A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily 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 covariates Baseline + Country + Baseline Oral Antihyperglycemic Medication (OAM) Use (Metformin (Met), Met plus Sulfonylurea (SU)) + Treatment + Time + Treatment\*Time (Type III sum of squares).

Time frame: Baseline, Week 40

Population: All randomized participants belonging to the 10 mg, 15 mg Tirzepatide and Insulin Glargine arms who received at least one dose of study drug, had a baseline and at least one post-baseline value, excluding data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date + 7 days).

DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 40 or early termination. The treatment satisfaction score ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS mean was determined by ANCOVA model for endpoint measures with Baseline + Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline OAM Use (Met, Met plus SU) + Treatment (Type III sum of squares) as covariates.

Time frame: Baseline, Week 40

Population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline value, excluding data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date + 7 days).

LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (\<= 8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as covariates.

Time frame: Baseline, Week 40

Population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline value, excluding data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date + 7 days).

Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (\<= 8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as covariates.

Time frame: Baseline, Week 40

Population: All randomized participants who had received at least one dose of study drug, had a baseline and at least one post-baseline value, excluding data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date + 7 days).

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model with covariates Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Treatment + Time + Treatment\*Time (Type III sum of squares).

Time frame: Baseline, Week 40

Population: All randomized participants belonging to the 5 mg Tirzepatide and Insulin Glargine arms who received at least one dose of study drug, had a baseline and at least one post-baseline value, excluding data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date + 7 days).

The SMBG data was collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post-meal, Midday Premeal, Midday 2-hour Post-meal, Evening Premeal, Evening 2-hour Post-meal and Bedtime. LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (\<= 8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as covariates.

Time frame: Baseline, Week 40

Population: All randomized participants who have received at least one dose of study drug, had a baseline and at least one post-baseline value, excluding data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date + 7 days).

HbA1c is the glycosylated fraction of hemoglobin A. Imputed data includes observed value and imputed value if endpoint measure is missing.

Time frame: Week 40

Population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline value, excluding data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date + 7 days).

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing.

Time frame: Week 40

Population: All randomized participants who received at least one dose of study drug and had a baseline and at least one post-baseline value, excluding data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date + 7 days).

Imputed data includes observed value and imputed value if endpoint measure is missing.

Time frame: Week 40

Population: All randomized participants who received at least one dose of study drug, had a baseline and had at least one post-baseline value, excluding data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date + 7 days).

The hypoglycemia events were defined by participant reported events with blood glucose \< 54 mg/dL \[\<3.0 Millimole per Liter (mmol/L)\] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of post-baseline hypoglycemia was estimated by negative binomial model: Number of episodes = Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (\<= 8.5%, \>8.5%) + Treatment, with log (exposure in days/365.25) as an offset variable.

Time frame: Baseline through end of safety follow-up (Up To Week 44)

Population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline value, excluding data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date + 7 days).