Overview

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