Overview

A Study of LY900014 in Participants With Type 2 Diabetes Mellitus

Status:
Completed
Trial end date:
2017-12-14
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 2 diabetes mellitus. The study will be conducted in participants with type 2 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog). 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 and 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 2 Diabetes Mellitus (T2DM) for at least 1
year

- Have a body mass index (BMI) of 18.5 to 35.0 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 T2DM), 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