Clinical Trial Details
| Trial ID: | L0493 |
| Source ID: | NCT04515849 |
| Associated Drug: | Cotadutide 100 Micrograms |
| Title: | A Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT04515849/results |
| Conditions: | Type 2 Diabetes Mellitus|Chronic Kidney Diseases |
| Interventions: | DRUG: Cotadutide 100 micrograms|DRUG: Cotadutide 300 micrograms|DRUG: Cotadutide 600 micrograms|DRUG: Semaglutide|DRUG: Placebo |
| Outcome Measures: | Primary: 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., Baseline to the end of 14 weeks of dosing | Secondary: 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., 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., 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, 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, Baseline to end of 14 weeks of dosing|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, 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, 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, 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, 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, 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, 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, Baseline to 26 weeks of dosing |
| Sponsor/Collaborators: | Sponsor: AstraZeneca |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 248 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2020-08-31 |
| Completion Date: | 2022-03-08 |
| Results First Posted: | 2025-01-17 |
| Last Update Posted: | 2025-01-17 |
| Locations: | Research Site, Box Hill, 3128, Australia|Research Site, Elizabeth Vale, 5112, Australia|Research Site, Fitzroy, 3065, Australia|Research Site, Heidelberg, 3084, Australia|Research Site, Melbourne, 3004, Australia|Research Site, Merewether, 2291, Australia|Research Site, Oaklands Park, 5046, Australia|Research Site, Wollongong, 2500, Australia|Research Site, Woolloongabba, 4102, Australia|Research Site, Vancouver, British Columbia, V5Y 3W2, Canada|Research Site, Barrie, Ontario, L4N 7L3, Canada|Research Site, Brampton, Ontario, L6S 0C6, Canada|Research Site, Concord, Ontario, L4K 4M2, Canada|Research Site, Etobicoke, Ontario, M9R 4E1, Canada|Research Site, Oakville, Ontario, L6M 1M1, Canada|Research Site, Oshawa, Ontario, L1G 2B9, Canada|Research Site, Ottawa, Ontario, K2J 0V2, Canada|Research Site, Toronto, Ontario, M4G 3E8, Canada|Research Site, Toronto, Ontario, M5G 2C4, Canada|Research Site, Waterloo, Ontario, N2T 0C1, Canada|Research Site, Laval, Quebec, H7T 2P5, Canada|Research Site, Montreal, Quebec, H4A 2C6, Canada|Research Site, Berlin, 10409, Germany|Research Site, Berlin, 10437, Germany|Research Site, Berlin, 10789, Germany|Research Site, Dortmund, 44137, Germany|Research Site, Dusseldorf, 40210, Germany|Research Site, Essen, 45359, Germany|Research Site, Kassel, 34121, Germany|Research Site, Ludwigshafen, 67059, Germany|Research Site, Magdeburg, 39120, Germany|Research Site, Mainz, 55116, Germany|Research Site, München, 81241, Germany|Research Site, Münster, 48145, Germany|Research Site, Münster, 48153, Germany|Research Site, Riesa, 01587, Germany|Research Site, Sankt Ingbert, 66386, Germany|Research Site, Arakawa-ku, 116-0012, Japan|Research Site, Chitose-shi, 066-0032, Japan|Research Site, Fujisawa-shi, 251-0041, Japan|Research Site, Kamakura-shi, 247-8533, Japan|Research Site, Obihiro-shi, 080-0848, Japan|Research Site, Sapporo-shi, 060-0062, Japan|Research Site, Shinjyuku-ku, 160-0022, Japan|Research Site, Auckland, 2025, New Zealand|Research Site, Auckland, ?0620, New Zealand|Research Site, Christchurch, 8011, New Zealand|Research Site, Grafton, 1010, New Zealand|Research Site, Havelock North, 4130, New Zealand|Research Site, New Plymouth, 4310, New Zealand|Research Site, Tauranga, 3110, New Zealand|Research Site, Wellington, 6021, New Zealand|Research Site, Białystok, 15-435, Poland|Research Site, Grodzisk Mazowiecki, 05-825, Poland|Research Site, Katowice, 40-081, Poland|Research Site, Krakow, 30-033, Poland|Research Site, Krakow, 31-261, Poland|Research Site, Kraków, 31-530, Poland|Research Site, Lublin, 20064, Poland|Research Site, Poznań, 61-655, Poland|Research Site, Skierniewice, 96-100, Poland|Research Site, Warszawa, 00-660, Poland|Research Site, Warszawa, 01-518, Poland|Research Site, Warszawa, 02-507, Poland|Research Site, Wierzchosławice, 33-122, Poland|Research Site, Barcelona, 08036, Spain|Research Site, Cordoba, 14004, Spain|Research Site, L'Hospitalet de Llobregat, 08907, Spain|Research Site, La Coruna, 15006, Spain|Research Site, Lérida, 25198, Spain|Research Site, Madrid, 28006, Spain|Research Site, Majadahonda, 28222, Spain|Research Site, Malaga, 29010, Spain|Research Site, Palma de Mallorca, 07010, Spain|Research Site, Palma, 07198, Spain|Research Site, Pozuelo de Alarcón, 28223, Spain|Research Site, Sevilla, 41003, Spain|Research Site, Sevilla, 41009, Spain|Research Site, Valencia, 46009, Spain|Research Site, Vitoria, 01009, Spain|Research Site, Dundee, DD1 9SY, United Kingdom|Research Site, Liverpool, L9 7AL, United Kingdom|Research Site, London, SE5 9RS, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT04515849 |
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