A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects

Overview[ - collapse ][ - ]

Purpose The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin. The study will also gather information on the safety and tolerability of LY2963016 in healthy subjects. The study is approximately 12 weeks.
ConditionDiabetes Mellitus
InterventionDrug: LY2963016
Drug: Lantus
PhasePhase 1
SponsorEli Lilly and Company
Responsible PartyEli Lilly and Company
ClinicalTrials.gov IdentifierNCT01374178
First ReceivedJune 13, 2011
Last UpdatedAugust 1, 2011
Last verifiedAugust 2011

Tracking Information[ + expand ][ + ]

First Received DateJune 13, 2011
Last Updated DateAugust 1, 2011
Start DateJune 2011
Estimated Primary Completion DateJuly 2011
Current Primary Outcome MeasuresPharmacokinetics: area under the concentration-time curve (AUC) [Time Frame: Periods 1 and 2: Baseline up to 24 hours] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Pharmacokinetics, maximum concentration (Cmax) [Time Frame: Periods 1 and 2: Baseline up to 24 hours] [Designated as safety issue: No]
  • Maximum glucose infusion rate (Rmax) [Time Frame: Periods 1 and 2: Baseline up to 24 hours] [Designated as safety issue: No]
  • Total glucose infused Gtot) [Time Frame: Periods 1 and 2: Baseline up to 24 hours] [Designated as safety issue: No]
  • Time of maximum glucose infusion rate (tRmax) [Time Frame: Periods 1 and 2: Baseline up to 24 hours] [Designated as safety issue: No]
  • Number of participants with clinically significant effects (vital signs and labs) [Time Frame: Baseline to study completion (estimate 1 month)] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleA Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects
Official TitleRelative Bioavailability of LY2963016 to LANTUS® After Single Dose Subcutaneous Administration to Healthy Subjects
Brief Summary
The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of
LY2963016 compared to those of basal insulin. The study will also gather information on the
safety and tolerability of LY2963016 in healthy subjects. The study is approximately 12
weeks.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionDiabetes Mellitus
InterventionDrug: LY2963016
Administered subcutaneously
Drug: Lantus
Administered subcutaneously
Study Arm (s)
  • Experimental: LY2963016
    A single 0.5-U/kg dose of LY2963016 will be administered subcutaneously.
  • Active Comparator: Lantus
    A single 0.5-U/kg dose of Lantus will be administered subcutaneously.

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment16
Estimated Completion DateJuly 2011
Estimated Primary Completion DateJuly 2011
Eligibility Criteria
Inclusion Criteria:

- Are overtly healthy males or females

- Have a body mass index (BMI) between 18.5 and 29.9 kg/m2

- Are nonsmokers

- Have normal blood pressure and pulse rate

- Have an ECG considered as within normal limits

- Have clinical laboratory test results within normal reference range

Exclusion Criteria:

- Are currently enrolled in, or discontinued within the last 30 days from, a clinical
trial involving an investigational drug or device

- Have known allergies to insulin or its excipients

- Have significant history of or current cardiovascular, respiratory, hepatic, renal,
gastrointestinal, endocrine, hematological, or neurological disorders

- Show evidence of significant active neuropsychiatric disease

- Have a history of first-degree relatives known to have diabetes mellitus

- Have a fasting venous blood glucose >6.0 mmol/L

- Intend to use over-the-counter or prescription medication

- Have donated or had a blood loss of 450 mL or more in the past 3 months

- Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14
units per week (females)
GenderBoth
Ages21 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesSingapore

Administrative Information[ + expand ][ + ]

NCT Number NCT01374178
Other Study ID Numbers14094
Has Data Monitoring CommitteeNo
Information Provided ByEli Lilly and Company
Study SponsorEli Lilly and Company
CollaboratorsNot Provided
Investigators Study Director: 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) Eli Lilly and Company
Verification DateAugust 2011

Locations[ + expand ][ + ]

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.
Singapore, Singapore