Phase 2
Completed N=266
A Study of LY3209590 in Participants With Type 1 Diabetes
Source: ClinicalTrials.gov NCT04450407 ↗Enrolled (actual)
266
Serious AEs
3.4%
Results posted
Oct 2022
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) — 0.04; -0.13 Percentage of HbA1c
Summary
The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 1 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) |
0.04; -0.13 | — |
| SECONDARY Change From Baseline in Fasting Serum Glucose |
-5.9; -16.7 | — |
| SECONDARY Change From Baseline in Bolus Insulin Dose |
0.04; 0.05 | — |
| SECONDARY Rate of Documented Hypoglycemia |
20.7; 18.4 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590 |
3520 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must have a diagnosis of type 1 diabetes mellitus for at least 1 year
- Participants must have been using multiple daily injections without interruption for at least 3 months
- Participants must have HbA1c values of 5.6% to 9.5%, inclusive
- Participants must have a body mass index (BMI) of ≤35 kilograms per meter squared (kg/m²)
Exclusion Criteria
- Have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to study screening
- Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
- Have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
- Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
- Have an estimated glomerular filtration rate (eGFR) 14 days) systemic glucocorticoid therapy
Data sourced from ClinicalTrials.gov (NCT04450407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.