Overview
A Study to Compare and Measure the Effects of Insulin Peglispro (LY2605541) and Glargine on Meal Time Insulin Requirements
Status:
Completed
Completed
Trial end date:
2014-12-01
2014-12-01
Target enrollment:
0
0
Participant gender:
All
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 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Eli Lilly and CompanyTreatments:
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