A Study in Adults With Type 1 Diabetes (ELEMENT 1)

Lilly

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Insulin Lispro; Drug: Lantus; Drug: LY2963016

Study type: Interventional

Funder types: Industry

Identifiers

NCT01421147

13712

I4L-MC-ABEB (Other Identifier)

2011-000829-73 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 536 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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536 participants in 2 patient groups

LY2963016 + Insulin Lispro

Experimental group

Description:

LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks.

Treatment:

Drug: Insulin Lispro

Drug: LY2963016

Lantus + Insulin Lispro

Active Comparator group

Description:

Lantus titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks.

Treatment:

Drug: Insulin Lispro

Drug: Lantus