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

Lilly

Status and phase: Completed; Phase 1

Conditions: Type 1 Diabetes Mellitus

Treatments: Biological: LY2605541; Biological: Insulin Glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01925989

I2R-MC-BIDO (Other Identifier)

14872

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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27 participants in 3 patient groups

Insulin Peglispro/Insulin Glargine

Experimental group

Description:

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.

Treatment:

Biological: LY2605541

Insulin Glargine/Insulin Peglispro

Active Comparator group

Description:

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.

Treatment:

Biological: Insulin Glargine

Control

No Intervention group

Description:

Control Arm. Untreated healthy participants.