A Study of LY3209590 Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-2)

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A Study of LY3209590 Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-2)

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Efficacy and safety of LY3209590 compared to Degludec in adults with T2DM who are starting basal insulin for the first time (QWINT 2)

clinicaltrials.gov

Eligibility

Inclusion Criteria
  1. Have diagnosis of T2D according to the World Health Organization Criteria
  2. Have an HbA1c of 7.0% – 10% inclusive, at screening
  3. 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
Exclusion Criteria
  1. Have a diagnosis of 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.
  2. Have a history of >1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening.
  3. Have had severe hypoglycemia episodes within 6 months prior to screening.
  4. Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
  5. Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening
    • acute myocardial infarction
    • cerebrovascular accident (stroke), or
    • coronary bypass surgery.
  6. Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening
  7. Have had significant weight gain or loss within 3 months prior to screening, for example, ≥5%.
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