A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)

Change From Baseline in HbA1c

Time frame · 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.

Change From Baseline in Body Weight

Time frame · 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 HbA1c <7%

Time frame · 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%

Time frame · 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%

Time frame · 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%

Time frame · 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%

Time frame · 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 ≥15%

Time frame · 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 Achieved Composite Endpoint (HbA1c <=6.5% & Weight Loss >=10% & No-Hypoglycemia)

Time frame · 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)

Time frame · 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

Time frame · 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.