A Study in Adults With Type 1 Diabetes

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus when taken once daily in combination with insulin lispro before meals three times a day.

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

Details

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

Criteria

Inclusion Criteria:

• Have type 1 diabetes mellitus based on the disease diagnostic criteria [World Health Organization (WHO) Classification]

• Have duration of diabetes greater than or equal to one year

• Have Hemoglobin A1c (HbA1c) less than or equal to 11.0%

• On basal-bolus insulin therapy for at least 1 year [basal insulin must be once daily (QD) injection of human insulin isophane suspension (NPH), Lantus, or detemir and combined with mealtime injections of human regular insulin, or insulin analog lispro, aspart or glulisine]

• Have a body mass index (BMI) of less than or equal to 35 kilograms/square meter (kg/m²)

Exclusion Criteria:

• Have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study

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

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

• Have significant renal, cardiac, gastrointestinal or liver disease

• Have active cancer or cancer within the past 5 years