A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 1 Diabetes Mellitus

• Status: Completed
• Trial end date: 2020-03-05
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus® in combination with mealtime insulin lispro in adult Chinese participants with Type 1 Diabetes Mellitus (T1DM).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Have T1DM based on the disease diagnostic criteria (World Health Organization [WHO] Classification).

• Have duration of T1DM ≥1 year.

• Have HbA1c ≤11 %.

• Have been administered with basal-bolus insulins or pre-mixed insulins for at least 90 days prior to screening.

• Have a body mass index (BMI) ≤35 kilograms per meter squared.

Exclusion Criteria:

• Exposure to an insulin glargine other than Lantus® within previous 30 days.

• Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.

• Have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within 6 months prior to entry into the study.

• Have known hypersensitivity or allergy to any of the study insulins (Lantus® or insulin lispro) or to excipients of the study insulins.

• Are pregnant, intend to become pregnant during the course of the study.

• Women who are breastfeeding.

• Are currently taking traditional medicine (herbal medicine or patent medicine) with known/specified content of anti-hyperglycemic effects within 3 months before screening.

• Have congestive heart failure Class III and IV.

• Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease.

• Have any active cancer.

• Have a history or diagnosis of human immunodeficiency virus (HIV) infection.

• Have presence of clinically significant gastrointestinal disease.

• Have a history of renal transplantation, or are currently receiving renal dialysis.

• Are receiving chronic systemic glucocorticoid therapy at pharmacological doses.