Bioequivalence of Two Lispro Formulations

NCT ID: NCT01133392

Last Updated: 2014-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-08-31

Brief Summary

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This study will compare how the body treats 2 different forms of insulin lispro and how they affect blood sugar levels.

Detailed Description

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The 2 formulations of insulin lispro will be referred to here as:

Lispro A

Lispro B

Conditions

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Healthy Volunteers

Keywords

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insulin lispro

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin Lispro A

20 units (U) subcutaneously (SC)

Group Type EXPERIMENTAL

Insulin lispro A

Intervention Type DRUG

20 units (U) subcutaneously (SC).

Insulin lispro B

20 units (U) subcutaneously (SC)

Group Type ACTIVE_COMPARATOR

Insulin lispro B

Intervention Type DRUG

20 U subcutaneously (SC).

Interventions

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Insulin lispro A

20 units (U) subcutaneously (SC).

Intervention Type DRUG

Insulin lispro B

20 U subcutaneously (SC).

Intervention Type DRUG

Other Intervention Names

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LY275585 LY275585

Eligibility Criteria

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Inclusion Criteria

* Are healthy males or females.
* Body mass index (BMI) between 18.5 and 29.9 kilograms per meter squared (kg/m\^2)
* Are nonsmokers.
* Have normal blood pressure and pulse rate, a normal electrocardiogram (ECG), and clinical laboratory test results within normal reference range at screening.

Exclusion Criteria

* History of first-degree relatives known to have diabetes mellitus.
* Evidence of significant active neuropsychiatric disease.
* Evidence of an acute infection with fever or infectious disease.
* Intend to use over-the-counter or prescription medication (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods).
* Have used systemic glucocorticoids within 3 months prior to entry into the study.
* Have donated blood of 1 unit or more within the last 3 months prior to study entry.
* Excessive alcohol intake
* Have a fasting venous blood glucose (FBG, plasma) \>6 millimoles/liter (mmol/L) at screening.
* Have positive hepatitis B surface antigen.
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Site Status

Countries

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Singapore

Other Identifiers

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F3Z-EW-IOPY

Identifier Type: OTHER

Identifier Source: secondary_id

13300

Identifier Type: -

Identifier Source: org_study_id