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

Korábbi kezelés

• 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

Más betegség

• T1DM, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
• 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

• 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