DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 1

Intervention: LY2963016 (Drug); Lantus (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company


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.

Clinical Details

Official title: Pharmacodynamics of LY2963016 Compared to LANTUS® in Subjects With Type 1 Diabetes Mellitus

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Pharmacodynamics: Duration of Action of LY2963016 and Lantus

Secondary outcome:

Maximum Glucose Infusion Rate (Rmax)

Total Glucose Infused (Gtot)

Time of Maximum Glucose Infusion Rate (tRmax)

Pharmacokinetics: Maximum Concentration (Cmax) of LY2963016 and Lantus

Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2963016 and Lantus


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


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


- 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


- 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


- 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


- smoke more than 10 cigarettes (or equivalent other tobacco products) per day

Locations and Contacts

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 41460, Germany
Additional Information

Starting date: May 2012
Last updated: October 3, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017