Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 in subjects with type 2 diabetes.
Interventions
DRUGinsulin degludec/insulin aspart
Twice daily subcutaneous (sc, under the skin) injection.
DRUGbiphasic insulin aspart
Twice daily subcutaneous (sc, under the skin) injection.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Male or female at least 18 years of age * Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months * Insulin treated subjects on current treatment: basal insulin, premixed insulin or a self-mixed insulin regimen, all administered once daily (OD) or BID with or without metformin. The treatment regimen should have remained unchanged for at least 8 weeks prior to randomisation * HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis * Body mass index (BMI) equal or below 40.0 kg/m\^2
Exclusion criteria
* Treatment with sulphonylureas, meglitinides, DPP-4 inhibitors, alpha-glycosidase inhibitors within 8 weeks prior to screening (Visit 1) or thiazolidinediones (TZDs) or GLP-1 receptor agonists within 12 weeks prior to screening (Visit 1) * Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and monoamine oxidase (MAO) inhibitors * Anticipated significant lifestyle changes during the trial according to the discretion of the investigator, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits * Cardiovascular disease, within the last 6 months prior to screening (Visit 1), defined as: stroke; decompensated heart failure NYHA1 class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty * Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the investigator's opinion could interfere with the results of the trial * Previous participation in this trial. Participation is defined as screened. * Known or suspected hypersensitivity to trial products or related products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin) | At 26 weeks | Change from baseline in HbA1c after 26 weeks of treatment. The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate. Missing values imputed using last observed value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes | Weeks 0-26 | The number of events was analysed using a negative binomial model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate. Confirmed hypoglycaemia is defined as either severe episodes or episodes with plasma glucose \< 3.1 mmol/L (56 mg/dL) with or without symptoms. The nocturnal period was defined as the period between 00:01 and 05:59 a.m. (both inclusive). A treatment emergent hypoglycaemic episode was defined as an episode that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. |
| Number of Treatment Emergent Confirmed Hypoglycaemic Episodes | Weeks 0-26 | The number of events was analysed using a negative binomial model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate. Confirmed hypoglycaemia was defined as either severe episodes or episodes with plasma glucose \< 3.1 mmol/L (56 mg/dL) with or without symptoms. A treatment emergent hypoglycaemic episode was defined as an episode that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. |
| Change From Baseline in Body Weight | Week 0, Week 26 | Change from baseline in body week at week 26. The response and change from baseline in response after 26 weeks are analysed using an ANCOVA model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate. Missing values imputed using last observed value. |
| Responder Without Confirmed Hypoglycaemic Episodes HbA1c Below 7.0% | At 26 weeks | A responder for HbA1c without confirmed hypoglycaemia was defined as a subject who meets the HbA1c target (\<7.0%) at end of trial without treatment emergent confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days after the last randomised treatment. Confirmed hypoglycaemia was defined as either severe episodes or episodes with plasma glucose \< 3.1 mmol/L (56 mg/dL) with or without symptoms. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Missing data is imputed using last observed value. |
| Incidence of Treatment Emergent Adverse Events (TEAEs) | Weeks 0-26 | A treatment emergent adverse event was defined as an episode that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Incidence of AEs was reported in terms of rate, defined as number of adverse events divided by patient years of exposure (PYE) multiplied by 100 (1 PYE=365.25 days). |
| Responder for HbA1c (HbA1c <7%) After 26 Weeks of Treatment | Week 26 | Number of subjects with HbA1c \<7% after 26 weeks of treatment. Missing HbA1c data was imputed using last observed value. |
| Responder for HbA1c (HbA1c <=6.5%) After 26 Weeks of Treatment | Week 26 | Number of subjects with HbA1c \<=6.5% after 26 weeks of treatment. Missing HbA1c data was imputed using last observed value. |
| Responder for HbA1c (HbA1c <7%) Without Severe Hypoglycaemic Episodes | At week 26 | A responder for HbA1c without severe hypoglycaemia was defined as a subject who meets the HbA1c target (\<7%) at end of trial without severe treatment emergent hypoglycaemia during the last 12 weeks of treatment or within 7 days after the last randomised treatment. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Missing HbA1c data was imputed using last observed value. |
| Responder for HbA1c (HbA1c ≤6.5%) Without Confirmed Hypoglycaemic Episodes | At 26 weeks | A responder for HbA1c without confirmed hypoglycaemia was defined as a subject who meets the HbA1c target (≤6.5%) at end of trial without treatment emergent confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days after the last randomised treatment. Confirmed hypoglycaemia was defined as either severe episodes or episodes with plasma glucose \< 3.1 mmol/L (56 mg/dL) with or without symptoms. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Missing data is imputed using last observed value. |
| Responder for HbA1c (HbA1c ≤6.5%) Without Severe Hypoglycaemic Episodes | At week 26 | A responder for HbA1c without severe hypoglycaemia was defined as a subject who meets the HbA1c target (≤6.5%) at end of trial without severe treatment emergent hypoglycaemia during the last 12 weeks of treatment or within 7 days after the last randomised treatment. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Missing HbA1c data was imputed using last observed value. |
| 9-point Profile (SMPG) After 26 Weeks of Treatment | At week 26 | SMPG values were recorded at 9 time-points: before and after (90 min after the start of the meal) breakfast, lunch, main evening meal, before bedtime, at 4 am and before breakfast on the next day. Missing values were imputed using last observed value. |
| Mean of the 9-point Profile (SMPG) After 26 Weeks of Treatment | At week 26 | SMPG values were recorded at 9 time-points: before and after (90 min after the start of the meal) breakfast, lunch, main evening meal, before bedtime, at 4 am and before breakfast on the next day. Missing values were imputed using last observed value. The mean of 9-point profile (SMPG) was defined as the area under the profile divided by the measurement time and was calculated using the trapezoidal method. |
| Fluctuation in the 9-point Profile (SMPG) After 26 Weeks of Treatment | At week 26 | SMPG values were recorded at 9 time-points: before and after (90 min after the start of the meal) breakfast, lunch, main evening meal, before bedtime, at 4 am and before breakfast on the next day. Missing values were imputed using last observed value. Fluctuation in 9-point SMPG profile is the average absolute difference to the mean of the profile of the 9-point SMPG measurements accumulated over the profile. |
| 9-point Profile (SMPG) - Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment | At week 26 | SMPG values were recorded at 9 time-points: before and after (90 min after the start of the meal) breakfast, lunch, main evening meal, before bedtime, at 4 am and before breakfast on the next day. Missing values were imputed using last observed value. Prandial PG increment for each meal was derived from the 9-point profile (SMPG) as the difference between PG values after meal (90 min) and before meal. The reported results are mean prandial PG increment overall meals (the mean of all available meal increments). |
| 2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Time From Randomisation (Measured in Weeks) to Achieve Titration Targets | From randomization till achievement of titration target (up to week 26) | 2-point profiles (SMPG): pre-breakfast and pre-dinner (main evening meal) SMPGs were to be taken for titration/dose adjustments. The pre-specified titration targets were to achieve SMPG level \<5 mmol/L (90 mg/dL) both before breakfast and before main evening meal. For each target, the time from randomisation to the date a subject achieves the titration target for the first time was derived (Kaplan-Meier method). Reported results are time to all titration target (pre-breakfast and pre-dinner) was met for the first time. |
| 2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Within-subject Variability as Measured by Coefficient of Variance (CV)% After 26 Weeks of Treatment | At week 26 | The logarithm transformed SMPG values available before breakfast and main evening meal were analysed separately as repeated measures in a linear mixed model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age as covariate and subject as random factor. The model assumed independent within- and between-subject errors with variances depending on treatment. Within-subject variability as measured by CoV% for a treatment could be calculated from the corresponding residual variance. |
| Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition During 26 Weeks of Treatment | Week 0-26 | ADA classification of hypoglycaemia: 1. Severe: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. 2. Asymptomatic: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG level ≤3.9 mmol/L. 3. Documented symptomatic: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG level ≤3.9 mmol/L. 4. Relative: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia, and interprets those as indicative of hypoglycaemia, but with a measured PG level \>3.9 mmol/L. 5. Probable symptomatic: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG level ≤3.9 mmol/L. Number of treatment emergent hypoglycaemic episodes were reported in terms of rate, defined as number of events divided by PYE multiplied by 100 (1 PYE=365.25 days). |
| Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period | From week 16 to end of treatment (week 26) + 1 week follow-up | Confirmed hypoglycaemia was defined as either severe episodes or episodes with plasma glucose \< 3.1 mmol/L (56 mg/dL) with or without symptoms. Severe: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Maintenance period was defined as the period from week 16 to end of treatment, including 1 week follow-up. Number of treatment emergent hypoglycaemic episodes were reported in terms of rate, defined as number of events divided by PYE multiplied by 100 (1 PYE=365.25 days). |
| Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes in the Maintenance Period | From week 16 to end of treatment (week 26) + 1 week follow-up | Confirmed hypoglycaemia was defined as either severe episodes or episodes with plasma glucose \< 3.1 mmol/L (56 mg/dL) with or without symptoms. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. The nocturnal period was defined as the period between 00:01 and 05:59 a.m. (both inclusive). Maintenance period was defined as the period from week 16 to end of treatment, including 1 week follow-up. Number of treatment emergent hypoglycaemic episodes were reported in terms of rate, defined as number of events divided by PYE multiplied by 100 (1 PYE=365.25 days). |
| Change in Health Related Quality of Life Questionnaire (SF -36) | Week 0, week 26 | Change from baseline in SF-36 at week 26. The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score). Missing data was imputed using last observed value. |
| Change in Treatment Satisfaction Questionnaire (Treatment Related Impact Measure-diabetes [TRIM-D]) | Week 0, week 26 | Change from baseline in TRIM-D scores at week 26. TRIM-D score measured treatment satisfaction which included an overall score as well the subscale scores (daily life, diabetes management, compliance and psychological health). The scores were transformed to a 0-100 scale with higher scores indicating less treatment related impact. Missing data was imputed using last observed value. |
| Treatment Satisfaction Questionnaire (Treatment Related Impact Measures - Diabetes Device [TRIM-D Device]) | At week 26 | TRIM-D device is an eight item measure with two domains assessing Device Bother and Device Function. This captures information on the ease of use, convenience, and handling of the device(s) used to take diabetes medication. The measure has acceptable reliability, validity and ability to detect change. The scores were transformed to a 0-100 scale with higher scores indicating less treatment related impact. Missing data was imputed using last observed value. |
| Device Specific Questionnaires I (How Easy or Difficult is it to Read the Dose Scale) | week 26 | Device Specific Questionnaires I (How easy or difficult is it to read the dose scale) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Device Specific Questionnaires I (How Easy or Difficult do You Find it to Hold the Pen Stable When Injecting?) | week 26 | Device Specific Questionnaires I (How easy or difficult do you find it to hold the pen stable when injecting?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Device Specific Questionnaires I (How Easy or Difficult is it to Hear the Clicks for Each Unit Increment?) | week 26 | Device Specific Questionnaires I (How easy or difficult is it to hear the clicks for each unit increment?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Device Specific Questionnaires I (How Easy or Difficult is it to Feel the Clicks for Each Unit Increment?) | week 26 | Device Specific Questionnaires I (How easy or difficult is it to feel the clicks for each unit increment?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Device Specific Questionnaires I (How Easy or Difficult is it to Push Down the Injection Button?) | week 26 | Device Specific Questionnaires I (How easy or difficult is it to push down the injection button?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Device Specific Questionnaires I (How Easy/Difficult is it to Turn the Dose Selector When Choosing the Right Dose?) | week 26 | Device Specific Questionnaires I (How easy/difficult is it to turn the dose selector when choosing the right dose?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Device Specific Questionnaires I (How Easy/Difficult is it to Know if the Push Button Has Been Pushed Completely Down?) | week 26 | Device Specific Questionnaires I (How easy/difficult is it to know if the push button has been pushed completely down?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult or Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Device Specific Questionnaires I (How Easy or Difficult is it to See the Dose Scale When Injecting?) | week 26 | Device Specific Questionnaires I (How easy or difficult is it to see the dose scale when injecting?) was measured on following categories: Very confident, Very easy, Fairly easy, Neither easy nor difficult, Rather difficult, and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Device Specific Questionnaires I (How Confident Are You That You Set the Insulin Dose Correctly Every Time?) | week 26 | Device Specific Questionnaires I (How confident are you that you set the insulin dose correctly every time?) was measured on following categories: Very confident, Rather confident, Fairly confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Device Specific Questionnaires I (How Confident Are You That You Inject the Correct Amount of Insulin Every Time?) | week 26 | Device Specific Questionnaires I (How confident are you that you inject the correct amount of insulin every time?) was measured on following categories: Very confident, Rather confident, Fairly confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Device Specific Questionnaires I (Overall, How Confident Are You in Your Management of Your Daily Insulin Injections Using This Pen?) | week 26 | Device Specific Questionnaires I (Overall, how confident are you in your management of your daily insulin injections using this pen?) was measured on following categories: Very confident, Fairly confident, Rather confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Device Specific Questionnaires I (Overall, How Confident Are You in Controlling Your Blood Sugar Level Using This Pen?) | week 26 | Device Specific Questionnaires I (Overall, how confident are you in controlling your blood sugar level using this pen?) was measured on following categories: Very confident, Fairly confident, Rather confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Device Specific Questionnaires I (How Suitable is the Pen to Use in Public?) | week 26 | Device Specific Questionnaires I (How suitable is the pen to use in public?) was measured on following scale: Very suitable, Fairly suitable, Rather suitable, Not very suitable and Not at all suitable. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Device Specific Questionnaires I (How Confident Are You That the Air Shot Has Been Done Correctly?) | week 26 | Device Specific Questionnaires I (How confident are you that the air shot has been done correctly?) was measured on following categories: Very confident, Fairly confident, Rather confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Device Specific Questionnaires I (How Convenient do You Find the Size of the Pen?) | week 26 | Device Specific Questionnaires I (How convenient do you find the size of the pen?) was measured on following categories: Very convenient, Fairly convenient, Rather convenient, Not very convenient and Not at all convenient. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Device Specific Questionnaires I (How Comfortable do You Find the Handling of the Pen?) | week 26 | Device Specific Questionnaires I (How comfortable do you find the handling of the pen?) was measured on following categories: Very comfortable, Fairly comfortable, Rather comfortable, Not very comfortable and Not at all comfortable. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Device Specific Questionnaires I (Did You Have Any Problems Using the Pen?) | week 26 | Participants were asked to report whether they had any problems using the pen. Number of participants reporting yes and no are presented. Missing data was imputed using last observed value. |
| Device Specific Questionnaires II (How Easy or Difficult Was it to Learn How to Use This Pen?) | week 26 | Device Specific Questionnaires II (How easy or difficult was it to learn how to use this pen?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Change From Baseline in FPG (Fasting Plasma Glucose) | At 26 weeks | Change from baseline in FPG at week 26. The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate. Missing values imputed using last observed value. |
| Device Specific Questionnaires II (How Easy or Difficult is it to Inject Your Usual Insulin Dose?) | week 26 | Device Specific Questionnaires II (How easy or difficult is it to inject your usual insulin dose?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Device Specific Questionnaires II (How Easy/Difficult is it to Reach the Dose Button When Inject Your Insulin Dose?) | week 26 | Device Specific Questionnaires II (How easy/difficult is it to reach the dose button when inject your insulin dose?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Device Specific Questionnaires II (How Easy or Difficult is it to Inject Yourself in Different Places of the Body Using This Pen?) | week 26 | Device Specific Questionnaires II (How easy or difficult is it to inject yourself in different places of the body using this pen?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult, Very difficult and Not applicable. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Device Specific Questionnaires II (How Confident Are You That the Full Dose Has Been Delivered?) | week 26 | Device Specific Questionnaires II (How confident are you that the full dose has been delivered?) was measured on following categories: Very confident, Fairly confident, Fairly easy, Rather confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
| Device Specific Questionnaires II (Would You Recommend the Pen?) | week 26 | Participants were asked the question would you recommend the pen? Number of participants reporting yes and no are presented. Missing data was imputed using last observed value. |
| Device Specific Questionnaires II (How Easy or Difficult is it to Distinguish Between Dialling up and Down?) | week 26 | Device Specific Questionnaires II (How easy or difficult is it to distinguish between dialling up and down?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value. |
Countries
China
Participant flow
Recruitment details
A total of 41 sites were approved for recruiting subjects, of which 40 sites screened and randomized the subjects.
Pre-assignment details
Insulin treated subjects on current treatment: basal insulin, premixed insulin or a self-mixed insulin regimen, all administered once daily or twice daily (BID) with or without metformin. The treatment regimen should have remained unchanged for at least 8 weeks prior to randomisation.
Participants by arm
| Arm | Count |
|---|---|
| IDegAsp BID Subjects received subcutaneous (s.c.) injections of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) for 26 weeks. Subjects started insulin treatment at dose corresponding to their pre-trial insulin treatment. The insulin dose adjustments aimed to reach pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) ≤ 5.0 mmol/L, based on the subject's pre-breakfast and pre-dinner SMPG. The dose taken with main evening meal was adjusted according to mean pre-breakfast plasma glucose measured on the day of adjustment and the two preceding days. The dose taken at breakfast was adjusted according to mean pre-main evening meal plasma glucose measured on the three days preceding the adjustment day. If one of the PG values was below target (\< 4.0 mmol/L), the corresponding dose was to be reduced. If one or more SMPG values were missing, the adjustment was to be performed on remaining SMPG values. Subjects continued the pre-trial treatment with metformin at stable dose. | 361 |
| BIAsp 30 BID Subjects received s.c. injections of biphasic insulin aspart 30 (BIAsp 30, a mixture of soluble insulin aspart \[IAsp\] 30% and protaminated IAsp 70%) BID for 26 weeks. Subjects started insulin treatment at dose corresponding to their pre-trial insulin treatment. The insulin dose adjustments aimed to reach pre-breakfast and pre-dinner SMPG ≤5.0 mmol/L, based on the subject's pre-breakfast and pre-dinner SMPG. The dose taken with main evening meal was adjusted according to mean pre-breakfast plasma glucose measured on day of adjustment and the two preceding days. The dose taken at breakfast was adjusted according to mean pre-main evening meal plasma glucose measured on the three days preceding the adjustment day. If one of the PG values was below target (\< 4.0 mmol/L), the corresponding dose was to be reduced. If one or more SMPG values were missing, the adjustment was to be performed on the remaining SMPG values. Subjects continued the pre-trial treatment with metformin at stable dose. | 182 |
| Total | 543 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 6 |
| Overall Study | Protocol Violation | 4 | 2 |
| Overall Study | Unclassified | 6 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | IDegAsp BID | BIAsp 30 BID | Total |
|---|---|---|---|
| Age, Continuous | 59.64 years STANDARD_DEVIATION 9.04 | 58.78 years STANDARD_DEVIATION 9.41 | 59.35 years STANDARD_DEVIATION 9.16 |
| Body weight | 68.50 kg STANDARD_DEVIATION 11.63 | 69.41 kg STANDARD_DEVIATION 12.38 | 68.80 kg STANDARD_DEVIATION 11.88 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 361 Participants | 182 Participants | 543 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fasting plasma glucose (FPG) | 9.07 mmol/L STANDARD_DEVIATION 2.21 | 9.07 mmol/L STANDARD_DEVIATION 2.49 | 9.07 mmol/L STANDARD_DEVIATION 2.31 |
| Glycosylated haemoglobin (HbA1c) | 8.32 percentage of HbA1c STANDARD_DEVIATION 0.76 | 8.33 percentage of HbA1c STANDARD_DEVIATION 0.77 | 8.32 percentage of HbA1c STANDARD_DEVIATION 0.76 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 361 Participants | 182 Participants | 543 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 163 Participants | 83 Participants | 246 Participants |
| Sex: Female, Male Male | 198 Participants | 99 Participants | 297 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 360 | 0 / 181 |
| other Total, other adverse events | 109 / 360 | 65 / 181 |
| serious Total, serious adverse events | 16 / 360 | 14 / 181 |
Outcome results
Primary
Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)
Change from baseline in HbA1c after 26 weeks of treatment. The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate. Missing values imputed using last observed value.
Time frame: At 26 weeks
Population: Full analysis set. Number of subject analysed=subjects with available data for HbA1c
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| IDegAsp BID | Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin) | -1.48 percentage of HbA1c | Standard Error 0.05 |
| BIAsp 30 BID | Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin) | -1.40 percentage of HbA1c | Standard Error 0.06 |
Comparison: Change from baseline in HbA1c after 26 weeks of treatments was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline HbA1c as covariates.p-value: 0.24395% CI: [-0.2, 0.05]ANCOVA
Comparison: Change from baseline in HbA1c after 26 weeks of treatments was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline HbA1c as covariates.p-value: 0.24395% CI: [-0.2, 0.05]ANCOVA
Secondary
2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Time From Randomisation (Measured in Weeks) to Achieve Titration Targets
2-point profiles (SMPG): pre-breakfast and pre-dinner (main evening meal) SMPGs were to be taken for titration/dose adjustments. The pre-specified titration targets were to achieve SMPG level \<5 mmol/L (90 mg/dL) both before breakfast and before main evening meal. For each target, the time from randomisation to the date a subject achieves the titration target for the first time was derived (Kaplan-Meier method). Reported results are time to all titration target (pre-breakfast and pre-dinner) was met for the first time.
Time frame: From randomization till achievement of titration target (up to week 26)
Population: Full analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IDegAsp BID | 2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Time From Randomisation (Measured in Weeks) to Achieve Titration Targets | NA week |
| BIAsp 30 BID | 2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Time From Randomisation (Measured in Weeks) to Achieve Titration Targets | NA week |
Secondary
2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Within-subject Variability as Measured by Coefficient of Variance (CV)% After 26 Weeks of Treatment
The logarithm transformed SMPG values available before breakfast and main evening meal were analysed separately as repeated measures in a linear mixed model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age as covariate and subject as random factor. The model assumed independent within- and between-subject errors with variances depending on treatment. Within-subject variability as measured by CoV% for a treatment could be calculated from the corresponding residual variance.
Time frame: At week 26
Population: Full analysis set. Number of subjects analysed=subjects who contributed to this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDegAsp BID | 2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Within-subject Variability as Measured by Coefficient of Variance (CV)% After 26 Weeks of Treatment | Before breakfast | 17.26 Coefficient of variation |
| IDegAsp BID | 2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Within-subject Variability as Measured by Coefficient of Variance (CV)% After 26 Weeks of Treatment | Before main evening meal | 22.45 Coefficient of variation |
| BIAsp 30 BID | 2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Within-subject Variability as Measured by Coefficient of Variance (CV)% After 26 Weeks of Treatment | Before breakfast | 17.19 Coefficient of variation |
| BIAsp 30 BID | 2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Within-subject Variability as Measured by Coefficient of Variance (CV)% After 26 Weeks of Treatment | Before main evening meal | 22.96 Coefficient of variation |
Secondary
9-point Profile (SMPG) After 26 Weeks of Treatment
SMPG values were recorded at 9 time-points: before and after (90 min after the start of the meal) breakfast, lunch, main evening meal, before bedtime, at 4 am and before breakfast on the next day. Missing values were imputed using last observed value.
Time frame: At week 26
Population: Full analysis set. Number of subjects analysed=subjects with SMPG values available at individual timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDegAsp BID | 9-point Profile (SMPG) After 26 Weeks of Treatment | 90 minutes after start of breakfast | 8.68 mmol/L | Standard Deviation 2.81 |
| IDegAsp BID | 9-point Profile (SMPG) After 26 Weeks of Treatment | 90 minutes after the start of main evening meal | 9.35 mmol/L | Standard Deviation 3.04 |
| IDegAsp BID | 9-point Profile (SMPG) After 26 Weeks of Treatment | 90 minutes after start of lunch | 10.22 mmol/L | Standard Deviation 3.06 |
| IDegAsp BID | 9-point Profile (SMPG) After 26 Weeks of Treatment | Before bedtime | 8.65 mmol/L | Standard Deviation 3 |
| IDegAsp BID | 9-point Profile (SMPG) After 26 Weeks of Treatment | Before lunch | 6.47 mmol/L | Standard Deviation 2.39 |
| IDegAsp BID | 9-point Profile (SMPG) After 26 Weeks of Treatment | At 4:00 a.m. | 6.00 mmol/L | Standard Deviation 1.93 |
| IDegAsp BID | 9-point Profile (SMPG) After 26 Weeks of Treatment | Before main evening meal | 7.09 mmol/L | Standard Deviation 2.35 |
| IDegAsp BID | 9-point Profile (SMPG) After 26 Weeks of Treatment | Before breakfast the following day | 5.69 mmol/L | Standard Deviation 1.49 |
| IDegAsp BID | 9-point Profile (SMPG) After 26 Weeks of Treatment | Before breakfast | 5.81 mmol/L | Standard Deviation 1.29 |
| BIAsp 30 BID | 9-point Profile (SMPG) After 26 Weeks of Treatment | Before breakfast the following day | 6.87 mmol/L | Standard Deviation 1.82 |
| BIAsp 30 BID | 9-point Profile (SMPG) After 26 Weeks of Treatment | Before breakfast | 6.81 mmol/L | Standard Deviation 1.9 |
| BIAsp 30 BID | 9-point Profile (SMPG) After 26 Weeks of Treatment | 90 minutes after start of breakfast | 9.56 mmol/L | Standard Deviation 3.25 |
| BIAsp 30 BID | 9-point Profile (SMPG) After 26 Weeks of Treatment | Before lunch | 6.65 mmol/L | Standard Deviation 2.5 |
| BIAsp 30 BID | 9-point Profile (SMPG) After 26 Weeks of Treatment | 90 minutes after start of lunch | 10.52 mmol/L | Standard Deviation 3.17 |
| BIAsp 30 BID | 9-point Profile (SMPG) After 26 Weeks of Treatment | Before main evening meal | 7.97 mmol/L | Standard Deviation 2.92 |
| BIAsp 30 BID | 9-point Profile (SMPG) After 26 Weeks of Treatment | 90 minutes after the start of main evening meal | 8.96 mmol/L | Standard Deviation 3.26 |
| BIAsp 30 BID | 9-point Profile (SMPG) After 26 Weeks of Treatment | Before bedtime | 8.12 mmol/L | Standard Deviation 2.89 |
| BIAsp 30 BID | 9-point Profile (SMPG) After 26 Weeks of Treatment | At 4:00 a.m. | 6.78 mmol/L | Standard Deviation 1.95 |
Secondary
9-point Profile (SMPG) - Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment
SMPG values were recorded at 9 time-points: before and after (90 min after the start of the meal) breakfast, lunch, main evening meal, before bedtime, at 4 am and before breakfast on the next day. Missing values were imputed using last observed value. Prandial PG increment for each meal was derived from the 9-point profile (SMPG) as the difference between PG values after meal (90 min) and before meal. The reported results are mean prandial PG increment overall meals (the mean of all available meal increments).
Time frame: At week 26
Population: Full analysis set. Number of subjects analysed=subjects with SMPG values available before and after (90 min after the start of the meal) breakfast, lunch, main evening meal.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDegAsp BID | 9-point Profile (SMPG) - Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment | 2.95 mmol/L | Standard Deviation 2.1 |
| BIAsp 30 BID | 9-point Profile (SMPG) - Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment | 2.60 mmol/L | Standard Deviation 2.15 |
Secondary
Change From Baseline in Body Weight
Change from baseline in body week at week 26. The response and change from baseline in response after 26 weeks are analysed using an ANCOVA model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate. Missing values imputed using last observed value.
Time frame: Week 0, Week 26
Population: Full analysis set. Number of subject analysed=subjects with data available for body weight.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| IDegAsp BID | Change From Baseline in Body Weight | 2.82 kg | Standard Error 0.14 |
| BIAsp 30 BID | Change From Baseline in Body Weight | 2.21 kg | Standard Error 0.19 |
Comparison: The response and change from baseline in response after 26 weeks were analysed using an ANCOVA model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate.p-value: 0.009295% CI: [0.15, 1.08]ANCOVA
Secondary
Change From Baseline in FPG (Fasting Plasma Glucose)
Change from baseline in FPG at week 26. The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate. Missing values imputed using last observed value.
Time frame: At 26 weeks
Population: Full analysis set. Number of subject analysed=subjects with available data for FPG.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| IDegAsp BID | Change From Baseline in FPG (Fasting Plasma Glucose) | -2.99 mmol/L | Standard Error 0.09 |
| BIAsp 30 BID | Change From Baseline in FPG (Fasting Plasma Glucose) | -1.57 mmol/L | Standard Error 0.13 |
Comparison: Change from baseline in FPG after 26 weeks of treatment was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline FPG as covariates.p-value: <0.000195% CI: [-1.74, -1.1]ANCOVA
Secondary
Change in Health Related Quality of Life Questionnaire (SF -36)
Change from baseline in SF-36 at week 26. The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score). Missing data was imputed using last observed value.
Time frame: Week 0, week 26
Population: Full analysis set. Number of subjects analysed=subjects with data available for individual component of SF-36 questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDegAsp BID | Change in Health Related Quality of Life Questionnaire (SF -36) | Physical Score | 0.19 units on a scale | Standard Deviation 6.89 |
| IDegAsp BID | Change in Health Related Quality of Life Questionnaire (SF -36) | Physical Functioning | -1.01 units on a scale | Standard Deviation 6.85 |
| IDegAsp BID | Change in Health Related Quality of Life Questionnaire (SF -36) | Role-Physical | 0.41 units on a scale | Standard Deviation 8.88 |
| IDegAsp BID | Change in Health Related Quality of Life Questionnaire (SF -36) | Bodily Pain | 0.93 units on a scale | Standard Deviation 10.1 |
| IDegAsp BID | Change in Health Related Quality of Life Questionnaire (SF -36) | General Health | 3.00 units on a scale | Standard Deviation 10.24 |
| IDegAsp BID | Change in Health Related Quality of Life Questionnaire (SF -36) | Mental Score | 2.08 units on a scale | Standard Deviation 9.65 |
| IDegAsp BID | Change in Health Related Quality of Life Questionnaire (SF -36) | Vitality | 1.56 units on a scale | Standard Deviation 9.57 |
| IDegAsp BID | Change in Health Related Quality of Life Questionnaire (SF -36) | Social Functioning | 1.35 units on a scale | Standard Deviation 8.46 |
| IDegAsp BID | Change in Health Related Quality of Life Questionnaire (SF -36) | Role-Emotional | 1.54 units on a scale | Standard Deviation 10.6 |
| IDegAsp BID | Change in Health Related Quality of Life Questionnaire (SF -36) | Mental Health | 1.39 units on a scale | Standard Deviation 9.53 |
| BIAsp 30 BID | Change in Health Related Quality of Life Questionnaire (SF -36) | Social Functioning | -0.12 units on a scale | Standard Deviation 9.98 |
| BIAsp 30 BID | Change in Health Related Quality of Life Questionnaire (SF -36) | Physical Score | -0.13 units on a scale | Standard Deviation 6.61 |
| BIAsp 30 BID | Change in Health Related Quality of Life Questionnaire (SF -36) | Mental Score | 0.72 units on a scale | Standard Deviation 10.11 |
| BIAsp 30 BID | Change in Health Related Quality of Life Questionnaire (SF -36) | Physical Functioning | -0.50 units on a scale | Standard Deviation 6.58 |
| BIAsp 30 BID | Change in Health Related Quality of Life Questionnaire (SF -36) | Mental Health | -0.17 units on a scale | Standard Deviation 9.81 |
| BIAsp 30 BID | Change in Health Related Quality of Life Questionnaire (SF -36) | Role-Physical | -0.18 units on a scale | Standard Deviation 8.92 |
| BIAsp 30 BID | Change in Health Related Quality of Life Questionnaire (SF -36) | Vitality | 0.69 units on a scale | Standard Deviation 9.33 |
| BIAsp 30 BID | Change in Health Related Quality of Life Questionnaire (SF -36) | Bodily Pain | -0.71 units on a scale | Standard Deviation 10.38 |
| BIAsp 30 BID | Change in Health Related Quality of Life Questionnaire (SF -36) | Role-Emotional | 1.01 units on a scale | Standard Deviation 11.14 |
| BIAsp 30 BID | Change in Health Related Quality of Life Questionnaire (SF -36) | General Health | 2.19 units on a scale | Standard Deviation 9.45 |
Secondary
Change in Treatment Satisfaction Questionnaire (Treatment Related Impact Measure-diabetes [TRIM-D])
Change from baseline in TRIM-D scores at week 26. TRIM-D score measured treatment satisfaction which included an overall score as well the subscale scores (daily life, diabetes management, compliance and psychological health). The scores were transformed to a 0-100 scale with higher scores indicating less treatment related impact. Missing data was imputed using last observed value.
Time frame: Week 0, week 26
Population: Full analysis set. Number of subjects analysed=subjects with data available for TRIM-D total score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDegAsp BID | Change in Treatment Satisfaction Questionnaire (Treatment Related Impact Measure-diabetes [TRIM-D]) | 4.87 units on a scale | Standard Deviation 11.15 |
| BIAsp 30 BID | Change in Treatment Satisfaction Questionnaire (Treatment Related Impact Measure-diabetes [TRIM-D]) | 4.11 units on a scale | Standard Deviation 10.49 |
Secondary
Device Specific Questionnaires I (Did You Have Any Problems Using the Pen?)
Participants were asked to report whether they had any problems using the pen. Number of participants reporting yes and no are presented. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires I (Did You Have Any Problems Using the Pen?) | Yes | 12 Participants |
| IDegAsp BID | Device Specific Questionnaires I (Did You Have Any Problems Using the Pen?) | No | 346 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (Did You Have Any Problems Using the Pen?) | Yes | 8 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (Did You Have Any Problems Using the Pen?) | No | 169 Participants |
Secondary
Device Specific Questionnaires I (How Comfortable do You Find the Handling of the Pen?)
Device Specific Questionnaires I (How comfortable do you find the handling of the pen?) was measured on following categories: Very comfortable, Fairly comfortable, Rather comfortable, Not very comfortable and Not at all comfortable. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires I (How Comfortable do You Find the Handling of the Pen?) | Very comfortable | 146 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Comfortable do You Find the Handling of the Pen?) | Fairly comfortable | 107 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Comfortable do You Find the Handling of the Pen?) | Rather comfortable | 104 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Comfortable do You Find the Handling of the Pen?) | Not very comfortable | 1 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Comfortable do You Find the Handling of the Pen?) | Not very comfortable | 0 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Comfortable do You Find the Handling of the Pen?) | Very comfortable | 66 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Comfortable do You Find the Handling of the Pen?) | Rather comfortable | 44 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Comfortable do You Find the Handling of the Pen?) | Fairly comfortable | 68 Participants |
Secondary
Device Specific Questionnaires I (How Confident Are You That the Air Shot Has Been Done Correctly?)
Device Specific Questionnaires I (How confident are you that the air shot has been done correctly?) was measured on following categories: Very confident, Fairly confident, Rather confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires I (How Confident Are You That the Air Shot Has Been Done Correctly?) | Very confident | 157 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Confident Are You That the Air Shot Has Been Done Correctly?) | Fairly confident | 85 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Confident Are You That the Air Shot Has Been Done Correctly?) | Rather confident | 109 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Confident Are You That the Air Shot Has Been Done Correctly?) | Not very confident | 7 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Confident Are You That the Air Shot Has Been Done Correctly?) | Not very confident | 3 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Confident Are You That the Air Shot Has Been Done Correctly?) | Very confident | 73 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Confident Are You That the Air Shot Has Been Done Correctly?) | Rather confident | 47 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Confident Are You That the Air Shot Has Been Done Correctly?) | Fairly confident | 55 Participants |
Secondary
Device Specific Questionnaires I (How Confident Are You That You Inject the Correct Amount of Insulin Every Time?)
Device Specific Questionnaires I (How confident are you that you inject the correct amount of insulin every time?) was measured on following categories: Very confident, Rather confident, Fairly confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires I (How Confident Are You That You Inject the Correct Amount of Insulin Every Time?) | Very confident | 202 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Confident Are You That You Inject the Correct Amount of Insulin Every Time?) | Fairly confident | 52 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Confident Are You That You Inject the Correct Amount of Insulin Every Time?) | Rather confident | 104 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Confident Are You That You Inject the Correct Amount of Insulin Every Time?) | Very confident | 83 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Confident Are You That You Inject the Correct Amount of Insulin Every Time?) | Fairly confident | 28 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Confident Are You That You Inject the Correct Amount of Insulin Every Time?) | Rather confident | 67 Participants |
Secondary
Device Specific Questionnaires I (How Confident Are You That You Set the Insulin Dose Correctly Every Time?)
Device Specific Questionnaires I (How confident are you that you set the insulin dose correctly every time?) was measured on following categories: Very confident, Rather confident, Fairly confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires I (How Confident Are You That You Set the Insulin Dose Correctly Every Time?) | Very confident | 209 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Confident Are You That You Set the Insulin Dose Correctly Every Time?) | Fairly confident | 43 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Confident Are You That You Set the Insulin Dose Correctly Every Time?) | Rather confident | 106 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Confident Are You That You Set the Insulin Dose Correctly Every Time?) | Not very confident | 0 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Confident Are You That You Set the Insulin Dose Correctly Every Time?) | Not very confident | 2 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Confident Are You That You Set the Insulin Dose Correctly Every Time?) | Very confident | 85 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Confident Are You That You Set the Insulin Dose Correctly Every Time?) | Rather confident | 65 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Confident Are You That You Set the Insulin Dose Correctly Every Time?) | Fairly confident | 26 Participants |
Secondary
Device Specific Questionnaires I (How Convenient do You Find the Size of the Pen?)
Device Specific Questionnaires I (How convenient do you find the size of the pen?) was measured on following categories: Very convenient, Fairly convenient, Rather convenient, Not very convenient and Not at all convenient. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires I (How Convenient do You Find the Size of the Pen?) | Very convenient | 143 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Convenient do You Find the Size of the Pen?) | Fairly convenient | 109 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Convenient do You Find the Size of the Pen?) | Rather convenient | 101 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Convenient do You Find the Size of the Pen?) | Not very convenient | 5 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Convenient do You Find the Size of the Pen?) | Not very convenient | 4 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Convenient do You Find the Size of the Pen?) | Very convenient | 63 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Convenient do You Find the Size of the Pen?) | Rather convenient | 42 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Convenient do You Find the Size of the Pen?) | Fairly convenient | 69 Participants |
Secondary
Device Specific Questionnaires I (How Easy/Difficult is it to Know if the Push Button Has Been Pushed Completely Down?)
Device Specific Questionnaires I (How easy/difficult is it to know if the push button has been pushed completely down?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult or Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires I (How Easy/Difficult is it to Know if the Push Button Has Been Pushed Completely Down?) | Very easy | 213 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy/Difficult is it to Know if the Push Button Has Been Pushed Completely Down?) | Fairly easy | 134 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy/Difficult is it to Know if the Push Button Has Been Pushed Completely Down?) | Neither easy nor difficult | 11 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy/Difficult is it to Know if the Push Button Has Been Pushed Completely Down?) | Very easy | 92 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy/Difficult is it to Know if the Push Button Has Been Pushed Completely Down?) | Fairly easy | 77 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy/Difficult is it to Know if the Push Button Has Been Pushed Completely Down?) | Neither easy nor difficult | 9 Participants |
Secondary
Device Specific Questionnaires I (How Easy/Difficult is it to Turn the Dose Selector When Choosing the Right Dose?)
Device Specific Questionnaires I (How easy/difficult is it to turn the dose selector when choosing the right dose?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires I (How Easy/Difficult is it to Turn the Dose Selector When Choosing the Right Dose?) | Very easy | 222 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy/Difficult is it to Turn the Dose Selector When Choosing the Right Dose?) | Fairly easy | 128 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy/Difficult is it to Turn the Dose Selector When Choosing the Right Dose?) | Neither easy nor difficult | 7 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy/Difficult is it to Turn the Dose Selector When Choosing the Right Dose?) | Rather difficult | 1 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy/Difficult is it to Turn the Dose Selector When Choosing the Right Dose?) | Rather difficult | 0 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy/Difficult is it to Turn the Dose Selector When Choosing the Right Dose?) | Very easy | 99 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy/Difficult is it to Turn the Dose Selector When Choosing the Right Dose?) | Neither easy nor difficult | 6 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy/Difficult is it to Turn the Dose Selector When Choosing the Right Dose?) | Fairly easy | 72 Participants |
Secondary
Device Specific Questionnaires I (How Easy or Difficult do You Find it to Hold the Pen Stable When Injecting?)
Device Specific Questionnaires I (How easy or difficult do you find it to hold the pen stable when injecting?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult do You Find it to Hold the Pen Stable When Injecting?) | Very easy | 228 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult do You Find it to Hold the Pen Stable When Injecting?) | Fairly easy | 121 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult do You Find it to Hold the Pen Stable When Injecting?) | Neither easy nor difficult | 8 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult do You Find it to Hold the Pen Stable When Injecting?) | Very difficult | 1 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult do You Find it to Hold the Pen Stable When Injecting?) | Very difficult | 0 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult do You Find it to Hold the Pen Stable When Injecting?) | Very easy | 99 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult do You Find it to Hold the Pen Stable When Injecting?) | Neither easy nor difficult | 7 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult do You Find it to Hold the Pen Stable When Injecting?) | Fairly easy | 72 Participants |
Secondary
Device Specific Questionnaires I (How Easy or Difficult is it to Feel the Clicks for Each Unit Increment?)
Device Specific Questionnaires I (How easy or difficult is it to feel the clicks for each unit increment?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to Feel the Clicks for Each Unit Increment?) | Very easy | 217 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to Feel the Clicks for Each Unit Increment?) | Fairly easy | 128 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to Feel the Clicks for Each Unit Increment?) | Neither easy nor difficult | 12 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to Feel the Clicks for Each Unit Increment?) | Rather difficult | 1 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to Feel the Clicks for Each Unit Increment?) | Rather difficult | 1 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to Feel the Clicks for Each Unit Increment?) | Very easy | 103 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to Feel the Clicks for Each Unit Increment?) | Neither easy nor difficult | 9 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to Feel the Clicks for Each Unit Increment?) | Fairly easy | 65 Participants |
Secondary
Device Specific Questionnaires I (How Easy or Difficult is it to Hear the Clicks for Each Unit Increment?)
Device Specific Questionnaires I (How easy or difficult is it to hear the clicks for each unit increment?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to Hear the Clicks for Each Unit Increment?) | Very easy | 230 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to Hear the Clicks for Each Unit Increment?) | Fairly easy | 119 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to Hear the Clicks for Each Unit Increment?) | Neither easy nor difficult | 9 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to Hear the Clicks for Each Unit Increment?) | Rather difficult | 0 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to Hear the Clicks for Each Unit Increment?) | Rather difficult | 1 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to Hear the Clicks for Each Unit Increment?) | Very easy | 108 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to Hear the Clicks for Each Unit Increment?) | Neither easy nor difficult | 6 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to Hear the Clicks for Each Unit Increment?) | Fairly easy | 63 Participants |
Secondary
Device Specific Questionnaires I (How Easy or Difficult is it to Push Down the Injection Button?)
Device Specific Questionnaires I (How easy or difficult is it to push down the injection button?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to Push Down the Injection Button?) | Very easy | 224 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to Push Down the Injection Button?) | Fairly easy | 125 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to Push Down the Injection Button?) | Neither easy nor difficult | 9 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to Push Down the Injection Button?) | Rather difficult | 0 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to Push Down the Injection Button?) | Rather difficult | 0 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to Push Down the Injection Button?) | Very easy | 89 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to Push Down the Injection Button?) | Neither easy nor difficult | 14 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to Push Down the Injection Button?) | Fairly easy | 75 Participants |
Secondary
Device Specific Questionnaires I (How Easy or Difficult is it to Read the Dose Scale)
Device Specific Questionnaires I (How easy or difficult is it to read the dose scale) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to Read the Dose Scale) | Very easy | 220 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to Read the Dose Scale) | Fairly easy | 128 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to Read the Dose Scale) | Neither easy nor difficult | 10 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to Read the Dose Scale) | Rather difficult | 0 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to Read the Dose Scale) | Rather difficult | 0 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to Read the Dose Scale) | Very easy | 104 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to Read the Dose Scale) | Neither easy nor difficult | 5 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to Read the Dose Scale) | Fairly easy | 69 Participants |
Secondary
Device Specific Questionnaires I (How Easy or Difficult is it to See the Dose Scale When Injecting?)
Device Specific Questionnaires I (How easy or difficult is it to see the dose scale when injecting?) was measured on following categories: Very confident, Very easy, Fairly easy, Neither easy nor difficult, Rather difficult, and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to See the Dose Scale When Injecting?) | Very easy | 215 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to See the Dose Scale When Injecting?) | Neither easy nor difficult | 14 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to See the Dose Scale When Injecting?) | Fairly easy | 126 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to See the Dose Scale When Injecting?) | Rather difficult | 2 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Easy or Difficult is it to See the Dose Scale When Injecting?) | Very confident | 1 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to See the Dose Scale When Injecting?) | Rather difficult | 2 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to See the Dose Scale When Injecting?) | Very confident | 0 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to See the Dose Scale When Injecting?) | Very easy | 94 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to See the Dose Scale When Injecting?) | Fairly easy | 78 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Easy or Difficult is it to See the Dose Scale When Injecting?) | Neither easy nor difficult | 4 Participants |
Secondary
Device Specific Questionnaires I (How Suitable is the Pen to Use in Public?)
Device Specific Questionnaires I (How suitable is the pen to use in public?) was measured on following scale: Very suitable, Fairly suitable, Rather suitable, Not very suitable and Not at all suitable. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires I (How Suitable is the Pen to Use in Public?) | Fairly suitable | 117 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Suitable is the Pen to Use in Public?) | Rather suitable | 94 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Suitable is the Pen to Use in Public?) | Rather confident | 0 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Suitable is the Pen to Use in Public?) | Not very suitable | 18 Participants |
| IDegAsp BID | Device Specific Questionnaires I (How Suitable is the Pen to Use in Public?) | Very suitable | 129 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Suitable is the Pen to Use in Public?) | Not very suitable | 18 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Suitable is the Pen to Use in Public?) | Very suitable | 60 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Suitable is the Pen to Use in Public?) | Fairly suitable | 64 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Suitable is the Pen to Use in Public?) | Rather confident | 1 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (How Suitable is the Pen to Use in Public?) | Rather suitable | 35 Participants |
Secondary
Device Specific Questionnaires II (How Confident Are You That the Full Dose Has Been Delivered?)
Device Specific Questionnaires II (How confident are you that the full dose has been delivered?) was measured on following categories: Very confident, Fairly confident, Fairly easy, Rather confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires II (How Confident Are You That the Full Dose Has Been Delivered?) | Not at all confident | 1 Participants |
| IDegAsp BID | Device Specific Questionnaires II (How Confident Are You That the Full Dose Has Been Delivered?) | Very confident | 184 Participants |
| IDegAsp BID | Device Specific Questionnaires II (How Confident Are You That the Full Dose Has Been Delivered?) | Fairly confident | 54 Participants |
| IDegAsp BID | Device Specific Questionnaires II (How Confident Are You That the Full Dose Has Been Delivered?) | Fairly easy | 0 Participants |
| IDegAsp BID | Device Specific Questionnaires II (How Confident Are You That the Full Dose Has Been Delivered?) | Rather confident | 117 Participants |
| IDegAsp BID | Device Specific Questionnaires II (How Confident Are You That the Full Dose Has Been Delivered?) | Not very confident | 2 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Confident Are You That the Full Dose Has Been Delivered?) | Rather confident | 56 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Confident Are You That the Full Dose Has Been Delivered?) | Not at all confident | 0 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Confident Are You That the Full Dose Has Been Delivered?) | Fairly easy | 1 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Confident Are You That the Full Dose Has Been Delivered?) | Very confident | 79 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Confident Are You That the Full Dose Has Been Delivered?) | Not very confident | 0 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Confident Are You That the Full Dose Has Been Delivered?) | Fairly confident | 42 Participants |
Secondary
Device Specific Questionnaires II (How Easy/Difficult is it to Reach the Dose Button When Inject Your Insulin Dose?)
Device Specific Questionnaires II (How easy/difficult is it to reach the dose button when inject your insulin dose?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires II (How Easy/Difficult is it to Reach the Dose Button When Inject Your Insulin Dose?) | Very easy | 193 Participants |
| IDegAsp BID | Device Specific Questionnaires II (How Easy/Difficult is it to Reach the Dose Button When Inject Your Insulin Dose?) | Fairly easy | 153 Participants |
| IDegAsp BID | Device Specific Questionnaires II (How Easy/Difficult is it to Reach the Dose Button When Inject Your Insulin Dose?) | Neither easy nor difficult | 11 Participants |
| IDegAsp BID | Device Specific Questionnaires II (How Easy/Difficult is it to Reach the Dose Button When Inject Your Insulin Dose?) | Rather difficult | 1 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Easy/Difficult is it to Reach the Dose Button When Inject Your Insulin Dose?) | Rather difficult | 0 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Easy/Difficult is it to Reach the Dose Button When Inject Your Insulin Dose?) | Very easy | 90 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Easy/Difficult is it to Reach the Dose Button When Inject Your Insulin Dose?) | Neither easy nor difficult | 6 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Easy/Difficult is it to Reach the Dose Button When Inject Your Insulin Dose?) | Fairly easy | 82 Participants |
Secondary
Device Specific Questionnaires II (How Easy or Difficult is it to Distinguish Between Dialling up and Down?)
Device Specific Questionnaires II (How easy or difficult is it to distinguish between dialling up and down?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires II (How Easy or Difficult is it to Distinguish Between Dialling up and Down?) | Very easy | 203 Participants |
| IDegAsp BID | Device Specific Questionnaires II (How Easy or Difficult is it to Distinguish Between Dialling up and Down?) | Fairly easy | 144 Participants |
| IDegAsp BID | Device Specific Questionnaires II (How Easy or Difficult is it to Distinguish Between Dialling up and Down?) | Neither easy nor difficult | 10 Participants |
| IDegAsp BID | Device Specific Questionnaires II (How Easy or Difficult is it to Distinguish Between Dialling up and Down?) | Rather difficult | 1 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Easy or Difficult is it to Distinguish Between Dialling up and Down?) | Rather difficult | 0 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Easy or Difficult is it to Distinguish Between Dialling up and Down?) | Very easy | 91 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Easy or Difficult is it to Distinguish Between Dialling up and Down?) | Neither easy nor difficult | 6 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Easy or Difficult is it to Distinguish Between Dialling up and Down?) | Fairly easy | 81 Participants |
Secondary
Device Specific Questionnaires II (How Easy or Difficult is it to Inject Yourself in Different Places of the Body Using This Pen?)
Device Specific Questionnaires II (How easy or difficult is it to inject yourself in different places of the body using this pen?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult, Very difficult and Not applicable. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires II (How Easy or Difficult is it to Inject Yourself in Different Places of the Body Using This Pen?) | Fairly easy | 169 Participants |
| IDegAsp BID | Device Specific Questionnaires II (How Easy or Difficult is it to Inject Yourself in Different Places of the Body Using This Pen?) | Rather difficult | 1 Participants |
| IDegAsp BID | Device Specific Questionnaires II (How Easy or Difficult is it to Inject Yourself in Different Places of the Body Using This Pen?) | Neither easy nor difficult | 20 Participants |
| IDegAsp BID | Device Specific Questionnaires II (How Easy or Difficult is it to Inject Yourself in Different Places of the Body Using This Pen?) | Very difficult | 1 Participants |
| IDegAsp BID | Device Specific Questionnaires II (How Easy or Difficult is it to Inject Yourself in Different Places of the Body Using This Pen?) | Very easy | 167 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Easy or Difficult is it to Inject Yourself in Different Places of the Body Using This Pen?) | Very difficult | 0 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Easy or Difficult is it to Inject Yourself in Different Places of the Body Using This Pen?) | Very easy | 77 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Easy or Difficult is it to Inject Yourself in Different Places of the Body Using This Pen?) | Fairly easy | 85 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Easy or Difficult is it to Inject Yourself in Different Places of the Body Using This Pen?) | Neither easy nor difficult | 16 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Easy or Difficult is it to Inject Yourself in Different Places of the Body Using This Pen?) | Rather difficult | 0 Participants |
Secondary
Device Specific Questionnaires II (How Easy or Difficult is it to Inject Your Usual Insulin Dose?)
Device Specific Questionnaires II (How easy or difficult is it to inject your usual insulin dose?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires II (How Easy or Difficult is it to Inject Your Usual Insulin Dose?) | Very easy | 193 Participants |
| IDegAsp BID | Device Specific Questionnaires II (How Easy or Difficult is it to Inject Your Usual Insulin Dose?) | Fairly easy | 154 Participants |
| IDegAsp BID | Device Specific Questionnaires II (How Easy or Difficult is it to Inject Your Usual Insulin Dose?) | Neither easy nor difficult | 11 Participants |
| IDegAsp BID | Device Specific Questionnaires II (How Easy or Difficult is it to Inject Your Usual Insulin Dose?) | Rather difficult | 0 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Easy or Difficult is it to Inject Your Usual Insulin Dose?) | Rather difficult | 1 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Easy or Difficult is it to Inject Your Usual Insulin Dose?) | Very easy | 93 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Easy or Difficult is it to Inject Your Usual Insulin Dose?) | Neither easy nor difficult | 3 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Easy or Difficult is it to Inject Your Usual Insulin Dose?) | Fairly easy | 81 Participants |
Secondary
Device Specific Questionnaires II (How Easy or Difficult Was it to Learn How to Use This Pen?)
Device Specific Questionnaires II (How easy or difficult was it to learn how to use this pen?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires II (How Easy or Difficult Was it to Learn How to Use This Pen?) | Very easy | 206 Participants |
| IDegAsp BID | Device Specific Questionnaires II (How Easy or Difficult Was it to Learn How to Use This Pen?) | Fairly easy | 145 Participants |
| IDegAsp BID | Device Specific Questionnaires II (How Easy or Difficult Was it to Learn How to Use This Pen?) | Neither easy nor difficult | 7 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Easy or Difficult Was it to Learn How to Use This Pen?) | Very easy | 92 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Easy or Difficult Was it to Learn How to Use This Pen?) | Fairly easy | 79 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (How Easy or Difficult Was it to Learn How to Use This Pen?) | Neither easy nor difficult | 7 Participants |
Secondary
Device Specific Questionnaires II (Would You Recommend the Pen?)
Participants were asked the question would you recommend the pen? Number of participants reporting yes and no are presented. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires II (Would You Recommend the Pen?) | Yes | 338 Participants |
| IDegAsp BID | Device Specific Questionnaires II (Would You Recommend the Pen?) | No | 19 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (Would You Recommend the Pen?) | Yes | 161 Participants |
| BIAsp 30 BID | Device Specific Questionnaires II (Would You Recommend the Pen?) | No | 17 Participants |
Secondary
Device Specific Questionnaires I (Overall, How Confident Are You in Controlling Your Blood Sugar Level Using This Pen?)
Device Specific Questionnaires I (Overall, how confident are you in controlling your blood sugar level using this pen?) was measured on following categories: Very confident, Fairly confident, Rather confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires I (Overall, How Confident Are You in Controlling Your Blood Sugar Level Using This Pen?) | Very confident | 180 Participants |
| IDegAsp BID | Device Specific Questionnaires I (Overall, How Confident Are You in Controlling Your Blood Sugar Level Using This Pen?) | Fairly confident | 85 Participants |
| IDegAsp BID | Device Specific Questionnaires I (Overall, How Confident Are You in Controlling Your Blood Sugar Level Using This Pen?) | Rather confident | 92 Participants |
| IDegAsp BID | Device Specific Questionnaires I (Overall, How Confident Are You in Controlling Your Blood Sugar Level Using This Pen?) | Not very confident | 1 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (Overall, How Confident Are You in Controlling Your Blood Sugar Level Using This Pen?) | Not very confident | 3 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (Overall, How Confident Are You in Controlling Your Blood Sugar Level Using This Pen?) | Very confident | 71 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (Overall, How Confident Are You in Controlling Your Blood Sugar Level Using This Pen?) | Rather confident | 42 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (Overall, How Confident Are You in Controlling Your Blood Sugar Level Using This Pen?) | Fairly confident | 60 Participants |
Secondary
Device Specific Questionnaires I (Overall, How Confident Are You in Your Management of Your Daily Insulin Injections Using This Pen?)
Device Specific Questionnaires I (Overall, how confident are you in your management of your daily insulin injections using this pen?) was measured on following categories: Very confident, Fairly confident, Rather confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.
Time frame: week 26
Population: Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Device Specific Questionnaires I (Overall, How Confident Are You in Your Management of Your Daily Insulin Injections Using This Pen?) | Very confident | 197 Participants |
| IDegAsp BID | Device Specific Questionnaires I (Overall, How Confident Are You in Your Management of Your Daily Insulin Injections Using This Pen?) | Fairly confident | 59 Participants |
| IDegAsp BID | Device Specific Questionnaires I (Overall, How Confident Are You in Your Management of Your Daily Insulin Injections Using This Pen?) | Rather confident | 102 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (Overall, How Confident Are You in Your Management of Your Daily Insulin Injections Using This Pen?) | Very confident | 82 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (Overall, How Confident Are You in Your Management of Your Daily Insulin Injections Using This Pen?) | Fairly confident | 39 Participants |
| BIAsp 30 BID | Device Specific Questionnaires I (Overall, How Confident Are You in Your Management of Your Daily Insulin Injections Using This Pen?) | Rather confident | 57 Participants |
Secondary
Fluctuation in the 9-point Profile (SMPG) After 26 Weeks of Treatment
SMPG values were recorded at 9 time-points: before and after (90 min after the start of the meal) breakfast, lunch, main evening meal, before bedtime, at 4 am and before breakfast on the next day. Missing values were imputed using last observed value. Fluctuation in 9-point SMPG profile is the average absolute difference to the mean of the profile of the 9-point SMPG measurements accumulated over the profile.
Time frame: At week 26
Population: Full analysis set. Number of subjects analysed=subjects with available data for SMPG.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IDegAsp BID | Fluctuation in the 9-point Profile (SMPG) After 26 Weeks of Treatment | 1.40 mmol/L |
| BIAsp 30 BID | Fluctuation in the 9-point Profile (SMPG) After 26 Weeks of Treatment | 1.43 mmol/L |
Secondary
Incidence of Treatment Emergent Adverse Events (TEAEs)
A treatment emergent adverse event was defined as an episode that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Incidence of AEs was reported in terms of rate, defined as number of adverse events divided by patient years of exposure (PYE) multiplied by 100 (1 PYE=365.25 days).
Time frame: Weeks 0-26
Population: Safety analysis set included all subjects receiving at least one dose of IDegAsp or BIAsp.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDegAsp BID | Incidence of Treatment Emergent Adverse Events (TEAEs) | 321.74 events per 100 PYE |
| BIAsp 30 BID | Incidence of Treatment Emergent Adverse Events (TEAEs) | 348.82 events per 100 PYE |
Secondary
Mean of the 9-point Profile (SMPG) After 26 Weeks of Treatment
SMPG values were recorded at 9 time-points: before and after (90 min after the start of the meal) breakfast, lunch, main evening meal, before bedtime, at 4 am and before breakfast on the next day. Missing values were imputed using last observed value. The mean of 9-point profile (SMPG) was defined as the area under the profile divided by the measurement time and was calculated using the trapezoidal method.
Time frame: At week 26
Population: Full analysis set. Number of subjects analysed=subjects with available data for SMPG.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDegAsp BID | Mean of the 9-point Profile (SMPG) After 26 Weeks of Treatment | 7.70 mmol/L | Standard Deviation 1.6 |
| BIAsp 30 BID | Mean of the 9-point Profile (SMPG) After 26 Weeks of Treatment | 8.11 mmol/L | Standard Deviation 1.71 |
Secondary
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
The number of events was analysed using a negative binomial model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate. Confirmed hypoglycaemia was defined as either severe episodes or episodes with plasma glucose \< 3.1 mmol/L (56 mg/dL) with or without symptoms. A treatment emergent hypoglycaemic episode was defined as an episode that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.
Time frame: Weeks 0-26
Population: Full analysis set. Number of subjects analysed=subjects with data available for confirmed hypoglycaemic episodes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDegAsp BID | Number of Treatment Emergent Confirmed Hypoglycaemic Episodes | 223.56 events per 100 patient years of exposure |
| BIAsp 30 BID | Number of Treatment Emergent Confirmed Hypoglycaemic Episodes | 394.17 events per 100 patient years of exposure |
Comparison: The number of events was analysed using a Negative Binomial Model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariatep-value: 0.000295% CI: [0.42, 0.77]Negative binomial regression model
Secondary
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period
Confirmed hypoglycaemia was defined as either severe episodes or episodes with plasma glucose \< 3.1 mmol/L (56 mg/dL) with or without symptoms. Severe: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Maintenance period was defined as the period from week 16 to end of treatment, including 1 week follow-up. Number of treatment emergent hypoglycaemic episodes were reported in terms of rate, defined as number of events divided by PYE multiplied by 100 (1 PYE=365.25 days).
Time frame: From week 16 to end of treatment (week 26) + 1 week follow-up
Population: Safety analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDegAsp BID | Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period | 159.08 hypoglycaemic episodes per 100 PYE |
| BIAsp 30 BID | Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period | 361.18 hypoglycaemic episodes per 100 PYE |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition During 26 Weeks of Treatment
ADA classification of hypoglycaemia: 1. Severe: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. 2. Asymptomatic: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG level ≤3.9 mmol/L. 3. Documented symptomatic: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG level ≤3.9 mmol/L. 4. Relative: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia, and interprets those as indicative of hypoglycaemia, but with a measured PG level \>3.9 mmol/L. 5. Probable symptomatic: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG level ≤3.9 mmol/L. Number of treatment emergent hypoglycaemic episodes were reported in terms of rate, defined as number of events divided by PYE multiplied by 100 (1 PYE=365.25 days).
Time frame: Week 0-26
Population: Safety analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDegAsp BID | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition During 26 Weeks of Treatment | 1699.53 hypoglycaemic episodes per 100 PYE |
| BIAsp 30 BID | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition During 26 Weeks of Treatment | 1585.31 hypoglycaemic episodes per 100 PYE |
Secondary
Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes in the Maintenance Period
Confirmed hypoglycaemia was defined as either severe episodes or episodes with plasma glucose \< 3.1 mmol/L (56 mg/dL) with or without symptoms. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. The nocturnal period was defined as the period between 00:01 and 05:59 a.m. (both inclusive). Maintenance period was defined as the period from week 16 to end of treatment, including 1 week follow-up. Number of treatment emergent hypoglycaemic episodes were reported in terms of rate, defined as number of events divided by PYE multiplied by 100 (1 PYE=365.25 days).
Time frame: From week 16 to end of treatment (week 26) + 1 week follow-up
Population: Safety analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDegAsp BID | Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes in the Maintenance Period | 19.20 hypoglycaemic episodes per 100 PYE |
| BIAsp 30 BID | Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes in the Maintenance Period | 38.60 hypoglycaemic episodes per 100 PYE |
Secondary
Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes
The number of events was analysed using a negative binomial model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate. Confirmed hypoglycaemia is defined as either severe episodes or episodes with plasma glucose \< 3.1 mmol/L (56 mg/dL) with or without symptoms. The nocturnal period was defined as the period between 00:01 and 05:59 a.m. (both inclusive). A treatment emergent hypoglycaemic episode was defined as an episode that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.
Time frame: Weeks 0-26
Population: Full analysis set. Number of subjects analysed=subjects with data available for nocturnal confirmed hypoglycaemic episodes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDegAsp BID | Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes | 31.18 events per 100 patient years of exposure |
| BIAsp 30 BID | Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes | 58.55 events per 100 patient years of exposure |
Comparison: The number of events was analysed using a Negative Binomial Model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate.p-value: 0.011295% CI: [0.33, 0.87]Negative binomial regression model
Secondary
Responder for HbA1c (HbA1c <=6.5%) After 26 Weeks of Treatment
Number of subjects with HbA1c \<=6.5% after 26 weeks of treatment. Missing HbA1c data was imputed using last observed value.
Time frame: Week 26
Population: Full analysis set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Responder for HbA1c (HbA1c <=6.5%) After 26 Weeks of Treatment | Yes | 106 Participants |
| IDegAsp BID | Responder for HbA1c (HbA1c <=6.5%) After 26 Weeks of Treatment | No | 255 Participants |
| BIAsp 30 BID | Responder for HbA1c (HbA1c <=6.5%) After 26 Weeks of Treatment | Yes | 54 Participants |
| BIAsp 30 BID | Responder for HbA1c (HbA1c <=6.5%) After 26 Weeks of Treatment | No | 128 Participants |
Secondary
Responder for HbA1c (HbA1c ≤6.5%) Without Confirmed Hypoglycaemic Episodes
A responder for HbA1c without confirmed hypoglycaemia was defined as a subject who meets the HbA1c target (≤6.5%) at end of trial without treatment emergent confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days after the last randomised treatment. Confirmed hypoglycaemia was defined as either severe episodes or episodes with plasma glucose \< 3.1 mmol/L (56 mg/dL) with or without symptoms. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Missing data is imputed using last observed value.
Time frame: At 26 weeks
Population: Full analysis set. Number of subjects analysed=subjects who have been exposed for at least 12 treatment weeks.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Responder for HbA1c (HbA1c ≤6.5%) Without Confirmed Hypoglycaemic Episodes | Yes | 82 Participants |
| IDegAsp BID | Responder for HbA1c (HbA1c ≤6.5%) Without Confirmed Hypoglycaemic Episodes | No | 266 Participants |
| BIAsp 30 BID | Responder for HbA1c (HbA1c ≤6.5%) Without Confirmed Hypoglycaemic Episodes | Yes | 26 Participants |
| BIAsp 30 BID | Responder for HbA1c (HbA1c ≤6.5%) Without Confirmed Hypoglycaemic Episodes | No | 147 Participants |
Secondary
Responder for HbA1c (HbA1c ≤6.5%) Without Severe Hypoglycaemic Episodes
A responder for HbA1c without severe hypoglycaemia was defined as a subject who meets the HbA1c target (≤6.5%) at end of trial without severe treatment emergent hypoglycaemia during the last 12 weeks of treatment or within 7 days after the last randomised treatment. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Missing HbA1c data was imputed using last observed value.
Time frame: At week 26
Population: Full analysis set. Number of subjects analysed=subjects who have been exposed for at least 12 treatment weeks.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Responder for HbA1c (HbA1c ≤6.5%) Without Severe Hypoglycaemic Episodes | Yes | 105 Participants |
| IDegAsp BID | Responder for HbA1c (HbA1c ≤6.5%) Without Severe Hypoglycaemic Episodes | No | 243 Participants |
| BIAsp 30 BID | Responder for HbA1c (HbA1c ≤6.5%) Without Severe Hypoglycaemic Episodes | Yes | 50 Participants |
| BIAsp 30 BID | Responder for HbA1c (HbA1c ≤6.5%) Without Severe Hypoglycaemic Episodes | No | 123 Participants |
Secondary
Responder for HbA1c (HbA1c <7%) After 26 Weeks of Treatment
Number of subjects with HbA1c \<7% after 26 weeks of treatment. Missing HbA1c data was imputed using last observed value.
Time frame: Week 26
Population: Full analysis set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Responder for HbA1c (HbA1c <7%) After 26 Weeks of Treatment | Yes | 201 Participants |
| IDegAsp BID | Responder for HbA1c (HbA1c <7%) After 26 Weeks of Treatment | No | 160 Participants |
| BIAsp 30 BID | Responder for HbA1c (HbA1c <7%) After 26 Weeks of Treatment | Yes | 88 Participants |
| BIAsp 30 BID | Responder for HbA1c (HbA1c <7%) After 26 Weeks of Treatment | No | 94 Participants |
Secondary
Responder for HbA1c (HbA1c <7%) Without Severe Hypoglycaemic Episodes
A responder for HbA1c without severe hypoglycaemia was defined as a subject who meets the HbA1c target (\<7%) at end of trial without severe treatment emergent hypoglycaemia during the last 12 weeks of treatment or within 7 days after the last randomised treatment. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Missing HbA1c data was imputed using last observed value.
Time frame: At week 26
Population: Full analysis set. Number of subjects analysed=subjects who have been exposed for at least 12 treatment weeks.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Responder for HbA1c (HbA1c <7%) Without Severe Hypoglycaemic Episodes | Yes | 197 Participants |
| IDegAsp BID | Responder for HbA1c (HbA1c <7%) Without Severe Hypoglycaemic Episodes | No | 151 Participants |
| BIAsp 30 BID | Responder for HbA1c (HbA1c <7%) Without Severe Hypoglycaemic Episodes | Yes | 84 Participants |
| BIAsp 30 BID | Responder for HbA1c (HbA1c <7%) Without Severe Hypoglycaemic Episodes | No | 89 Participants |
Secondary
Responder Without Confirmed Hypoglycaemic Episodes HbA1c Below 7.0%
A responder for HbA1c without confirmed hypoglycaemia was defined as a subject who meets the HbA1c target (\<7.0%) at end of trial without treatment emergent confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days after the last randomised treatment. Confirmed hypoglycaemia was defined as either severe episodes or episodes with plasma glucose \< 3.1 mmol/L (56 mg/dL) with or without symptoms. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Missing data is imputed using last observed value.
Time frame: At 26 weeks
Population: Full analysis set. Number of subjects analysed=subjects who have been exposed for at least 12 treatment weeks.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDegAsp BID | Responder Without Confirmed Hypoglycaemic Episodes HbA1c Below 7.0% | Yes | 153 Participants |
| IDegAsp BID | Responder Without Confirmed Hypoglycaemic Episodes HbA1c Below 7.0% | No | 195 Participants |
| BIAsp 30 BID | Responder Without Confirmed Hypoglycaemic Episodes HbA1c Below 7.0% | Yes | 48 Participants |
| BIAsp 30 BID | Responder Without Confirmed Hypoglycaemic Episodes HbA1c Below 7.0% | No | 125 Participants |
Comparison: The endpoint was analysed in a logistic regression model using a logit link, including treatment, sex and anti-diabetic treatment at screening as fixed effects, and age and HbA1c as covariates.p-value: 0.000295% CI: [1.47, 3.35]Regression, Logistic
Secondary
Treatment Satisfaction Questionnaire (Treatment Related Impact Measures - Diabetes Device [TRIM-D Device])
TRIM-D device is an eight item measure with two domains assessing Device Bother and Device Function. This captures information on the ease of use, convenience, and handling of the device(s) used to take diabetes medication. The measure has acceptable reliability, validity and ability to detect change. The scores were transformed to a 0-100 scale with higher scores indicating less treatment related impact. Missing data was imputed using last observed value.
Time frame: At week 26
Population: Full analysis set. Number of subjects analysed=subjects with data available for TRIM-D device total score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDegAsp BID | Treatment Satisfaction Questionnaire (Treatment Related Impact Measures - Diabetes Device [TRIM-D Device]) | 72.31 units on a scale | Standard Deviation 14.78 |
| BIAsp 30 BID | Treatment Satisfaction Questionnaire (Treatment Related Impact Measures - Diabetes Device [TRIM-D Device]) | 69.43 units on a scale | Standard Deviation 14.12 |