| Outcome Measures: |
Primary: Change in HbA1c, Change from baseline (week 0) in HbA1c was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: 1) the last dose of trial product + 7 days or 2) initiation of rescue medication., Week 0, week 30 | Secondary: Change in Body Weight (kg), Change from baseline (week 0) in body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period., Week 0, week 30|Change in Fasting Plasma Glucose (FPG), Change from baseline (week 0) in FPG was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period., Week 0, week 30|Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean 7-point Profile, Change from baseline (week 0) in mean of the SMPG, 7-point profile was evaluated at week 30. Mean 7-point profile (the area under the profile) was calculated using the trapezoidal method and divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period. Participants measured their plasma glucose at 7 different time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime., Week 0, week 30|Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean Post Prandial Increment (Over All Meals), Change from baseline (week 0) in mean post prandial increment (over all meals) in the SMPG, 7-point profile was evaluated at week 30. The mean increment over all meals was derived as the mean of all available meal increments. Results are based on the 'on-treatment without rescue medication' observation period., Week 0, week 30|Change in Fasting Blood Lipid, Total Cholesterol, Change from baseline (week 0) in total cholesterol (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period., Week 0, week 30|Change in Fasting Blood Lipid, Low-density Lipoprotein (LDL) Cholesterol, Change from baseline (week 0) in LDL (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period., Week 0, week 30|Change in Fasting Blood Lipid, High-density Lipoprotein (HDL) Cholesterol, Change from baseline (week 0) in HDL (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period., Week 0, week 30|Change in Fasting Blood Lipid, Triglycerides, Change from baseline (week 0) in triglycerides (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period., Week 0, week 30|Change in Body Weight (%), Percent (%) change from baseline (week 0) in body weight (measured in kilogram (kg)) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period., Week 0, week 30|Change in Body Mass Index, Change from baseline (week 0) in body mass index (BMI) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. BMI was calculated as 'body weight in kg/(height in meters) x (height in meters)'., Week 0, week 30|Change in Waist Circumference, Change from baseline (week 0) in waist circumference was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period., Week 0, week 30|Change in Systolic Blood Pressure, Change from baseline (week 0) in systolic blood pressure was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period., Week 0, week 30|Change in Diastolic Blood Pressure, Change from baseline (week 0) in diastolic blood pressure was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period., Week 0, week 30|Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains, Change from baseline (week 0) in patient reported outcome (PRO) questionnaire, SF-36v2TM was evaluated at week 30. The SF-36v2™ questionnaire was used to assess the overall health related quality of life of participants. This questionnaire contains 36 items and measures the individual overall health related quality of life on 8 domains: 1) Physical functioning, 2) Role functioning, 3) Bodily pain, 4) General health, 5) Vitality, 6) Social functioning, 7) Role emotional and 8) Mental health. Each item is scored on a scale from 1 to either 2, 3, 5, or 6; each item score is then converted to a scale of 0-100, representing the percentage of total possible score achieved and with higher scores indicating a higher health status; items on the same scale are then averaged to obtain the 8 scale scores. Physical component summary (PCS) includes domains 1-4 and mental component summary (MCS) includes domains 5-8. Higher PCS and MCS scores on a scale of 0-100 indicate a higher health status., Week 0, week 30|Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately, Change from baseline (week 0) in PRO questionnaire, DTSQ was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. The DTSQ measures satisfaction with diabetes treatment. The DTSQ consists of 8 items evaluating 6 aspects of treatment satisfaction and 2 perceived recent event rates of hyperglycemia/hypoglycemia. Each item is scored on a 7- point Likert scale ranging from 0 (very dissatisfied) to 6 (very satisfied). Items evaluating 6 aspects (items 3-8) of treatment satisfaction are summed to produce a total treatment satisfaction score; DTSQ status total scores range from 0-36, with higher scores indicating greater satisfaction; the perceived frequency of hyperglycemia/hypoglycemia items are scored separately, with lower scores indicating better perceived blood glucose control., Week 0, week 30|HbA1c Below 7.0% (53 mmol/Mol), Percentage of participants with HbA1c below 7.0% (53 mmol/mol) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period., After 30 weeks|HbA1c Equal to or Below 6.5% (48 mmol/Mol), Percentage of participants with HbA1c equal to or below 6.5% (48 mmol/mol) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period., After 30 weeks|Weight Loss Equal to or Above 3%, Percentage of participants with weight loss equal to or above 3% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period., After 30 weeks|Weight Loss Equal to or Above 5%, Percentage of participants with weight loss equal to or above 5% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period., After 30 weeks|Weight Loss Equal to or Above 10%, Percentage of participants with weight loss equal to or above 10% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period., After 30 weeks|HbA1c Below 7.0% (53 mmol/Mol) Without Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain, Percentage of participants with HbA1c below 7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain from their baseline (week 0) body weight was evaluated at week 30. Severe or blood glucose (BG)-confirmed symptomatic hypoglycaemia: an episode that was severe according to the American Diabetes Association (ADA) classification or confirmed by a plasma glucose (PG) value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment without rescue medication' observation period., After 30 weeks|HbA1c Reduction Equal to or Above 1%-Point, Percentage of participants with HbA1c reduction equal to or above 1%-point was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period., After 30 weeks|HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 3%, Percentage of participants with HbA1c reduction equal to or above 1%-point and weight loss equal to or above 3% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period., After 30 weeks|HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 5%, Percentage of participants with HbA1c reduction equal to or above 1%-point and weight loss equal to or above 5% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period., After 30 weeks|HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 10%, Percentage of participants with HbA1c reduction equal to or above 1%-point and weight loss equal to or above 10% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period., After 30 weeks|Number of Treatment-emergent Adverse Events (TEAEs), A TEAE was defined as an event that has onset date (or increase in severity) during the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 42 days., Week 0 - week 30|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes, Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 42 days. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or confirmed by a PG value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia., Week 0 - week 30|Change in Haematology: Haemoglobin, Change from baseline (week 0) in haemoglobin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30|Change in Haematology: Haematocrit, Change from baseline (week 0) in haematocrit was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30|Change in Haematology: Thrombocytes, Change from baseline (week 0) in thrombocytes was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30|Change in Haematology: Erythrocytes, Change from baseline (week 0) in erythrocytes was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30|Change in Haematology: Leucocytes, Change from baseline (week 0) in leucocytes was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30|Change in Biochemistry: Amylase, Change from baseline (week 0) in amylase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30|Change in Biochemistry: Lipase, Change from baseline (week 0) in lipase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30|Change in Biochemistry: Alkaline Phosphatase, Change from baseline (week 0) in alkaline phosphatase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30|Change in Biochemistry: Alanine Aminotransferase, Change from baseline (week 0) in alanine aminotransferase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30|Change in Biochemistry: Aspartate Aminotransferase, Change from baseline (week 0) in aspartate aminotransferase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30|Change in Biochemistry: Total Bilirubin, Change from baseline (week 0) in total bilirubin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30|Change in Biochemistry: Albumin, Change from baseline (week 0) in albumin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30|Change in Biochemistry: Calcium (Total), Change from baseline (week 0) in albumin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30|Change in Biochemistry: Potassium, Change from baseline (week 0) in potassium was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30|Change in Biochemistry: Sodium, Change from baseline (week 0) in sodium was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30|Change in Biochemistry: Bicarbonate, Change from baseline (week 0) in bicarbonate was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30|Change in Biochemistry: Estimated Glomerular Filtration Rate (eGFR), Change from baseline (week 0) in eGFR was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30|Change in Biochemistry: Creatinine, Change from baseline (week 0) in creatinine was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30|Change in Calcitonin, Change from baseline (week 0) in calcitonin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30|Change in Pulse, Change from baseline (week 0) in pulse rate was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30|Change in Electrocardiogram, Electrocardiogram (ECG) results are presented for week 0 (baseline) and week 30. ECG finding are presented as percentage of participants with normal, abnormal non-clinically significant (NCS) and abnormal clinically significant (CS) ECG values. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 42 days., Week 0, week 30|Change in Physical Examination: General Appearance, Physical examination (general appearance) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week -2, week 30|Change in Physical Examination: Central and Peripheral Nervous System, Physical examination (central and peripheral nervous system) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week -2, week 30|Change in Physical Examination: Cardiovascular System, Physical examination (cardiovascular system) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week -2, week 30|Change in Physical Examination: Gastrointestinal System Including Mouth, Physical examination (gastrointestinal system including mouth) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week -2, week 30|Change in Physical Examination: Skin, Physical examination (skin) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week -2, week 30|Change in Physical Examination: Respiratory System, Physical examination (respiratory system) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week -2, week 30|Change in Physical Examination: Lymph Node Palpation, Physical examination (lymph node palpation) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week -2, week 30|Change in Physical Examination: Thyroid Gland, Physical examination (thyroid gland) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week -2, week 30|Change in Fundoscopy, Fundoscopy results for both left and right eyes are presented for week 0 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days., Week 0, week 30
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| Locations: |
Novo Nordisk Investigational Site, Andalusia, Alabama, 36420, United States|Novo Nordisk Investigational Site, Anniston, Alabama, 36207, United States|Novo Nordisk Investigational Site, Glendale, Arizona, 85308, United States|Novo Nordisk Investigational Site, Phoenix, Arizona, 85037, United States|Novo Nordisk Investigational Site, Tempe, Arizona, 85283, United States|Novo Nordisk Investigational Site, Little Rock, Arkansas, 72211, United States|Novo Nordisk Investigational Site, La Jolla, California, 92037, United States|Novo Nordisk Investigational Site, Lincoln, California, 95648, United States|Novo Nordisk Investigational Site, Northridge, California, 91325, United States|Novo Nordisk Investigational Site, Edgewater, Florida, 32132, United States|Novo Nordisk Investigational Site, Maitland, Florida, 32751-4422, United States|Novo Nordisk Investigational Site, Lawrenceville, Georgia, 30046, United States|Novo Nordisk Investigational Site, Woodstock, Georgia, 30189-4255, United States|Novo Nordisk Investigational Site, Hutchinson, Kansas, 67502-1131, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, United States|Novo Nordisk Investigational Site, Baltimore, Maryland, 21204, United States|Novo Nordisk Investigational Site, Troy, Michigan, 48098, United States|Novo Nordisk Investigational Site, Jefferson City, Missouri, 65109, United States|Novo Nordisk Investigational Site, Albany, New York, 12206, United States|Novo Nordisk Investigational Site, Smithtown, New York, 11787, United States|Novo Nordisk Investigational Site, West Seneca, New York, 14224, United States|Novo Nordisk Investigational Site, Charlotte, North Carolina, 28207, United States|Novo Nordisk Investigational Site, Charlotte, North Carolina, 28226, United States|Novo Nordisk Investigational Site, Gastonia, North Carolina, 28054, United States|Novo Nordisk Investigational Site, Greenville, North Carolina, 27834, United States|Novo Nordisk Investigational Site, Kinston, North Carolina, 28501, United States|Novo Nordisk Investigational Site, Morehead City, North Carolina, 28557-4346, United States|Novo Nordisk Investigational Site, Norman, Oklahoma, 73069, United States|Novo Nordisk Investigational Site, Beaver, Pennsylvania, 15009, United States|Novo Nordisk Investigational Site, McMurray, Pennsylvania, 15317, United States|Novo Nordisk Investigational Site, Pittsburgh, Pennsylvania, 15243, United States|Novo Nordisk Investigational Site, Arlington, Texas, 76012-4637, United States|Novo Nordisk Investigational Site, Austin, Texas, 78745, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75208, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75231, United States|Novo Nordisk Investigational Site, Houston, Texas, 77081, United States|Novo Nordisk Investigational Site, Irving, Texas, 75061-2210, United States|Novo Nordisk Investigational Site, Shavano Park, Texas, 78231, United States|Novo Nordisk Investigational Site, Sugar Land, Texas, 77479, United States|Novo Nordisk Investigational Site, Victoria, Texas, 77901, United States|Novo Nordisk Investigational Site, Murray, Utah, 84123, United States|Novo Nordisk Investigational Site, Chesapeake, Virginia, 23321, United States|Novo Nordisk Investigational Site, Olympia, Washington, 98502, United States|Novo Nordisk Investigational Site, Saint Stefan, 8511, Austria|Novo Nordisk Investigational Site, Wien, 1030, Austria|Novo Nordisk Investigational Site, Wien, 1060, Austria|Novo Nordisk Investigational Site, Wien, 1130, Austria|Novo Nordisk Investigational Site, Edmonton, Alberta, T6H 2L4, Canada|Novo Nordisk Investigational Site, Winnipeg, Manitoba, R3E 3P4, Canada|Novo Nordisk Investigational Site, Brampton, Ontario, L6S 0C6, Canada|Novo Nordisk Investigational Site, Brampton, Ontario, L6T 0G1, Canada|Novo Nordisk Investigational Site, Etobicoke, Ontario, M9R 4E1, Canada|Novo Nordisk Investigational Site, Smiths Falls, Ontario, K7A 4W8, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M5T 3L9, Canada|Novo Nordisk Investigational Site, Waterloo, Ontario, N2J 1C4, Canada|Novo Nordisk Investigational Site, Kanagawa, 232-0064, Japan|Novo Nordisk Investigational Site, Nagakute-shi, Aichi, 480-1195, Japan|Novo Nordisk Investigational Site, Suita-shi, Osaka, 565-0853, Japan|Novo Nordisk Investigational Site, Tokyo, 160-0008, Japan|Novo Nordisk Investigational Site, Hamar, 2317, Norway|Novo Nordisk Investigational Site, Hoenefoss, 3515, Norway|Novo Nordisk Investigational Site, Namsos, 7801, Norway|Novo Nordisk Investigational Site, Olso, 0953, Norway|Novo Nordisk Investigational Site, Oslo, 0176, Norway|Novo Nordisk Investigational Site, Skedsmokorset, NO-2020, Norway|Novo Nordisk Investigational Site, Stavanger, 4005, Norway|Novo Nordisk Investigational Site, Ponce, 00716, Puerto Rico|Novo Nordisk Investigational Site, Barnaul, 656045, Russian Federation|Novo Nordisk Investigational Site, Novosibirsk, 630099, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 191119, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 194358, Russian Federation|Novo Nordisk Investigational Site, St. Petersburg, 194354, Russian Federation
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