Diabetes Mellitus, Type 1 Clinical Trial
Official title:
Effects of LY900014 on Recovery From Hyperglycemia Compared to Humalog in Subjects With Type 1 Diabetes Mellitus (T1DM) on Continuous Subcutaneous Insulin Infusion
Verified date | July 2021 |
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 compare LY900014 to insulin lispro (Humalog) in participants with type 1 diabetes who are using an insulin pump and have high blood sugar after eating. For each participant, the study will last about two to nine weeks.
Status | Completed |
Enrollment | 32 |
Est. completion date | August 10, 2020 |
Est. primary completion date | August 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: - Male or female participants with type 1 diabetes - Body mass index (BMI) between 18.5 and 30.0 kilograms per square meter, inclusive - Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%) - Using CSII and stable insulin regimen for at least 3 months prior to inclusion into the trial Exclusion Criteria: - Known or suspected hypersensitivity to investigational medical product(s) or related products - Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomization in this trial - Known slowing of gastric emptying and or gastrointestinal surgery that, in the opinion of the investigator, might change gastrointestinal motility and food absorption - Proliferative retinopathy or maculopathy as judged by the Investigator based on a recent (less than 1.5 years) ophthalmologic examination - Widespread subcutaneous lipodystrophy in the abdomen - Current use of any glucose-lowering agents other than insulin within 3 months prior to screening - Chronic or recent use of corticosteroids |
Country | Name | City | State |
---|---|---|---|
Germany | Profil Mainz GmbH & Co. KG | Mainz | Rheinland-Pfalz |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Missed Meal Bolus | Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 Milligrams per deciliter (mg/dL). | Day 1: Baseline up to 5 hours after missed meal bolus | |
Primary | Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Pump Suspension | Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 mg/dL. | Day 2: Baseline up to 5 hours after pump suspension | |
Secondary | Pharmacodynamics (PD): Maximum Observed Plasma Glucose (PGmax) Following Administration of LY900014 and Insulin Lispro (Humalog) | PD: PGmax following administration of LY900014 and insulin lispro (Humalog) | Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspension | |
Secondary | Pharmacokinetics (PK): Time to Maximum Observed Insulin Lispro Concentration (Tmax) Following Administration of LY900014 and Insulin Lispro (Humalog) | PK: Tmax following administration of LY900014 and insulin lispro (Humalog) | Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspension |
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