Type 2 Diabetes
Conditions
Brief summary
The main purpose of this study is to investigate the efficacy and safety of switching from weekly dulaglutide to weekly tirzepatide compared to increasing the dulaglutide dose in adults with type 2 diabetes.
Interventions
DRUGTirzepatide
Administered SC
DRUGDulaglutide
Administered SC
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 * Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤9.5% (≤80 mmol/mol) * Are currently on a stable dose of dulaglutide weekly (0.75 mg or 1.5 mg) for at least 6 months prior to screening. * No treatment with oral antihyperglycemic medication (OAM), or on a stable dose of up to 3 OAMs, which may include metformin, sodium glucose cotransporter-2 inhibitors (SGLT-2i), and/or sulfonylurea, for at least 3 months before screening. * Have had stable body weight (±5%) during the 90 days preceding screening * Have BMI ≥25 kilogram/square meter (kg/m²)
Exclusion criteria
* Have type 1 diabetes * Have a history of chronic or acute pancreatitis * Have a history of * proliferative diabetic retinopathy, or * diabetic maculopathy, or * nonproliferative diabetic retinopathy that requires acute treatment. * Have any of these cardiovascular (CV) conditions within 60 days prior to screening: * acute myocardial infarction, * cerebrovascular accident (stroke), or * hospitalization due to congestive heart failure (CHF). * Have New York Heart Assocation (NYHA) Functional Classification Class IV CHF * Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2). * Have within 90 days prior to screening received treatment with medications intended to promote weight loss. This includes prescribed, over-the-counter, or alternative remedies * Have an estimated glomerular filtration rate (eGFR) \<30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label) * Have been treated with insulin prior to screening * Exception: use of insulin for gestational diabetes or short-term use (\<14 days) for acute conditions such as acute illness, hospitalization, or elective surgery. * Have a history of reduction of dose of dulaglutide, due to intolerability, without successful reescalation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HbA1c | Baseline, Week 40 | HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved HbA1c <7% | Week 40 | The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable. Missing endpoint measures are imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for Baseline HbA1c Value, Baseline SGLT2i use(Yes/No), Treatment, Visit, and Treatment by Visit interaction. |
| Percentage of Participants Who Achieved HbA1c <=6.5% | Week 40 | The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable. Logistic regression model was used with missing endpoint measures imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for baseline HbA1c, geographic region 1, number of background OAMs in group 1, dulaglutide dose at screening, and treatment as factors. |
| Percentage of Participants Who Achieved HbA1c <5.7% | Week 40 | The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable. Logistic regression model was used with missing endpoint measures imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for baseline HbA1c, geographic region 1, number of background OAMs in group 1, dulaglutide dose at screening, and treatment as factors. |
| Percentage of Participants Who Achieve Weight Loss From Baseline of ≥5% | Week 40 | Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HBA1C Group + Treatment + Time + Treatment\*Time. |
| Percentage of Participants Who Achieve Weight Loss From Baseline of ≥10% | Week 40 | Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HBA1C Group + Treatment + Time + Treatment\*Time. |
| Change From Baseline in Body Weight | Baseline, Week 40 | LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Baseline HbA1c Group + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured. |
| Percentage of Participants Who Achieved Composite Endpoint (HbA1c <=6.5% & Weight Loss >=10% & No-Hypoglycemia) | Week 40 | A composite endpoint is defined as HbA1c ≤ 6.5%, weight loss ≥ 10%, and no hypoglycemia, defined as blood glucose (BG) \<3.0 millimole/liter (mmol/L) and/or severe hypoglycemia. Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: For HbA1c: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Treatment + Time + Treatment\*Time. For Weight: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HbA1c Group + Treatment + Time + Treatment\*Time. |
| Change From Baseline in Fasting Serum Glucose (FSG) | Baseline, Week 40 | LSMean was calculated using the ANCOVA model for endpoint measures: Variable = Baseline + A1CGR1 + DULDSCRN + OAMGR1 + REGION1 + Treatment (Type I sum of squares). |
| Change From Baseline in Waist Circumference | Baseline, Week 40 | LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Baseline HbA1c Group + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured. |
| Change From Baseline in Body Mass Index (BMI) | Baseline, Week 40 | Change from Baseline in BMI is presented. LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Baseline HbA1c Group + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured. |
| Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score | Baseline, Week 40 | The IWQOL-Lite-CT is a 20-item, obesity-specific PRO (patient-reported outcome) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items, where 5 of the items comprise the physical functioning sub-domain) and psychosocial (13 items). The IWQOL-Lite-CT provides composite scores for each domain, as well as a total score, all ranging from 0 to 100. Higher scores reflect better levels of functioning. This endpoint shows results for 'physical function domain.' |
| Percentage of Participants Who Achieve Weight Loss From Baseline of ≥15% | Week 40 | Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HBA1C Group + Treatment + Time + Treatment\*Time. |
Countries
Belgium, Germany, Mexico, Romania, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 15 mg Tirzepatide or MTD Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached. | 139 |
| 4.5 mg Dulaglutide or MTD Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached. | 143 |
| Total | 282 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Death | 1 | 1 |
| Overall Study | Inadvertent enrollment | 3 | 6 |
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Total | 4.5 mg Dulaglutide or MTD | 15 mg Tirzepatide or MTD |
|---|---|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 9.8 | 57.3 years STANDARD_DEVIATION 10 | 57.9 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants | 14 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 19 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 213 Participants | 110 Participants | 103 Participants |
| Percentage of Hemoglobin A1c (HbA1c) at Baseline | 7.82 Percentage of HbA1c STANDARD_DEVIATION 0.71 | 7.82 Percentage of HbA1c STANDARD_DEVIATION 0.73 | 7.82 Percentage of HbA1c STANDARD_DEVIATION 0.69 |
| Race (NIH/OMB) American Indian or Alaska Native | 42 Participants | 19 Participants | 23 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 229 Participants | 120 Participants | 109 Participants |
| Region of Enrollment Belgium | 19 Participants | 10 Participants | 9 Participants |
| Region of Enrollment Germany | 40 Participants | 21 Participants | 19 Participants |
| Region of Enrollment Mexico | 91 Participants | 48 Participants | 43 Participants |
| Region of Enrollment Romania | 63 Participants | 31 Participants | 32 Participants |
| Region of Enrollment United States | 69 Participants | 33 Participants | 36 Participants |
| Sex: Female, Male Female | 136 Participants | 72 Participants | 64 Participants |
| Sex: Female, Male Male | 146 Participants | 71 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 139 | 1 / 143 |
| other Total, other adverse events | 77 / 139 | 79 / 143 |
| serious Total, serious adverse events | 10 / 139 | 10 / 143 |
Outcome results
Primary
Change From Baseline in HbA1c
HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.
Time frame: Baseline, Week 40
Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 15 mg Tirzepatide or MTD | Change From Baseline in HbA1c | -1.59 percentage of HbA1c | Standard Error 0.073 |
| 4.5 mg Dulaglutide or MTD | Change From Baseline in HbA1c | -0.69 percentage of HbA1c | Standard Error 0.074 |
p-value: <0.000195% CI: [-1.1, -0.69]Mixed Models Analysis
Secondary
Change From Baseline in Body Mass Index (BMI)
Change from Baseline in BMI is presented. LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Baseline HbA1c Group + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.
Time frame: Baseline, Week 40
Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 15 mg Tirzepatide or MTD | Change From Baseline in Body Mass Index (BMI) | -3.9 Kilogram per square meter (kg/m^2) | Standard Error 0.17 |
| 4.5 mg Dulaglutide or MTD | Change From Baseline in Body Mass Index (BMI) | -1.3 Kilogram per square meter (kg/m^2) | Standard Error 0.18 |
p-value: <0.000195% CI: [-3.1, -2.1]Mixed Models Analysis
Secondary
Change From Baseline in Body Weight
LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Baseline HbA1c Group + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.
Time frame: Baseline, Week 40
Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 15 mg Tirzepatide or MTD | Change From Baseline in Body Weight | -11.0 kilograms (kg) | Standard Error 0.48 |
| 4.5 mg Dulaglutide or MTD | Change From Baseline in Body Weight | -3.6 kilograms (kg) | Standard Error 0.49 |
p-value: <0.000195% CI: [-8.7, -6]Mixed Models Analysis
Secondary
Change From Baseline in Fasting Serum Glucose (FSG)
LSMean was calculated using the ANCOVA model for endpoint measures: Variable = Baseline + A1CGR1 + DULDSCRN + OAMGR1 + REGION1 + Treatment (Type I sum of squares).
Time frame: Baseline, Week 40
Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 15 mg Tirzepatide or MTD | Change From Baseline in Fasting Serum Glucose (FSG) | -2.00 millimole per liter (mmol/L) | Standard Error 0.149 |
| 4.5 mg Dulaglutide or MTD | Change From Baseline in Fasting Serum Glucose (FSG) | -1.10 millimole per liter (mmol/L) | Standard Error 0.15 |
p-value: <0.00195% CI: [-1.32, -0.49]ANCOVA
Secondary
Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score
The IWQOL-Lite-CT is a 20-item, obesity-specific PRO (patient-reported outcome) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items, where 5 of the items comprise the physical functioning sub-domain) and psychosocial (13 items). The IWQOL-Lite-CT provides composite scores for each domain, as well as a total score, all ranging from 0 to 100. Higher scores reflect better levels of functioning. This endpoint shows results for 'physical function domain.'
Time frame: Baseline, Week 40
Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding patients discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 15 mg Tirzepatide or MTD | Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score | 11.8 score on a scale | Standard Error 1.77 |
| 4.5 mg Dulaglutide or MTD | Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score | 7.8 score on a scale | Standard Error 1.91 |
p-value: 0.118195% CI: [-1, 9.2]ANCOVA
Secondary
Change From Baseline in Waist Circumference
LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Baseline HbA1c Group + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.
Time frame: Baseline, Week 40
Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 15 mg Tirzepatide or MTD | Change From Baseline in Waist Circumference | -8.2 centimeter (cm) | Standard Error 0.94 |
| 4.5 mg Dulaglutide or MTD | Change From Baseline in Waist Circumference | -3.1 centimeter (cm) | Standard Error 0.97 |
p-value: 0.000295% CI: [-7.8, -2.5]Mixed Models Analysis
Secondary
Percentage of Participants Who Achieved Composite Endpoint (HbA1c <=6.5% & Weight Loss >=10% & No-Hypoglycemia)
A composite endpoint is defined as HbA1c ≤ 6.5%, weight loss ≥ 10%, and no hypoglycemia, defined as blood glucose (BG) \<3.0 millimole/liter (mmol/L) and/or severe hypoglycemia. Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: For HbA1c: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Treatment + Time + Treatment\*Time. For Weight: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HbA1c Group + Treatment + Time + Treatment\*Time.
Time frame: Week 40
Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 15 mg Tirzepatide or MTD | Percentage of Participants Who Achieved Composite Endpoint (HbA1c <=6.5% & Weight Loss >=10% & No-Hypoglycemia) | 46.62 percentage of participants |
| 4.5 mg Dulaglutide or MTD | Percentage of Participants Who Achieved Composite Endpoint (HbA1c <=6.5% & Weight Loss >=10% & No-Hypoglycemia) | 4.58 percentage of participants |
p-value: <0.000195% CI: [8.4, 49.77]Regression, Logistic
Secondary
Percentage of Participants Who Achieved HbA1c <5.7%
The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable. Logistic regression model was used with missing endpoint measures imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for baseline HbA1c, geographic region 1, number of background OAMs in group 1, dulaglutide dose at screening, and treatment as factors.
Time frame: Week 40
Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 15 mg Tirzepatide or MTD | Percentage of Participants Who Achieved HbA1c <5.7% | 21.64 percentage of participants |
| 4.5 mg Dulaglutide or MTD | Percentage of Participants Who Achieved HbA1c <5.7% | 2.27 percentage of participants |
p-value: <0.000195% CI: [4.58, 51.36]Regression, Logistic
Secondary
Percentage of Participants Who Achieved HbA1c <=6.5%
The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable. Logistic regression model was used with missing endpoint measures imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for baseline HbA1c, geographic region 1, number of background OAMs in group 1, dulaglutide dose at screening, and treatment as factors.
Time frame: Week 40
Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 15 mg Tirzepatide or MTD | Percentage of Participants Who Achieved HbA1c <=6.5% | 73.88 percentage of participants |
| 4.5 mg Dulaglutide or MTD | Percentage of Participants Who Achieved HbA1c <=6.5% | 22.73 percentage of participants |
p-value: <0.000195% CI: [6.51, 23.02]Regression, Logistic
Secondary
Percentage of Participants Who Achieved HbA1c <7%
The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable. Missing endpoint measures are imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for Baseline HbA1c Value, Baseline SGLT2i use(Yes/No), Treatment, Visit, and Treatment by Visit interaction.
Time frame: Week 40
Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 15 mg Tirzepatide or MTD | Percentage of Participants Who Achieved HbA1c <7% | 84.21 percentage of participants |
| 4.5 mg Dulaglutide or MTD | Percentage of Participants Who Achieved HbA1c <7% | 52.38 percentage of participants |
p-value: <0.000195% CI: [3.82, 13.32]Regression, Logistic
Secondary
Percentage of Participants Who Achieve Weight Loss From Baseline of ≥10%
Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HBA1C Group + Treatment + Time + Treatment\*Time.
Time frame: Week 40
Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 15 mg Tirzepatide or MTD | Percentage of Participants Who Achieve Weight Loss From Baseline of ≥10% | 58.21 percentage of participants |
| 4.5 mg Dulaglutide or MTD | Percentage of Participants Who Achieve Weight Loss From Baseline of ≥10% | 6.87 percentage of participants |
p-value: <0.000195% CI: [9.07, 41.3]Regression, Logistic
Secondary
Percentage of Participants Who Achieve Weight Loss From Baseline of ≥15%
Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HBA1C Group + Treatment + Time + Treatment\*Time.
Time frame: Week 40
Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 15 mg Tirzepatide or MTD | Percentage of Participants Who Achieve Weight Loss From Baseline of ≥15% | 27.61 percentage of participants |
| 4.5 mg Dulaglutide or MTD | Percentage of Participants Who Achieve Weight Loss From Baseline of ≥15% | 0.76 percentage of participants |
p-value: <0.000195% CI: [7.18, 178.89]Regression, Logistic
Secondary
Percentage of Participants Who Achieve Weight Loss From Baseline of ≥5%
Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HBA1C Group + Treatment + Time + Treatment\*Time.
Time frame: Week 40
Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 15 mg Tirzepatide or MTD | Percentage of Participants Who Achieve Weight Loss From Baseline of ≥5% | 84.33 percentage of participants |
| 4.5 mg Dulaglutide or MTD | Percentage of Participants Who Achieve Weight Loss From Baseline of ≥5% | 37.40 percentage of participants |
p-value: <0.000195% CI: [5.11, 16.98]Regression, Logistic