A Study in Adults With Type 1 Diabetes

HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.

Time frame: Baseline, Endpoint (up to 24 weeks)

Population: All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline HbA1c measurement. Last observation carried forward (LOCF) principle was used.

7-point SMBG measurements are completed at the following timepoints: Morning (AM) Pre-Meal, AM Post-Prandial (PP), Midday (MD) Pre-Meal, MD PP, Evening (EV) Pre-Meal, Bed Time and 0300 hours. PP glucose is measured 2 hours (hrs) after the start of the meal. Values for the 7-point SMBG profiles were averaged over the three 7-point SMBG profiles during 2-week period prior to each visit. If only 1 of the 3 days of data was collected, then the value of the 1 day was used. If only 2 of the 3 days of data were collected, then the average of the 2 days was used. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.

Time frame: Baseline and Endpoints [up to 24 weeks (wk) and up to 52 weeks]

Population: All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline SMBG measurement. Last observation carried forward (LOCF) principle was used.

ALBSS contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (almost always). Items are categorized in 2 domains: Behavior (or avoidance) Items 1 to 15 and Worry (or affect) Items 16 to 33. Behavior Total Score (TS) range is 0 to 60 and Worry TS range is 0 to 72. Higher scores on Behavior items (related to avoidance of hypoglycemia) reflect greater awareness and/or effort of the participant to prevent low blood sugar. Higher scores on Worry items (related to worries about low blood sugar and its consequences) reflect greater participant concern about having low blood sugar. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.

Time frame: Baseline and 24 weeks and Endpoint (up to 52 weeks)

Population: All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline ALBSS measurement. Last observation carried forward (LOCF) principle was used for Endpoint (up to 52 weeks).

Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.

Time frame: Baseline, 6 weeks and 12 weeks and 18 weeks and Endpoints (up to 24 weeks and up to 52 weeks)

Population: All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline body weight measurement. Last observation carried forward (LOCF) principle was used for Endpoints (up to 24 weeks and up to 52 weeks).

HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.

Time frame: Baseline, 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoint (up to 52 weeks)

Population: All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline HbA1c measurements. Last observation carried forward (LOCF) principle was used for Endpoint (up to 52 weeks).

Blood samples are collected from participants and percentage of insulin antibody binding was measured to determine the insulin antibody levels. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.

Time frame: Baseline, 6 weeks and 12 weeks and Endpoints (up to 24 weeks and up to 52 weeks)

Population: All randomized participants who received at least 1 dose of study drug and were insulin antibody positive at baseline and had at least 1 post-baseline insulin antibody positive measurement. Last observation carried forward (LOCF) principle was used for Endpoints (up to 24 and up to 52 weeks).

Glycemic variability is the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning premeal blood glucose value from the 7-point self-monitoring blood glucose (SMBG) profiles. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.

Time frame: Baseline and Endpoints (up to 24 weeks and up 52 weeks)

Population: All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline fasting blood glucose measurement. Last observation carried forward (LOCF) principle was used.

Incidence of hypoglycemic events is defined as the number of hypoglycemic events. A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose (BG) concentration of ≤ 70 milligrams/deciliter \[mg/dL (3.9 millimoles/liter (mmol/L)\], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines \[American Diabetes Association (ADA) 2005\]. Severe hypoglycemia is defined as a hypoglycemic event requiring 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; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.

Time frame: Baseline through 24 weeks (wk) and 52 weeks

Population: All randomized participants who received at least 1 dose of study drug.

Total daily insulin dose was adjusted for body weight \[units of insulin/kilogram/day (U/kg/day)\]. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.

Time frame: Endpoints [up to 24 weeks (wk) and up to 52 weeks]

Population: All randomized participants who received at least 1 dose of study drug and had at least 1 daily insulin dose per body weight measurements. Last observation carried forward (LOCF) principle was used.

Units of insulin taken daily were presented. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.

Time frame: Endpoints [up to 24 weeks (wk) and up to 52 weeks]

Population: All randomized participants who received at least 1 dose of study drug and had at least 1 insulin daily dose measurements. Last observation carried forward (LOCF) principle was used.

ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. Items divided into 5 domains: Inconvenience of Regimen \[(IR) 5 items: scores range 5-35\], Lifestyle Flexibility \[(LF) 3 items: scores range 3-21\], Glycemic Control \[(GC) 3 items: scores range 3-21\], Hypoglycemic Control \[(HC) 5 items: scores range 5-35\], Insulin Delivery Device \[(IDD) 6 items: scores range 6-42\]. ITSQ Total Overall Scores range from 22-154. Data presented are the transformed score on a scale of 0-100, where transformed score=100×\[(7-raw score)/6\]. Higher scores indicate better treatment satisfaction. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.

Time frame: Baseline and 24 weeks and Endpoint (up to 52 weeks)

Population: All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline ITSQ measurements. Last observation carried forward (LOCF) principle was used for Endpoint (up to 52 weeks).

HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. The percentage of participants with Hemoglobin A1c (HbA1c) \<7.0% or HbA1c ≤6.5% is calculated as the number of participants with an HbA1c level of the cut-off value (\<7.0% or ≤6.5%) divided by the number of participants treated, then multiplied by 100.

Time frame: Baseline and 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoints (up to 24 weeks and up to 52 weeks)

Population: All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline HbA1c measurement. Last observation carried forward (LOCF) principle was used for Endpoints (up to 24 weeks and up to 52 weeks).

The rate of hypoglycemic events per 30 days is defined as the total number of events between visits divided by the actual number of days between visits, and then multiplied by 30 days. A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose (BG) concentration of ≤ 70 milligrams/deciliter \[mg/dL (3.9 millimoles/liter (mmol/L)\], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005). Severe hypoglycemia is defined as a hypoglycemic event requiring 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; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.

Time frame: Baseline through 24 weeks (wk) and 52 weeks

Population: All randomized participants who received at least 1 dose of study drug.