Diabetes Mellitus, Type 2
Conditions
Brief summary
The main purpose of this study is to learn about the side effects of LY3502970 when given to Japanese participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last up to 24 weeks, inclusive of screening and will include 10 visits to the study center.
Interventions
DRUGLY3502970
Administered orally
DRUGPlacebo
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Males and females not of childbearing potential * Have type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year * Have glycated hemoglobin (HbA1c) value ≥ 7.0% and ≤ 10.0% for participants treated with diet and exercise or HbA1c ≥ 6.5% and ≤ 9.0% for participants who have washed out antidiabetic medications at screening * Have type 2 diabetes controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (OAM); either metformin, DPP-4 (dipeptidyl peptidase-4) inhibitor, or SGLT2 (sodium-glucose co-transporter-2) inhibitor within 3 months prior to screening. Participants must withdraw from their OAM treatment for at least 28 days prior to dosing.
Exclusion criteria
* Have type 1 diabetes mellitus or latent autoimmune diabetes in adults. * Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization * Have had an episode of severe hypoglycemia, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery or have a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. * Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of \>500 milligram per deciliter (mg/dL). * Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) greater than 3× upper limit of normal (ULN).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline Through Follow-Up (Up To Week 15) | A TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. An overall summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3502970 on Day 1 | Day 1 (Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72 and 96 hours post-dose) | PK: Cmax of LY3502970. |
| Part A: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 1 | Day 1 (Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72 and 96 hours post-dose) | PK: AUC\[0-tlast\] of LY3502970. |
| Part B: PK: Cmax of LY3502970 on Day 84 | Day 84 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96 and 336 hours post-dose) | PK: Cmax of LY3502970. |
| Part B: PK: AUC[0-tlast] of LY3502970 on Day 84 | Day 84 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96 and 336 hours post-dose) | PK: AUC\[0-tlast\] of LY3502970. |
| Change From Baseline in Fasting Glucose | Baseline through Day 85 | Change from Baseline in Fasting Glucose was reported. Least square mean was calculated using the model: Log(Parameter) - Log(Baseline) = Log(Baseline) + Treatment + Timepoint + Treatment\*Timepoint + Participant + Random Error, where participant was fitted as a random effect. |
| Change From Baseline in Glycated Hemoglobin (HbA1c) | Baseline through Day 85 | Change from Baseline in HbA1c. Least square mean was calculated using model Log(Parameter) - Log(Baseline) = Log(Baseline) + Treatment + Timepoint + Treatment\*Timepoint + Participant + Random Error, where participant is fitted as a random effect |
| Change From Baseline in Body Weight | Baseline through Day 88 | Change from Baseline in Body Weight. Least square mean was calculated using Model: Change from baseline = Baseline + Treatment + Time + Treatment\*Time + participant + Random Error, where participant was fitted as a random effect |
Countries
Japan
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Participant flow
Recruitment details
A total of 62 participants were enrolled in the trial. Part A consisted of 23 participants of which 21 completed. Part B consisted of 60 participants inclusive of the 21 completers from Part A as per the Protocol.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous Part A | 55.3 years STANDARD_DEVIATION 8.5 |
| Age, Continuous Part B | 56.1 years STANDARD_DEVIATION 8 |
| Race (NIH/OMB) Part A American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Part A Asian | 10 Participants |
| Race (NIH/OMB) Part A Black or African American | 0 Participants |
| Race (NIH/OMB) Part A More than one race | 0 Participants |
| Race (NIH/OMB) Part A Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Part A Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Part A White | 0 Participants |
| Race (NIH/OMB) Part B American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Part B Asian | 60 Participants |
| Race (NIH/OMB) Part B Black or African American | 0 Participants |
| Race (NIH/OMB) Part B More than one race | 0 Participants |
| Race (NIH/OMB) Part B Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Part B Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Part B White | 0 Participants |
| Region of Enrollment Japan | 0 Participants |
| Sex: Female, Male Part A Female | 0 Participants |
| Sex: Female, Male Part A Male | 23 Participants |
| Sex: Female, Male Part B Female | 0 Participants |
| Sex: Female, Male Part B Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 10 | 0 / 9 | 0 / 11 | 0 / 14 | 0 / 17 | 0 / 18 |
| other Total, other adverse events | 2 / 4 | 5 / 10 | 6 / 9 | 5 / 11 | 11 / 14 | 13 / 17 | 9 / 18 |
| serious Total, serious adverse events | 0 / 4 | 0 / 10 | 0 / 9 | 0 / 11 | 0 / 14 | 0 / 17 | 0 / 18 |
Outcome results
None listed