Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of flexible versus fixed dosing and simple versus stepwise titration with OD insulin degludec in inadequately treated subjects with type 2 diabetes.
Interventions
DRUGinsulin degludec
Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD with the option to vary time of administration within a window of plus/minus 8 hours. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current treatment with IGlar (insulin glargine) with or without OADs (oral antidiabetic drug). All antidiabetic treatments should have been on-going for at least 12 weeks prior to randomisation, and doses of OADs should have been stable in this period of time. - Please note that a maximum of 3 OADs are allowed during this trial: metformin, sulphonylurea (SU)/glinides, dipeptidyl peptidase 4 (DPP-IV) inhibitors, alfa-glucosidaseinhibitors or pioglitazone. * Diagnosis of T2DM (type 2 diabetes mellitus) at the discretion of the investigator for at least 26 weeks prior to visit 1 (Screening visit) * HbA1c 7.0-9.5% (both inclusive) by central laboratory analysis * Body mass index (BMI) equal to or below 35 kg/m\^2
Exclusion criteria
* Any chronic disorder or severe disease which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol * Stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 26 weeks prior to Visit 1 (Screening visit) * Impaired renal function, defined as serum-creatinine higher than or equal to 1.4 mg/dL for males and higher than or equal to 1.3 mg/dL for females * Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma) * Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to randomisation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HbA1c (%) Glycosylated Haemoglobin) | Week 0, week 26 | Changes from baseline in HbA1c values over time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial | After 26 weeks of treatment | The number of subjects who achieved the pre-defined HbA1c target (\<7.0%) after 26 weeks of treatment was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise). |
| Incidence of Treatment Emergent Adverse Events (TEAEs) | Weeks 0-26 | 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). |
| Number of Treatment Emergent 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)) | Weeks 0-26 | 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). |
| Change From Baseline in Fasting Plasma Glucose (FPG) | Week 0, week 26 | Changes from baseline in FPG values over the time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise). |
| Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period | From Week 16 to end of trial (week 27) | 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. |
| Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes | Weeks 0-26 | 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. |
| Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes in the Maintenance Period | From week 16 to end of trial (week 27) | 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. |
| Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Weeks 0-26 | 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). |
Countries
Japan
Participant flow
Recruitment details
The trial was conducted at 39 sites in Japan.
Pre-assignment details
Pre-assignment: Subjects switched from their pre-trial IGlar to IDeg unit-to-unit and continued pre-trial OADs (maximum of 3) at unchanged doses and frequency.
Participants by arm
| Arm | Count |
|---|---|
| IDeg OD Fixed Dosing and Simple Titration (Arm A) 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 and the simple titration algorithm. | 114 |
| IDeg OD Fixed Dosing and Stepwise Titration (Arm B) 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 and the stepwise titration algorithm. | 115 |
| IDeg OD Flexible Dosing and Simple Titration (Arm C) 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. | 115 |
| IDeg OD Flexible Dosing and Stepwise Titration (Arm D) 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. | 114 |
| Total | 458 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal Criteria | 1 | 2 | 1 | 5 |
Baseline characteristics
| Characteristic | IDeg OD Fixed Dosing and Simple Titration (Arm A) | IDeg OD Fixed Dosing and Stepwise Titration (Arm B) | IDeg OD Flexible Dosing and Simple Titration (Arm C) | IDeg OD Flexible Dosing and Stepwise Titration (Arm D) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 60.4 years STANDARD_DEVIATION 10.6 | 60.7 years STANDARD_DEVIATION 10.5 | 60.0 years STANDARD_DEVIATION 10.8 | 60.2 years STANDARD_DEVIATION 10.8 | 60.3 years STANDARD_DEVIATION 10.7 |
| Fasting plasma glucose (FPG) | 129.8 mg/dL STANDARD_DEVIATION 30 | 136.0 mg/dL STANDARD_DEVIATION 38.1 | 131.8 mg/dL STANDARD_DEVIATION 33.5 | 134.5 mg/dL STANDARD_DEVIATION 39.6 | 133.0 mg/dL STANDARD_DEVIATION 35.5 |
| Gender Female | 41 Participants | 41 Participants | 50 Participants | 34 Participants | 166 Participants |
| Gender Male | 73 Participants | 74 Participants | 65 Participants | 80 Participants | 292 Participants |
| Glycosylated haemoglobin (HbA1c) | 7.8 percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.6 | 7.8 percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.6 | 7.8 percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.5 | 7.8 percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.6 | 7.8 percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 79 / 229 | 82 / 229 | 78 / 229 | 83 / 229 |
| serious Total, serious adverse events | 8 / 229 | 6 / 229 | 7 / 229 | 7 / 229 |
Outcome results
Primary
Change From Baseline in HbA1c (%) Glycosylated Haemoglobin)
Changes from baseline in HbA1c values over time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise)
Time frame: Week 0, week 26
Population: The full analysis set (FAS) included all randomised subjects. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Analysis was per intention to treat principle. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDeg OD Flexible (Arm C+Arm D) | Change From Baseline in HbA1c (%) Glycosylated Haemoglobin) | -0.54 Percent (%) glycosylated haemoglobin | Standard Deviation 0.76 |
| IDeg OD Fixed (Arm A+Arm B) | Change From Baseline in HbA1c (%) Glycosylated Haemoglobin) | -0.62 Percent (%) glycosylated haemoglobin | Standard Deviation 0.75 |
| IDeg OD Simple (Arm A+Arm C) | Change From Baseline in HbA1c (%) Glycosylated Haemoglobin) | -0.57 Percent (%) glycosylated haemoglobin | Standard Deviation 0.72 |
| IDeg OD Stepwise (Arm B+Arm D) | Change From Baseline in HbA1c (%) Glycosylated Haemoglobin) | -0.59 Percent (%) glycosylated haemoglobin | Standard Deviation 0.8 |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG)
Changes from baseline in FPG values over the time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).
Time frame: Week 0, week 26
Population: The FAS included all randomised subjects. 458 subjects were grouped according to dosing pattern or treatment algorithm received. Analysis was per intention to treat principle. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDeg OD Flexible (Arm C+Arm D) | Change From Baseline in Fasting Plasma Glucose (FPG) | -28.8 mg/dL | Standard Deviation 39 |
| IDeg OD Fixed (Arm A+Arm B) | Change From Baseline in Fasting Plasma Glucose (FPG) | -25.4 mg/dL | Standard Deviation 40.2 |
| IDeg OD Simple (Arm A+Arm C) | Change From Baseline in Fasting Plasma Glucose (FPG) | -27.0 mg/dL | Standard Deviation 35.3 |
| IDeg OD Stepwise (Arm B+Arm D) | Change From Baseline in Fasting Plasma Glucose (FPG) | -27.2 mg/dL | Standard Deviation 43.6 |
Secondary
Incidence of Treatment Emergent Adverse Events (TEAEs)
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).
Time frame: Weeks 0-26
Population: The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation as treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDeg OD Flexible (Arm C+Arm D) | Incidence of Treatment Emergent Adverse Events (TEAEs) | 150 events |
| IDeg OD Fixed (Arm A+Arm B) | Incidence of Treatment Emergent Adverse Events (TEAEs) | 154 events |
| IDeg OD Simple (Arm A+Arm C) | Incidence of Treatment Emergent Adverse Events (TEAEs) | 138 events |
| IDeg OD Stepwise (Arm B+Arm D) | Incidence of Treatment Emergent Adverse Events (TEAEs) | 166 events |
Secondary
Number of Treatment Emergent 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))
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).
Time frame: Weeks 0-26
Population: The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation as treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDeg OD Flexible (Arm C+Arm D) | Number of Treatment Emergent 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)) | 476 episodes |
| IDeg OD Fixed (Arm A+Arm B) | Number of Treatment Emergent 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)) | 371 episodes |
| IDeg OD Simple (Arm A+Arm C) | Number of Treatment Emergent 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)) | 469 episodes |
| IDeg OD Stepwise (Arm B+Arm D) | Number of Treatment Emergent 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)) | 378 episodes |
Secondary
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period
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.
Time frame: From Week 16 to end of trial (week 27)
Population: The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product. Subjects were grouped either according to dosing pattern or treatment algorithm received. 451 subjects contributed to the analysis. Subjects in the safety analysis set contributed to the evaluation as treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDeg OD Flexible (Arm C+Arm D) | Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period | 227 episodes |
| IDeg OD Fixed (Arm A+Arm B) | Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period | 192 episodes |
| IDeg OD Simple (Arm A+Arm C) | Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period | 241 episodes |
| IDeg OD Stepwise (Arm B+Arm D) | Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period | 178 episodes |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition
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).
Time frame: Weeks 0-26
Population: The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation as treated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDeg OD Flexible (Arm C+Arm D) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Severe | 0 episodes |
| IDeg OD Flexible (Arm C+Arm D) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Probable symptomatic | 87 episodes |
| IDeg OD Flexible (Arm C+Arm D) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | ADA Events Overall | 3053 episodes |
| IDeg OD Flexible (Arm C+Arm D) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Asymptomatic | 1523 episodes |
| IDeg OD Flexible (Arm C+Arm D) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Documented symptomatic | 1262 episodes |
| IDeg OD Flexible (Arm C+Arm D) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Relative | 181 episodes |
| IDeg OD Fixed (Arm A+Arm B) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Documented symptomatic | 1141 episodes |
| IDeg OD Fixed (Arm A+Arm B) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Asymptomatic | 1283 episodes |
| IDeg OD Fixed (Arm A+Arm B) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Relative | 180 episodes |
| IDeg OD Fixed (Arm A+Arm B) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Severe | 1 episodes |
| IDeg OD Fixed (Arm A+Arm B) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Probable symptomatic | 131 episodes |
| IDeg OD Fixed (Arm A+Arm B) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | ADA Events Overall | 2736 episodes |
| IDeg OD Simple (Arm A+Arm C) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Probable symptomatic | 103 episodes |
| IDeg OD Simple (Arm A+Arm C) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | ADA Events Overall | 3089 episodes |
| IDeg OD Simple (Arm A+Arm C) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Severe | 1 episodes |
| IDeg OD Simple (Arm A+Arm C) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Documented symptomatic | 1293 episodes |
| IDeg OD Simple (Arm A+Arm C) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Asymptomatic | 1505 episodes |
| IDeg OD Simple (Arm A+Arm C) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Relative | 187 episodes |
| IDeg OD Stepwise (Arm B+Arm D) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Documented symptomatic | 1110 episodes |
| IDeg OD Stepwise (Arm B+Arm D) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Severe | 0 episodes |
| IDeg OD Stepwise (Arm B+Arm D) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | ADA Events Overall | 2700 episodes |
| IDeg OD Stepwise (Arm B+Arm D) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Probable symptomatic | 115 episodes |
| IDeg OD Stepwise (Arm B+Arm D) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Relative | 174 episodes |
| IDeg OD Stepwise (Arm B+Arm D) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition | Asymptomatic | 1301 episodes |
Secondary
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes
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.
Time frame: Weeks 0-26
Population: The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation as treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDeg OD Flexible (Arm C+Arm D) | Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes | 77 episodes |
| IDeg OD Fixed (Arm A+Arm B) | Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes | 58 episodes |
| IDeg OD Simple (Arm A+Arm C) | Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes | 80 episodes |
| IDeg OD Stepwise (Arm B+Arm D) | Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes | 55 episodes |
Secondary
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes in the Maintenance Period
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.
Time frame: From week 16 to end of trial (week 27)
Population: The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation as treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDeg OD Flexible (Arm C+Arm D) | Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes in the Maintenance Period | 34 episodes |
| IDeg OD Fixed (Arm A+Arm B) | Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes in the Maintenance Period | 23 episodes |
| IDeg OD Simple (Arm A+Arm C) | Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes in the Maintenance Period | 40 episodes |
| IDeg OD Stepwise (Arm B+Arm D) | Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes in the Maintenance Period | 17 episodes |
Secondary
Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial
The number of subjects who achieved the pre-defined HbA1c target (\<7.0%) after 26 weeks of treatment was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).
Time frame: After 26 weeks of treatment
Population: The FAS included all randomised subjects. 458 subjects were grouped according to dosing pattern or treatment algorithm received. Analysis was per intention to treat principle. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDeg OD Flexible (Arm C+Arm D) | Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial | 90 Subjects |
| IDeg OD Fixed (Arm A+Arm B) | Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial | 95 Subjects |
| IDeg OD Simple (Arm A+Arm C) | Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial | 91 Subjects |
| IDeg OD Stepwise (Arm B+Arm D) | Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial | 94 Subjects |