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

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1

Treatments: Biological: Insulin Glargine; Biological: Insulin Peglispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT01771250

I2R-MC-BIDN (Other Identifier)

14871

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Insulin Peglispro

Experimental group

Description:

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.

Treatment:

Biological: Insulin Peglispro

Insulin Glargine

Active Comparator group

Description:

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.

Treatment:

Biological: Insulin Glargine