A Study of LY3209590 Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy (QWINT-5)

In by alicia.green

Locations
Macon
Condition
Diabetes

A Study of LY3209590 Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy (QWINT-5)

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A Phase 3, Multicenter, Randomized, Parallel-Design, Open Label Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared with Insulin Degludec in Participants with Type 1 Diabetes Treated with Multiple Daily Injection Therapy

clinicaltrials.gov

Eligibility

Inclusion Criteria
  1. Have a clinical diagnosis of type 1 diabetes for at least 1 year prior to screening
  2. Have received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening
  3. Have an HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central laboratory at screening.
  4. Have a body mass index of ≤35 kilogram/square meter (kg/m²)
Exclusion Criteria
  1. Have a diagnosis of type 2 diabetes, latent autoimmune diabetes, or specific types of diabetes other than type 1 diabetes
  2. Have a history of more than 1 episode of severe hypoglycemia, within the 6 months prior to screening.
  3. Have a history of more than 1 episode of diabetic ketoacidosis or hyperosmolar state or coma requiring hospitalization within the 6 months prior to screening.
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