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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
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

RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Type 2 Diabetes Mellitus

Interventions: Elecoglipron, Placebo

Countries: United States, Australia, Bulgaria, Canada, China, Czechia, Germany, India

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (132)
  • Little Rock, Arkansas, United States
  • Sacramento, California, United States
  • Aurora, Colorado, United States
  • DeLand, Florida, United States
  • Doral, Florida, United States
  • Ocoee, Florida, United States
  • Decatur, Georgia, United States
  • Potomac, Maryland, United States
  • Brooklyn, New York, United States
  • Cary, North Carolina, United States
  • Morehead City, North Carolina, United States
  • Myrtle Beach, South Carolina, United States
  • Memphis, Tennessee, United States
  • Houston, Texas, United States
  • Round Rock, Texas, United States
  • San Antonio, Texas, United States
  • Renton, Washington, United States
  • Campbelltown, Australia
  • East Toowoomba, Australia
  • Heidelberg Heights, Australia
  • Parkville, Australia
  • St Leonards, Australia
  • Dupnitsa, Bulgaria
  • Kozloduy, Bulgaria
  • Plovdiv, Bulgaria
  • Sofia, Bulgaria
  • Stara Zagora, Bulgaria
  • Veliko Tarnovo, Bulgaria
  • Yambol, Bulgaria
  • Surrey, British Columbia, Canada
  • + 102 more on CT.gov