Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
The purpose of this study is to evaluate how well LY4057996 is tolerated and what side effects may occur in healthy participants and participants with Type 1 and Type 2 Diabetes. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4057996 gets into the bloodstream and how long it takes the body to eliminate it. The study will last 11 weeks for Part A1-A2, 4 weeks for A3-A5, 6 weeks for Part B and 7 weeks for Part C, all approximations, excluding a screening period.
Interventions
DRUGLY4057996 SC
Administered SC
DRUGLY4057996 IV
Administered IV
DRUGPlacebo SC
Administered SC
DRUGPlacebo IV
Administered IV
DRUGDegludec SC
Administered SC
DRUGLispro SC
Administered SC
DRUGDegludec IV
Administered IV
DRUGPre-study basal insulin SC
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Part A is Double-Blinded, Parts B and C are Open-Label
Intervention model description
Parts A and C are sequential: Parts B and C are crossover
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Part A for Healthy Participants: * Are overtly healthy as determined by medical evaluation, including medical history, physical exam, laboratory tests, and cardiac screening assessment Part A for Type 2 Diabetes (T2DM) Participants: * Are participants with T2DM diagnosed greater than 1 year before enrollment, * On basal insulin therapy, insulin glargine, insulin detemir, or insulin degludec, greater than 10 units per day for at least 6 months (for Cohort 5 only) * Glycated hemoglobin (HbA1c) 6.5% to 9.5% inclusive at screening Part B * Have Type 1 Diabetes (T1D) for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol/L) or less or non-fasting C-peptide level of 0.30 nmol/L or less at screening * HbA1c 6% to 8.5% inclusive at screening Part C * Have T1D for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol/L) or less or non-fasting C-peptide level of 0.30 nmol/L or less at screening * HbA1c 6 to 8.5% inclusive at screening All Parts * Have blood pressure of less than 140/90 millimeters of mercury (mmHg) for healthy participants or 150/90 mmHg for participants with diabetes and pulse rate of less than 90 beats per minute (bpm) (supine) * No hypoglycemia unawareness for all Type 1 and Type 2 Diabetes participants
Exclusion criteria
* Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening * Have had any episodes of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia), hypoglycemia unawareness, or both within the 6 months prior to screening All Parts * Cardiovascular: no significant history of cardiovascular disease (CVD) * Gastrointestinal: have gastroparesis or have undergone gastric surgery * Hepatic: have acute or chronic hepatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline to Study Completion (Up to 47 Weeks) | A summary of SAEs and AEs regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4057996 | Baseline to Study Completion (Up to 47 Weeks) | PK: AUC of LY4057996 |
| PK: Maximum Concentration (Cmax) of LY4057996 | Baseline to Study Completion (Up to 47 Weeks) | PK: Cmax of LY4057996 |
| Pharmacodynamic (PD): Change from Baseline in Fasting Glucose | Baseline to Study Completion (Up to 47 Weeks) | PD: Change from Baseline in Fasting Glucose |
| PD: AUC of Glucose Infusion Rate (GIR) | Baseline Up to 10 weeks | PD: AUC of GIR |
Countries
Germany
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