Overview

A Study of LY900014 in Elderly and Younger Adult Participants With Type 1 Diabetes Mellitus

Status:
Completed
Trial end date:
2017-11-18
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in elderly and younger adults with type 1 diabetes mellitus. Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be between 3 to 8 weeks.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Insulin
Insulin Lispro
Insulin, Globin Zinc
Criteria
Inclusion Criteria:

- Are male or female participants with Type 1 Diabetes Mellitus (T1DM)

- Have a body mass index (BMI) of 18.5 to 30.0 kilogram per meter square (kg/m²)

- Have a glycated hemoglobin (HbA1c) less than (<)9.0 percent (%)

- Have had no episodes of severe hypoglycaemia in the last 6 months

Exclusion Criteria:

- Have a history or current cardiovascular, respiratory, hepatic, renal,
gastrointestinal, endocrine (apart from T1DM), hematological, or neurological
disorders capable of significantly altering the absorption, metabolism, or elimination
of drugs; of constituting a risk when taking the investigational product; or of
interfering with the interpretation of data

- Have a history of renal impairment

- Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg
vein thrombosis in first-degree relatives

- Have proliferative retinopathy or maculopathy and/or severe neuropathy