A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)

Korábbi kezelés

• Have a history of >1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening.
• Have had severe hypoglycemia episodes within 6 months prior to screening.
• Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening
• coronary bypass surgery.
• Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening
• Have had significant weight gain or loss within 3 months prior to screening, for example, ≥5%.

Más betegség

• Have a diagnosis of type 1 diabetes (T1D), latent autoimmune diabetes, or specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug induced or chemical-induced diabetes.
• acute myocardial infarction
• cerebrovascular accident (stroke), or

Laborértékek

• Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.

• Have a diagnosis of T2D according to the World Health Organization criteria.
• Have an HbA1c of 7.0% to 10.0%, inclusive, at screening.
• Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study.
• Are insulin naive
  • Exceptions:
• short-term insulin treatment for a maximum of 14 days, prior to screening, and
• prior insulin treatment for gestational diabetes.