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OpenTrials
Completed

NCT Number: NCT01374178

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

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LY2963016

Drug

Administered subcutaneously

Lantus

Drug

Administered subcutaneously

Other names: Insulin Glargine

Primary outcomes

  1. Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)

    Time frame: Periods 1 and 2: Baseline up to 24 hours

    AUC from time zero to 24 hours (AUC0-24) is reported for this outcome measure.

Secondary outcomes

  1. Pharmacokinetics: Maximum Concentration (Cmax)

    Time frame: Periods 1 and 2: Baseline up to 24 hours

  2. Maximum Glucose Infusion Rate (Rmax)

    Time frame: Periods 1 and 2: Baseline up to 24 hours

  3. Total Glucose Infused (Gtot)

    Time frame: Periods 1 and 2: Baseline up to 24 hours

  4. Time of Maximum Glucose Infusion Rate (tRmax)

    Time frame: Periods 1 and 2: Baseline up to 24 hours

  5. Number of Participants With Clinically Significant Effects

    Time frame: Baseline up to 30 days

    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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Relative Bioavailability of LY2963016 to LANTUS® After Single Dose Subcutaneous Administration to Healthy Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 15, 2011
Registry last updated
Oct 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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