A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes

  • STATUS
    Recruiting
  • End date
    Dec 28, 2021
  • participants needed
    350
  • sponsor
    Eli Lilly and Company
Updated on 20 June 2021
diabetes
insulin
body mass index
hemoglobin a1c
glycosylated hemoglobin
humalog

Summary

The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in combination with insulin glargine or insulin degludec, is safe and effective in participants with type 1 diabetes (T1D).

Details
Condition Diabetes Mellitus, Insulin dependent diabetes mellitus, Autoimmune disease, Diabetes Mellitus, Type 1, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric), type 1 diabetes mellitus, type 1 diabetes, diabetes type 1, diabetes mellitus type 1, insulin-dependent diabetes, iddm, type i diabetes mellitus
Treatment Insulin glargine, insulin degludec, LY900014, Insulin Lispro
Clinical Study IdentifierNCT03952130
SponsorEli Lilly and Company
Last Modified on20 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year
Participants must have HbA1c of 7.0 and 10.0%
Participants must have been treated for at least 90 days prior to screening with either multiple daily injection(s) (MDI) or premixed analog/human insulin regimens at least twice daily
Participants must have body mass index (BMI) of 35.0 kilograms per square meter (kg/m2)

Exclusion Criteria

Participants must not have used other anti-hyperglycemic medications or therapies (inhaled, oral or injectable) except for metformin within 90-days of screening
Participants must not have had more than 1 severe hypoglycemic episode within 6 months of screening
Participants must not have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months of screening
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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