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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01374178
First received: June 13, 2011
Last updated: October 3, 2014
Last verified: October 2014

June 13, 2011
October 3, 2014
June 2011
July 2011   (final data collection date for primary outcome measure)
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) [ Time Frame: Periods 1 and 2: Baseline up to 24 hours ] [ Designated as safety issue: No ]
AUC from time zero to 24 hours (AUC0-24) is reported for this outcome measure.
Pharmacokinetics: area under the concentration-time curve (AUC) [ Time Frame: Periods 1 and 2: Baseline up to 24 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01374178 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: Baseline up to 30 days ] [ Designated as safety issue: Yes ]
    Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module.
  • 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 ]
Not Provided
Not Provided
 
A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects
Relative Bioavailability of LY2963016 to LANTUS® After Single Dose Subcutaneous Administration to Healthy Subjects

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
  • Drug: LY2963016
    Administered subcutaneously
  • Drug: Lantus
    Administered subcutaneously
    Other Name: Insulin Glargine
  • Experimental: LY2963016
    A single 0.5-unit per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously.
    Intervention: Drug: LY2963016
  • Active Comparator: Lantus
    A single 0.5-U/kg dose of Lantus will be administered subcutaneously.
    Intervention: Drug: Lantus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Are overtly healthy males or females
  • Have a body mass index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m^2)
  • Are nonsmokers
  • Have normal blood pressure and pulse rate
  • Have an electrocardiogram (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 millimoles per liter (mmol/L)
  • Intend to use over-the-counter or prescription medication
  • Have donated or had a blood loss of 450 milliliters (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)
Both
21 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01374178
14094, I4L-MC-ABEI
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP