A Study of Insulin Peglispro and Glargine on Fats in Participants With Type 1 Diabetes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-12-31

Brief Summary

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This study has two parts. Each participant will receive a daily injection of insulin peglispro during one treatment period and a daily injection of insulin glargine during the other treatment period. Each treatment period is 3 to 4 weeks and is followed by procedures to look at how the body uses or stores fats while taking each study drug.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Insulin Peglispro

Stable dose of insulin peglispro (0.2 - 0.8 units per kilogram \[U/kg\]) administered subcutaneously (SC) once daily for at least 21 days in one of two treatment periods. Dose based on prestudy basal insulin dosing regimen.

Group Type EXPERIMENTAL

Insulin Peglispro

Intervention Type BIOLOGICAL

Daily doses administered SC.

Insulin Glargine

Stable dose of insulin glargine (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods. Dose based on prestudy basal insulin dosing regimen.

Group Type ACTIVE_COMPARATOR

Insulin Glargine

Intervention Type BIOLOGICAL

Daily doses administered SC.

Interventions

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Insulin Peglispro

Daily doses administered SC.

Intervention Type BIOLOGICAL

Insulin Glargine

Daily doses administered SC.

Intervention Type BIOLOGICAL

Other Intervention Names

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LY2605541

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetic for more than 1 year with glycated hemoglobin (HbA1c) of less than 8.5%
* Otherwise fit and healthy
* Non smoker

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No