Status:
COMPLETED
A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are used in insulin pump therapy in adults with type 1 diabetes (T1D).
Eligibility Criteria
Inclusion
- Have been diagnosed with T1D and continuously using insulin for at least 1 year
- Have been using CSII therapy for a minimum of 6 months
- Currently treated with \<100 Units of one of following rapid-acting analog insulin via CSII for at least the past 30 days: insulin lispro U-100, insulin aspart, fast-acting insulin aspart, insulin glulisine
- Must be using a MiniMed 530G (US), Paradigm Revel (US), or MiniMed 630G (US and Canada), MiniMed 640G or Paradigm Veo (select countries outside the US), insulin pump for at least the past 90 days
Exclusion
- Have hypoglycemia unawareness
- Have had more than 1 episode of severe hypoglycemia within 6 months prior to screening
- Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening
Key Trial Info
Start Date :
February 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2020
Estimated Enrollment :
471 Patients enrolled
Trial Details
Trial ID
NCT03830281
Start Date
February 14 2019
End Date
January 6 2020
Last Update
January 22 2021
Active Locations (83)
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1
John Muir Physician Network Clinical Research Center
Concord, California, United States, 94520
2
Valley Research
Fresno, California, United States, 93720
3
Marin Endocrine Associates
Greenbrae, California, United States, 94904
4
Diabetes and Endocrine Associates
La Mesa, California, United States, 91942