Phase 2
Completed N=278
A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT04450394 ↗Enrolled (actual)
278
Serious AEs
4.0%
Results posted
Nov 2022
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) — -1.20; -1.26 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 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) |
-1.20; -1.26 | — |
| SECONDARY Change From Baseline in Fasting Serum Glucose |
-50.7; -58.7 | — |
| SECONDARY Rate of Documented Hypoglycemia |
0.21; 0.15 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590 |
5890 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must have type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with a stable dose of metformin in combination with a stable dose of Dipeptidyl Peptidase IV (DPPIV) inhibitor and/or a Sodium-glucose co-transporter-2 (SGLT2) inhibitor for at least 3 months prior to screening
- Participants must have a HbA1c value of 7.0% to 9.5%, inclusive
- Participants must have a body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m²), inclusive
Exclusion Criteria
- Have type 1 diabetes mellitus or latent autoimmune diabetes
- 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 (NCT04450394). 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.