020
Date registered
17/08/2020
Date last updated
29/03/2022
Titles & IDs
Public title
A Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus
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Scientific title
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
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Secondary ID [1]
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2020-000255-12
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Secondary ID [2]
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D5676C00001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus
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Chronic Kidney Diseases
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Renal and Urogenital
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0
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0
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Other renal and urogenital disorders
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Metabolic and Endocrine
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0
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cotadutide 100 micrograms
Treatment: Drugs - Cotadutide 300 micrograms
Treatment: Drugs - Cotadutide 600 micrograms
Treatment: Drugs - Semaglutide
Treatment: Drugs - Placebo
Experimental: Cotadutide 100 micrograms - Cotadutide 100 micrograms administered subcutaneously
Experimental: Cotadutide 300 micrograms - Cotadutide 300 micrograms administered subcutaneously
Experimental: Cotadutide 600 micrograms - Cotadutide 600 micrograms administered subcutaneously
Placebo Comparator: Placebo - Placebo administered subcutaneously
Active Comparator: Semaglutide - Semaglutide 1.0 miligrams administered subcutaneously
Treatment: Drugs: Cotadutide 100 micrograms
Cotadutide 100 micrograms administered subcutaneously
Treatment: Drugs: Cotadutide 300 micrograms
Cotadutide 300 micrograms administered subcutaneously
Treatment: Drugs: Cotadutide 600 micrograms
Cotadutide 600 micrograms administered subcutaneously
Treatment: Drugs: Semaglutide
Semaglutide 1.0 miligrams administered subcutaneously
Treatment: Drugs: Placebo
Placebo administered subcutaneously
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To assess the effects of cotadutide at different dose levels compared to placebo on UACR after 14 weeks
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Assessment method [1]
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Change and percentage change in UACR versus placebo from baseline to the end of 14 weeks of dosing
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Timepoint [1]
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14 weeks
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Secondary outcome [1]
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To assess the effects of cotadutide at different dose levels compared to placebo on UACR after 14 weeks
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Assessment method [1]
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Change and percentage change in UACR versus placebo from baseline to the end of 14 weeks of dosing
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Timepoint [1]
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14 weeks
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Secondary outcome [2]
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To assess the effects of cotadutide at different dose levels compared to placebo on UACR after 26 weeks
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Assessment method [2]
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Change and percentage change in UACR versus placebo from baseline to the end of 26 weeks of dosing
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Timepoint [2]
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26 weeks
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Secondary outcome [3]
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To assess the effects of cotadutide at different dose levels compared to placebo on HbA1c and fasting glucose
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Assessment method [3]
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Change in HbA1c versus placebo from baseline to the end of 14 and 26 weeks of dosing
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Timepoint [3]
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26 weeks
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Secondary outcome [4]
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To assess the effects of cotadutide at different dose levels compared to placebo on HbA1c and fasting glucose
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Assessment method [4]
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Change in fasting glucose from baseline versus placebo after 14 and 26 weeks of dosing
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Timepoint [4]
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26 weeks
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Secondary outcome [5]
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To assess the effects of cotadutide at different dose levels compared to placebo on glucose levels as measured by CGM
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Assessment method [5]
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Change in 10-day average glucose levels as measured by CGM versus placebo from baseline to the end of 14 and 26 weeks of dosing
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Timepoint [5]
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26 weeks
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Secondary outcome [6]
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To assess the effects of cotadutide at different dose levels compared to placebo on glucose levels as measured by CGM
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Assessment method [6]
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Change in percentage time spent in hyperglycaemia (> 10 mmol/L), target range (3.9 -10 mmol/L), hypoglycaemia (< 3.9 mmol/L), and clinically significant hypoglycaemia (< 3.0 mmol/l) over 10 days as measured by CGM versus placebo from baseline to the end of 14 and 26 weeks of dosing
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Timepoint [6]
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26 weeks
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Secondary outcome [7]
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To assess the effects of cotadutide at different dose levels compared to placebo on body weight
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Assessment method [7]
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Change and percentage change in body weight versus placebo from baseline to the end of 14 and 26 weeks of dosing
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Timepoint [7]
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26 weeks
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Secondary outcome [8]
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To assess the effects of cotadutide at different dose levels compared to placebo on body weight
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Assessment method [8]
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Proportion of participants achieving = 5% and = 10% body weight loss versus placebo from baseline to the end of 14 and 26 weeks of dosing
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Timepoint [8]
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26 weeks
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Secondary outcome [9]
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To evaluate the immunogenicity profile of cotadutide compared to placebo
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Assessment method [9]
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ADAs during the titration treatment period and follow-up period
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Timepoint [9]
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30 weeks
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Secondary outcome [10]
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To evaluate the safety and tolerability of cotadutide compared to placebo by assessment of Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE V4.0
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Assessment method [10]
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Safety and tolerability of daily SC doses of Cotadutide by assessment of the following using CTCAE V4.0: The number of Treatment Emergent Adverse events (TEAEs)
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Timepoint [10]
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26 weeks
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Secondary outcome [11]
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To evaluate the safety and tolerability of cotadutide compared to placebo by assessment of Treatment Emergent Serious Adverse Events (TESAEs) as assessed by CTCAE V4.0
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Assessment method [11]
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Safety and tolerability of daily SC doses of Cotadutide by assessment of the following using CTCAE V4.0: The number of Treatment-Emergent Serious Adverse Events (TESAEs)
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Timepoint [11]
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26 weeks
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Secondary outcome [12]
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To evaluate the safety and tolerability of cotadutide compared to placebo by assessment of Treatment Emergent Adverse Events of Special Interest (AESIs) as assessed by CTCAE V4.0
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Assessment method [12]
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Safety and tolerability of daily SC doses of Cotadutide by assessment of the following using CTCAE V4.0: The number of Treatment Emergent Adverse Events of Special Interest (AESIs)
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Timepoint [12]
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26 weeks
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Secondary outcome [13]
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To evaluate the safety and tolerability of cotadutide compared to placebo by assessment of changes in blood pressure
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Assessment method [13]
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Number of subjects with clinically significant changes in systolic and diastolic blood pressure (mmHg)
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Timepoint [13]
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26 weeks
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Secondary outcome [14]
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To evaluate the safety and tolerability of cotadutide compared to placebo by assessment of changes in blood pressure
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Assessment method [14]
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Percentage of subjects with clinically significant changes in systolic and diastolic blood pressure (mmHg)
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Timepoint [14]
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26 weeks
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Secondary outcome [15]
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To evaluate the safety and tolerability of cotadutide compared to placebo by assessment of changes in heart rate
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Assessment method [15]
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Number of subjects with clinically significant changes in heart rate
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Timepoint [15]
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26 weeks
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Secondary outcome [16]
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To evaluate the safety and tolerability of cotadutide compared to placebo by assessment of changes in heart rate
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Assessment method [16]
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Percentage of subjects with clinically significant changes in heart rate
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Timepoint [16]
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26 weeks
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Secondary outcome [17]
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To evaluate the safety and tolerability of cotadutide compared to placebo by assessment of changes in haematology and clinical chemistry parameters
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Assessment method [17]
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Percentage of subjects with clinically significant changes in in haematology and or clinical chemistry parameters
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Timepoint [17]
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26 weeks
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Secondary outcome [18]
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To evaluate the safety and tolerability of cotadutide compared to placebo by assessment of changes in haematology and clinical chemistry parameters
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Assessment method [18]
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Number of subjects with clinically significant changes in in haematology and or clinical chemistry parameters
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Timepoint [18]
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26 weeks
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Secondary outcome [19]
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To evaluate the safety and tolerability of cotadutide compared to placebo by assessment of changes in ECG
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Assessment method [19]
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Number of subjects with an ECG determined to be abnormal and clinically significant
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Timepoint [19]
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26 weeks
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Secondary outcome [20]
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To evaluate the safety and tolerability of cotadutide compared to placebo by assessment of changes in ECG
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Assessment method [20]
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Percentage of subjects with an ECG determined to be abnormal and clinically significant
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Timepoint [20]
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26 weeks
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Eligibility
Key inclusion criteria
- Estimated glomerular filtration rate = 20 to < 90 mL/min/1.73 m2 determined at the
screening visit or a documented occurrence in medical history at least 3 months prior
to randomisation.
- Receiving background standard of care treatment for renal disease and/or T2DM and
being treated according to locally recognised guidelines, as appropriate.
- 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.
- Micro- or macroalbuminuria as defined by UACR > 50 mg/g or 5.7 mg/mmol.
- Diagnosed with T2DM with glucose control managed with any insulin and/or any oral
therapy combination including metformin, SGLT2 inhibitor, thiazolidinedione, or
acarbose where no major dose changes (eg, > 50% increase in dose) have occurred within
the 4 weeks prior to the start of the run-in period. Participants taking sulfonylureas
or glitinides may be randomised following a 4-week washout period of the
sulfonylurea/glitinide.
- Haemoglobin A1c range of 6.5 % to 12.5% (inclusive) at screening
- Body mass index > 25 kg/m2 at screening or > 23 kg/m2 for participants enrolled in
Japan
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Minimum age
18
Years
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Maximum age
79
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- History or presence of significant medical or psychological conditions, including
significant abnormalities in laboratory parameters or vital signs including ECG, which
in the opinion of the investigator, would compromise the participant's safety or
successful participation in the study.
- 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 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
- Received any of the following medications within the specified time frame prior to the
start of the study (Visit 2):
1. 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)
2. 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)
3. 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)
- 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)
- Participants with a known severe allergy/hypersensitivity to any of the proposed study
interventions or excipients of the product
- Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight
loss) or recent episodes of severe hypoglycaemia
- Type 1 diabetes mellitus (T1DM), history of diabetic ketoacidosis, or clinical
suspicion of T1DM
- Participants with recent acute or subacute renal function deterioration
- Significant inflammatory bowel disease, gastroparesis, or other severe disease or
surgery affecting the upper gastrointestinal tract (including weight-reducing surgery
and procedures) which may affect gastric emptying or could affect the interpretation
of safety and tolerability data
- History of acute or chronic pancreatitis
- Significant hepatic disease (except for non-alcoholic steatohepatitis or nonalcoholic
fatty liver disease without portal hypertension or cirrhosis) and/or participants with
any of the following results:
1. Aspartate transaminase (AST) = 3 × upper limit of normal (ULN)
2. Alanine transaminase (ALT) = 3 × ULN
3. Total bilirubin = 2 × ULN
- Poorly controlled hypertension defined as:
1. Systolic BP > 180 mm Hg
2. Diastolic BP = 90 mm Hg after 10 minutes of seated rest and confirmed by repeated
measurement at screening. Participants who fail BP screening criteria may be
considered for 24-hour ambulatory BP monitoring at the discretion of the
investigator. Participants who maintain a mean 24-hour systolic BP = 180 or
diastolic BP < 90 mm Hg with a preserved nocturnal dip of > 15% will be
considered eligible
- Unstable angina pectoris, myocardial infarction, transient ischemic attack or stroke
within 3 months prior to screening, or participants who have undergone percutaneous
coronary intervention or a coronary artery bypass graft within the past 6 months or
who are due to undergo these procedures at the time of screening
- Decompensated heart failure or hospitalisation for heart failure in the 3 months prior
to screening or symptoms consistent with New York Heart Association heart failure
Class III/IV
- Basal calcitonin level > 50 ng/L at screening or history/family history of medullary
thyroid carcinoma or multiple endocrine neoplasia
- History of neoplastic disease within 5 years prior to screening, except for adequately
treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/08/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/03/2022
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Sample size
Target
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Accrual to date
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Final
247
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Box Hill
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Recruitment hospital [2]
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Research Site - Elizabeth Vale
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Recruitment hospital [3]
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Research Site - Fitzroy
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Recruitment hospital [4]
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Research Site - Heidelberg
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Recruitment hospital [5]
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Research Site - Melbourne
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Recruitment hospital [6]
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Research Site - Merewether
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Recruitment hospital [7]
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Research Site - Oaklands Park
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Recruitment hospital [8]
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Research Site - Wollongong
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Recruitment hospital [9]
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Research Site - Woolloongabba
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Recruitment postcode(s) [1]
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3128 - Box Hill
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Recruitment postcode(s) [2]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [3]
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3065 - Fitzroy
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment postcode(s) [6]
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2291 - Merewether
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Recruitment postcode(s) [7]
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5046 - Oaklands Park
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Recruitment postcode(s) [8]
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2500 - Wollongong
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Recruitment postcode(s) [9]
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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British Columbia
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Country [2]
0
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Canada
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State/province [2]
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Ontario
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Country [3]
0
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Canada
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State/province [3]
0
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Quebec
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Country [4]
0
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Germany
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State/province [4]
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Berlin
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Country [5]
0
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Germany
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State/province [5]
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Dortmund
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Country [6]
0
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Germany
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State/province [6]
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Dusseldorf
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Country [7]
0
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Germany
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State/province [7]
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Essen
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Country [8]
0
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Germany
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State/province [8]
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Ludwigshafen
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Country [9]
0
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Germany
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State/province [9]
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Magdeburg
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Country [10]
0
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Germany
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State/province [10]
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Mainz
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Country [11]
0
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Germany
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State/province [11]
0
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München
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Country [12]
0
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Germany
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State/province [12]
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Münster
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Country [13]
0
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Japan
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State/province [13]
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Arakawa-ku
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Country [14]
0
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Japan
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State/province [14]
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Chitose-shi
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Country [15]
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Japan
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State/province [15]
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Fujisawa-shi
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Country [16]
0
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Japan
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State/province [16]
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Kamakura-shi
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Country [17]
0
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Japan
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State/province [17]
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Obihiro-shi
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Country [18]
0
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Japan
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State/province [18]
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Sapporo-shi
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Country [19]
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Japan
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State/province [19]
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Shinjyuku-ku
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Country [20]
0
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New Zealand
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State/province [20]
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Auckland
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Country [21]
0
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New Zealand
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State/province [21]
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Christchurch
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Country [22]
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New Zealand
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State/province [22]
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Grafton
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Country [23]
0
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New Zealand
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State/province [23]
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Havelock North
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Country [24]
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New Zealand
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State/province [24]
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Tauranga
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Country [25]
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New Zealand
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State/province [25]
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Wellington
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Country [26]
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Poland
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State/province [26]
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Bialystok
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0
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Poland
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State/province [27]
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Krakow
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Country [28]
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Poland
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State/province [28]
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Lublin
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Country [29]
0
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Poland
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New York
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Country [30]
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Poland
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State/province [30]
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Poznan
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Country [31]
0
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Poland
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State/province [31]
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Warszawa
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Spain
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Barcelona
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Country [33]
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Spain
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State/province [33]
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Cordoba
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Country [34]
0
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Spain
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State/province [34]
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L'Hospitalet de Llobregat
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Country [35]
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Spain
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State/province [35]
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La Coruna
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Spain
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State/province [36]
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Lérida
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Spain
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Majadahonda
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Spain
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State/province [38]
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Malaga
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Spain
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Palma de Mallorca
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Country [40]
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Spain
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State/province [40]
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Pozuelo de Alarcón
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Country [41]
0
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Spain
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State/province [41]
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Sevilla
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Country [42]
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Spain
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State/province [42]
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Valencia
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Country [43]
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United Kingdom
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State/province [43]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04515849
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
0
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Fax
0
0
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Email
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Contact person for public queries
Name
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Address
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04515849
Download to PDF