| Outcome Measures: |
Primary: Change in HbA1c (Week 26), Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period started at the date of the first dose of trial product and includes the period after initiation of rescue medication, if any, and excludes the period after premature trial discontinuation, if any., Week 0, week 26 | Secondary: Change in Body Weight (Week 26), Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also evaluated based on data from the on-treatment without rescue medication observation period. It started at the date of first dose of trial product and excluded the period after initiation of rescue medication and/or premature trial product discontinuation, if any., Week 0, week 26|Change in HbA1c (Week 52), Change from baseline (week 0) in HbA1c to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any., Week 0, week 52|Change in Body Weight (kg) (Week 52), Change from baseline (week 0) in body weight to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any., Week 0, week 52|Change in Fasting Plasma Glucose (FPG), Change from baseline (week 0) in FPG to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any., Week 0, week 26, week 52|Change in Self-measured Plasma Glucose (SMPG) Mean 7-point Profile, Change from baseline (week 0) in self-measured plasma glucose (SMPG) mean 7-point profile to week 26 and week 52. 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. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any., Week 0, week 26, week 52|Change in SMPG Mean Postprandial Increment Over All Meals, Change from baseline (week 0) in SMPG mean postprandial increment over all meals to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any., Week 0, week 26, week 52|Change in Body Weight (Percentage), Relative change from baseline (week 0) in body weight (%) was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any., Week 0, week 26, week 52|Change in Body Mass Index, Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26 and 52. BMI was calculated based on body weight and height based on the formula: BMI kg/m\^2 = body weight (kg)/(Height (m) x Height (m)). Data based on in-trial observation period is presented. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any., Week 0, week 26, week 52|Change in Waist Circumference, Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any., Week 0, week 26, week 52|Change in Total Cholesterol - Ratio to Baseline, Change from baseline in total cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any., Week 0, week 26, week 52|Change in LDL Cholesterol - Ratio to Baseline, Change from baseline in LDL cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any., Week 0, week 26, week 52|Change in HDL Cholesterol - Ratio to Baseline, Change from baseline (week 0) in HDL cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any., Week 0, week 26, week 52|Change in Triglycerides - Ratio to Baseline, Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any., Week 0, week 26, week 52|Change in Total Daily Insulin Dose, Change from baseline in total daily insulin dose to week 26 and week 52 is presented. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any., Week 0, week 26, week 52|Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no), Number of particpants achieving HbA1c \< 7.0 % (53 mmol/mol) according to American Diabetes Association (ADA) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any., Week 26, week 52|Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no), Number of participants achieving HbA1c ≤ 6.5% (48 mmol/mol) according to American Association of Clinical Endocrinologists (AACE) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any., Week 26, week 52|Participants Who Achieve Body Weight Loss ≥5% (Yes/no), Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any., Week 26, week 52|Participants Who Achieve Body Weight Loss ≥10% (Yes/no), Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiatiion of of rescue medication and/or premature trial product discontinuation, if any., Week 26, week 52|Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no), Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. 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 and/or premature discontinuation of trial product., Week 26, week 52|Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no), Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. 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 and/or premature discontinuation of trial product., Week 26, week 52|Time to Additional Anti-diabetic Medication, Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as use of new anti-diabetic medication for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification 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 and/or premature discontinuation of trial product., Weeks 0-52|Time to Rescue Medication, Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as 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 (week 1) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation., Weeks 0-52|Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product, Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication., Weeks 0-57|Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes, Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia., Weeks 0-57|Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes, Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia., Weeks 0-57|Change in Amylase - Ratio to Baseline, Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication., Week 0, week 26, week 52|Change in Lipase - Ratio to Baseline, Change from baseline (week 0) in lipase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication, Week 0, week 26, week 52|Change in Pulse Rate, Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52 Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication., Week 0, week 26, week 52|Change in SBP and DBP, Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at weeks 26 and 52 Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication., Week 0, week 26, week 52|Change in ECG Evaluation, Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. Change from baseline results are presented as shift in findings (normal; abnormal and not clinically significant (NCS); abnormal and clinically significant (CS)) from week 0 to week 26 and 52. 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 and/or premature discontinuation of trial product., Week 0, week 26, week 52|Change in Physical Examination, Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2) and weeks 52 presented. 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 and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland., Week -2, week 52|Change in Eye Examination Category, Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. 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 and/or premature discontinuation of trial product., Week -2, week 52|Semaglutide Plasma Concentrations for Population PK Analyses, This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Semaglutide plasma concentrations were measured at week 4, 14, 26, 38 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication., Weeks 0-52|Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS), 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™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (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. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period., Week 0, week 26, week 52|Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains, The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. The items of the IWQOL-Lite-CT pertain to physical functioning (physical, physical function and pain/discomfort) and psychosocial domains and all items employ a 5-point graded response scale (never, rarely, sometimes, usually, always; or not at all true, a little true, moderately true, mostly true, completely true). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any., Week 0, week 26, week 52|Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed), Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26 and week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of hyperglycaemia and hypoglycaemia, respectively. Thus, lower scores indicate a perception of blood glucose levels being "none of the time" unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score has a minimum of 0 and a maximum of 36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction., Week 0, week 26, week 52
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| Locations: |
Novo Nordisk Investigational Site, Anniston, Alabama, 36207, United States|Novo Nordisk Investigational Site, Birmingham, Alabama, 35211, United States|Novo Nordisk Investigational Site, Fountain Hills, Arizona, 85268, United States|Novo Nordisk Investigational Site, Glendale, Arizona, 85308, United States|Novo Nordisk Investigational Site, Mesa, Arizona, 85213, United States|Novo Nordisk Investigational Site, Phoenix, Arizona, 85037, United States|Novo Nordisk Investigational Site, Tucson, Arizona, 85723-0001, United States|Novo Nordisk Investigational Site, Tucson, Arizona, 85741, United States|Novo Nordisk Investigational Site, Anaheim, California, 92801, United States|Novo Nordisk Investigational Site, Fresno, California, 93720, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90017, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057, United States|Novo Nordisk Investigational Site, Riverside, California, 92506, United 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South Carolina, 29485, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Kingsport, Tennessee, 37660-4652, United States|Novo Nordisk Investigational Site, Austin, Texas, 78731, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75251, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75390-9302, United States|Novo Nordisk Investigational Site, Houston, Texas, 77090, United States|Novo Nordisk Investigational Site, Mesquite, Texas, 75149, United States|Novo Nordisk Investigational Site, Midland, Texas, 79707, United States|Novo Nordisk Investigational Site, Round Rock, Texas, 78681, United States|Novo Nordisk Investigational Site, Murray, Utah, 84123, United States|Novo Nordisk Investigational Site, Winchester, Virginia, 22601, United States|Novo Nordisk Investigational Site, Winnipeg, Manitoba, R3E 3P4, Canada|Novo Nordisk Investigational Site, Moncton, New Brunswick, E1G 1A7, Canada|Novo Nordisk Investigational Site, Brampton, Ontario, L6S 0C6, Canada|Novo Nordisk Investigational Site, Etobicoke, Ontario, M9W 1P1, Canada|Novo Nordisk Investigational Site, London, Ontario, N6G 2M1, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M5T 3L9, Canada|Novo Nordisk Investigational Site, Waterloo, Ontario, N2J 1C4, Canada|Novo Nordisk Investigational Site, Besançon cedex, 25030, France|Novo Nordisk Investigational Site, Bourgoin-jallieu, 38302, France|Novo Nordisk Investigational Site, Brest, 29200, France|Novo Nordisk Investigational Site, LA ROCHE-sur-YON cedex 9, 85295, France|Novo Nordisk Investigational Site, LA ROCHELLE cedex, 17019, France|Novo Nordisk Investigational Site, Le Coudray, 28630, France|Novo Nordisk Investigational Site, Le Creusot, 71200, France|Novo Nordisk Investigational Site, Narbonne, 11108, France|Novo Nordisk Investigational Site, Paris, 75014, France|Novo Nordisk Investigational Site, Saint Herblain, 44800, France|Novo Nordisk 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Site, New Dehli, New Delhi, 110029, India|Novo Nordisk Investigational Site, Jaipur, Rajasthan, 302004, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600086, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700054, India|Novo Nordisk Investigational Site, Kolkata, 700020, India|Novo Nordisk Investigational Site, Amagasaki-shi, Hyogo, 661-0002, Japan|Novo Nordisk Investigational Site, Chuo-ku, Tokyo, 103-0002, Japan|Novo Nordisk Investigational Site, Ebina-shi, Kanagawa, 243-0432, Japan|Novo Nordisk Investigational Site, Iruma-shi, Saitama, 358-0011, Japan|Novo Nordisk Investigational Site, Kanagawa, 247-0055, Japan|Novo Nordisk Investigational Site, Kumamoto-shi, Kumamoto, 860-0811, Japan|Novo Nordisk Investigational Site, Kumamoto, 862-0976, Japan|Novo Nordisk Investigational Site, Miyazaki, 880-0034, Japan|Novo Nordisk Investigational Site, Naka-shi, 311 0113, Japan|Novo Nordisk Investigational Site, Osaka, 569-1045, Japan|Novo Nordisk Investigational 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