Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog Following a Single Dose in Patients With T2DM
Verified date | January 2018 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | December 14, 2017 |
Est. primary completion date | December 14, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Neuss | Nordrhein-Westfalen |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetics (PK): Insulin Lispro Area Under the Plasma Concentration Curve Zero to 10 Hours (AUC[0-10) Following Each Treatment Arm | Pharmacokinetics(PK): Insulin Lispro AUC from zero to 10 hours postdose [AUC(0-10)] following each treatment arm | Predose, 5 minutes (mn), 10mn, 15mn, 20mn, 25mn, 30mn, 35mn, 40mn,45 mn,50mn, 55mn, 60mn, 70mn, 90mn, 120mn, 150mn, 180mn, 240mn, 300mn, 360mn, 420mn, 480mn, 540mn, and 600 minutes(10 hours) postdose | |
Secondary | Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm | Glucodynamics: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp procedure. | Predose, every minute starting from run-in and throughout the duration of the 10 hours |
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