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

Recruiting · NCT07664553 · Interventional (participants receive a specific treatment) · Lead sponsor: AstraZeneca

View the official record on ClinicalTrials.gov →

Interventions studied

What this trial is about

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)

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

60 locations listed across 12 US states.

Research Site - Little Rock, Arkansas, United States
Research Site - Sacramento, California, United States
Research Site - Aurora, Colorado, United States
Research Site - DeLand, Florida, United States
Research Site - Doral, Florida, United States
Research Site - Ocoee, Florida, United States
Research Site - Decatur, Georgia, United States
Research Site - Potomac, Maryland, United States
Research Site - Brooklyn, New York, United States
Research Site - Cary, North Carolina, United States
Research Site - Morehead City, North Carolina, United States
Research Site - Myrtle Beach, South Carolina, United States
Research Site - Memphis, Tennessee, United States
Research Site - Houston, Texas, United States
Research Site - Round Rock, Texas, United States
Research Site - San Antonio, Texas, United States
Research Site - Renton, Washington, United States
Research Site - Amberg, Germany
Research Site - Asahikawa-shi, Japan
Research Site - Bad Oeynhausen, Germany
Research Site - Bangalore, India
Research Site - Bangkok, Thailand
Research Site - Bangkok, Thailand
Research Site - Bangkok, Thailand
Research Site - Batu Caves, Malaysia
Research Site - Belagavi, India
Research Site - Berlin, Germany
Research Site - Bialystok, Poland
Research Site - Bochum, Germany
Research Site - Brandenburg an der Havel, Germany
Research Site - Broumov, Czechia
Research Site - Bucheon-si, South Korea
Research Site - Campbelltown, Australia
Research Site - Changsha, China
Research Site - Changsha, China
Research Site - Chennai, India
Research Site - Coimbatore, India
Research Site - Częstochowa, Poland
Research Site - Daaden, Germany
Research Site - Duisburg, Germany
Research Site - Dupnitsa, Bulgaria
Research Site - East Toowoomba, Australia
Research Site - Eisenach, Germany
Research Site - Elsterwerda, Germany
Research Site - Falkensee, Germany
Research Site - Frankfurt, Germany
Research Site - Fulda, Germany
Research Site - Gladbeck, Germany
Research Site - Guntur, India
Research Site - Gyeonggi-do, South Korea
Research Site - Hamburg, Germany
Research Site - Hannoversch Münden, Germany
Research Site - Hat Yai, Thailand
Research Site - Hefei, China
Research Site - Hefei, China
Research Site - Heidelberg Heights, Australia
Research Site - Huai'an, China
Research Site - Hyderabad, India
Research Site - Indore, India
Research Site - Jongno-gu, South Korea

Showing 60 of 132 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →