Type 2 Diabetes
Conditions
Brief summary
The main purpose of this study is to evaluate the efficacy and safety of LY3502970 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 30 weeks.
Interventions
DRUGLY3502970
Administered orally
DRUGDulaglutide
Administered subcutaneously
DRUGPlacebo
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Have been diagnosed with Type 2 Diabetes on diet and exercise and/or a stable dose of metformin * Have a stable body weight for the 3 months prior to randomization * Have a body mass index (BMI) ≥23 kilogram/square meter (kg/m²) * Males must agree to use highly effective methods of contraception * Women not of childbearing potential (WNOCBP) may participate in this trial * Note: Hormone replacement therapy in post-menopausal women is allowed but women must be on stable therapy for 3 months prior to day 1.
Exclusion criteria
* Have Type 1 diabetes mellitus (T1DM) or history of ketoacidosis or hyperosmolar coma * Have a history of diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that requires immediate treatment intervention * Have had more than 1 episode of severe hypoglycemia and aware of hypoglycemic symptoms * Have acute or chronic pancreatitis * Have obesity induced other endocrine disorders (Cushing's syndrome or Prader - Willi syndrome) * Have gastric emptying abnormality or chronically take medications impacting GI motility * Have poorly controlled hypertension * Have the following heart conditions within the last 6 months: myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack (TIA), cerebrovascular accident (stroke)or decompensated congestive heart failure, or IV heart failure * Have any symptoms of other liver diseases besides nonalcoholic fatty liver disease (NAFLD) * Have HIV, or Hepatitis B or Hepatitis C
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HbA1c in LY3502970 as Compared to Placebo | Baseline, Week 26 | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HbA1c ≤ 6.5% | Week 26 | Percentage of Participants with HbA1c ≤ 6.5%. Odds ratio was calculated using logistic regression model. |
| Percentage of Participants With HbA1c <7.0% | Week 26 | Percentage of Participants with HbA1c \<7.0%. Odds ratio was calculated using logistic regression model. |
| Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide | Baseline, Week 26 | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
| Change From Baseline in Body Weight | Baseline, Week 26 | LS mean was determined by MMRM model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
| Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970 | Pre-dose (Week (wk) 0, wk 8, wk 12, and wk 26); Post-dose (wk 4, wk 8, wk 16, wk 20, and end of treatment). | PK: Steady State AUC of LY3502970 |
| Change From Baseline in Fasting Serum Glucose | Baseline, Week 26 | Fasting glucose is a test to determine sugar levels in blood sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, 8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
Countries
Hungary, Poland, Puerto Rico, Slovakia, United States
Participant flow
Pre-assignment details
For maintenance doses of LY3502970: 3, 12, 24, 36, and 45 milligrams (mg), the initial dose will be 2 or 3 mg followed by additional escalation steps as appropriate. The dose escalation varied by dose group where the target maintenance dose was achieved between Weeks 4 and 12.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received matching placebo. | 55 |
| 3 mg LY3502970 Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally QD. | 51 |
| 12 mg LY3502970 Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD. | 56 |
| 24 mg LY3502970 Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD. | 47 |
| 36 mg LY3502970 - 1 Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD. | 27 |
| 36 mg LY3502970 - 2 Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD. | 34 |
| 45 mg LY3502970 - 1 Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD. | 31 |
| 45 mg LY3502970 - 2 Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD. | 32 |
| 1.5 mg Dulaglutide Participants received 1.5 mg Dulaglutide administered SC QW. | 50 |
| Total | 383 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 2 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Death | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 3 | 1 | 1 | 1 | 1 | 0 |
| Overall Study | Participant decided to Discontinue Treatment and only Return for Single Final Visit | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Participant was Unresponsive and Too Far Out of Window to Resume Treatment | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Patient Decision due To Changes in Personal Life | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Site Terminated Participant due to Sponsor Directions | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Sponsor decision due To inadvertent Enrollment | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 3 | 1 | 0 | 2 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | 36 mg LY3502970 - 2 | Total | 1.5 mg Dulaglutide | 45 mg LY3502970 - 2 | 45 mg LY3502970 - 1 | 36 mg LY3502970 - 1 | 24 mg LY3502970 | 12 mg LY3502970 | 3 mg LY3502970 |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 58.30 years STANDARD_DEVIATION 9.52 | 60.10 years STANDARD_DEVIATION 9.37 | 58.90 years STANDARD_DEVIATION 9.4 | 58.80 years STANDARD_DEVIATION 10.19 | 58.90 years STANDARD_DEVIATION 8.18 | 58.10 years STANDARD_DEVIATION 10.63 | 59.20 years STANDARD_DEVIATION 9.07 | 60.50 years STANDARD_DEVIATION 9.11 | 57.40 years STANDARD_DEVIATION 9.23 | 59.00 years STANDARD_DEVIATION 9.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 7 Participants | 74 Participants | 7 Participants | 6 Participants | 7 Participants | 6 Participants | 5 Participants | 15 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 27 Participants | 309 Participants | 43 Participants | 26 Participants | 24 Participants | 21 Participants | 42 Participants | 41 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Hemoglobin A1c (HbA1c) | 8.1 Percentage of HbA1c STANDARD_DEVIATION 0.9 | 8.1 Percentage of HbA1c STANDARD_DEVIATION 0.8 | 8.1 Percentage of HbA1c STANDARD_DEVIATION 0.8 | 8.0 Percentage of HbA1c STANDARD_DEVIATION 0.7 | 8.0 Percentage of HbA1c STANDARD_DEVIATION 0.8 | 8.3 Percentage of HbA1c STANDARD_DEVIATION 1 | 8.0 Percentage of HbA1c STANDARD_DEVIATION 0.7 | 8.2 Percentage of HbA1c STANDARD_DEVIATION 0.9 | 8.2 Percentage of HbA1c STANDARD_DEVIATION 0.9 | 8.0 Percentage of HbA1c STANDARD_DEVIATION 0.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 5 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 0 Participants | 22 Participants | 4 Participants | 3 Participants | 2 Participants | 0 Participants | 2 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 4 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 50 Participants | 33 Participants | 348 Participants | 44 Participants | 28 Participants | 29 Participants | 25 Participants | 43 Participants | 49 Participants | 47 Participants |
| Region of Enrollment Hungary | 10 Participants | 6 Participants | 63 Participants | 9 Participants | 4 Participants | 6 Participants | 3 Participants | 8 Participants | 9 Participants | 8 Participants |
| Region of Enrollment Poland | 11 Participants | 9 Participants | 85 Participants | 12 Participants | 6 Participants | 7 Participants | 6 Participants | 10 Participants | 11 Participants | 13 Participants |
| Region of Enrollment Slovakia | 10 Participants | 5 Participants | 65 Participants | 7 Participants | 6 Participants | 5 Participants | 5 Participants | 9 Participants | 10 Participants | 8 Participants |
| Region of Enrollment United States | 24 Participants | 14 Participants | 170 Participants | 22 Participants | 16 Participants | 13 Participants | 13 Participants | 20 Participants | 26 Participants | 22 Participants |
| Sex: Female, Male Female | 27 Participants | 16 Participants | 157 Participants | 20 Participants | 13 Participants | 10 Participants | 9 Participants | 17 Participants | 20 Participants | 25 Participants |
| Sex: Female, Male Male | 28 Participants | 18 Participants | 226 Participants | 30 Participants | 19 Participants | 21 Participants | 18 Participants | 30 Participants | 36 Participants | 26 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 | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 55 | 0 / 51 | 0 / 56 | 0 / 47 | 0 / 27 | 0 / 34 | 0 / 31 | 0 / 32 | 0 / 50 |
| other Total, other adverse events | 25 / 55 | 34 / 51 | 40 / 56 | 32 / 47 | 21 / 27 | 18 / 34 | 21 / 31 | 23 / 32 | 23 / 50 |
| serious Total, serious adverse events | 3 / 55 | 3 / 51 | 1 / 56 | 5 / 47 | 1 / 27 | 1 / 34 | 0 / 31 | 1 / 32 | 1 / 50 |
Outcome results
Primary
Change From Baseline in HbA1c in LY3502970 as Compared to Placebo
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 26
Population: All participants who received at least one dose of LY3502970 or placebo and had baseline and at least one post-baseline value for HbA1c.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 3 mg LY3502970 | Change From Baseline in HbA1c in LY3502970 as Compared to Placebo | -1.19 Percentage of HbA1c | Standard Error 0.137 |
| 12 mg LY3502970 | Change From Baseline in HbA1c in LY3502970 as Compared to Placebo | -1.91 Percentage of HbA1c | Standard Error 0.133 |
| 24 mg LY3502970 | Change From Baseline in HbA1c in LY3502970 as Compared to Placebo | -1.79 Percentage of HbA1c | Standard Error 0.149 |
| 36 mg LY3502970 | Change From Baseline in HbA1c in LY3502970 as Compared to Placebo | -2.03 Percentage of HbA1c | Standard Error 0.127 |
| 45 mg LY3502970 | Change From Baseline in HbA1c in LY3502970 as Compared to Placebo | -2.10 Percentage of HbA1c | Standard Error 0.124 |
| Placebo | Change From Baseline in HbA1c in LY3502970 as Compared to Placebo | -0.43 Percentage of HbA1c | Standard Error 0.128 |
p-value: <0.00195% CI: [-1.13, -0.4]Mixed Models Analysis
p-value: <0.00195% CI: [-1.85, -1.12]Mixed Models Analysis
p-value: <0.00195% CI: [-1.75, -0.98]Mixed Models Analysis
p-value: <0.00195% CI: [-1.96, -1.25]Mixed Models Analysis
p-value: <0.00195% CI: [-2.02, -1.32]Mixed Models Analysis
Secondary
Change From Baseline in Body Weight
LS mean was determined by MMRM model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 26
Population: All participants who received at least one dose of study drug, had baseline and at least one post-baseline body weight data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 3 mg LY3502970 | Change From Baseline in Body Weight | -3.7 kilograms (kg) | Standard Error 0.79 |
| 12 mg LY3502970 | Change From Baseline in Body Weight | -6.5 kilograms (kg) | Standard Error 0.76 |
| 24 mg LY3502970 | Change From Baseline in Body Weight | -9.7 kilograms (kg) | Standard Error 0.85 |
| 36 mg LY3502970 | Change From Baseline in Body Weight | -9.5 kilograms (kg) | Standard Error 0.73 |
| 45 mg LY3502970 | Change From Baseline in Body Weight | -10.1 kilograms (kg) | Standard Error 0.71 |
| Placebo | Change From Baseline in Body Weight | -2.2 kilograms (kg) | Standard Error 0.74 |
| 1.5 mg Dulaglutide | Change From Baseline in Body Weight | -3.9 kilograms (kg) | Standard Error 0.76 |
p-value: 0.15395% CI: [-3.7, 0.6]Mixed Models Analysis
p-value: <0.00195% CI: [-6.4, -2.2]Mixed Models Analysis
p-value: <0.00195% CI: [-9.8, -5.3]Mixed Models Analysis
p-value: <0.00195% CI: [-9.4, -5.3]Mixed Models Analysis
p-value: <0.00195% CI: [-9.9, -5.9]Mixed Models Analysis
p-value: 0.91495% CI: [-2, 2.3]Mixed Models Analysis
p-value: 0.01595% CI: [-4.7, -0.5]Mixed Models Analysis
p-value: <0.00195% CI: [-8.1, -3.6]Mixed Models Analysis
p-value: <0.00195% CI: [-7.8, -3.6]Mixed Models Analysis
p-value: <0.00195% CI: [-8.3, -4.2]Mixed Models Analysis
Secondary
Change From Baseline in Fasting Serum Glucose
Fasting glucose is a test to determine sugar levels in blood sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, 8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 26
Population: All participants who received at least one dose of study drug, had baseline and at least one post-baseline fasting glucose data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 3 mg LY3502970 | Change From Baseline in Fasting Serum Glucose | -32.6 milligrams per deciliter (mg/dL) | Standard Error 4.14 |
| 12 mg LY3502970 | Change From Baseline in Fasting Serum Glucose | -53.7 milligrams per deciliter (mg/dL) | Standard Error 3.92 |
| 24 mg LY3502970 | Change From Baseline in Fasting Serum Glucose | -52.2 milligrams per deciliter (mg/dL) | Standard Error 4.49 |
| 36 mg LY3502970 | Change From Baseline in Fasting Serum Glucose | -53.9 milligrams per deciliter (mg/dL) | Standard Error 3.79 |
| 45 mg LY3502970 | Change From Baseline in Fasting Serum Glucose | -55.9 milligrams per deciliter (mg/dL) | Standard Error 3.69 |
| Placebo | Change From Baseline in Fasting Serum Glucose | -11.1 milligrams per deciliter (mg/dL) | Standard Error 3.9 |
| 1.5 mg Dulaglutide | Change From Baseline in Fasting Serum Glucose | -33.2 milligrams per deciliter (mg/dL) | Standard Error 3.91 |
p-value: <0.00195% CI: [-32.7, -10.3]Mixed Models Analysis
p-value: <0.00195% CI: [-53.4, -31.7]Mixed Models Analysis
p-value: <0.00195% CI: [-52.7, -29.3]Mixed Models Analysis
p-value: <0.00195% CI: [-53.5, -32]Mixed Models Analysis
p-value: <0.00195% CI: [-55.3, -34.2]Mixed Models Analysis
p-value: <0.00195% CI: [-10.6, 11.8]Mixed Models Analysis
p-value: <0.00195% CI: [-31.4, -9.5]Mixed Models Analysis
p-value: 0.00295% CI: [-30.7, -7.2]Mixed Models Analysis
p-value: <0.00195% CI: [-31.4, -9.9]Mixed Models Analysis
p-value: <0.00195% CI: [-33.2, -12.1]Mixed Models Analysis
Secondary
Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 26
Population: All participants who received at least one dose of LY3502970 or dulaglutide, had a baseline, and at least one post-baseline value for HbA1c.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 3 mg LY3502970 | Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide | -1.19 Percentage of HbA1c | Standard Error 0.137 |
| 12 mg LY3502970 | Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide | -1.91 Percentage of HbA1c | Standard Error 0.133 |
| 24 mg LY3502970 | Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide | -1.79 Percentage of HbA1c | Standard Error 0.149 |
| 36 mg LY3502970 | Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide | -2.03 Percentage of HbA1c | Standard Error 0.127 |
| 45 mg LY3502970 | Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide | -2.10 Percentage of HbA1c | Standard Error 0.124 |
| Placebo | Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide | -1.10 Percentage of HbA1c | Standard Error 0.131 |
p-value: 0.62695% CI: [-0.47, 0.28]Mixed Models Analysis
p-value: <0.00195% CI: [-1.18, -0.44]Mixed Models Analysis
p-value: <0.00195% CI: [-1.08, -0.3]Mixed Models Analysis
p-value: <0.00195% CI: [-1.29, -0.57]Mixed Models Analysis
p-value: <0.00195% CI: [-1.36, -0.64]Mixed Models Analysis
Secondary
Percentage of Participants With HbA1c ≤ 6.5%
Percentage of Participants with HbA1c ≤ 6.5%. Odds ratio was calculated using logistic regression model.
Time frame: Week 26
Population: All participants who received at least one dose of study drug, had a baseline and at least one post-baseline HbA1c value.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3 mg LY3502970 | Percentage of Participants With HbA1c ≤ 6.5% | 45.30 Percentage of participants |
| 12 mg LY3502970 | Percentage of Participants With HbA1c ≤ 6.5% | 70.73 Percentage of participants |
| 24 mg LY3502970 | Percentage of Participants With HbA1c ≤ 6.5% | 80.12 Percentage of participants |
| 36 mg LY3502970 | Percentage of Participants With HbA1c ≤ 6.5% | 79.39 Percentage of participants |
| 45 mg LY3502970 | Percentage of Participants With HbA1c ≤ 6.5% | 83.52 Percentage of participants |
| Placebo | Percentage of Participants With HbA1c ≤ 6.5% | 14.56 Percentage of participants |
| 1.5 mg Dulaglutide | Percentage of Participants With HbA1c ≤ 6.5% | 41.04 Percentage of participants |
p-value: <0.00195% CI: [2.21, 20.75]Regression, Logistic
p-value: <0.00195% CI: [9.92, 117.16]Regression, Logistic
p-value: <0.00195% CI: [11.9, 196.24]Regression, Logistic
p-value: <0.00195% CI: [13.61, 153.64]Regression, Logistic
p-value: <0.00195% CI: [20.26, 294.48]Regression, Logistic
p-value: 0.67895% CI: [0.48, 3.13]Regression, Logistic
p-value: <0.00195% CI: [2.19, 17.24]Regression, Logistic
p-value: <0.00195% CI: [2.55, 29.79]Regression, Logistic
p-value: <0.00195% CI: [3.05, 22.3]Regression, Logistic
p-value: <0.00195% CI: [4.51, 43.01]Regression, Logistic
Secondary
Percentage of Participants With HbA1c <7.0%
Percentage of Participants with HbA1c \<7.0%. Odds ratio was calculated using logistic regression model.
Time frame: Week 26
Population: All participants who received at least one dose of study drug, had a baseline and at least one post-baseline HbA1c value.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3 mg LY3502970 | Percentage of Participants With HbA1c <7.0% | 65.17 Percentage of participants |
| 12 mg LY3502970 | Percentage of Participants With HbA1c <7.0% | 78.92 Percentage of participants |
| 24 mg LY3502970 | Percentage of Participants With HbA1c <7.0% | 91.24 Percentage of participants |
| 36 mg LY3502970 | Percentage of Participants With HbA1c <7.0% | 92.75 Percentage of participants |
| 45 mg LY3502970 | Percentage of Participants With HbA1c <7.0% | 95.76 Percentage of participants |
| Placebo | Percentage of Participants With HbA1c <7.0% | 24.27 Percentage of participants |
| 1.5 mg Dulaglutide | Percentage of Participants With HbA1c <7.0% | 64.06 Percentage of participants |
p-value: <0.00195% CI: [2.93, 22.9]Regression, Logistic
p-value: <0.00195% CI: [7.57, 82.69]Regression, Logistic
p-value: <0.00195% CI: [12.26, 316.63]Regression, Logistic
p-value: <0.00195% CI: [17.56, 259.97]Regression, Logistic
p-value: <0.00195% CI: [26.72, 628.09]Regression, Logistic
p-value: 0.80295% CI: [0.43, 2.96]Regression, Logistic
p-value: 0.02695% CI: [1.16, 10.31]Regression, Logistic
p-value: 0.00695% CI: [1.83, 40.51]Regression, Logistic
p-value: <0.00195% CI: [2.67, 32.71]Regression, Logistic
p-value: <0.00195% CI: [4.02, 79.7]Regression, Logistic
Secondary
Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970
PK: Steady State AUC of LY3502970
Time frame: Pre-dose (Week (wk) 0, wk 8, wk 12, and wk 26); Post-dose (wk 4, wk 8, wk 16, wk 20, and end of treatment).
Population: All participants who received at least one dose of LY3502970 and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 3 mg LY3502970 | Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970 | 364 nanogram *hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 38.7 |
| 12 mg LY3502970 | Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970 | 1020 nanogram *hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 63.5 |
| 24 mg LY3502970 | Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970 | 1500 nanogram *hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 84.5 |
| 36 mg LY3502970 | Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970 | 1830 nanogram *hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 94.6 |
| 45 mg LY3502970 | Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970 | 2430 nanogram *hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 39.8 |
| Placebo | Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970 | 2230 nanogram *hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 80.4 |
| 1.5 mg Dulaglutide | Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970 | 2550 nanogram *hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 55.3 |