Type 2 Diabetes
Conditions
Brief summary
The purpose of this study is to determine the long-term safety of the study intervention orforglipron as a monotherapy or in combination with oral antihyperglycemic medication. This study includes 3 periods as follows: * screening and lead-in period: up to 4 weeks * treatment period: 52 weeks, including 20 weeks of dose escalation, and * safety follow-up period: 2 weeks.
Interventions
DRUGOrforglipron
Administered orally
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Have Type 2 Diabetes (T2D) * Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤10.5% (≤91 mmol/mol) as determined by the central laboratory at screening. * Are of stable weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment. * Have a BMI ≥23.0 kilogram/square meter (kg/m²) at screening.
Exclusion criteria
* Have Type 1 Diabetes (T1D). * Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening, or between screening and randomization. * Have New York Heart Association functional classification IV congestive heart failure. * Have had any of the following cardiovascular (CV) conditions within 60 days prior to screening, or between screening and randomization. * acute myocardial infarction * cerebrovascular accident (stroke), or * hospitalization for congestive heart failure * Have acute or chronic hepatitis and pancreatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Baseline to Week 54 | A TEAE was defined as any adverse event that began on or after the first dose of study drug or began before the first dose of study drug and worsened on or after the first dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 52 | HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. |
| Percentage of Participants Who Achieved HbA1c <7.0% | Week 52 | HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule. |
| Percentage of Participants Who Achieved HbA1c ≤6.5% | Week 52 | HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule. |
| Percentage of Participants Who Achieved HbA1c <5.7% | Week 52 | HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule. |
| Change From Baseline in Fasting Serum Glucose | Baseline, Week 52 | — |
| Change From Baseline in Body Weight | Baseline, Week 52 | — |
| Percentage of Participants Who Achieved Weight Loss of ≥5% From Baseline | Week 52 | The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule. |
| Percentage of Participants Who Achieved Weight Loss of ≥10% From Baseline | Week 52 | The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule. |
| Percentage of Participants Who Achieved Weight Loss of ≥15% From Baseline | Week 52 | The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule. |
| Change From Baseline in Waist Circumference | Baseline, Week 52 | — |
| Change From Baseline in Body Mass Index (BMI) | Baseline, Week 52 | — |
| Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) | Baseline, Week 52 | SMBG is measured using a glucometer. The SMBG profiles will consist of the following 7-point measurements obtained on a single day: * before 3 main meals, * approximately 2 hours after 3 main meals, and * at bedtime Daily average glucose was calculated as the mean of 7 time point specific averages obtained from up to 2 non-consecutive SMBG profiles within week 52. |
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
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.5 years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 132 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 134 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Japan | 401 Participants |
| Sex: Female, Male Female | 118 Participants |
| Sex: Female, Male Male | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 132 | 0 / 135 | 1 / 134 |
| other Total, other adverse events | 106 / 132 | 114 / 135 | 118 / 134 |
| serious Total, serious adverse events | 4 / 132 | 3 / 135 | 6 / 134 |
Outcome results
None listed