A Study of LY2963016 Compared to LANTUS® in Adult Participants With Type 2 Diabetes Mellitus

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 baseline of response, treatment (LY2963016, LANTUS), pooled country, basal insulin at entry (yes/no), sulfonylurea (SU) use (yes/no), visit, treatment and visit\*treatment in the model.

Time frame: Baseline, 24 weeks

Population: All randomized participants who received at least 1 dose of study drug and with a Baseline and at least 1 post-Baseline HbA1c measure.

Basal Insulin dose in units (U) per body weight in kilograms (kg) per day. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit\*treatment in the model.

Time frame: Week 24

Population: All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline Basal Insulin Dose per Body Weight measure.

Units of Basal Insulin dose taken per day (U/day). Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit\*treatment in the model.

Time frame: Week 24

Population: All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline Basal Insulin Dose.

Seven-point SMBG are completed at the following timepoints: Before Morning Meal, 2 Hours After Morning Meal, Before Mid-Day Meal, 2 Hours After Mid-Day Meal, Before Evening Meal, Bed Time and 03:00 AM hours. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit\*treatment in the model.

Time frame: Baseline, Week 24

Population: All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline SMBG measure.

Change from baseline in body weight. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit\*treatment in the model.

Time frame: Baseline, 24 Weeks

Population: All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline body weight measure.

ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items divided into 5 domains of satisfaction: Inconvenience of Regimen \[(IR) 5 items: domain scores range (DSR) 5-35\], Lifestyle Flexibility \[(LF) 3 items: DSR 3-21\], Glycemic Control \[(GC) 3 items: DSR 3-21\], Hypoglycemic Control \[(HC) 5 items: DSR 5-35\], Insulin Delivery Device \[(IDD) 6 items: DSR 6-42\]. All items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. ITSQ Total Overall Raw Scores range from 22-154. Both raw domain and overall scores are transformed on a scale of 0-100, where transformed score=100\*\[(7-mean raw score)/6\]. Higher scores indicate better treatment satisfaction. LS means was determined by MMRM with baseline of response, baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit\*treatment in the model.

Time frame: Week 4 and Week 24

Population: All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline ITSQ measure.

Fasting blood glucose (FBG) is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Intra-Participant FBG variability was calculated based on the standard deviation (SD) of the morning pre-meal BG value. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit\*treatment in the model.

Time frame: Week 24

Population: All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline fasting blood glucose measure.

The percentage of participants with detected insulin antibodies were summarized as counts and percentages at baseline, at each visit, at the 24-week endpoint (LOCF), and overall for the 24-week treatment period.

Time frame: Endpoint [up to 24 weeks]

Population: All randomized participants who received at least 1 dose of study drug and with a Baseline and at least 1 post-Baseline with detectable anti-drug antibodies; last observation carried forward (LOCF).

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.

Time frame: Endpoint [up to 24 weeks]

Population: All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline HbA1c measure; last observation carried forward (LOCF).

The percentage of participants (with at least 1 hypoglycemic event (total, severe, nocturnal, and others) or incidence during the study was analyzed using Fisher's exact test. A hypoglycemic event is defined as any time a participant has a blood glucose (BG) level of ≤70 milligrams per deciliter (mg/dL) even if the event was not associated with signs, symptoms, or treatment consistent with current guidelines (American Diabetes Association 2005). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrates, glucagons, or other resuscitative actions. Severe Hypoglycemic events may or may not have a reported BG ≤70 mg/dL. These events may be associated with sufficient neuroglycopenia to induce seizure or coma.

Time frame: Endpoint [up to 24 weeks]

Population: All randomized participants who had a post-baseline measurement for Hypoglycemic Events; last observation carried forward (LOCF).

The rate of hypoglycemic events were analyzed at baseline, titration, maintenance, and overall study periods and at endpoint using the Wilcoxon test. In addition, a negative binomial model was used as a sensitivity analysis. A hypoglycemic event is defined as any time a participant has a blood glucose (BG) level of ≤70 milligrams per deciliter (mg/dL) even if the event was not associated with signs, symptoms, or treatment consistent with current guidelines (American Diabetes Association 2005). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrates, glucagons, or other resuscitative actions. Severe Hypoglycemic events may or may not have a reported BG ≤70 mg/dL. These events may be associated with sufficient neuroglycopenia to induce seizure or coma.

Time frame: Baseline through Endpoint [up to 24 weeks]

Population: All randomized participants who received at 1 dose of study drug with Baseline at least 1 post-Baseline hypoglycemic event; last observation carried forward (LOCF).