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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01374178
• Other study ID #: 14094
• Secondary ID: I4L-MC-ABEI
• Status: Completed
• Phase: Phase 1
• First received: June 13, 2011
• Last updated: October 3, 2014
• Start date: June 2011
• Est. completion date: July 2011

Study information

• Verified date: October 2014
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences AuthoritySingapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• LY2963016
Administered subcutaneously
• Lantus
Administered subcutaneously

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)	AUC from time zero to 24 hours (AUC0-24) is reported for this outcome measure.	Periods 1 and 2: Baseline up to 24 hours	No
Secondary	Pharmacokinetics: Maximum Concentration (Cmax)		Periods 1 and 2: Baseline up to 24 hours	No
Secondary	Maximum Glucose Infusion Rate (Rmax)		Periods 1 and 2: Baseline up to 24 hours	No
Secondary	Total Glucose Infused (Gtot)		Periods 1 and 2: Baseline up to 24 hours	No
Secondary	Time of Maximum Glucose Infusion Rate (tRmax)		Periods 1 and 2: Baseline up to 24 hours	No
Secondary	Number of Participants With Clinically Significant Effects	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.	Baseline up to 30 days	Yes