Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in HbA1c (Week 26) |
Change from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c). The endpoint was analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. The endpoint was also evaluated based on data from the in-trial observation period. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
Week 0, week 26 |
|
| Secondary |
Change in HbA1c (Week 52) |
Change from baseline (week 0) to week 52 in HbA1c. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 52 |
|
| Secondary |
Change in Body Weight (kg) |
Change from baseline (week 0) in body weight. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 26, week 52 |
|
| Secondary |
Change in Fasting Plasma Glucose |
Change from baseline (week 0) in fasting plasma glucose. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 26, week 52 |
|
| Secondary |
Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile |
Change from baseline (week 0) in mean 7-point self-measured plasma glucose (SMPG) profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 26, week 52 |
|
| Secondary |
Change in Mean Postprandial Increment Over All Meals in SMPG |
Change from baseline (week 0) in the average of the post-prandial increments over all meals. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 26 and week 52 |
|
| Secondary |
Change in Body Weight (%) |
Relative change (%) from baseline (week 0) in body weight (kg). Data based on on-treatment without resue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 26 and week 52 |
|
| Secondary |
Change in Body Mass Index |
Change from baseline (week 0) in body mass index (BMI). BMI was calculated based on body weight and height based on the formulae: BMI kg/m^2 = body weight (kg)/(Height (m) x Height (m)). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 26 and week 52 |
|
| Secondary |
Change in Waist Circumference |
Change from baseline (week 0) in waist circumference. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 26 and week 52 |
|
| Secondary |
Change in Total Cholesterol (Ratio to Baseline) |
Change from baseline (week 0) in total cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 26 and week 52 |
|
| Secondary |
Change in HDL Cholesterol (Ratio to Baseline) |
Change from baseline (week 0) in high density lipoprotein (HDL) cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 26 and week 52 |
|
| Secondary |
Change in LDL Cholesterol (Ratio to Baseline) |
Change from baseline (week 0) in low density lipoprotein (LDL) cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 26 and week 52 |
|
| Secondary |
Change in VLDL Cholesterol (Ratio to Baseline) |
Change from baseline (week 0) in very low density lipoprotein (VLDL) cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 26 and week 52 |
|
| Secondary |
Change in Triglycerides (Ratio to Baseline) |
Change from baseline (week 0) in triglycerides (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 26 and week 52 |
|
| Secondary |
Change in Fasting Insulin (Ratio to Baseline) |
Change from baseline (week 0) in fasting insulin (measured as picomoles per liter [pmol/L]) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 26 and week 52 |
|
| Secondary |
Change in Fasting C-peptide (Ratio to Baseline) |
Change from baseline (week 0) in fasting C-peptide (measured as nanomoles per liter [nmol/L]) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 26 and week 52 |
|
| Secondary |
Change in Fasting Glucagon (Ratio to Baseline) |
Change from baseline (week 0) in fasting glucagon (measured as picograms per milliliter [pg/mL]) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 26 and week 52 |
|
| Secondary |
Change in Fasting Pro-insulin (Ratio to Baseline) |
Change from baseline (week 0) in fasting pro-insulin (measured as pmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 26 and week 52 |
|
| Secondary |
Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline) |
Change from baseline (week 0) in fasting pro-insulin/insulin ratio is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 26 and week 52 |
|
| Secondary |
Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline) |
Change from baseline (week 0) in insulin resistance (measured as percentage of insulin resistance) by homeostatic model assessment index of insulin resistance (HOMA-IR) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 26 and week 52 |
|
| Secondary |
Change in Beta-cell Function (HOMA-B) (Ratio to Baseline) |
Change from baseline (week 0) in beta-cell function (measured as percentage of beta-cell function) by homeostatic model assessment index of beta-cell function is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 26 and week 52 |
|
| Secondary |
Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) |
Participants who achieved HbA1c <7.0% (53 millimoles per mole [mmol/mol]) according to American Diabetes Association (ADA) target, at week 26 and week 52. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 26 and week 52 |
|
| Secondary |
Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) |
Participants who achieved HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists target (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 26 and week 52 |
|
| Secondary |
Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) |
Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 milligrams per deciliter [mg/dL]) with symptoms consistent with hypoglycaemia. Number of participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 26 and week 52 |
|
| Secondary |
Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% |
Participants who achieved above or equal to 1% (10.9 mmol/mol) reduction in HbA1c and losing 3% or more of baseline body weight (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 26 and week 52 |
|
| Secondary |
Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) |
Participants losing 5% or more of baseline body weight (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 26 and week 52 |
|
| Secondary |
Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) |
Participants losing 10% or more of baseline body weight (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 26 and week 52 |
|
| Secondary |
Time to Additional Anti-diabetic Medication |
Presented results are the number of participants who had taken additional anti-diabetic medication anytime from week 0 to week 52. 'Additional anti-diabetic medication': use of new anti-diabetic medication for more than 21 days with the initiation at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
Weeks 0 - 52 |
|
| Secondary |
Time to Rescue Medication |
Presented results are the number of participants who had taken rescue medication anytime from week 0 to week 52. 'Rescue medication': use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation and before last day on trial product. Time to rescue medication was estimated based on data from on-treatment without rescue medication observation period. |
Weeks 0 - 52 |
|
| Secondary |
Number of Treatment-emergent Adverse Events (TEAEs) |
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) with onset in the on-treatment observation period (time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any, and excluding any period after premature trial product discontinuation) assessed up to approximately 57 weeks (52 weeks treatment period + 5 weeks follow-up period). |
Weeks 0 - 57 |
|
| Secondary |
Change in Amylase (Ratio to Baseine) |
Change in amylase (measured as units per liter [U/L]) is presented as ratio to baseline. Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation. |
Week 0, week 26, week 52 |
|
| Secondary |
Change in Lipase (Ratio to Baseine) |
Change in lipase (measured as U/L) is presented as ratio to baseline. Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation. |
Week 0, week 26, week 52 |
|
| Secondary |
Change in Pulse Rate |
Change from baseline in pulse rate. Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation. |
Week 0, week 26, week 52 |
|
| Secondary |
Change in Blood Pressure |
Change from baseline in blood pressure (systolic [sBP] and diastolic [dBP]). Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation. |
Week 0, week 26, week 52 |
|
| Secondary |
Change in ECG Evaluation |
Electrocardiogram (ECG) was evaluated and interpreted by the investigator and categorised as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). The number of participants who had shifted from normal, abnormal NCS or abnormal CS ECG results from baseline (week 0) to week 26, week 52 is presented. Data based on in-trial observation period is presented. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
Week 0, week 26, week 52 |
|
| Secondary |
Change in Physical Examination |
Physical examination included examination of cardiovascular system, nervous system (central and peripheral), gastrointestinal system including mouth, general appearence, head and neck (head, ears, eyes, nose, throat, neck), lymph node palpation, musculoskeletal system, respiratory system, skin and thyroid gland. Physical examination was performed by the investigator and categorised as normal, abnormal NCS or abnormal CS. Data based on in-trial observation period is presented. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
Baseline (Week -8), week 26, week 52 |
|
| Secondary |
Change in Eye Examination Category |
Eye examination was performed by the investigator and categorised as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Data based on in-trial observation period is presented. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
Week -8, Week 52 |
|
| Secondary |
Anti-semaglutide Binding Antibodies (Yes/no) |
Number of participants with the presence or absence (yes/no) of anti-semaglutide binding antibodies in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups "Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg". Data based on the in-trial observation period was presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
Week 0 - 57 |
|
| Secondary |
Anti-semaglutide Neutralising Antibodies (Yes/no) |
Number of participants with the presence or absence (yes/no) of anti-semaglutide neutralising antibodies in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups "Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg". Data based on the in-trial observation period is presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
Week 0 - 57 |
|
| Secondary |
Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no) |
Number of participants with the presence or absence (yes/no) of anti-semaglutide binding antibodies cross reacting with native GLP-1 in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups "Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg". Data based on the in-trial observation period was presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
Week 0 - 57 |
|
| Secondary |
Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no) |
Number of participants with the presence or absence (yes/no) of anti-semaglutide neutralising antibodies cross reacting with native GLP-1 in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups "Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg". Data based on the in-trial observation period was presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
Week 0 - 57 |
|
| Secondary |
Anti-semaglutide Binding Antibody Levels |
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-57). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
Weeks 0-57 |
|
| Secondary |
Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes |
Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data based on on-treatment observation period was presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation. |
Week 0 - 57 |
|
| Secondary |
Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes |
Number of participants with treatment emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes. Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data based on on-treatment observation period was presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation. |
Weeks 0 - 57 |
|
| Secondary |
Semaglutide Plasma Concentration |
Semaglutide plasma concentration is presented. Samples for pharmacokinetic (PK) analysis were drawn at any time during the visit except for the visit at week 26 where samples were taken both pre-dose and 60-90 minutes post dosing. This endpoint is applicable only to the reporting groups, "Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg". Data based on on-treatment observation period was presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation. |
Week 26 and week 52 |
|
| Secondary |
Change in SF-36: Sub-domains |
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores is presented. A positive change score indicates an improvement since baseline. Data based on on-treatment without rescue medication observation period is presented. |
Week 0, week 26, week 52 |
|
| Secondary |
Change in SF-36: Physical Component Summary (PCS) |
Change in short form 36 v2.0 acute domain PCS from baseline (week 0) to week 56. SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. It consists of 2 component summary measures that further summarize 8 health domain scales. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Data based on on-treatment without rescue medication observation period is presented. |
Week 0, week 26, week 52 |
|
| Secondary |
Change in SF-36: Mental Component Summary (MCS) |
Change in short form 36 v2.0 acute domain MCS from baseline (week 0) to week 56. SF- 36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Data based on on-treatment without rescue medication observation period is presented. |
Week 0, week 26, week 52 |
|
| Secondary |
Change From Baseline in DTR-QOL: Total Score |
Diabetes Therapy-Related QOL (DTR-QOL) questionnaire is a 29-item patient-reported survey of patient health that measures the influence of diabetes treatment on HRQoL on 4 domains on individual scale ranges: "Burden on social activities and daily activities", "Anxiety and dissatisfaction with treatment", "Hypoglycemia" and "Satisfaction with treatment" on a 7-point graded response scale. Higher item scores indicate a higher level of HRQoL for items 1-25. For items 26-29 a higher score indicates a lower level of HRQoL. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100. The total score, after simple addition of the item scores, is converted to 0 - 100 (best-case response = 100; worstcase response = 0). Data based on on-treatment without rescue medication observation period is presented. |
Week 0, week 26, week 52 |
|
| Secondary |
Change From Baseline in DTR-QOL: Sub-domains |
DTR-QOL questionnaire is a 29-item patient-reported survey of patient health that measures the the influence of diabetes treatment on HRQoL. DTR-QOL questionnaire measured the HRQoL on 4 domains on individual scale ranges: "Burden on social activities and daily activities", "Anxiety and dissatisfaction with treatment", "Hypoglycemia" and "Satisfaction with treatment" on a 7-point graded response scale. Higher item scores indicate a higher level of HRQoL for items 1-25. For items 26-29 a higher score indicates a lower level of HRQoL. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100. W26 and W52 refer to week 26 and week 52 respectively. Data based on on-treatment without rescue medication observation period was presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
Week 0, week 26, week 52 |
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