Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2Diabetes
- Interventions
- Registration Number
- NCT03018028
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Asia. The aim of this trial is to investigate the dose-response relationship of once-daily dosing of three dose levels (3, 7 and 14 mg) of oral semaglutide versus placebo as monotherapy on glycaemic control in Japanese subjects with type 2 diabetes mellitus
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 243
- 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
- Japanese male or female, age above or equal to 20 years at the time of signing informed consent
- Diagnosed with type 2 diabetes mellitus for at least 30 days prior to day of screening
- HbA1c 6.5%-9.5% (48-80 mmol/mol) (both inclusive) for subjects treated with oral antidiabetic drug as monotherapy and 7.0%-10.0% (53-86 mmol/mol) (both inclusive) for subjects treated with diet and exercise therapy alone
- Treatment for at least 30 days prior to day of screening with;- stable daily dose of oral anti-diabetic drug as monotherapy (allowed oral anti-diabetic drugs are: metformin, sulphonylurea, glinide, α-glucosidase inhibitor, dipeptidyl peptidase-4 inhibitor and sodium-glucose cotransporter-2 inhibitor) at a half-maximum approved dose or below according to Japanese labelling in addition to diet and exercise therapy. or - diet and exercise therapy alone
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives
- Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
- Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC)
- History of pancreatitis (acute or chronic)
- History of major surgical procedures involving the stomach and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
- Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation
- Subject presently classified as being in New York Heart Association (NYHA) Class IV
- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- Subjects with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL)
- Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 30 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)
- Treatment with once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA), once weekly dipeptidyl peptidase-4 (DPP-4) inhibitor or thiazolidinedione in a period of 90 days before the day of screening
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of below or equal to 14 days
- Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation
- History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)
- Initiation of anti-diabetic medication between the day of screening and the day of randomisation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Liraglutide 0.9 mg Liraglutide - Oral placebo Placebo - Oral semaglutide 7 mg Semaglutide - Oral semaglutide 14 mg Semaglutide - Oral semaglutide 3 mg Semaglutide -
- Primary Outcome Measures
Name Time Method Change in HbA1c (Week 26) Week 0, 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.
- Secondary Outcome Measures
Name Time Method Change in HbA1c (Week 52) Week 0, 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.
Change in Fasting Plasma Glucose Week 0, week 26, week 52 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.
Change in VLDL Cholesterol (Ratio to Baseline) Week 0, week 26 and week 52 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.
Change in Fasting Insulin (Ratio to Baseline) Week 0, week 26 and week 52 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.
Change in Fasting C-peptide (Ratio to Baseline) Week 0, week 26 and week 52 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.
Change in Fasting Pro-insulin (Ratio to Baseline) Week 0, week 26 and week 52 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.
Change in Body Weight (kg) Week 0, week 26, week 52 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.
Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile Week 0, week 26, week 52 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.
Change in Body Weight (%) Week 0, week 26 and week 52 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.
Change in Waist Circumference Week 0, week 26 and week 52 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.
Change in Fasting Glucagon (Ratio to Baseline) Week 0, week 26 and week 52 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.
Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline) Week 0, week 26 and week 52 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.
Change in Beta-cell Function (HOMA-B) (Ratio to Baseline) Week 0, week 26 and week 52 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.
Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) Week 26 and week 52 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.
Change in Mean Postprandial Increment Over All Meals in SMPG Week 0, week 26 and week 52 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.
Change in Body Mass Index Week 0, week 26 and week 52 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.
Change in Total Cholesterol (Ratio to Baseline) Week 0, week 26 and week 52 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.
Change in HDL Cholesterol (Ratio to Baseline) Week 0, week 26 and week 52 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.
Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline) Week 0, week 26 and week 52 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.
Change in LDL Cholesterol (Ratio to Baseline) Week 0, week 26 and week 52 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.
Change in Triglycerides (Ratio to Baseline) Week 0, week 26 and week 52 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.
Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) Week 26 and week 52 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.
Change in Physical Examination Baseline (Week -8), week 26, week 52 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.
Anti-semaglutide Neutralising Antibodies (Yes/no) Week 0 - 57 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.
Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) Week 26 and week 52 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.
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) Week 26 and week 52 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.
Time to Rescue Medication Weeks 0 - 52 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.
Anti-semaglutide Binding Antibodies (Yes/no) Week 0 - 57 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.
Anti-semaglutide Binding Antibody Levels Weeks 0-57 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.
Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% Week 26 and week 52 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.
Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) Week 26 and week 52 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.
Change in Amylase (Ratio to Baseine) Week 0, week 26, week 52 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.
Change in Lipase (Ratio to Baseine) Week 0, week 26, week 52 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.
Change in Pulse Rate Week 0, week 26, week 52 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.
Change in ECG Evaluation Week 0, week 26, week 52 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.
Time to Additional Anti-diabetic Medication Weeks 0 - 52 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.
Number of Treatment-emergent Adverse Events (TEAEs) Weeks 0 - 57 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).
Change in Blood Pressure Week 0, week 26, week 52 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.
Change in Eye Examination Category Week -8, Week 52 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.
Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no) Week 0 - 57 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.
Change From Baseline in DTR-QOL: Total Score Week 0, week 26, week 52 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.
Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no) Week 0 - 57 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.
Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes Week 0 - 57 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.
Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes Weeks 0 - 57 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.
Semaglutide Plasma Concentration Week 26 and week 52 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.
Change in SF-36: Sub-domains Week 0, week 26, week 52 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.
Change From Baseline in DTR-QOL: Sub-domains Week 0, week 26, week 52 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.
Change in SF-36: Physical Component Summary (PCS) Week 0, week 26, week 52 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.
Change in SF-36: Mental Component Summary (MCS) Week 0, week 26, week 52 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.
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇯🇵Tokyo, Japan