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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc

Criteria

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