A Study of How Insulin Peglispro (LY2605541) and Insulin Glargine Affect the Breakdown of Fat and Sugar in Type 1 Diabetics

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-10-31

Brief Summary

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This is a two-period study of participants with type 1 diabetes mellitus (T1DM). In each period, participants will receive once daily injections of stable dose LY2605541 or insulin glargine for 28 to 35 days followed by procedures to look at how the body uses or stores fats and sugars. Participants will continue to use meal time insulin throughout the study. Healthy participants will also enroll in the study. They will not receive any study medication.

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Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Insulin Peglispro/Insulin Glargine

Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin.

Group Type EXPERIMENTAL

LY2605541

Intervention Type BIOLOGICAL

Administered SQ

Insulin Glargine/Insulin Peglispro

Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin. Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen.

Group Type ACTIVE_COMPARATOR

Insulin Glargine

Intervention Type BIOLOGICAL

Administered SQ

Control

Control Arm. Untreated healthy participants.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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LY2605541

Administered SQ

Intervention Type BIOLOGICAL

Insulin Glargine

Administered SQ

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Type 1 Diabetics:

\- T1DM for more than 1 year with Hemoglobin A1c (HbA1c) of less than 9.5%

All Participants:

* Otherwise fit and healthy
* Non smoker

Exclusion Criteria

Type 1 Diabetics:

* Taking medication or supplements other than insulin to control diabetes
* Suffered a hypoglycemic event in the last 12 months that required hospitalization or have poor awareness of hypoglycemia

All Participants:

\- Taking fibrates, thyroid replacement therapy, testosterone, beta blockers or systemic corticosteroids

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes