| Outcome Measures: |
Primary: Change in HbA1c, Change from baseline (week 0) to week 26 in glycosylated haemoglobin was evaluated for 2 different observation period 'in-trial' observation period and 'on-treatment without rescue medication" observation period. The 'in-trial' observation period represents the time-period where subjects were considered to be in the trial, regardless of whether or not the subjects had initiated rescue medication or prematurely discontinued trial product. The 'on-treatment' observation period is the part of the in-trial observation period during which subjects were treated with the trial product, that is the time from the first dose to the last dose of trial product. The 'on-treatment without rescue medication' observation period is a part of 'on-treatment' observation period during which subjects were considered treated with trial product and had not initiated any rescue medications., Week 0, Week 26 | Secondary: Change in Body Weight, Change from baseline (week 0) to week 26 in body weight was evaluated for 2 different observation period 'in-trial' observation period and 'on-treatment without rescue medication" observation period. The 'in-trial' observation period represents the time-period where subjects were considered to be in the trial, regardless of whether or not the subjects had initiated rescue medication or prematurely discontinued trial product. The 'on-treatment' observation period is the part of the in-trial observation period during which subjects were treated with the trial product, that is the time from the first dose to the last dose of trial product. The 'on-treatment without rescue medication' observation period is a part of 'on-treatment' observation period during which subjects were considered treated with trial product and had not initiated any rescue medications., Week 0, Week 26|Change in Fasting Plasma Glucose, Change from baseline (week 0) to week 26 in fasting plasma glucose ('in-trial' observation period), Week 0, Week 26|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association Target, Percentage of subjects who achieve HbA1c below 7.0% (53 mmol/mol), American Diabetes Association target, after 26 weeks ('in-trial' observation period), Week 26|Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target, Percentage of subjects who achieve HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists target, after 26 weeks ('in-trial' observation period), Week 26|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain., Percentage of subjects who achieve HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain, after 26 weeks ('in-trial' observation period), Week 26|Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) and Weight Loss Above or Equal to 3%., Percentage of subjects who achieve HbA1c reduction above or equal to 1% (11mmol/mol) and weight loss above or equal to 3%, after 26 weeks ('in-trial' observation period), Week 26|Change in Self-measured Plasma Glucose 7-point Profile - Mean 7-point Profile, Change in self-measured plasma glucose 7-point profile - mean 7-point profile after 26 weeks. Subjects were instructed to measure their plasma glucose at following 7 timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime. Mean of the 7-point profile was calculated ('in-trial' observation period)., Week 0, Week 26|Change in Self-measured Plasma Glucose 7-point Profile - Mean Post Prandial Increments (Over All Meals), Subjects were instructed to measure their plasma glucose at following 7 timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime. The mean increment over all meals was derived as the mean of all available meal increments ('in-trial' observation period), Week 0, Week 26|Change in Body Mass Index (BMI), Observed mean change from baseline (week 0) to week 26 in body mass index (BMI). BMI was calculated based on body weight and height ('in-trial' observation period), Week 0, Week 26|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain, Percentage of subjects who achieve HbA1c below 7.0% (53 mmol/mol) and no weight gain, after 26 week ('in-trial' observation period)., Week 26|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), no Weight Gain and Systolic Blood Pressure Below 140 mmHg., Percentage of subjects who achieve HbA1c below 7.0% (53 mmol/mol), no weight gain and systolic blood pressure below 140 mmHg, after 26 weeks ('in-trial' observation period), Week 26|Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol), Percentage of subjects who achieve HbA1c reduction above or equal to 1% (11mmol/mol), after 26 weeks ('in-trial' observation period), Week 26|Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) and no Weight Gain, Percentage of subjects who achieve HbA1c reduction above or equal to 1% (11mmol/mol) and no weight gain, after 26 weeks., Week 26|Number of Treatment Emergent Adverse Events, The on-treatment summary of adverse events includes treatment-emergent events with onset on or after the first day of exposure to randomised treatment and no later than the minimum of the date of the follow-up visit or the last day of randomised treatment + 7 days or the date of last subject-investigator contact., Week 0 - 26 + 7 days|Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes, Treatment emergent hypoglycaemic episode is defined episode with onset on or after the first day of exposure to randomised treatment and no later than the minimum of the date of the follow-up visit or the last day of randomised treatment + 1 days or the date of last subject-investigator contact. Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to American Diabetes Association's (ADA) classification or blood glucose confirmed by a plasma glucose value \< 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions., Week 0 - 26|Change in Fasting Blood Lipids - Total Cholesterol, Fasting total cholesterol measured in mg/dL. Observed mean change in fasting total cholesterol from baseline (week 0) to week 26 is presented as ratio to baseline value., Week 0, Week 26|Change in Fasting Blood Lipids - Low Density Lipoprotein (LDL) Cholesterol, Low density lipoprotein (LDL) cholesterol measured in mg/dL. Observed mean change in fasting low density lipoprotein cholesterol from baseline (week 0) to week 26 is presented as ratio to baseline value., Week 0, Week 26|Change in Fasting Blood Lipids - High Density Lipoprotein (HDL) Cholesterol, High density lipoprotein (HDL) cholesterol measured in mg/dL. Observed mean change in fasting high density lipoprotein cholesterol from baseline (week 0) to week 26 is presented as ratio to baseline value., Week 0, Week 26|Change in Fasting Blood Lipids - Very Low Density Lipoprotein (VLDL) Cholesterol, Very low density lipoprotein (VLDL) cholesterol measured in mg/dL. Observed mean change in fasting very low density lipoprotein cholesterol from baseline (week 0) to week 26 is presented as ratio to baseline value., Week 0, Week 26|Change in Fasting Blood Lipids-triglycerides, Fasting triglycerides measured in mg/dL. Observed mean change in fasting triglycerides from baseline (week 0) to week 26 is presented as ratio to baseline value., Week 0, Week 26|Change in Fasting Blood Lipids- Free Fatty Acids (FFA), Free fatty acids measured in mg/dL. Observed mean change in fasting free fatty acids from baseline (week 0) to week 26 is presented as ratio to baseline value., Week 0, Week 26|Change in Waist Circumference, Change from baseline (week 0) to week 26 in waist circumference ('in-trial' observation period)., Week 0, Week 26|Change in Systolic Blood Pressure, Change from baseline (week 0) in systolic blood pressure after 26 weeks ('in-trial' observation period)., Week 0, Week 26|Change in Diastolic Blood Pressure, Change from baseline (week 0) in diastolic blood pressure after 26 weeks ('in-trial' observation period)., Week 0, Week 26|Subjects Who Achieve Weight Loss by 3% or More, Percentage of subjects who achieve HbA1c reduction above or equal to 1% (11mmol/mol) and weight loss above or equal to 3%, after 26 weeks ('in-trial' observation period)., Week 26
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| Locations: |
Novo Nordisk Investigational Site, Birmingham, Alabama, 35294, United States|Novo Nordisk Investigational Site, Montgomery, Alabama, 36109, United States|Novo Nordisk Investigational Site, Tucson, Arizona, 85741, United States|Novo Nordisk Investigational Site, Lancaster, California, 93534, United States|Novo Nordisk Investigational Site, Northridge, California, 91325, United States|Novo Nordisk Investigational Site, Sacramento, California, 95821, United States|Novo Nordisk Investigational Site, San Diego, California, 92111, United States|Novo Nordisk Investigational Site, San Ramon, California, 94583, United States|Novo Nordisk Investigational Site, Vista, California, 92083, United States|Novo Nordisk Investigational Site, Gainesville, Florida, 32653, United States|Novo Nordisk Investigational Site, Hollywood, Florida, 33024, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32216, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32256, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32258, United States|Novo Nordisk Investigational Site, Maitland, Florida, 32751, United States|Novo Nordisk Investigational Site, Miami Lakes, Florida, 33016, United States|Novo Nordisk Investigational Site, Miami, Florida, 33165, United States|Novo Nordisk Investigational Site, Miami, Florida, 33176, United States|Novo Nordisk Investigational Site, Tampa, Florida, 33606, United States|Novo Nordisk Investigational Site, Lawrenceville, Georgia, 30046, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Statesboro, Georgia, 30461, United States|Novo Nordisk Investigational Site, Blackfoot, Idaho, 83221, United States|Novo Nordisk Investigational Site, Evansville, Indiana, 47714, United States|Novo Nordisk Investigational Site, Topeka, Kansas, 66606, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, United States|Novo Nordisk Investigational Site, New Orleans, Louisiana, 70115, United States|Novo Nordisk Investigational Site, Kalamazoo, Michigan, 49009, United States|Novo Nordisk Investigational Site, Rochester, Michigan, 48307, United States|Novo Nordisk Investigational Site, Billings, Montana, 59101, United States|Novo Nordisk Investigational Site, Henderson, Nevada, 89052-2649, United States|Novo Nordisk Investigational Site, Albany, New York, 12203, United States|Novo Nordisk Investigational Site, West Seneca, New York, 14224, United States|Novo Nordisk Investigational Site, Charlotte, North Carolina, 28210, United States|Novo Nordisk Investigational Site, Charlotte, North Carolina, 28226, United States|Novo Nordisk Investigational Site, Charlotte, North Carolina, 28277, United States|Novo Nordisk Investigational Site, Kinston, North Carolina, 28501, United States|Novo Nordisk Investigational Site, Wilmington, North Carolina, 28401, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45245, United States|Novo Nordisk Investigational Site, Columbus, Ohio, 43212, United States|Novo Nordisk Investigational Site, McMurray, Pennsylvania, 15317, United States|Novo Nordisk Investigational Site, Pittsburgh, Pennsylvania, 15243, United States|Novo Nordisk Investigational Site, Moncks Corner, South Carolina, 29461, United States|Novo Nordisk Investigational Site, Mount Pleasant, South Carolina, 29464, United States|Novo Nordisk Investigational Site, Myrtle Beach, South Carolina, 29572, United States|Novo Nordisk Investigational Site, Spartanburg, South Carolina, 29303, United States|Novo Nordisk Investigational Site, Memphis, Tennessee, 38119, United States|Novo Nordisk Investigational Site, Nashville, Tennessee, 37203, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75231, United States|Novo Nordisk Investigational Site, Edinburg, Texas, 78539, United States|Novo Nordisk Investigational Site, Houston, Texas, 77024, United States|Novo Nordisk Investigational Site, Houston, Texas, 77030, United States|Novo Nordisk Investigational Site, Humble, Texas, 77338, United States|Novo Nordisk Investigational Site, Round Rock, Texas, 78681, United States|Novo Nordisk Investigational Site, Schertz, Texas, 78154, United States|Novo Nordisk Investigational Site, Spokane, Washington, 99201, United States|Novo Nordisk Investigational Site, Curitiba, Parana, 80030-110, Brazil|Novo Nordisk Investigational Site, Porto Alegre, Rio Grande Do Sul, 90035-170, Brazil|Novo Nordisk Investigational Site, São Paulo, Sao Paulo, 01228-000, Brazil|Novo Nordisk Investigational Site, Ahmedabad, Gujarat, 380008, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560 017, India|Novo Nordisk Investigational Site, Indore, Madhya Pradesh, 452010, India|Novo Nordisk Investigational Site, Pune, Maharashtra, 411004, India|Novo Nordisk Investigational Site, Jaipur, Rajasthan, 302006, India|Novo Nordisk Investigational Site, Coimbatore, Tamil Nadu, 641009, India|Novo Nordisk Investigational Site, Hyderabad, Telengana, 500003, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700080, India|Novo Nordisk Investigational Site, New Delhi, 110001, India|Novo Nordisk Investigational Site, Haifa, 35152, Israel|Novo Nordisk Investigational Site, Kfar Saba, 44281, Israel|Novo Nordisk Investigational Site, Tel Hashomer, 52621, Israel|Novo Nordisk Investigational Site, Tel-Aviv, 62038, Israel|Novo Nordisk Investigational Site, Ponce, 00716, Puerto Rico|Novo Nordisk Investigational Site, Saint-Petersburg, 190013, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 190068, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 195197, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 199226, Russian Federation|Novo Nordisk Investigational Site, St. Petersburg, 194354, Russian Federation|Novo Nordisk Investigational Site, Al Ain, 1006, United Arab Emirates|Novo Nordisk Investigational Site, Dubai, 7272, United Arab Emirates|Novo Nordisk Investigational Site, Umm Al Quwain, 24, United Arab Emirates|Novo Nordisk Investigational Site, Umm Al Quwain, 499, United Arab Emirates
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