A Study of LY3209590 Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-2)
Efficacy and safety of LY3209590 compared to Degludec in adults with T2DM who are starting basal insulin for the first time (QWINT 2)
clinicaltrials.govEligibility
Inclusion Criteria
- Have diagnosis of T2D according to the World Health Organization Criteria
- Have an HbA1c of 7.0% – 10% 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
Exclusion Criteria
- 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.
- 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 known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
- 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.
- 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%.