SUSTAIN 9: Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus
Study Details
Study Description
Brief Summary
This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. Subjects will remain on their pre-trial medication.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Semaglutide
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Drug: Semaglutide
Semaglutide, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks
|
Placebo Comparator: Placebo
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Drug: Placebo
Semaglutide placebo, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks
|
Outcome Measures
Primary Outcome Measures
- Change in HbA1c [Week 0, week 30]
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.
Secondary Outcome Measures
- Change in Body Weight (kg) [Week 0, week 30]
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.
- Change in Fasting Plasma Glucose (FPG) [Week 0, week 30]
Change from baseline (week 0) in FPG was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
- Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean 7-point Profile [Week 0, week 30]
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.
- Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean Post Prandial Increment (Over All Meals) [Week 0, week 30]
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.
- Change in Fasting Blood Lipid, Total Cholesterol [Week 0, week 30]
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.
- Change in Fasting Blood Lipid, Low-density Lipoprotein (LDL) Cholesterol [Week 0, week 30]
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.
- Change in Fasting Blood Lipid, High-density Lipoprotein (HDL) Cholesterol [Week 0, week 30]
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.
- Change in Fasting Blood Lipid, Triglycerides [Week 0, week 30]
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.
- Change in Body Weight (%) [Week 0, week 30]
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.
- Change in Body Mass Index [Week 0, week 30]
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)'.
- Change in Waist Circumference [Week 0, week 30]
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.
- Change in Systolic Blood Pressure [Week 0, week 30]
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.
- Change in Diastolic Blood Pressure [Week 0, week 30]
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.
- 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 [Week 0, week 30]
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.
- 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 [Week 0, week 30]
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.
- HbA1c Below 7.0% (53 mmol/Mol) [After 30 weeks]
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.
- HbA1c Equal to or Below 6.5% (48 mmol/Mol) [After 30 weeks]
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.
- Weight Loss Equal to or Above 3% [After 30 weeks]
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.
- Weight Loss Equal to or Above 5% [After 30 weeks]
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.
- Weight Loss Equal to or Above 10% [After 30 weeks]
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.
- HbA1c Below 7.0% (53 mmol/Mol) Without Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain [After 30 weeks]
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.
- HbA1c Reduction Equal to or Above 1%-Point [After 30 weeks]
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.
- HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 3% [After 30 weeks]
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.
- HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 5% [After 30 weeks]
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.
- HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 10% [After 30 weeks]
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.
- Number of Treatment-emergent Adverse Events (TEAEs) [Week 0 - week 30]
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.
- Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes [Week 0 - week 30]
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.
- Change in Haematology: Haemoglobin [Week 0, week 30]
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.
- Change in Haematology: Haematocrit [Week 0, week 30]
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.
- Change in Haematology: Thrombocytes [Week 0, week 30]
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.
- Change in Haematology: Erythrocytes [Week 0, week 30]
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.
- Change in Haematology: Leucocytes [Week 0, week 30]
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.
- Change in Biochemistry: Amylase [Week 0, week 30]
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.
- Change in Biochemistry: Lipase [Week 0, week 30]
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.
- Change in Biochemistry: Alkaline Phosphatase [Week 0, week 30]
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.
- Change in Biochemistry: Alanine Aminotransferase [Week 0, week 30]
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.
- Change in Biochemistry: Aspartate Aminotransferase [Week 0, week 30]
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.
- Change in Biochemistry: Total Bilirubin [Week 0, week 30]
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.
- Change in Biochemistry: Albumin [Week 0, week 30]
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.
- Change in Biochemistry: Calcium (Total) [Week 0, week 30]
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.
- Change in Biochemistry: Potassium [Week 0, week 30]
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.
- Change in Biochemistry: Sodium [Week 0, week 30]
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.
- Change in Biochemistry: Bicarbonate [Week 0, week 30]
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.
- Change in Biochemistry: Estimated Glomerular Filtration Rate (eGFR) [Week 0, week 30]
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.
- Change in Biochemistry: Creatinine [Week 0, week 30]
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.
- Change in Calcitonin [Week 0, week 30]
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.
- Change in Pulse [Week 0, week 30]
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.
- Change in Electrocardiogram [Week 0, week 30]
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.
- Change in Physical Examination: General Appearance [Week -2, week 30]
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.
- Change in Physical Examination: Central and Peripheral Nervous System [Week -2, week 30]
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.
- Change in Physical Examination: Cardiovascular System [Week -2, week 30]
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.
- Change in Physical Examination: Gastrointestinal System Including Mouth [Week -2, week 30]
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.
- Change in Physical Examination: Skin [Week -2, week 30]
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.
- Change in Physical Examination: Respiratory System [Week -2, week 30]
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.
- Change in Physical Examination: Lymph Node Palpation [Week -2, week 30]
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.
- Change in Physical Examination: Thyroid Gland [Week -2, week 30]
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.
- Change in Fundoscopy [Week 0, week 30]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Male or female, above or equal to 18 years at the time of signing informed consent. For Japan only: Male or female, age equal to or above 20 years at the time of signing informed consent
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Diagnosed with type 2 diabetes mellitus
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HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive)
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Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed-dose drug combination) with a stable dose of metformin (equal to or above 1500 mg or maximum tolerated dose) or a SU for at least 90 days prior to the day of screening. All medications in compliance with current local label
Exclusion Criteria:
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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 measure as required by local regulation or practice)
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Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
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Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed
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Subjects with alanine aminotransferase above 2.5 x upper normal limit
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Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative
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History or presence of pancreatitis (acute or chronic)
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History of diabetic ketoacidosis
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Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
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Subjects presently classified as being in New York Heart Association Class IV
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Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
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Renal impairment measured as estimated Glomerular Filtration Rate value of eGFR below 60 ml/min/1.73 m^2 as defined by KDIGO 2012 classification using isotope dilution mass spectrometry for serum creatinine measured at screening
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Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation
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Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Novo Nordisk Investigational Site | Andalusia | Alabama | United States | 36420 |
2 | Novo Nordisk Investigational Site | Anniston | Alabama | United States | 36207 |
3 | Novo Nordisk Investigational Site | Glendale | Arizona | United States | 85308 |
4 | Novo Nordisk Investigational Site | Phoenix | Arizona | United States | 85037 |
5 | Novo Nordisk Investigational Site | Tempe | Arizona | United States | 85283 |
6 | Novo Nordisk Investigational Site | Little Rock | Arkansas | United States | 72211 |
7 | Novo Nordisk Investigational Site | La Jolla | California | United States | 92037 |
8 | Novo Nordisk Investigational Site | Lincoln | California | United States | 95648 |
9 | Novo Nordisk Investigational Site | Northridge | California | United States | 91325 |
10 | Novo Nordisk Investigational Site | Edgewater | Florida | United States | 32132 |
11 | Novo Nordisk Investigational Site | Maitland | Florida | United States | 32751-4422 |
12 | Novo Nordisk Investigational Site | Lawrenceville | Georgia | United States | 30046 |
13 | Novo Nordisk Investigational Site | Woodstock | Georgia | United States | 30189-4255 |
14 | Novo Nordisk Investigational Site | Hutchinson | Kansas | United States | 67502-1131 |
15 | Novo Nordisk Investigational Site | Lexington | Kentucky | United States | 40503 |
16 | Novo Nordisk Investigational Site | Baltimore | Maryland | United States | 21204 |
17 | Novo Nordisk Investigational Site | Troy | Michigan | United States | 48098 |
18 | Novo Nordisk Investigational Site | Jefferson City | Missouri | United States | 65109 |
19 | Novo Nordisk Investigational Site | Albany | New York | United States | 12206 |
20 | Novo Nordisk Investigational Site | Smithtown | New York | United States | 11787 |
21 | Novo Nordisk Investigational Site | West Seneca | New York | United States | 14224 |
22 | Novo Nordisk Investigational Site | Charlotte | North Carolina | United States | 28207 |
23 | Novo Nordisk Investigational Site | Charlotte | North Carolina | United States | 28226 |
24 | Novo Nordisk Investigational Site | Gastonia | North Carolina | United States | 28054 |
25 | Novo Nordisk Investigational Site | Greenville | North Carolina | United States | 27834 |
26 | Novo Nordisk Investigational Site | Kinston | North Carolina | United States | 28501 |
27 | Novo Nordisk Investigational Site | Morehead City | North Carolina | United States | 28557-4346 |
28 | Novo Nordisk Investigational Site | Norman | Oklahoma | United States | 73069 |
29 | Novo Nordisk Investigational Site | Beaver | Pennsylvania | United States | 15009 |
30 | Novo Nordisk Investigational Site | McMurray | Pennsylvania | United States | 15317 |
31 | Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | United States | 15243 |
32 | Novo Nordisk Investigational Site | Arlington | Texas | United States | 76012-4637 |
33 | Novo Nordisk Investigational Site | Austin | Texas | United States | 78745 |
34 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75208 |
35 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75231 |
36 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77081 |
37 | Novo Nordisk Investigational Site | Irving | Texas | United States | 75061-2210 |
38 | Novo Nordisk Investigational Site | Shavano Park | Texas | United States | 78231 |
39 | Novo Nordisk Investigational Site | Sugar Land | Texas | United States | 77479 |
40 | Novo Nordisk Investigational Site | Victoria | Texas | United States | 77901 |
41 | Novo Nordisk Investigational Site | Murray | Utah | United States | 84123 |
42 | Novo Nordisk Investigational Site | Chesapeake | Virginia | United States | 23321 |
43 | Novo Nordisk Investigational Site | Olympia | Washington | United States | 98502 |
44 | Novo Nordisk Investigational Site | Saint Stefan | Austria | 8511 | |
45 | Novo Nordisk Investigational Site | Wien | Austria | 1030 | |
46 | Novo Nordisk Investigational Site | Wien | Austria | 1060 | |
47 | Novo Nordisk Investigational Site | Wien | Austria | 1130 | |
48 | Novo Nordisk Investigational Site | Edmonton | Alberta | Canada | T6H 2L4 |
49 | Novo Nordisk Investigational Site | Winnipeg | Manitoba | Canada | R3E 3P4 |
50 | Novo Nordisk Investigational Site | Brampton | Ontario | Canada | L6S 0C6 |
51 | Novo Nordisk Investigational Site | Brampton | Ontario | Canada | L6T 0G1 |
52 | Novo Nordisk Investigational Site | Etobicoke | Ontario | Canada | M9R 4E1 |
53 | Novo Nordisk Investigational Site | Smiths Falls | Ontario | Canada | K7A 4W8 |
54 | Novo Nordisk Investigational Site | Toronto | Ontario | Canada | M5T 3L9 |
55 | Novo Nordisk Investigational Site | Waterloo | Ontario | Canada | N2J 1C4 |
56 | Novo Nordisk Investigational Site | Kanagawa | Japan | 232-0064 | |
57 | Novo Nordisk Investigational Site | Nagakute-shi, Aichi | Japan | 480-1195 | |
58 | Novo Nordisk Investigational Site | Suita-shi, Osaka | Japan | 565-0853 | |
59 | Novo Nordisk Investigational Site | Tokyo | Japan | 160-0008 | |
60 | Novo Nordisk Investigational Site | Hamar | Norway | 2317 | |
61 | Novo Nordisk Investigational Site | Hoenefoss | Norway | 3515 | |
62 | Novo Nordisk Investigational Site | Namsos | Norway | 7801 | |
63 | Novo Nordisk Investigational Site | Olso | Norway | 0953 | |
64 | Novo Nordisk Investigational Site | Oslo | Norway | 0176 | |
65 | Novo Nordisk Investigational Site | Skedsmokorset | Norway | NO-2020 | |
66 | Novo Nordisk Investigational Site | Stavanger | Norway | 4005 | |
67 | Novo Nordisk Investigational Site | Ponce | Puerto Rico | 00716 | |
68 | Novo Nordisk Investigational Site | Barnaul | Russian Federation | 656045 | |
69 | Novo Nordisk Investigational Site | Novosibirsk | Russian Federation | 630099 | |
70 | Novo Nordisk Investigational Site | Saint-Petersburg | Russian Federation | 191119 | |
71 | Novo Nordisk Investigational Site | Saint-Petersburg | Russian Federation | 194358 | |
72 | Novo Nordisk Investigational Site | St. Petersburg | Russian Federation | 194354 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- NN9535-4269
- 2016-000904-27
- U1111-1180-1213
- JapicCTI-173542
Study Results
Participant Flow
Recruitment Details | The trial was conducted at 61 sites in 6 countries as follows: Austria (4 sites), Canada (8 sites), Japan (4 sites), Norway (4 sites), Russian Federation (5 sites), United States of America (USA) (36 sites). In addition, 1 site in Norway and 3 sites in the USA screened, but didn't randomise any participant. |
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Pre-assignment Detail |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
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Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as subcutaneous (s.c.) injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Period Title: Overall Study | ||
STARTED | 151 | 151 |
Exposed | 150 | 151 |
COMPLETED | 147 | 147 |
NOT COMPLETED | 4 | 4 |
Baseline Characteristics
Arm/Group Title | Semaglutide 1.0 mg | Placebo | Total |
---|---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. | Total of all reporting groups |
Overall Participants | 151 | 151 | 302 |
Age (Years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Years] |
57.5
(8.9)
|
56.6
(10.1)
|
57.0
(9.5)
|
Sex: Female, Male (Count of Participants) | |||
Female |
62
41.1%
|
64
42.4%
|
126
41.7%
|
Male |
89
58.9%
|
87
57.6%
|
176
58.3%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
9
6%
|
13
8.6%
|
22
7.3%
|
Not Hispanic or Latino |
142
94%
|
138
91.4%
|
280
92.7%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race/Ethnicity, Customized (Count of Participants) | |||
American Indian or Alaska native |
2
1.3%
|
0
0%
|
2
0.7%
|
Asian |
36
23.8%
|
35
23.2%
|
71
23.5%
|
Black or African American |
9
6%
|
4
2.6%
|
13
4.3%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
White |
100
66.2%
|
109
72.2%
|
209
69.2%
|
Other |
4
2.6%
|
3
2%
|
7
2.3%
|
Glycosylated haemoglobin (HbA1c) (Percentage HbA1c) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Percentage HbA1c] |
8.0
(0.8)
|
8.1
(0.8)
|
8.0
(0.8)
|
Outcome Measures
Title | Change in HbA1c |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 151 | 151 |
Mean (Standard Deviation) [Percentage of HbA1c] |
-1.6
(0.8)
|
-0.2
(0.9)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Semaglutide 1.0 mg, Placebo |
---|---|---|
Comments | The responses were analysed using an analysis of covariance (ANCOVA) with treatment, stratification factor and region as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including stratification factor and region as categorical effects and data from baseline and all previous visits as covariates. | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | ANCOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | Treatment difference |
Estimated Value | -1.42 | |
Confidence Interval |
(2-Sided) 95% -1.61 to -1.24 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Change in Body Weight (kg) |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 151 | 151 |
Mean (Standard Deviation) [Kg] |
-4.7
(4.3)
|
-1.0
(3.1)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Semaglutide 1.0 mg, Placebo |
---|---|---|
Comments | The responses were analysed using an ANCOVA with treatment, stratification factor and region as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including stratification factor and region as categorical effects and data from baseline and all previous visits as covariates. | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | ANCOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | Treatment difference |
Estimated Value | -3.81 | |
Confidence Interval |
(2-Sided) 95% -4.70 to -2.93 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Change in Fasting Plasma Glucose (FPG) |
---|---|
Description | Change from baseline (week 0) in FPG was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 151 | 151 |
Mean (Standard Deviation) [mmol/L] |
-2.26
(2.05)
|
0.07
(2.07)
|
Title | Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean 7-point Profile |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 151 | 151 |
Mean (Standard Deviation) [mmol/L] |
-2.6
(1.9)
|
-0.3
(2.0)
|
Title | Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean Post Prandial Increment (Over All Meals) |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 151 | 151 |
Mean (Standard Deviation) [mmol/L] |
-1.2
(2.0)
|
0.0
(2.2)
|
Title | Change in Fasting Blood Lipid, Total Cholesterol |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 151 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [Ratio] |
0.91
(19.4)
|
1.02
(18.9)
|
Title | Change in Fasting Blood Lipid, Low-density Lipoprotein (LDL) Cholesterol |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 151 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [Ratio] |
0.90
(31.6)
|
1.04
(27.7)
|
Title | Change in Fasting Blood Lipid, High-density Lipoprotein (HDL) Cholesterol |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 151 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [Ratio] |
0.99
(15.8)
|
1.01
(13.9)
|
Title | Change in Fasting Blood Lipid, Triglycerides |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 151 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [Ratio] |
0.81
(41.3)
|
0.97
(38.7)
|
Title | Change in Body Weight (%) |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 151 | 151 |
Mean (Standard Deviation) [Percentage] |
-5.4
(4.8)
|
-1.0
(3.1)
|
Title | Change in Body Mass Index |
---|---|
Description | 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)'. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 151 | 151 |
Mean (Standard Deviation) [Kg/sqm] |
-1.7
(1.5)
|
-0.4
(1.1)
|
Title | Change in Waist Circumference |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 151 | 151 |
Mean (Standard Deviation) [cm] |
-4.4
(5.5)
|
-1.8
(4.5)
|
Title | Change in Systolic Blood Pressure |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 151 | 151 |
Mean (Standard Deviation) [mmHg] |
-4.3
(14.5)
|
1.1
(12.3)
|
Title | Change in Diastolic Blood Pressure |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 151 | 151 |
Mean (Standard Deviation) [mmHg] |
-0.1
(8.1)
|
-0.1
(6.7)
|
Title | 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 |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. Results are based on the 'on-treatment without rescue medication' observation period. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 151 | 151 |
Physical component summary |
1.9
(4.9)
|
0.7
(5.4)
|
1) Physical functioning |
1.3
(4.1)
|
1.1
(5.2)
|
2) Role functioning |
1.5
(6.1)
|
0.0
(6.0)
|
3) Bodily pain |
0.9
(7.4)
|
0.1
(8.1)
|
4) General health |
2.7
(6.8)
|
0.1
(6.8)
|
Mental component summary |
0.1
(5.6)
|
-0.9
(6.3)
|
5) Vitality |
1.5
(6.2)
|
0.2
(6.7)
|
6) Social functioning |
0.3
(7.3)
|
-1.0
(7.4)
|
7) Role emotional |
0.1
(6.7)
|
-0.2
(7.5)
|
8) Mental health |
0.5
(5.2)
|
-0.6
(6.0)
|
Title | 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 |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 151 | 151 |
1) Feeling of unacceptably high blood sugars |
-2.2
(1.9)
|
-0.8
(2.2)
|
2) Feeling of unacceptably low blood sugars |
0.3
(1.5)
|
-0.4
(1.5)
|
Total treatment satisfaction score (Sum of 3-8) |
4.2
(6.6)
|
1.9
(7.0)
|
3) Satisfaction with current treatment |
0.8
(1.6)
|
0.2
(1.4)
|
4) Convenience of current treatment |
0.7
(1.3)
|
0.5
(1.3)
|
5) Flexibility of current treatment |
0.7
(1.5)
|
0.4
(1.7)
|
6) Satisfaction with understanding of diabetes |
0.5
(1.2)
|
0.5
(1.5)
|
7) Recommending treatment to others |
0.8
(1.3)
|
0.2
(1.8)
|
8) Satisfaction to continue with present treatment |
0.8
(1.7)
|
0.2
(1.7)
|
Title | HbA1c Below 7.0% (53 mmol/Mol) |
---|---|
Description | 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. |
Time Frame | After 30 weeks |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 120 | 127 |
Number [Percentage of participants] |
82.5
54.6%
|
20.5
13.6%
|
Title | HbA1c Equal to or Below 6.5% (48 mmol/Mol) |
---|---|
Description | 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. |
Time Frame | After 30 weeks |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 120 | 127 |
Number [Percentage of participants] |
60.0
39.7%
|
3.9
2.6%
|
Title | Weight Loss Equal to or Above 3% |
---|---|
Description | 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. |
Time Frame | After 30 weeks |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 121 | 128 |
Number [Percentage of participants] |
69.4
46%
|
21.1
14%
|
Title | Weight Loss Equal to or Above 5% |
---|---|
Description | 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. |
Time Frame | After 30 weeks |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 121 | 128 |
Number [Percentage of participants] |
50.4
33.4%
|
7.8
5.2%
|
Title | Weight Loss Equal to or Above 10% |
---|---|
Description | 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. |
Time Frame | After 30 weeks |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 121 | 128 |
Number [Percentage of participants] |
15.7
10.4%
|
1.6
1.1%
|
Title | HbA1c Below 7.0% (53 mmol/Mol) Without Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain |
---|---|
Description | 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. |
Time Frame | After 30 weeks |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 120 | 127 |
Number [Percentage of participants] |
72.5
48%
|
17.3
11.5%
|
Title | HbA1c Reduction Equal to or Above 1%-Point |
---|---|
Description | 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. |
Time Frame | After 30 weeks |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 120 | 127 |
Number [Percentage of participants] |
80.8
53.5%
|
15.0
9.9%
|
Title | HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 3% |
---|---|
Description | 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. |
Time Frame | After 30 weeks |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 120 | 127 |
Number [Percentage of participants] |
56.7
37.5%
|
7.9
5.2%
|
Title | HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 5% |
---|---|
Description | 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. |
Time Frame | After 30 weeks |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 120 | 127 |
Number [Percentage of participants] |
41.7
27.6%
|
4.7
3.1%
|
Title | HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 10% |
---|---|
Description | 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. |
Time Frame | After 30 weeks |
Outcome Measure Data
Analysis Population Description |
---|
FAS which included all randomised participants. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 120 | 127 |
Number [Percentage of participants] |
15.0
9.9%
|
1.6
1.1%
|
Title | Number of Treatment-emergent Adverse Events (TEAEs) |
---|---|
Description | 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. |
Time Frame | Week 0 - week 30 |
Outcome Measure Data
Analysis Population Description |
---|
Safety analysis set (SAS), which included all participants exposed to at least one dose of trial product (semaglutide or placebo). |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Number [Events] |
356
|
247
|
Title | Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes |
---|---|
Description | 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. |
Time Frame | Week 0 - week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS, which included all participants exposed to at least one dose of trial product. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Number [Episodes] |
4
|
0
|
Title | Change in Haematology: Haemoglobin |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [mmol/L] |
1.1
(22.1)
|
1.1
(29.3)
|
Title | Change in Haematology: Haematocrit |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [% of red blood cells] |
1.4
(130.3)
|
1.1
(155.1)
|
Title | Change in Haematology: Thrombocytes |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [10^9 thrombocytes/L] |
25.3
(94.9)
|
20.2
(100.7)
|
Title | Change in Haematology: Erythrocytes |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [10^12 erythrocytes/L] |
0.16
(111.0)
|
0.11
(168.3)
|
Title | Change in Haematology: Leucocytes |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [10^9 leucocytes/L] |
0.65
(186.6)
|
0.54
(146.8)
|
Title | Change in Biochemistry: Amylase |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [U/L] |
10.2
(113.8)
|
5.0
(121.7)
|
Title | Change in Biochemistry: Lipase |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [U/L] |
11.6
(140.2)
|
4.5
(171.8)
|
Title | Change in Biochemistry: Alkaline Phosphatase |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [U/L] |
4.6
(171.2)
|
7.2
(106.7)
|
Title | Change in Biochemistry: Alanine Aminotransferase |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [U/L] |
4.5
(123.2)
|
4.8
(166.7)
|
Title | Change in Biochemistry: Aspartate Aminotransferase |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [U/L] |
3.4
(112.3)
|
3.5
(90.1)
|
Title | Change in Biochemistry: Total Bilirubin |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [umol/L] |
2.3
(128.1)
|
1.7
(134.8)
|
Title | Change in Biochemistry: Albumin |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [g/dL] |
0.1
(45.4)
|
0.1
(48.6)
|
Title | Change in Biochemistry: Calcium (Total) |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [mmol/L] |
0.04
(125.0)
|
0.05
(88.9)
|
Title | Change in Biochemistry: Potassium |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [mmol/L] |
0.3
(89.5)
|
0.2
(73.7)
|
Title | Change in Biochemistry: Sodium |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [mmol/L] |
1.7
(55.8)
|
1.5
(48.4)
|
Title | Change in Biochemistry: Bicarbonate |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [mmol/L] |
2.2
(67.6)
|
2.1
(69.0)
|
Title | Change in Biochemistry: Estimated Glomerular Filtration Rate (eGFR) |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [mL/min/1.73m2] |
3.4
(114.8)
|
3.2
(105.6)
|
Title | Change in Biochemistry: Creatinine |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [umol/L] |
4.6
(118.8)
|
2.6
(191.5)
|
Title | Change in Calcitonin |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Geometric Mean (Geometric Coefficient of Variation) [ng/L] |
1.3
(172.1)
|
1.7
(171.1)
|
Title | Change in Pulse |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Mean (Standard Deviation) [beats/min] |
4.0
(9.6)
|
0.1
(8.4)
|
Title | Change in Electrocardiogram |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Week 0: Normal |
62.4
41.3%
|
66.2
43.8%
|
Week 0: Abnormal, NCS |
36.9
24.4%
|
32.5
21.5%
|
Week 0: Abnormal, CS |
0.7
0.5%
|
1.3
0.9%
|
Week 30: Normal |
64.3
42.6%
|
66.4
44%
|
Week 30: Abnormal, NCS |
34.9
23.1%
|
32.2
21.3%
|
Week 30: Abnormal, CS |
0.8
0.5%
|
1.4
0.9%
|
Title | Change in Physical Examination: General Appearance |
---|---|
Description | 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. |
Time Frame | Week -2, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Week -2: Normal |
90.0
59.6%
|
86.0
57%
|
Week -2: Abnormal, NCS |
10.0
6.6%
|
14.0
9.3%
|
Week -2: Abnormal, CS |
0
0%
|
0
0%
|
Week 30: Normal |
87.6
58%
|
87.1
57.7%
|
Week 30: Abnormal, NCS |
11.6
7.7%
|
12.2
8.1%
|
Week 30: Abnormal, CS |
0.8
0.5%
|
0.7
0.5%
|
Title | Change in Physical Examination: Central and Peripheral Nervous System |
---|---|
Description | 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. |
Time Frame | Week -2, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Week -2: Normal |
92.0
60.9%
|
86.7
57.4%
|
Week -2: Abnormal, NCS |
7.3
4.8%
|
12.7
8.4%
|
Week -2: Abnormal, CS |
0.7
0.5%
|
0.7
0.5%
|
Week 30: Normal |
94.2
62.4%
|
87.8
58.1%
|
Week 30: Abnormal, NCS |
5.0
3.3%
|
12.2
8.1%
|
Week 30: Abnormal, CS |
0.8
0.5%
|
0
0%
|
Title | Change in Physical Examination: Cardiovascular System |
---|---|
Description | 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. |
Time Frame | Week -2, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Week -2: Normal |
98.7
65.4%
|
93.3
61.8%
|
Week -2: Abnormal, NCS |
1.3
0.9%
|
6.0
4%
|
Week -2: Abnormal, CS |
0
0%
|
0.7
0.5%
|
Week 30: Normal |
98.3
65.1%
|
92.8
61.5%
|
Week 30: Abnormal, NCS |
1.7
1.1%
|
7.2
4.8%
|
Week 30: Abnormal, CS |
0
0%
|
0
0%
|
Title | Change in Physical Examination: Gastrointestinal System Including Mouth |
---|---|
Description | 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. |
Time Frame | Week -2, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Week -2: Normal |
93.3
61.8%
|
93.3
61.8%
|
Week -2: Abnormal, NCS |
6.7
4.4%
|
6.7
4.4%
|
Week -2: Abnormal, CS |
0
0%
|
0
0%
|
Week 30: Normal |
95.9
63.5%
|
94.2
62.4%
|
Week 30: Abnormal, NCS |
3.3
2.2%
|
5.8
3.8%
|
Week 30: Abnormal, CS |
0.8
0.5%
|
0
0%
|
Title | Change in Physical Examination: Skin |
---|---|
Description | 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. |
Time Frame | Week -2, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Week -2: Normal |
91.3
60.5%
|
93.3
61.8%
|
Week -2: Abnormal, NCS |
8.7
5.8%
|
6.7
4.4%
|
Week -2: Abnormal, CS |
0
0%
|
0
0%
|
Week 30: Normal |
93.4
61.9%
|
95.0
62.9%
|
Week 30: Abnormal, NCS |
6.6
4.4%
|
4.3
2.8%
|
Week 30: Abnormal, CS |
0
0%
|
0.7
0.5%
|
Title | Change in Physical Examination: Respiratory System |
---|---|
Description | 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. |
Time Frame | Week -2, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Week -2: Normal |
100
66.2%
|
98.7
65.4%
|
Week -2: Abnormal, NCS |
0
0%
|
1.3
0.9%
|
Week -2: Abnormal, CS |
0
0%
|
0
0%
|
Week 30: Normal |
100
66.2%
|
99.3
65.8%
|
Week 30: Abnormal, NCS |
0
0%
|
0.7
0.5%
|
Week 30: Abnormal, CS |
0
0%
|
0
0%
|
Title | Change in Physical Examination: Lymph Node Palpation |
---|---|
Description | 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. |
Time Frame | Week -2, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Week -2: Normal |
99.3
65.8%
|
100
66.2%
|
Week -2: Abnormal, NCS |
0.7
0.5%
|
0
0%
|
Week -2: Abnormal, CS |
0
0%
|
0
0%
|
Week 30: Normal |
99.2
65.7%
|
100
66.2%
|
Week 30: Abnormal, NCS |
0
0%
|
0
0%
|
Week 30: Abnormal, CS |
0.8
0.5%
|
0
0%
|
Title | Change in Physical Examination: Thyroid Gland |
---|---|
Description | 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. |
Time Frame | Week -2, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Week -2: Normal |
98.0
64.9%
|
96.7
64%
|
Week -2: Abnormal, NCS |
2.0
1.3%
|
3.3
2.2%
|
Week -2: Abnormal, CS |
0
0%
|
0
0%
|
Week 30: Normal |
99.2
65.7%
|
97.1
64.3%
|
Week 30: Abnormal, NCS |
0.8
0.5%
|
2.9
1.9%
|
Week 30: Abnormal, CS |
0
0%
|
0
0%
|
Title | Change in Fundoscopy |
---|---|
Description | 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. |
Time Frame | Week 0, week 30 |
Outcome Measure Data
Analysis Population Description |
---|
SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data. |
Arm/Group Title | Semaglutide 1.0 mg | Placebo |
---|---|---|
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. |
Measure Participants | 150 | 151 |
Left eye: Week 0; normal |
70.7
46.8%
|
62.0
41.1%
|
Left eye: Week 0; abnormal, NCS |
24.7
16.4%
|
32.7
21.7%
|
Left eye: Week 0; abnormal, CS |
4.7
3.1%
|
5.3
3.5%
|
Left eye: Week 30; normal |
79.3
52.5%
|
64.1
42.5%
|
Left eye: Week 30; abnormal, NCS |
17.1
11.3%
|
31.5
20.9%
|
Left eye: Week 30; abnormal, CS |
3.7
2.5%
|
4.3
2.8%
|
Right eye: Week 0; normal |
69.3
45.9%
|
62.4
41.3%
|
Right eye: Week 0; abnormal, NCS |
25.3
16.8%
|
30.9
20.5%
|
Right eye: Week 0; abnormal, CS |
5.3
3.5%
|
6.7
4.4%
|
Right eye: Week 30; normal |
75.6
50.1%
|
63.7
42.2%
|
Right eye: Week 30; abnormal, NCS |
19.5
12.9%
|
31.9
21.1%
|
Right eye: Week 30; abnormal, CS |
4.9
3.2%
|
4.4
2.9%
|
Adverse Events
Time Frame | Week 0 to week 30 (treatment period) + 42 days (follow-up period). All the reported adverse events (AEs) are TEAEs. | |||
---|---|---|---|---|
Adverse Event Reporting Description | Results are based on the SAS. Treatment with semaglutide or placebo followed a fixed dose escalation. The maintenance dose of semaglutide 1.0 mg was reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg. The same fixed dose escalation scheme was followed for placebo, with respective dose matching volume. Hence, the adverse events are combinedly presented under 2 respective reporting groups, 'semaglutide 1.0 mg and placebo'. | |||
Arm/Group Title | Semaglutide 1.0 mg | Placebo | ||
Arm/Group Description | Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. | ||
All Cause Mortality |
||||
Semaglutide 1.0 mg | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/150 (0%) | 0/151 (0%) | ||
Serious Adverse Events |
||||
Semaglutide 1.0 mg | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 7/150 (4.7%) | 6/151 (4%) | ||
Cardiac disorders | ||||
Angina unstable | 1/150 (0.7%) | 1 | 0/151 (0%) | 0 |
Coronary artery disease | 1/150 (0.7%) | 1 | 0/151 (0%) | 0 |
Eye disorders | ||||
Retinal artery occlusion | 1/150 (0.7%) | 1 | 0/151 (0%) | 0 |
Gastrointestinal disorders | ||||
Colitis ischaemic | 1/150 (0.7%) | 1 | 0/151 (0%) | 0 |
Infections and infestations | ||||
Gastroenteritis bacterial | 0/150 (0%) | 0 | 1/151 (0.7%) | 1 |
Neurocysticercosis | 1/150 (0.7%) | 1 | 0/151 (0%) | 0 |
Injury, poisoning and procedural complications | ||||
Accidental overdose | 1/150 (0.7%) | 1 | 0/151 (0%) | 0 |
Ankle fracture | 0/150 (0%) | 0 | 1/151 (0.7%) | 1 |
Lower limb fracture | 0/150 (0%) | 0 | 1/151 (0.7%) | 1 |
Musculoskeletal and connective tissue disorders | ||||
Osteoarthritis | 0/150 (0%) | 0 | 1/151 (0.7%) | 1 |
Osteonecrosis | 0/150 (0%) | 0 | 1/151 (0.7%) | 1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Laryngeal squamous cell carcinoma | 0/150 (0%) | 0 | 1/151 (0.7%) | 1 |
Nervous system disorders | ||||
Transient ischaemic attack | 1/150 (0.7%) | 2 | 0/151 (0%) | 0 |
Renal and urinary disorders | ||||
Acute kidney injury | 1/150 (0.7%) | 1 | 0/151 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||
Chronic obstructive pulmonary disease | 1/150 (0.7%) | 3 | 0/151 (0%) | 0 |
Surgical and medical procedures | ||||
Thyroidectomy | 1/150 (0.7%) | 1 | 0/151 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
Semaglutide 1.0 mg | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 49/150 (32.7%) | 28/151 (18.5%) | ||
Eye disorders | ||||
Diabetic retinopathy | 2/150 (1.3%) | 2 | 8/151 (5.3%) | 9 |
Gastrointestinal disorders | ||||
Constipation | 10/150 (6.7%) | 10 | 0/151 (0%) | 0 |
Diarrhoea | 17/150 (11.3%) | 21 | 9/151 (6%) | 11 |
Nausea | 29/150 (19.3%) | 37 | 5/151 (3.3%) | 7 |
Vomiting | 14/150 (9.3%) | 21 | 3/151 (2%) | 3 |
Infections and infestations | ||||
Nasopharyngitis | 8/150 (5.3%) | 9 | 8/151 (5.3%) | 11 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Results Point of Contact
Name/Title | Clinical Reporting Anchor and Disclosure (1452) |
---|---|
Organization | Novo Nordisk A/S |
Phone | (+1) 866-867-7178 |
clinicaltrials@novonordisk.com |
- NN9535-4269
- 2016-000904-27
- U1111-1180-1213
- JapicCTI-173542