A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin

Change From Baseline in HbA1c [Noninferiority Analysis]

Timeframe: Baseline, Week 40

* Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A, measured to reflect average plasma glucose concentration over a prolonged period of time. * Values represented under "Least Squares (LS) Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE were calculated using a mixed-model repeated measures (MMRM) analysis for post-baseline measures, with country, baseline by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of HbA1c level (\<= \[less than or equal to\] 8.0% ,\> \[greater than\] 8.0%). Variance-covariance structure for change from baseline was unstructured.

Change From Baseline in HbA1c [Superiority Analysis]

Timeframe: Baseline, Week 40

* HbA1c is the glycosylated fraction of hemoglobin A, measured to reflect average plasma glucose concentration over a prolonged period of time. * Values represented under "Least Squares (LS) Mean" are MBE of the unconditional average treatment effect. MBE were calculated using MMRM analysis for post-baseline measures, with country, baseline by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of HbA1c level (\<=8.0%, \>8.0%). Variance-covariance structure for change from baseline was unstructured.

Percentage of Participants With an HbA1c Target Value of < 7.0% (53 mmol/Mol)

Timeframe: Week 40

Percentage of participants with an HbA1c target value of less than (\<) 7.0% (53 millimoles per mole \[mmol/mol\]) was analyzed using a logistic regression model with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by baseline HbA1c levels (\<=8.0% and \>8.0%). Missing Week 40 data were imputed using a multiple imputation method.

Percentage of Participants With an HbA1c Target Value of ≤6.5% (48 mmol/Mol)

Timeframe: Week 40

Percentage of participants with an HbA1c target value of less than or equal to (≤) 6.5% (48 mmol/mol) was analyzed by logistic regression model with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by baseline HbA1c levels (\<=8.0% and \>8.0%). Missing Week 40 data were imputed using a multiple imputation method.

Percent Change From Baseline in Body Weight

Timeframe: Baseline, Week 40

Values represented under "Least Squares (LS) Mean" are MBE of the unconditional average treatment effect. MBE were calculated using MMRM analysis for post-baseline measures, with country, baseline by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of HbA1c level (\<=8.0%, \>8.0%). Variance-covariance structure for change from baseline was unstructured.

Change From Baseline in Body Weight

Timeframe: Baseline, Week 40

Values represented under "Least Squares (LS) Mean" are MBE of the unconditional average treatment effect. MBE were calculated using MMRM analysis for post-baseline measures, with country, baseline by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of HbA1c level (\<=8.0%, \>8.0%). Variance-covariance structure for change from baseline was unstructured.

Percent Change From Baseline in Non-High-Density Lipoprotein (Non-HDL) Cholesterol

Timeframe: Baseline, Week 40

Values represented under "Geometric LS Mean" are MBE of the unconditional average treatment effect. MBE were calculated using MMRM analysis for post-baseline measures: log (actual measurement/baseline) = country, log (baseline) by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of HbA1c level (\<=8.0%, \>8.0%). Variance-covariance structure for change from baseline was unstructured.

Percent Change From Baseline in Triglycerides

Timeframe: Baseline, Week 40

Values represented under "Geometric LS Mean" are MBE of the unconditional average treatment effect. MBE were calculated using MMRM analysis for post-baseline measures: log (actual measurement/baseline) = country, log (baseline) by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of HbA1c level (\<=8.0%, \>8.0%). Variance-covariance structure for change from baseline was unstructured.

Change From Baseline in Systolic Blood Pressure (SBP)

Timeframe: Baseline, Week 40

Values represented under "Least Squares (LS) Mean" are MBE of the unconditional average treatment effect. MBE were calculated using MMRM analysis for post-baseline measures, with country, baseline by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of HbA1c level (\<=8.0%, \>8.0%). Variance-covariance structure for change from baseline was unstructured.

Change From Baseline in Fasting Serum Glucose (FSG)

Timeframe: Baseline, Week 40

Values represented under "Least Squares (LS) Mean" are MBE of the unconditional average treatment effect. MBE were calculated using MMRM analysis for post-baseline measures, with country, baseline by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of HbA1c level (\<=8.0%, \>8.0%). Variance-covariance structure for change from baseline was unstructured.

Percentage of Participants With ≥ 5% Body Weight Reduction

Timeframe: Week 40

Percentage of participants with greater than or equal to (≥) 5% body weight reduction was analyzed by logistic regression model with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by baseline HbA1c levels (\<=8.0% and \>8.0%). Missing Week 40 data were imputed using a multiple imputation method.

Percentage of Participants With ≥ 10% Body Weight Reduction

Timeframe: Week 40

Percentage of participants with ≥ 10% body weight reduction was analyzed by logistic regression model with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by baseline HbA1c levels (\<=8.0% and \>8.0%). Missing Week 40 data were imputed using a multiple imputation method.

Percentage of Participants With ≥ 15% Body Weight Reduction

Timeframe: Week 40

Percentage of participants with ≥ 15% body weight reduction was analyzed by logistic regression model with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by baseline HbA1c levels (\<=8.0% and \>8.0%). Missing Week 40 data were imputed using a multiple imputation method.

Change From Baseline in Diastolic Blood Pressure (DBP)

Timeframe: Baseline, Week 40

Values represented under "Least Squares (LS) Mean" are MBE of the unconditional average treatment effect. MBE were calculated using MMRM analysis for post-baseline measures, with country, baseline by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of HbA1c level (\<=8.0%, \>8.0%). Variance-covariance structure for change from baseline was unstructured.

Percent Change From Baseline in Total Cholesterol

Timeframe: Baseline, Week 40

Values represented under "Geometric LS Mean" are MBE of the unconditional average treatment effect. MBE were calculated using MMRM analysis for post-baseline measures: log (actual measurement/baseline) = country, log (baseline) by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of HbA1c level (\<=8.0%, \>8.0%). Variance-covariance structure for change from baseline was unstructured.

Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores

Timeframe: Baseline, Week 40

The SF-36v2 is a participant-reported measure designed to assess health status using 36 items across 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The physical functioning domain assesses limitations due to health "now," whereas the remaining domains assess functioning "in the past week." Each domain is scored individually, and information from these 8 domains is aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths (3-point, 5-point, or 6-point scales). Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.

Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc): Total Score of Treatment Satisfaction

Timeframe: Week 40

The DTSQc assesses relative change in participant satisfaction with diabetes treatment compared to previous treatment. The questionnaire consists of 8 items, of which 6 items were used to calculate the Total Score of Treatment Satisfaction, covering the following:1. satisfaction with current treatment; 2. convenience of treatment; 3. flexibility; 4. satisfaction with understanding of diabetes; 5. likelihood to recommend present treatment; and 6. satisfaction to continue present treatment. Each item is rated on a 7-point Likert scale from -3 (much less satisfied) to +3 (much more satisfied). Scores from these 6 items are summed to produce the Total Score of Treatment Satisfaction, ranging from -18 (much less satisfied) to +18 (much more satisfied). The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment.