A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus

NCT ID: NCT01600950

Last Updated: 2014-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-07-31

Brief Summary

The study involves a single injection of LY2963016 and a single injection of Lantus, on 2 separate occasions in participants with type I diabetes. Following each dose, participants will undergo a glucose clamp which lasts for 42 hours each time. There will be at least 7 days between the two periods, during which time there will be no study treatment, but participants will resume their regular therapy. The duration of this study can be up to 9.5 weeks. The purposes of this study are to understand how the blood sugar lowering effect of LY2963016 compares to that of Lantus, and to determine how LY2963016 and Lantus are metabolized by participants with type I diabetes.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LY2963016

A single 0.3 units per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously followed by a minimum washout period of 7 days.

Group Type: EXPERIMENTAL

LY2963016

Intervention Type: DRUG

Single 0.3 U/kg dose administered subcutaneously

Lantus

A single 0.3 U/kg dose of Lantus will be administered subcutaneously followed by a minimum washout period of 7 days.

Group Type: ACTIVE_COMPARATOR

Lantus

Intervention Type: DRUG

Single 0.3 U/kg dose administered subcutaneously

Interventions

LY2963016

Single 0.3 U/kg dose administered subcutaneously

Intervention Type: DRUG

Lantus

Single 0.3 U/kg dose administered subcutaneously

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• have type 1 diabetes mellitus (T1DM) based on the disease diagnostic criteria
• have had a duration of diabetes ≥1 year
• have hemoglobin A1c ≤10.0%
• have fasting C-peptide ≤0.3 nanomoles per liter (nmol/L)
• have a body mass index ≤29 kilograms per square meter (kg/m²)
• have venous access sufficient to allow blood sampling and cannulation for clamp procedures

Exclusion Criteria

• are currently enrolled in, have completed, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device
• have a total insulin requirement >1.2 units per kilogram per day (U/kg/day)
• have a history of proliferative retinopathy
• have known allergies to insulin glargine, insulin lispro, heparin, or related compounds
• have an electrocardiogram (ECG) reading considered outside the normal limits
• have an abnormal blood pressure
• have abnormal clinical laboratory tests
• have a history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
• history of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first-degree relatives
• show evidence of significant active neuropsychiatric disease
• regular use of known drugs of abuse and/or show positive findings on drug screening
• show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies
• show evidence of hepatitis C and/or positive hepatitis C antibody
• show evidence of hepatitis B and/or positive hepatitis B surface antigen
• are women with a positive pregnancy test or women who are lactating
• have an average weekly alcohol intake that exceeds 21 units per week (males) or 14 units per week (females)
• had more than 1 episode of severe hypoglycemia within 6 months prior to study
• undergoing therapy for a malignancy other than basal cell or squamous cell skin cancer
• had a blood transfusion or severe blood loss within 3 months; made a blood donation within 30 days prior to study entry; or have known hemoglobinopathy, haemolytic anemia, or sickle cell anemia
• are receiving systemic glucocorticoid therapy
• have irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night)
• show a history of adverse reactions to heparin, including heparin-induced thrombocytopenia
• smoke more than 10 cigarettes (or equivalent other tobacco products) per day

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Neuss, , Germany

Countries

Germany

Other Identifiers

I4L-MC-ABEE

Identifier Type: OTHER

Identifier Source: secondary_id

13831

Identifier Type: -

Identifier Source: org_study_id