Clinical trial NCT01600950: A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus
Official title: Pharmacodynamics of LY2963016 Compared to LANTUS® in Subjects With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-05-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pharmacodynamics: Duration of Action of LY2963016 and Lantus
timeFrame: Periods 1 and 2: Baseline up to 42 hours postdose
Secondary outcomes:
measure: Maximum Glucose Infusion Rate (Rmax)
timeFrame: Periods 1 and 2: Baseline up to 42 hours postdose
measure: Total Glucose Infused (Gtot)
timeFrame: Periods 1 and 2: Baseline up to 42 hours postdose
measure: Time of Maximum Glucose Infusion Rate (tRmax)
timeFrame: Periods 1 and 2: Baseline up to 42 hours postdose
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY2963016 and Lantus
timeFrame: Periods 1 and 2: Baseline up to 42 hours postdose
measure: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2963016 and Lantus
timeFrame: Periods 1 and 2: Baseline up to 42 hours postdose
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: