Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD at the same time each day. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.

Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered subcutaneously (under the skin) OD at the same time each day. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) are allowed during the trial at an unchanged, stable dose level and dosing frequency.

The incidences of treatment emergent adverse events (TEAEs) over the time period of Week 0-26 were recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise).

The confirmed hypoglycaemic episodes (defined as severe hypoglycaemia and/or a measured plasma glucose (PG) less than 3.1 mmol/L [less than 56 mg/dL]) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise).

Number of treatment emergent hypoglycaemic episodes according to the ADA definition (classified as severe hypoglycaemia, documented hypoglycaemia, asymptomatic hypoglycaemia, probable symptomatic hypoglycaemia, relative hypoglycaemia) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).

The number of treatment mergent confirmed hypoglycaemic episodes in the maintenance period from Week 16 to end of trial (week 27) was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs. stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L.

The number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.

The number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes in the maintenance period from 16 weeks to end of trial (week 27) was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.

The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the simple titration algorithm.

The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the stepwise titration algorithm.

The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.

The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.

The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.

The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.

The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.

The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.

The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.

The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.

The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.

The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.

The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.

The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.

The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.

The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.

The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.

The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.

The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.