A Study of LY2605541 and Glargine in Participants With Type 1 Diabetes

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1

Treatments: Biological: Insulin Glargine; Biological: LY2605541

Study type: Interventional

Funder types: Industry

Identifiers

NCT01769404

14870

I2R-MC-BIDM (Other Identifier)

Details and patient eligibility

About

This study has 2 parts. Each participant will receive a daily injection of LY2605541 during one treatment period and a daily injection of insulin glargine during one treatment period. Each treatment period is 2 to 3 weeks and is followed by a procedure to lower blood sugar levels to see how the body recovers after each treatment.

Enrollment: 25 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) less than 9%
• Otherwise fit and healthy
• Nonsmoker

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 has poor awareness of hypoglycemia

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

LY2605541

Experimental group

Description:

Stable dose of LY2605541 (0.2 to 0.6 units per kilogram \[U/kg\]) administered subcutaneously (SQ) once daily for at least 14 days in 1 of 2 treatment periods. Dose based on prestudy basal insulin dosing regimen.

Treatment:

Biological: LY2605541

Insulin Glargine

Active Comparator group

Description:

Stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in 1 of 2 treatment periods. Dose based on prestudy basal insulin dosing regimen.

Treatment:

Biological: Insulin Glargine