• Participants received once-weekly (QW) subcutaneous (SC) dulaglutide injections for 24 weeks, starting with either 1.5 milligrams (mg) as combination therapy or 0.75 mg as combination therapy or monotherapy (at the discretion of the investigator).
• For participants reporting gastrointestinal adverse events (GI AEs) after starting the 1.5 mg dulaglutide dose, the investigator reduced the dose to 0.75 mg for 2 to 3 weeks. Thereafter, the 1.5 mg dose was reintroduced.

Administered SC

• An AE was any untoward medical occurrence in a participant who was administered an investigational product that did not necessarily have a causal relationship with the treatment. A TEAE was defined as an AE that occurred post-dose or was present prior to dosing and became more severe post-dose.
• An SAE was any AE from the study that resulted in one of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that might not have been immediately life-threatening or resulted in death or hospitalization but might have jeopardized the participant or required intervention to prevent one of the other outcomes listed in the definition above.
• A summary of SAEs and other non-serious AEs, regardless of causality, is located in the reported Adverse Events section of this record.

Hypoglycemia events were defined as those with blood glucose (BG) levels less than (<) 70 milligrams per deciliter (mg/dL). Severe hypoglycemia events were defined as those with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrates, glucagon, or other resuscitative actions. These events could be associated with sufficient neuroglycopenia to induce seizures or coma. The total number of participants who experienced hypoglycemia events, including severe hypoglycemia, was summarized cumulatively.

The percentage of participants who reported AEs and SAEs was calculated by dividing the total number of affected participants by the number of participants analyzed, then multiplying by 100. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the reported Adverse Events section of this record.

HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The mean change in HbA1c levels was calculated using descriptive analysis, with baseline HbA1c as a covariate. Missing endpoints were addressed using the last observation carried forward (LOCF) method.

• Participants received QW dulaglutide SC injections for 24 weeks, starting with either 1.5 mg as combination therapy or 0.75 mg as combination therapy or monotherapy (at the discretion of the investigator).
• For participants reporting GI AEs after starting the 1.5 mg dulaglutide dose, the investigator reduced the dose to 0.75 mg for 2 to 3 weeks. Thereafter, the 1.5 mg dose was reintroduced.

• An AE was any untoward medical occurrence in a participant who was administered an investigational product that did not necessarily have a causal relationship with the treatment. A TEAE was defined as an AE that occurred post-dose or was present prior to dosing and became more severe post-dose.
• An SAE was any AE from the study that resulted in one of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that might not have been immediately life-threatening or resulted in death or hospitalization but might have jeopardized the participant or required intervention to prevent one of the other outcomes listed in the definition above.
• A summary of SAEs and other non-serious AEs, regardless of causality, is located in the reported Adverse Events section of this record.

All participants who received at least one dulaglutide dose and had at least one HbA1c measurement post-study treatment. As prespecified in the statistical analysis plan, the primary and secondary outcomes were planned to be analyzed and reported by dose level only if the proportion in each arm was more than 20 percent (%). However, the percentage in the 1.5 mg only or 0.75 mg only dulaglutide arm was lower than 20 %. Hence, outcomes are reported for the overall dulaglutide treatment group.

Participants in this arm received SC injections of both 1.5 mg and 0.75 mg dulaglutide QW doses at different points during the 24-week treatment period.