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Clinical Trial Details

Trial ID: L6022
Source ID: NCT03235050
Associated Drug: Medi0382 Low Dose
Title: A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03235050/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: MEDI0382 low dose|DRUG: MEDI0382 mid dose|DRUG: MEDI0382 high dose|DRUG: Placebo|DRUG: Liraglutide
Outcome Measures: Primary: Change in HbA1c, To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo, From baseline to 14 weeks|Percent Change in Body Weight, To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo, From baseline to 14 weeks | Secondary: Change in HbA1c, To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo, from baseline to 26 weeks and 54 weeks|Percentage of Participants Achieving an HbA1c Target < 7.0%, To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of participants achieving an HbA1c target of \<7% versus placebo, after 14, 26, and 54 weeks|Percent Change in Body Weight, To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus placebo, from baseline to 26 weeks and 54 weeks|Absolute Change in Body Weight, To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo, from baseline to 14 weeks, 26 weeks and 54 weeks|Percent Change in Body Weight Versus Active Comparator, To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily, from baseline to 14 weeks, 26 weeks and 54 weeks|Absolute Change in Body Weight Versus Active Comparator, To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily, from baseline to 14 weeks, 26 weeks and 54 weeks|Percentage of Participants Achieving Weight Loss of ≥5% and ≥10%, To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of subjects achieving weight loss of ≥5% and ≥10% versus placebo, after 14 weeks, 26 weeks and 54 weeks|Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control, To assess the effect of 100, 200, and 300 μg of cotadutide on the requirement for additional blood glucose-lowering therapies versus placebo, at 14 weeks, 26 weeks and 54 weeks|Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin), To characterise the PK profile of 100, 200, and 300 μg of cotadutide, Time points at which outcome measure were assessed for plasma concentration were Weeks 1,2,6,10,14,18,22,26, and 54|Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants), To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide, Baseline through 54-week treatment period and 28-day follow-up|Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants, To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide, Baseline through 54-week treatment period and 28-day follow-up
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: MedImmune LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 834
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-08-02
Completion Date: 2019-06-14
Results First Posted: 2020-07-20
Last Update Posted: 2020-08-17
Locations: Research Site, Birmingham, Alabama, 35205, United States|Research Site, Chandler, Arizona, 85224, United States|Research Site, Glendale, Arizona, 85306, United States|Research Site, Glendale, Arizona, 85308, United States|Research Site, Mesa, Arizona, 85213, United States|Research Site, Marietta, Georgia, 30067, United States|Research Site, Evansville, Indiana, 47715, United States|Research Site, Baton Rouge, Louisiana, 70808, United States|Research Site, Metairie, Louisiana, 70006, United States|Research Site, Elkridge, Maryland, 21075, United States|Research Site, Bridgeton, Missouri, 63044, United States|Research Site, Las Vegas, Nevada, 89117, United States|Research Site, Brooklyn, New York, 11229, United States|Research Site, Morehead City, North Carolina, 28557, United States|Research Site, Philadelphia, Pennsylvania, 19104, United States|Research Site, Greer, South Carolina, 29651, United States|Research Site, Houston, Texas, 77040, United States|Research Site, Houston, Texas, 77074, United States|Research Site, Plano, Texas, 75093, United States|Research Site, Layton, Utah, 84014, United States|Research Site, Arlington, Virginia, 22206, United States|Research Site, Manassas, Virginia, 20110, United States|Research Site, Botevgrad, 2140, Bulgaria|Research Site, Kozloduy, Bulgaria|Research Site, Kyustendil, 2500, Bulgaria|Research Site, Lukovit, Bulgaria|Research Site, Petrich, 2850, Bulgaria|Research Site, Pleven, 5800, Bulgaria|Research Site, Plovdiv, 4000, Bulgaria|Research Site, Russe, 7002, Bulgaria|Research Site, Sofia, 1223, Bulgaria|Research Site, Sofia, 1407, Bulgaria|Research Site, Sofia, 1606, Bulgaria|Research Site, Sofia, 1618, Bulgaria|Research Site, Stara Zagora, 6000, Bulgaria|Research Site, Red Deer, Alberta, T4N 6V7, Canada|Research Site, Sherwood Park, Alberta, T8L 0N2, Canada|Research Site, Burlington, Ontario, L7M 4Y1, Canada|Research Site, Etobicoke, Ontario, M9W 4L6, Canada|Research Site, Guelph, Ontario, N1H 1B1, Canada|Research Site, London, Ontario, N5W 6A2, Canada|Research Site, London, Ontario, N6G 5A9, Canada|Research Site, Newmarket, Ontario, L3Y 5G8, Canada|Research Site, Sarnia, Ontario, N7T 4X3, Canada|Research Site, Thornhill, Ontario, L4J 8L7, Canada|Research Site, Toronto, Ontario, M4G 3E8, Canada|Research Site, Levis, Quebec, G6W 0M5, Canada|Research Site, Montreal, Quebec, H4A 3T2, Canada|Research Site, Montreal, Quebec, H4N 2W2, Canada|Research Site, Saint-Marc-des-Carrieres, Quebec, G0A 4B0, Canada|Research Site, Beroun, 266 00, Czechia|Research Site, Jilove u Prahy, 254 01, Czechia|Research Site, Pardubice, 530 02, Czechia|Research Site, Plzen - Severni Predmesti, 301 00, Czechia|Research Site, Plzen, 301 66, Czechia|Research Site, Praha - Klanovice, 190 14, Czechia|Research Site, Praha 10, 104 00, Czechia|Research Site, Praha 4, 140 00, Czechia|Research Site, Praha 4, 149 00, Czechia|Research Site, Praha, 140 59, Czechia|Research Site, Uherske Hradiste, 686 01, Czechia|Research Site, Aschaffenburg, 63739, Germany|Research Site, Berlin, 10437, Germany|Research Site, Berlin, 10787, Germany|Research Site, Eschweiler, 52249, Germany|Research Site, Essen, 45136, Germany|Research Site, Essen, 45359, Germany|Research Site, Gelnhausen, 63571, Germany|Research Site, Hamburg, 21109, Germany|Research Site, Hamburg, 22607, Germany|Research Site, Hof, 95030, Germany|Research Site, Löhne, 32584, Germany|Research Site, Lübeck, 23538, Germany|Research Site, Magdeburg, 39120, Germany|Research Site, Mannheim, 68163, Germany|Research Site, Munster, 48145, Germany|Research Site, Oldenburg, 23758, Germany|Research Site, Pirna, 01796, Germany|Research Site, Rhaunen, 55624, Germany|Research Site, Villingen-Schwenningen, 78048, Germany|Research Site, Guadalajara, 44670, Mexico|Research Site, Monterrey, 66465, Mexico|Research Site, México, 03300, Mexico|Research Site, México, 11650, Mexico|Research Site, Veracruz, 91900, Mexico|Research Site, Veracruz, 91910, Mexico|Research Site, Chelyabinsk, 454091, Russian Federation|Research Site, Ekaterinburg, 620039, Russian Federation|Research Site, Izhevsk, 426035, Russian Federation|Research Site, Kemerovo, 650066, Russian Federation|Research Site, Moscow, 119034, Russian Federation|Research Site, Moscow, 119435, Russian Federation|Research Site, Moscow, 125367, Russian Federation|Research Site, Novosibirsk, 630051, Russian Federation|Research Site, Perm, 614000, Russian Federation|Research Site, Perm, 614068, Russian Federation|Research Site, Saint Petersburg, 196601, Russian Federation|Research Site, Saint-Petersburg, 199226, Russian Federation|Research Site, St. Petersburg, 196084, Russian Federation|Research Site, St.Petersburg, 198013, Russian Federation|Research Site, Vladikavkaz, 362007, Russian Federation|Research Site, Volgograd, 400131, Russian Federation|Research Site, Banska Bystrica, 974 01, Slovakia|Research Site, Bratislava, 831 01, Slovakia|Research Site, Dolny Kubin, 026 01, Slovakia|Research Site, Levice, 934 01, Slovakia|Research Site, Lucenec, 984 01, Slovakia|Research Site, Malacky, 901 01, Slovakia|Research Site, Namestovo, 029 01, Slovakia|Research Site, Nitra, 949 11, Slovakia|Research Site, Nove Mesto nad Vahom, 915 01, Slovakia|Research Site, Prievidza, 971 01, Slovakia|Research Site, Rimavska Sobota, 979 01, Slovakia|Research Site, Roznava, 048 01, Slovakia|Research Site, Sabinov, 083 01, Slovakia|Research Site, Trebisov, 075 01, Slovakia|Research Site, Trencin, 911 01, Slovakia|Research Site, Trnava, 917 01, Slovakia|Research Site, Zilina, 010 01, Slovakia
URL: https://clinicaltrials.gov/show/NCT03235050

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress