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A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus on Background Insulin

NCT07664553 · AstraZeneca
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Official title
A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus on Background Insulin (Eluminate-3)
About this study
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus (T2DM), treated with a background insulin and other background glucose-lowering medication(s)
Eligibility criteria
Inclusion Criteria: * Diagnosed with T2DM for at least 90 days prior to screening * Stable treatment with background insulin and other background glucose-lowering medication(s) * HbA1c value of ≥ 7% to ≤ 10.5% * Body mass index (BMI) of ≥ 23 kg/m2 at screening * Stable body weight (self-reported or documented) for 90 days prior to screening Exclusion Criteria: * T1DM, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma * Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema * Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms * Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying * History of acute or chronic pancreatitis. * Severe congestive heart failure (NYHA IV) * History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
Study design
Enrollment target: 600 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-07-08
Estimated completion: 2028-05-23
Last updated: 2026-08-04
Interventions
Drug: ElecoglipronDrug: Placebo
Primary outcomes
  • Change from baseline in Hemoglobin A1c (HbA1c) (Baseline to Week 40)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (132)
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Little Rock, Arkansas, United States
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Sacramento, California, United States
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Aurora, Colorado, United States
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DeLand, Florida, United States
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Doral, Florida, United States
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Ocoee, Florida, United States
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Decatur, Georgia, United States
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Potomac, Maryland, United States
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Brooklyn, New York, United States
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Cary, North Carolina, United States
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Morehead City, North Carolina, United States
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Myrtle Beach, South Carolina, United States
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Memphis, Tennessee, United States
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Houston, Texas, United States
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Round Rock, Texas, United States
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San Antonio, Texas, United States
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Renton, Washington, United States
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Campbelltown, Australia
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East Toowoomba, Australia
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Heidelberg Heights, Australia
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Parkville, Australia
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St Leonards, Australia
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Dupnitsa, Bulgaria
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Kozloduy, Bulgaria
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Veliko Tarnovo, Bulgaria
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Yambol, Bulgaria
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Surrey, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Brampton, Ontario, Canada
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North York, Ontario, Canada
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Sarnia, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Toronto, Ontario, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Changsha, China
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Changsha, China
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Hefei, China
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Hefei, China
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Huai'an, China
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Langfang, China
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Liangyugang, China
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Luoyang, China
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Nanjing, China
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Nanyang, China
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Pinggu, China
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Pingxiang, China
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Shijiazhuang, China
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Tianjin, China
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Yueyang, China
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Broumov, Czechia
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České Budějovice, Czechia
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Ostrava, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Prague, Czechia
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Prague, Czechia
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Amberg, Germany
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Bad Oeynhausen, Germany
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Berlin, Germany
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Bochum, Germany
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Brandenburg an der Havel, Germany
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Daaden, Germany
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Duisburg, Germany
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Eisenach, Germany
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Elsterwerda, Germany
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Falkensee, Germany
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Frankfurt, Germany
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Fulda, Germany
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Gladbeck, Germany
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Hamburg, Germany
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Hannoversch Münden, Germany
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Magdeburg, Germany
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Mannheim, Germany
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Münster, Germany
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Nittendorf, Germany
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Obertshausen, Germany
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Oldenburg, Germany
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Pirna, Germany
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Bangalore, India
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Belagavi, India
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Chennai, India
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Coimbatore, India
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Guntur, India
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Hyderabad, India
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Indore, India
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Kochi, India
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Madurai, India
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Mumbai, India
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New Delhi, India
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Pune, India
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Asahikawa-shi, Japan
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Kamakura-shi, Japan
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Kashiwa-shi, Japan
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Kobe, Japan
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Komoro, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Miyazaki, Japan
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Naka, Japan
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Sapporo, Japan
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Yokohama, Japan
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Batu Caves, Malaysia
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Kuala Lumpur, Malaysia
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Miri, Malaysia
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Putrajaya, Malaysia
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Seremban, Malaysia
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Bialystok, Poland
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Częstochowa, Poland
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Kielce, Poland
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Krakow, Poland
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Lodz, Poland
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Poznan, Poland
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Radom, Poland
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Warsaw, Poland
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Warsaw, Poland
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Bucheon-si, South Korea
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Gyeonggi-do, South Korea
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Jongno-gu, South Korea
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Junggu, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Bangkok, Thailand
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Bangkok, Thailand
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Bangkok, Thailand
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Hat Yai, Thailand
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Muang, Thailand
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Mueang, Thailand
A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus on Background Insulin · TrialPath