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Type 2 Diabetes MellitusPhase 2NCT04515849

A Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus

A Phase 2 study testing Cotadutide 100 micrograms, Cotadutide 300 micrograms and Cotadutide 600 micrograms in people with Type 2 Diabetes Mellitus and Chronic Kidney Diseases, run by AstraZeneca at 83 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 79 years
What is being tested?
Cotadutide 100 micrograms, Cotadutide 300 micrograms and Cotadutide 600 micrograms
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
248 participants
Where
83 sitesin 8 countries
Study dates
31 Aug 2020to 8 Mar 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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):
  • 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)
Show all 26Show fewer
  • 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)
  • 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:
  • Aspartate transaminase (AST) ≥ 3 × upper limit of normal (ULN)
  • Alanine transaminase (ALT) ≥ 3 × ULN
  • Total bilirubin ≥ 2 × ULN
  • Poorly controlled hypertension defined as:
  • Systolic BP > 180 mm Hg
  • 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

Trial locations and contacts

83 sites in 8 countries.

83 sites in 8 countries

Germany15 sites

  • Research Site

    Berlin, 10409

  • Research Site

    Berlin, 10437

  • Research Site

    Berlin, 10789

  • Research Site

    Dortmund, 44137

  • Research Site

    Düsseldorf, 40210

  • Research Site

    Essen, 45359

  • Research Site

    Kassel, 34121

  • Research Site

    Ludwigshafen, 67059

  • Research Site

    Magdeburg, 39120

  • Research Site

    Mainz, 55116

  • Research Site

    München, 81241

  • Research Site

    Münster, 48145

  • Research Site

    Münster, 48153

  • Research Site

    Riesa, 01587

  • Research Site

    Sankt Ingbert, 66386

Other trials in Germany

Spain15 sites

  • Research Site

    A Coruña, 15006

  • Research Site

    Barcelona, 08036

  • Research Site

    Córdoba, 14004

  • Research Site

    L'Hospitalet de Llobregat, 08907

  • Research Site

    Lleida, 25198

  • Research Site

    Madrid, 28006

  • Research Site

    Majadahonda, 28222

  • Research Site

    Málaga, 29010

  • Research Site

    Palma, 07198

  • Research Site

    Palma de Mallorca, 07010

  • Research Site

    Pozuelo de Alarcón, 28223

  • Research Site

    Seville, 41003

  • Research Site

    Seville, 41009

  • Research Site

    Valencia, 46009

  • Research Site

    Vitoria-Gasteiz, 01009

Other trials in Spain

Canada13 sites

  • Research Site

    Barrie, Ontario, L4N 7L3

  • Research Site

    Brampton, Ontario, L6S 0C6

  • Research Site

    Concord, Ontario, L4K 4M2

  • Research Site

    Etobicoke, Ontario, M9R 4E1

  • Research Site

    Laval, Quebec, H7T 2P5

  • Research Site

    Montreal, Quebec, H4A 2C6

  • Research Site

    Oakville, Ontario, L6M 1M1

  • Research Site

    Oshawa, Ontario, L1G 2B9

  • Research Site

    Ottawa, Ontario, K2J 0V2

  • Research Site

    Toronto, Ontario, M4G 3E8

  • Research Site

    Toronto, Ontario, M5G 2C4

  • Research Site

    Vancouver, British Columbia, V5Y 3W2

  • Research Site

    Waterloo, Ontario, N2T 0C1

Other trials in Canada

Poland13 sites

  • Research Site

    Bialystok, 15-435

  • Research Site

    Grodzisk Mazowiecki, 05-825

  • Research Site

    Katowice, 40-081

  • Research Site

    Krakow, 30-033

  • Research Site

    Krakow, 31-261

  • Research Site

    Krakow, 31-530

  • Research Site

    Lublin, 20064

  • Research Site

    Poznan, 61-655

  • Research Site

    Skierniewice, 96-100

  • Research Site

    Warsaw, 00-660

  • Research Site

    Warsaw, 01-518

  • Research Site

    Warsaw, 02-507

  • Research Site

    Wierzchosławice, 33-122

Other trials in Poland

Australia9 sites

  • Research Site

    Box Hill, 3128

  • Research Site

    Elizabeth Vale, 5112

  • Research Site

    Fitzroy, 3065

  • Research Site

    Heidelberg, 3084

  • Research Site

    Melbourne, 3004

  • Research Site

    Merewether, 2291

  • Research Site

    Oaklands Park, 5046

  • Research Site

    Wollongong, 2500

  • Research Site

    Woolloongabba, 4102

Other trials in Australia

New Zealand8 sites

  • Research Site

    Auckland, 2025

  • Research Site

    Auckland, ?0620

  • Research Site

    Christchurch, 8011

  • Research Site

    Grafton, 1010

  • Research Site

    Havelock North, 4130

  • Research Site

    New Plymouth, 4310

  • Research Site

    Tauranga, 3110

  • Research Site

    Wellington, 6021

Other trials in New Zealand

Japan7 sites

  • Research Site

    Arakawa-ku, 116-0012

  • Research Site

    Chitose-shi, 066-0032

  • Research Site

    Fujisawa-shi, 251-0041

  • Research Site

    Kamakura-shi, 247-8533

  • Research Site

    Obihiro-shi, 080-0848

  • Research Site

    Sapporo, 060-0062

  • Research Site

    Shinjyuku-ku, 160-0022

Other trials in Japan

United Kingdom3 sites

  • Research Site

    Dundee, DD1 9SY

  • Research Site

    Liverpool, L9 7AL

  • Research Site

    London, SE5 9RS

Other trials in United Kingdom

About this study

Official 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

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.

Read the 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.

Being tested
Cotadutide 100 micrograms, Cotadutide 300 micrograms, Cotadutide 600 micrograms, Semaglutide, Placebo
Keywords
MEDI0382, T2DM, Cotadutide, Diabetic Kidney Disease
Medical subject headings
Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic, Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cotadutide 100 microgramsDrug

    Also called MEDI0382

    Cotadutide 100 micrograms administered subcutaneously

  • Cotadutide 300 microgramsDrug

    Also called MEDI0382

    Cotadutide 300 micrograms administered subcutaneously

  • Cotadutide 600 microgramsDrug

    Also called MEDI0382

    Cotadutide 600 micrograms administered subcutaneously

  • SemaglutideDrug

    Also called Ozempic

    Semaglutide 1.0 miligrams administered subcutaneously

  • PlaceboDrug

    Placebo administered subcutaneously

Study groups in NCT04515849
Study groupRoleWhat they receive
Cotadutide 100 microgramsExperimentalCotadutide 100 micrograms administered subcutaneously
Receives: Drug: Cotadutide 100 micrograms
Cotadutide 300 microgramsExperimentalCotadutide 300 micrograms administered subcutaneously
Receives: Drug: Cotadutide 300 micrograms
Cotadutide 600 microgramsExperimentalCotadutide 600 micrograms administered subcutaneously
Receives: Drug: Cotadutide 600 micrograms
PlaceboPlacebo comparatorPlacebo administered subcutaneously
Receives: Drug: Placebo
SemaglutideActive comparatorSemaglutide 1.0 miligrams administered subcutaneously
Receives: Drug: Semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to the end of 14 weeks of dosing

Secondary outcomes (11)

  1. 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.

    Measured: Baseline to end of 26 weeks of dosing

  2. 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.

    Measured: Baseline to end of 14 weeks of dosing

  3. 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

    Measured: Baseline to end of 26 weeks of dosing

  4. 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

    Measured: Baseline to end of 14 weeks of dosing

  5. 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

    Measured: Baseline to end of 26 weeks of dosing

  6. 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

    Measured: Baseline to end of 14 weeks of dosing

  7. 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

    Measured: Baseline to end of 26 weeks of dosing

  8. 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

    Measured: Baseline to end of 14 weeks of dosing

  9. 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

    Measured: Baseline to end of 26 weeks of dosing

  10. 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

    Measured: Baseline to 14 weeks of dosing

  11. 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

    Measured: Baseline to 26 weeks of dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2020
  2. Study start31 Aug 2020
  3. Primary completion8 Mar 2022
  4. Study completion8 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04515849
Sponsor's protocol ID
D5676C00001
Other IDs
2020-000255-12
Status last verified
Dec 2024
First submitted
6 Jul 2020
Last updated
17 Jan 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Publications

  • Selvarajah V, Robertson D, Hansen L, Jermutus L, Smith K, Coggi A, Sanchez J, Chang YT, Yu H, Parkinson J, Khan A, Chung HS, Hess S, Dumas R, Duck T, Jolly S, Elliott TG, Baker J, Lecube A, Derwahl KM, Scott R, Morales C, Peters C, Goldenberg R, Parker VER, Heerspink HJL; study investigators. A randomized phase 2b trial examined the effects of the glucagon-like peptide-1 and glucagon receptor agonist cotadutide on kidney outcomes in patients with diabetic kidney disease. Kidney Int. 2024 Dec;106(6):1170-1180. doi: 10.1016/j.kint.2024.08.023. Epub 2024 Aug 31.

    PubMed 39218393

  • Yu H, Parker V, Selvarajah V, Hansen L, Robertson D, Hamren B, Khan A, Parkinson J. Pharmacokinetic-pharmacodynamic (PK/PD) modelling of cotadutide effect in patients with chronic kidney disease and type 2 diabetes mellitus. Br J Clin Pharmacol. 2025 Sep;91(9):2672-2683. doi: 10.1002/bcp.70093. Epub 2025 May 9.

    PubMed 40344607

  • Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

    PubMed 39963952

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cotadutide 100 micrograms, Cotadutide 300 micrograms and Cotadutide 600 micrograms in people with Type 2 Diabetes Mellitus and Chronic Kidney Diseases, run by AstraZeneca at 83 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in Germany, Spain, Canada, Poland, Australia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Primary Endpoint Was Percentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 14 Weeks (time frame: Baseline to the end of 14 weeks of dosing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04515849, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.

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