Diabetes Mellitus, Type 1 Clinical Trial
Official title:
A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900027 in Patients With Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy
Verified date | August 1, 2020 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main purpose of this study is to learn more about a new formulation of insulin lispro when given by an insulin pump to participants with type 1 diabetes mellitus. The study will investigate how the body processes the drug and how the drug affects the body. Information about side effects will be collected. The study will last from six to 12 weeks for each participant.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 14, 2020 |
Est. primary completion date | July 14, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of T1DM for at least 1 year - Fasting C-peptide =0.30 nanomoles per liter (nmol/L) - Bbody mass index between 18.5 and 33.0 kilograms per square meter (kg/m²) - Participants should have a glycated hemoglobin of =9.0% at screening Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
Germany | Profil Institut für Stoffwechselforschung | Neuss | Nordrhein-Westfalen |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetics (PK): Pharmacokinetics (PK): Area Under the Insulin Lispro Curve (AUC) 0 to 5 hours after Bolus Administration Prior to a Mixed Meal Tolerance Text (MMTT) | PK: AUC after Bolus Administration Prior to a MMTT | Day 1 through Day 10 in each dosing period | |
Primary | PK: Maximum Observed Insulin Lispro Concentration (Cmax) | PK: C PK: Cmax | Day 1 through Day 10 in each dosing period | |
Secondary | Pharmacodynamics (PD): Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion | PD: Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion | Day 1 through Day 10 in each dosing period | |
Secondary | PD: Total Daily Insulin Dose | PD: Total Daily Insulin Dose | Day 1 through Day 10 in each dosing period | |
Secondary | Duration Until Catheter Failure | Duration Until Catheter Failure | Day -1 through Day 10 in each dosing period |
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