Phase 1 Completed N=20 Randomized Double-blind Treatment

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

Diabetes Mellitus, Type 1

Source: ClinicalTrials.gov NCT01600950 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2014

Primary outcomePrimary: Pharmacodynamics: Duration of Action of LY2963016 and Lantus — 37.13; 40.00 hours (hr)

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacodynamics: Duration of Action of LY2963016 and Lantus	37.13; 40.00	—
SECONDARY Maximum Glucose Infusion Rate (Rmax)	0.530; 0.611	—
SECONDARY Total Glucose Infused (Gtot)	4.60; 6.52	—
SECONDARY Time of Maximum Glucose Infusion Rate (tRmax)	9.90; 11.7	—
SECONDARY Pharmacokinetics: Maximum Concentration (Cmax) of LY2963016 and Lantus	—	—
SECONDARY Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2963016 and Lantus	—	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01600950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.