A Study to Compare and Measure the Effects of Insulin Peglispro (LY2605541) and Glargine on Meal Time Insulin Requirements

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Insulin Peglispro; Drug: Insulin Glargine; Drug: Insulin Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT02152384

I2R-MC-BIDU (Other Identifier)

15406

Details and patient eligibility

About

This study will look into how a base dose of insulin peglispro and insulin glargine will affect the meal time dose and efficacy of insulin lispro in type 1 diabetics.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a stable (within 0.5 percent (%) from last measure) glycated hemoglobin (HbA1c) <9.0%
• Have a stable (within 30%) basal insulin dose of 0.2 to 1.0 units per kilogram per day (U/kg/day) and a total daily insulin dose (basal + prandial/bolus) <1.5 units per kilogram (U/kg)
• Have C-peptide <0.3 nanomoles per liter (nmol/L)
• Are able and willing to eat the protocol specified standard breakfast and other meals as required

Exclusion criteria

• Have corrected QT interval (QTc) prolongation >500 milliseconds (ms) or have any other abnormality in the 12 lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
• Have an abnormal blood pressure as determined by the investigator
• Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from Type 1 Diabetes Mellitus [T1DM]), hematological, or neurological disorders
• Have fasting triglycerides (TGs) >400 milligrams per deciliter (mg/dL) (4.52 micromoles per liter [mmol/L])
• Have used systemic corticosteroids within 4 weeks prior to randomization
• Currently receive insulin pump or insulin degludec
• Have poorly controlled diabetes or are known to have poor awareness of hypoglycemia
• Have history of gastroparesis or gastrointestinal malabsorption
• Require treatment with any drug other than insulin to treat diabetes
• Have a previous history of proliferative retinopathy

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Insulin peglispro (LY2605541, with Insulin Lispro)

Experimental group

Description:

Insulin peglispro (LY2605541) once daily subcutaneous (SC) injection at bedtime. Insulin lispro given SC prandially or as bolus as required

Treatment:

Drug: Insulin Lispro

Drug: Insulin Peglispro

Insulin Glargine (with Insulin Lispro)

Active Comparator group

Description:

Insulin glargine once daily SC injection at bedtime. Insulin lispro given SC prandially or as a bolus as required

Treatment:

Drug: Insulin Lispro

Drug: Insulin Glargine