Status:
COMPLETED
A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04276207
Start Date
February 25 2020
End Date
August 10 2020
Last Update
August 25 2021
Active Locations (1)
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1
Profil Mainz GmbH & Co. KG
Mainz, Rhineland-Palatinate, Germany, 55116