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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 13, 2011

Last Updated Date

August 1, 2011

Start Date ^ICMJE

June 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01374178 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Relative 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 Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Diabetes Mellitus

Intervention ^ICMJE

Drug: 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.

Intervention: Drug: LY2963016
Active Comparator: Lantus
A single 0.5-U/kg dose of Lantus will be administered subcutaneously.

Intervention: Drug: Lantus

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

21 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Singapore

Administrative Information

NCT Number ^ICMJE

NCT01374178

Other Study ID Numbers ^ICMJE

14094, I4L-MC-ABEI

Has Data Monitoring Committee

Responsible Party

Chief Medical Officer, Eli Lilly

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Eli Lilly and Company

Verification Date

August 2011

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

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