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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01374178
First received: June 13, 2011
Last updated: August 1, 2011
Last verified: August 2011
  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.


Condition Intervention Phase
Diabetes Mellitus
Drug: LY2963016
Drug: Lantus
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relative Bioavailability of LY2963016 to LANTUS® After Single Dose Subcutaneous Administration to Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics: area under the concentration-time curve (AUC) [ Time Frame: Periods 1 and 2: Baseline up to 24 hours ] [ Designated as safety issue: No ]

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 ]

Enrollment: 16
Study Start Date: June 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2963016
A single 0.5-U/kg dose of LY2963016 will be administered subcutaneously.
Drug: LY2963016
Administered subcutaneously
Active Comparator: Lantus
A single 0.5-U/kg dose of Lantus will be administered subcutaneously.
Drug: Lantus
Administered subcutaneously

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374178

Locations
Singapore
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
Sponsors and Collaborators
Eli Lilly and Company
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
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT01374178     History of Changes
Other Study ID Numbers: 14094, I4L-MC-ABEI
Study First Received: June 13, 2011
Last Updated: August 1, 2011
Health Authority: Singapore: Health Sciences Authority
Singapore: Domain Specific Review Boards

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014