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A Study to Compare LY2963016 and US-approved Lantus® After Single Dose Administration to Healthy Participants

NCT01688635 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2014-10-07

Study results available
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Summary

The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of LY2963016 and US-approved Lantus®. The study involves four single injections; two doses of LY2963016 and two doses of US-approved Lantus®. The study will have 4 periods. In each period, a single injection will be administered before undergoing a euglycemic clamp that lasts for 24 hours. There will be at least a 7 day washout between each period. Side effects will be documented. Study participation is expected to last up to 14 weeks.

Conditions

  • Healthy

Interventions

DRUG

LY2963016

Administered subcutaneously

DRUG

US Approved Lantus

Administered subcutaneously

Sponsors & Collaborators

Principal Investigators

  • 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

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Singapore

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01688635 on ClinicalTrials.gov