Phase 2
Completed N=399
A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT03736785 ↗Enrolled (actual)
399
Serious AEs
6.3%
Results posted
Mar 2021
Primary outcomePrimary: Change From Baseline in HbA1c — -0.58; -0.57; -0.66 HbA1C % — p=<0.001
Summary
The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes that have already been treated with basal insulin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c |
-0.58; -0.57; -0.66 | <0.001 sig |
| SECONDARY Change From Baseline in HbA1c Compared to Insulin Degludec |
-0.58; -0.57; -0.66 | — |
| SECONDARY Change From Baseline in Fasting Glucose |
-13.1; -18.6; -31.5 | — |
| SECONDARY Change From Baseline in Insulin Dose (LY3209590) |
0.12; 0.60 | — |
| SECONDARY Change From Baseline in Insulin Dose (Insulin Degludec) |
16.40 | — |
| SECONDARY Rate of Total Documented Symptomatic Hypoglycemia |
0.73; 1.22; 1.56 | — |
| SECONDARY Change From Baseline in Body Weight |
1.0; 1.0; 2.0 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590 |
5360; 5430 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with basal insulin and up to 3 of the following oral antihyperglycemic medication (OAM):
- dipeptidyl peptidase-4 (DPP-4) inhibitors
- sodium-glucose cotransporter (SGLT-2) inhibitors
- biguanides
- alpha-glucosidase inhibitors
- sulfonlyureas
- HbA1c value of 6.5% to 10%, inclusive
- Body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m2), inclusive
Exclusion Criteria
- Type 1 diabetes mellitus or latent autoimmune diabetes
- Any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
- Any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
- Acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
- Estimated glomerular filtration rate (eGFR) 14 days) systemic glucocorticoid therapy
Data sourced from ClinicalTrials.gov (NCT03736785). 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.