Diabetes Mellitus, Type 2
Conditions
Keywords
Glycemic control, Hypoglycemia, Hyperglycemia
Brief summary
The purpose of this study is to see how well LY3938577 works and how safe it is compared to degludec in people with type 2 diabetes. Participation in the study will last about 26 weeks.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Have type 2 diabetes * Are receiving ≥20 units of basal insulin per day and ≤55 units/day and ≤1.5 units/kg/day at screening * Have hemoglobin A1c (HbA1c) 7.5% to 10.5% inclusive * Have a body mass index (BMI) of 20 or higher and less than 35 kilograms per square meter (kg/m2)
Exclusion criteria
* Have type 1 diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Non-Inferiority Analysis) | Baseline through Week 20 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Superiority Analysis) | Baseline through Week 20 |
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 20 |
| Pharmacokinetics (PK): Average Concentration of LY3938577 | Baseline through Week 20 |
Countries
Argentina, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed