Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes
Official Title
Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes
Acronym
Not provided
Organization
Novo Nordisk A/SINDUSTRY
Status Module
Record Verification Date
Jan 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2, 2013Actual
Primary Completion Date
Dec 11, 2014Actual
Completion Date
Dec 11, 2014Actual
First Submitted Date
Aug 13, 2013
First Submission Date that Met QC Criteria
Aug 13, 2013
First Posted Date
Aug 15, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 15, 2019
Results First Submitted that Met QC Criteria
Oct 15, 2019
Results First Posted Date
Nov 5, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Mar 30, 2017
Certification/Extension First Submitted that Passed QC Review
Mar 30, 2017
Certification/Extension First Posted Date
Mar 31, 2017Actual
Last Update Submitted Date
Jan 14, 2021
Last Update Posted Date
Jan 15, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novo Nordisk A/SINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This trial is conducted globally. The aim of the trial is to examine the dose range, escalation and efficacy of oral semaglutide in subjects with type 2 diabetes.
Detailed Description
Not provided
Conditions Module
Conditions
Diabetes
Diabetes Mellitus, Type 2
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
632Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1:Semaglutide tablets : 2.5 mg
Experimental
2.5 mg for 26 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: semaglutide
2:Semaglutide tablets: 2.5 mg/5 mg
Experimental
2.5 mg for 4 weeks, then 5.0 mg for 22 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: semaglutide
3:Semaglutide tablets: 5.0 mg/10 mg
Experimental
5.0 mg for 4 weeks, then 10 mg for 22 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: semaglutide
4:Semaglutide tablets:5.0 mg/10 mg/20 mg
Experimental
5.0 mg for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 18 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: semaglutide
Interventions
Name
Type
Description
Arm Group Labels
Other Names
semaglutide
Drug
Once-daily oral administration as tablets.
1:Semaglutide tablets : 2.5 mg
2:Semaglutide tablets: 2.5 mg/5 mg
3:Semaglutide tablets: 5.0 mg/10 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change in HbA1c (Glycosylated Haemoglobin)
Change from baseline (week 0) in HbA1c was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Week 0, week 26
Secondary Outcomes
Measure
Description
Time Frame
Subjects Who Achieve (Yes/no) HbA1c Below 7 Percent (53 mmol/Mol)
Participants who achieved HbA1c <7.0%, was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
BMI above or equal to 25 and below or equal to 40 kg/m^2
Subjects diagnosed with T2D (Type 2 diabetes) treated with diet and exercise and/or who have been on a stable dose of metformin for at least 30 days prior to screening
HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive)
Exclusion Criteria:
Subjects on selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants
History of chronic pancreatitis or idiopathic acute pancreatitis
Chronic malabsorption, regardless of aetiology
History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
Treatment with glucose lowering agent(s) other than metformin as stated in the inclusion criteria in a period of 90 days before the screening visit
Davies M, Pieber TR, Hartoft-Nielsen ML, Hansen OKH, Jabbour S, Rosenstock J. Effect of Oral Semaglutide Compared With Placebo and Subcutaneous Semaglutide on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2017 Oct 17;318(15):1460-1470. doi: 10.1001/jama.2017.14752.
Data presented in "participant flow" is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Recruitment Details
The trial was conducted at 100 sites in 14 countries as follows: Austria (6), Bulgaria (3), Canada (6), Denmark (6), Germany (6), Israel (6), Italy (4), Malaysia (4), Serbia (1), South Africa (3), Spain (5), Sweden (3), United Kingdom (8) and United States (39).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Oral Semaglutide 2.5 mg
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Aug 24, 2016
Oct 15, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
5:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg
Experimental
5.0 mg for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 4 weeks, then 40 mg for 14 weeks.
All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: semaglutide
6:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg
Experimental
5.0 mg for 8 weeks, then 10 mg for 8 weeks, then 20 mg for 8 weeks, then 40 mg for 2 weeks All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: semaglutide
7:Semaglutide tablets: 5.0 mg/10 mg/20 mg/40 mg
Experimental
5.0 mg for 2 weeks, then 10 mg for 2 weeks, then 20 mg for 2 weeks, then 40 mg for 20 weeks.
All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: semaglutide
8:Placebo tablets
Placebo Comparator
All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: oral placebo
9:Semaglutide injections :0.25 mg/0.50 mg/1.0 mg
Active Comparator
0.25 mg for 4 weeks, then 0.50 mg for 4 weeks, then 1.0 mg for 18 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: semaglutide
4:Semaglutide tablets:5.0 mg/10 mg/20 mg
5:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg
6:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg
7:Semaglutide tablets: 5.0 mg/10 mg/20 mg/40 mg
semaglutide
Drug
Once-weekly,injected s.c./subcutaneously (under the skin) using a pen
9:Semaglutide injections :0.25 mg/0.50 mg/1.0 mg
oral placebo
Drug
Once-daily oral administration as tablets.
8:Placebo tablets
After 26 weeks of treatment
Change in Body Weight
Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Week 0, Week 26
Change in Waist Circumference
Change from baseline (week 0) in waist circumference was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Week 0, week 26
Change in Body Mass Index (BMI)
Change from baseline (week 0) in body mass index (BMI) was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Week 0, week 26
Number of Treatment Emergent Adverse Events (TEAEs) Recorded
TEAEs were recorded during weeks 0-31 (26 weeks treatment period+5 weeks follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Weeks 0-31
Number of Confirmed Hypoglycaemic Episodes Recorded
Treatment-emergent confirmed hypoglycaemic episodes were recorded during weeks 0-31 (26 weeks treatment period + 5 weeks follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Confirmed hypoglycaemic episode is an episode that is severe according to the American Diabetes Association (ADA) classification or plasma glucose value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia.
Weeks 0-31
Chula Vista
California
91911
United States
Novo Nordisk Investigational Site
Long Beach
California
90806
United States
Novo Nordisk Investigational Site
Poway
California
92064
United States
Novo Nordisk Investigational Site
Santa Ana
California
92705
United States
Novo Nordisk Investigational Site
Spring Valley
California
91978
United States
Novo Nordisk Investigational Site
Walnut Creek
California
94598
United States
Novo Nordisk Investigational Site
Colorado Springs
Colorado
80904
United States
Novo Nordisk Investigational Site
Denver
Colorado
80220
United States
Novo Nordisk Investigational Site
Jacksonville
Florida
32207
United States
Novo Nordisk Investigational Site
Miami
Florida
33014
United States
Novo Nordisk Investigational Site
Plantation
Florida
33324
United States
Novo Nordisk Investigational Site
South Miami
Florida
33143
United States
Novo Nordisk Investigational Site
Athens
Georgia
30606
United States
Novo Nordisk Investigational Site
Conyers
Georgia
30094-5965
United States
Novo Nordisk Investigational Site
Addison
Illinois
60101
United States
Novo Nordisk Investigational Site
Chicago
Illinois
60634
United States
Novo Nordisk Investigational Site
Wichita
Kansas
67205
United States
Novo Nordisk Investigational Site
Rockville
Maryland
20852
United States
Novo Nordisk Investigational Site
Las Vegas
Nevada
89103
United States
Novo Nordisk Investigational Site
Las Vegas
Nevada
89109
United States
Novo Nordisk Investigational Site
New York
New York
10001
United States
Novo Nordisk Investigational Site
New York
New York
10032
United States
Novo Nordisk Investigational Site
Rochester
New York
14609
United States
Novo Nordisk Investigational Site
Asheville
North Carolina
28801
United States
Novo Nordisk Investigational Site
Raleigh
North Carolina
27609
United States
Novo Nordisk Investigational Site
Salisbury
North Carolina
28144
United States
Novo Nordisk Investigational Site
Fargo
North Dakota
58104
United States
Novo Nordisk Investigational Site
Norman
Oklahoma
73069
United States
Novo Nordisk Investigational Site
Jersey Shore
Pennsylvania
17740
United States
Novo Nordisk Investigational Site
Philadelphia
Pennsylvania
19140
United States
Novo Nordisk Investigational Site
Philadelphia
Pennsylvania
19147
United States
Novo Nordisk Investigational Site
Moncks Corner
South Carolina
29461
United States
Novo Nordisk Investigational Site
Humboldt
Tennessee
38343
United States
Novo Nordisk Investigational Site
Spring Hill
Tennessee
37174
United States
Novo Nordisk Investigational Site
Dallas
Texas
75230
United States
Novo Nordisk Investigational Site
San Antonio
Texas
78209
United States
Novo Nordisk Investigational Site
Sugar Land
Texas
77478
United States
Novo Nordisk Investigational Site
Newport News
Virginia
23606
United States
Novo Nordisk Investigational Site
Wenatchee
Washington
98801-2028
United States
Novo Nordisk Investigational Site
Graz
8036
Austria
Novo Nordisk Investigational Site
Saint Stefan
8511
Austria
Novo Nordisk Investigational Site
Vienna
1010
Austria
Novo Nordisk Investigational Site
Vienna
1030
Austria
Novo Nordisk Investigational Site
Vienna
1060
Austria
Novo Nordisk Investigational Site
Vienna
1130
Austria
Novo Nordisk Investigational Site
Sofia
1431
Bulgaria
Novo Nordisk Investigational Site
Bathurst
New Brunswick
E2A 4Z9
Canada
Novo Nordisk Investigational Site
Moncton
New Brunswick
E1G 1A7
Canada
Novo Nordisk Investigational Site
Burlington
Ontario
L7R 1E2
Canada
Novo Nordisk Investigational Site
Stayner
Ontario
L0M 1S0
Canada
Novo Nordisk Investigational Site
Toronto
Ontario
M9W 4L6
Canada
Novo Nordisk Investigational Site
Pointe-Claire
Quebec
H9R 3J1
Canada
Novo Nordisk Investigational Site
Aalborg
9100
Denmark
Novo Nordisk Investigational Site
Ã…rhus C
8000
Denmark
Novo Nordisk Investigational Site
Esbjerg
6700
Denmark
Novo Nordisk Investigational Site
Hellerup
2900
Denmark
Novo Nordisk Investigational Site
Hillerød
3400
Denmark
Novo Nordisk Investigational Site
Svendborg
5700
Denmark
Novo Nordisk Investigational Site
Elsterwerda
04910
Germany
Novo Nordisk Investigational Site
Falkensee
14612
Germany
Novo Nordisk Investigational Site
Friedrichsthal
66299
Germany
Novo Nordisk Investigational Site
Hamburg
22607
Germany
Novo Nordisk Investigational Site
Münster
48145
Germany
Novo Nordisk Investigational Site
Saint Ingbert-Oberwürzbach
66386
Germany
Novo Nordisk Investigational Site
Speyer
67346
Germany
Novo Nordisk Investigational Site
Beersheba
84101
Israel
Novo Nordisk Investigational Site
Haifa
31096
Israel
Novo Nordisk Investigational Site
Herzliya
46851
Israel
Novo Nordisk Investigational Site
Holon
58100
Israel
Novo Nordisk Investigational Site
Jerusalem
91120
Israel
Novo Nordisk Investigational Site
Kfar Saba
44281
Israel
Novo Nordisk Investigational Site
Rishon LeZiyyon
75650
Israel
Novo Nordisk Investigational Site
Milan
20132
Italy
Novo Nordisk Investigational Site
Padova
35128
Italy
Novo Nordisk Investigational Site
Roma
00133
Italy
Novo Nordisk Investigational Site
Roma
00161
Italy
Novo Nordisk Investigational Site
Verona
37126
Italy
Novo Nordisk Investigational Site
George Town
10450
Malaysia
Novo Nordisk Investigational Site
Ipoh
30450
Malaysia
Novo Nordisk Investigational Site
Kota Bharu
15586
Malaysia
Novo Nordisk Investigational Site
Seri Manjung
32040
Malaysia
Novo Nordisk Investigational Site
Belgrade
11000
Serbia
Novo Nordisk Investigational Site
Port Elizabeth
Eastern Cape
6045
South Africa
Novo Nordisk Investigational Site
Johannesburg
Gauteng
1829
South Africa
Novo Nordisk Investigational Site
Johannesburg
Gauteng
2090
South Africa
Novo Nordisk Investigational Site
AlmerÃa
04001
Spain
Novo Nordisk Investigational Site
Sabadell
08208
Spain
Novo Nordisk Investigational Site
Seville
41003
Spain
Novo Nordisk Investigational Site
Seville
41010
Spain
Novo Nordisk Investigational Site
Valencia
46026
Spain
Novo Nordisk Investigational Site
Karlstad
651 85
Sweden
Novo Nordisk Investigational Site
Linköping
582 16
Sweden
Novo Nordisk Investigational Site
Oskarshamn
572 28
Sweden
Novo Nordisk Investigational Site
Örebro
701 85
Sweden
Novo Nordisk Investigational Site
Belfast
BT16 1RH
United Kingdom
Novo Nordisk Investigational Site
Bexhill-on-Sea
TN39 4SP
United Kingdom
Novo Nordisk Investigational Site
Chester
CH2 1UL
United Kingdom
Novo Nordisk Investigational Site
Chesterfield, Derbyshire
S40 4AA
United Kingdom
Novo Nordisk Investigational Site
Crewe
CW5 5NX
United Kingdom
Novo Nordisk Investigational Site
Hinckley
LE10 2SE
United Kingdom
Novo Nordisk Investigational Site
Leicester
LE5 4PW
United Kingdom
Novo Nordisk Investigational Site
London
W6 7HY
United Kingdom
FG001
Oral Semaglutide 5 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
FG002
Oral Semaglutide 10 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
FG003
Oral Semaglutide 20 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
FG004
Oral Semaglutide 40 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
FG005
Oral Semaglutide 40 mg Slow Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
FG006
Oral Semaglutide 40 mg Fast Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
FG007
Subcutaneous Semaglutide 1 mg
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
FG008
Placebo
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
FG00070 subjects
FG00170 subjects
FG00269 subjects
FG00370 subjects
FG00471 subjects
FG00570 subjects
FG00670 subjects
FG00769 subjects
FG00871 subjects
Full Analysis Set (FAS)
FG00070 subjects
FG00170 subjects
FG00269 subjects
FG00370 subjects
FG00471 subjects
FG00570 subjects
FG00670 subjects
FG00769 subjects
FG00871 subjects
Safety Analysis Set (SAS)
FG00070 subjects
FG00170 subjects
FG00269 subjects
FG00370 subjects
FG00471 subjects
FG00570 subjects
FG00670 subjects
FG00769 subjects
FG00871 subjects
COMPLETED
FG00067 subjects
FG00164 subjects
FG00267 subjects
FG00365 subjects
FG00463 subjects
FG00566 subjects
FG00662 subjects
FG00761 subjects
FG00868 subjects
NOT COMPLETED
FG0003 subjects
FG0016 subjects
FG0022 subjects
FG0035 subjects
FG0048 subjects
FG0054 subjects
FG0068 subjects
FG0078 subjects
FG0083 subjects
Type
Comment
Reasons
Protocol Violation
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG0042 subjects
FG0051 subjects
FG0061 subjects
FG0072 subjects
FG0081 subjects
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Other
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0013 subjects
FG0022 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Oral Semaglutide 2.5 mg
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
BG001
Oral Semaglutide 5 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
BG002
Oral Semaglutide 10 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
BG003
Oral Semaglutide 20 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
BG004
Oral Semaglutide 40 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
BG005
Oral Semaglutide 40 mg Slow Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
BG006
Oral Semaglutide 40 mg Fast Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
BG007
Subcutaneous Semaglutide 1 mg
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
BG008
Placebo
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00070
BG00170
BG00269
BG00370
BG00471
BG00570
BG00670
BG00769
BG00871
BG009630
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00056.7± 9.9
BG00155.7± 11.0
BG00256.5± 10.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00025
BG00123
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0006
BG0017
BG002
Race/Ethnicity, Customized
Race of participants
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG00057
BG00163
BG002
Glycosylated haemoglobin (HbA1c)
Mean
Standard Deviation
Percentage of HbA1c
Title
Denominators
Categories
Title
Measurements
BG0007.99± 0.72
BG0017.80± 0.62
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change in HbA1c (Glycosylated Haemoglobin)
Change from baseline (week 0) in HbA1c was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Overall number of participants analyzed = number of participants with available data.
Posted
Mean
Standard Deviation
Percentage of HbA1c
Week 0, week 26
ID
Title
Description
OG000
Oral Semaglutide 2.5 mg
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG001
Oral Semaglutide 5 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG002
Oral Semaglutide 10 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG003
Oral Semaglutide 20 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG004
Oral Semaglutide 40 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG005
Oral Semaglutide 40 mg Slow Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG006
Oral Semaglutide 40 mg Fast Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
OG007
Oral Semaglutide 40 mg Pooled
The data from participants in oral semaglutide 40 mg arm and oral semaglutide fast dose-escalation arm were pooled in this arm.
OG008
Subcutaneous Semaglutide 1 mg
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
OG009
Placebo
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
Units
Counts
Participants
OG00056
OG00158
OG00257
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.88± 0.77
OG001-1.23± 0.79
OG002-1.56± 0.92
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG007
OG009
Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
Mixed Models Analysis
<0.0001
Mean treatment difference
-1.47
2-Sided
95
-1.73
-1.22
Oral semaglutide 40 mg pooled - Placebo
Superiority
This hypothesis was controlled for multiplicity.
Secondary
Subjects Who Achieve (Yes/no) HbA1c Below 7 Percent (53 mmol/Mol)
Participants who achieved HbA1c <7.0%, was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Overall number of participants analyzed = number of participants with available data.
Posted
Count of Participants
Participants
After 26 weeks of treatment
ID
Title
Description
OG000
Oral Semaglutide 2.5 mg
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG001
Oral Semaglutide 5 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
Secondary
Change in Body Weight
Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Overall number of participants analyzed = number of participants with available data.
Posted
Mean
Standard Deviation
kg
Week 0, Week 26
ID
Title
Description
OG000
Oral Semaglutide 2.5 mg
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG001
Oral Semaglutide 5 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
Secondary
Change in Waist Circumference
Change from baseline (week 0) in waist circumference was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Overall number of participants analyzed = number of participants with available data.
Posted
Mean
Standard Deviation
cm
Week 0, week 26
ID
Title
Description
OG000
Oral Semaglutide 2.5 mg
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG001
Oral Semaglutide 5 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
Secondary
Change in Body Mass Index (BMI)
Change from baseline (week 0) in body mass index (BMI) was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Overall number of participants analyzed = number of participants with available data.
Posted
Mean
Standard Deviation
kg/m^2
Week 0, week 26
ID
Title
Description
OG000
Oral Semaglutide 2.5 mg
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG001
Oral Semaglutide 5 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
Secondary
Number of Treatment Emergent Adverse Events (TEAEs) Recorded
TEAEs were recorded during weeks 0-31 (26 weeks treatment period+5 weeks follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Overall number of participants analyzed = safety analysis set (SAS) which comprised all participants exposed to at least 1 dose of randomised semaglutide or placebo.
Posted
Number
Events
Weeks 0-31
ID
Title
Description
OG000
Oral Semaglutide 2.5 mg
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG001
Oral Semaglutide 5 mg
Secondary
Number of Confirmed Hypoglycaemic Episodes Recorded
Treatment-emergent confirmed hypoglycaemic episodes were recorded during weeks 0-31 (26 weeks treatment period + 5 weeks follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Confirmed hypoglycaemic episode is an episode that is severe according to the American Diabetes Association (ADA) classification or plasma glucose value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia.
Overall number of participants analyzed = SAS which comprised all participants exposed to at least 1 dose of randomised semaglutide or placebo.
Posted
Number
Episodes
Weeks 0-31
ID
Title
Description
OG000
Oral Semaglutide 2.5 mg
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
Time Frame
Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Description
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Oral Semaglutide 2.5 mg
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
0
70
1
70
35
70
EG001
Oral Semaglutide 5 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
0
70
2
70
32
70
EG002
Oral Semaglutide 10 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
0
69
2
69
37
69
EG003
Oral Semaglutide 20 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
0
70
0
70
49
70
EG004
Oral Semaglutide 40 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
0
71
1
71
49
71
EG005
Oral Semaglutide 40 mg Slow Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
0
70
3
70
42
70
EG006
Oral Semaglutide 40 mg Fast Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
0
70
5
70
55
70
EG007
Subcutaneous Semaglutide 1 mg
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
0
69
2
69
44
69
EG008
Placebo
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
0
71
5
71
34
71
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Adrenal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG0030 events0 affected70 at risk
EG004
Appendicitis
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Calculus ureteric
Renal and urinary disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Groin abscess
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Joint abscess
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0021 events1 affected69 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Pancreatic enzymes increased
Investigations
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 20
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Postoperative adhesion
Injury, poisoning and procedural complications
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0022 events1 affected69 at risk
EG003
Pterygium
Eye disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0021 events1 affected69 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0021 events1 affected69 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal discomfort
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected70 at risk
EG0022 events2 affected69 at risk
EG0033 events3 affected70 at risk
EG0042 events2 affected71 at risk
EG0051 events1 affected70 at risk
EG0065 events4 affected70 at risk
EG0077 events5 affected69 at risk
EG0080 events0 affected71 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0013 events3 affected70 at risk
EG0021 events1 affected69 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0003 events3 affected70 at risk
EG0011 events1 affected70 at risk
EG0021 events1 affected69 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0012 events2 affected70 at risk
EG0021 events1 affected69 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0004 events4 affected70 at risk
EG0014 events4 affected70 at risk
EG0028 events6 affected69 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20
Systematic Assessment
EG0002 events2 affected70 at risk
EG0012 events2 affected70 at risk
EG0024 events4 affected69 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20
Systematic Assessment
EG0004 events3 affected70 at risk
EG0012 events2 affected70 at risk
EG00210 events10 affected69 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0006 events5 affected70 at risk
EG0017 events7 affected70 at risk
EG00220 events16 affected69 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20
Systematic Assessment
EG0005 events5 affected70 at risk
EG0013 events3 affected70 at risk
EG0023 events3 affected69 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0006 events2 affected70 at risk
EG0017 events5 affected70 at risk
EG0026 events6 affected69 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0021 events1 affected69 at risk
EG003
Fatigue
General disorders
MedDRA 20
Systematic Assessment
EG0003 events3 affected70 at risk
EG0013 events3 affected70 at risk
EG0023 events3 affected69 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected70 at risk
EG0023 events2 affected69 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0002 events2 affected70 at risk
EG0012 events2 affected70 at risk
EG0024 events4 affected69 at risk
EG003
Headache
Nervous system disorders
MedDRA 20
Systematic Assessment
EG0006 events4 affected70 at risk
EG0019 events9 affected70 at risk
EG00210 events8 affected69 at risk
EG003
Hypertension
Vascular disorders
MedDRA 20
Systematic Assessment
EG0004 events4 affected70 at risk
EG0013 events3 affected70 at risk
EG0022 events2 affected69 at risk
EG003
Influenza
Infections and infestations
MedDRA 20
Systematic Assessment
EG0002 events2 affected70 at risk
EG0010 events0 affected70 at risk
EG0025 events3 affected69 at risk
EG003
Lipase increased
Investigations
MedDRA 20
Systematic Assessment
EG0002 events2 affected70 at risk
EG0011 events1 affected70 at risk
EG0021 events1 affected69 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 20
Systematic Assessment
EG0007 events6 affected70 at risk
EG0014 events3 affected70 at risk
EG0023 events3 affected69 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG00012 events9 affected70 at risk
EG00113 events10 affected70 at risk
EG00227 events23 affected69 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0003 events3 affected70 at risk
EG0015 events4 affected70 at risk
EG0021 events1 affected69 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0008 events4 affected70 at risk
EG0015 events4 affected70 at risk
EG00218 events14 affected69 at risk
EG003
Weight decreased
Investigations
MedDRA 20
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected70 at risk
EG0020 events0 affected69 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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 are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
Mixed Models Analysis
0.0069
Treatment difference
-0.40
2-Sided
95
-0.69
-0.11
Oral semaglutide 2.5 mg - Placebo
Superiority
This hypothesis was not controlled for multiplicity.
OG001
OG009
Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
Mixed Models Analysis
<0.0001
Treatment difference
-0.89
2-Sided
95
-1.18
-0.60
Oral semaglutide 5 mg - Placebo
Superiority
This hypothesis was not controlled for multiplicity.
OG002
OG009
Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
Mixed Models Analysis
<0.0001
Treatment difference
-1.18
2-Sided
95
-1.47
-0.90
Oral semaglutide 10 mg - Placebo
Superiority
This hypothesis was not controlled for multiplicity.
OG003
OG009
Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
Mixed Models Analysis
<0.0001
Treatment difference
-1.38
2-Sided
95
-1.68
-1.09
Oral Semaglutide 20 mg - Placebo
Superiority
This hypothesis was not controlled for multiplicity.
OG004
OG009
Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
Mixed Models Analysis
<0.0001
Treatment difference
-1.60
2-Sided
95
-1.89
-1.30
Oral semaglutide 40 mg - Placebo
Superiority
This hypothesis was not controlled for multiplicity.
OG005
OG009
Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
This hypothesis was not controlled for multiplicity.
OG006
OG009
Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
Mixed Models Analysis
<0.0001
Treatment difference
-1.34
2-Sided
95
-1.64
-1.04
Oral semaglutide 40 mg fast dose-escalation - Placebo
Superiority
This hypothesis was not controlled for multiplicity.
OG008
OG009
Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
Mixed Models Analysis
<0.0001
Treatment difference
-1.56
2-Sided
95
-1.85
-1.27
Subcutaneous semaglutide 1 mg - Placebo
Superiority
This hypothesis was not controlled for multiplicity.
OG000
OG008
Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
This hypothesis was not controlled for multiplicity.
OG001
OG008
Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
This hypothesis was not controlled for multiplicity.
OG002
OG008
Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
This hypothesis was not controlled for multiplicity.
OG003
OG008
Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
This hypothesis was not controlled for multiplicity.
OG004
OG008
Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
This hypothesis was not controlled for multiplicity.
OG005
OG008
Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
This hypothesis was not controlled for multiplicity.
OG006
OG008
Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
This hypothesis was not controlled for multiplicity.
OG004
OG005
Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
This hypothesis was not controlled for multiplicity.
OG004
OG006
Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
This hypothesis was not controlled for multiplicity.
OG005
OG006
Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.
This hypothesis was not controlled for multiplicity.
OG002
Oral Semaglutide 10 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG003
Oral Semaglutide 20 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG004
Oral Semaglutide 40 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG005
Oral Semaglutide 40 mg Slow Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG006
Oral Semaglutide 40 mg Fast Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
OG007
Subcutaneous Semaglutide 1 mg
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
OG008
Placebo
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
Units
Counts
Participants
OG00056
OG00158
OG00257
OG00348
OG00446
OG00552
OG00644
OG00748
OG00851
Title
Denominators
Categories
Yes
Title
Measurements
OG00027
OG00150
OG00249
OG00341
OG00442
OG00547
OG00638
OG00745
OG00818
No
Title
Measurements
OG00029
OG0018
OG0028
OG003
OG002
Oral Semaglutide 10 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG003
Oral Semaglutide 20 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG004
Oral Semaglutide 40 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG005
Oral Semaglutide 40 mg Slow Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG006
Oral Semaglutide 40 mg Fast Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
OG007
Subcutaneous Semaglutide 1 mg
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
OG008
Placebo
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
Units
Counts
Participants
OG00056
OG00157
OG00257
OG00347
OG00446
OG00551
OG00644
OG00746
OG00851
Title
Denominators
Categories
Title
Measurements
OG000-2.01± 3.08
OG001-2.89± 3.32
OG002-4.90± 4.04
OG003-5.75± 5.63
OG004-6.91± 4.57
OG005-5.93± 4.34
OG006-8.29± 5.27
OG007-6.71± 3.18
OG008-1.16± 2.59
OG002
Oral Semaglutide 10 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG003
Oral Semaglutide 20 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG004
Oral Semaglutide 40 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG005
Oral Semaglutide 40 mg Slow Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG006
Oral Semaglutide 40 mg Fast Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
OG007
Subcutaneous Semaglutide 1 mg
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
OG008
Placebo
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
Units
Counts
Participants
OG00056
OG00156
OG00257
OG00347
OG00446
OG00551
OG00644
OG00746
OG00851
Title
Denominators
Categories
Title
Measurements
OG000-2.00± 4.31
OG001-2.29± 4.54
OG002-5.28± 5.55
OG003-4.08± 4.01
OG004-5.71± 4.65
OG005-4.86± 5.48
OG006-6.24± 4.71
OG007-6.34± 4.65
OG008-2.29± 3.99
OG002
Oral Semaglutide 10 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG003
Oral Semaglutide 20 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG004
Oral Semaglutide 40 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG005
Oral Semaglutide 40 mg Slow Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG006
Oral Semaglutide 40 mg Fast Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
OG007
Subcutaneous Semaglutide 1 mg
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
OG008
Placebo
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
Units
Counts
Participants
OG00056
OG00157
OG00257
OG00347
OG00446
OG00551
OG00644
OG00746
OG00851
Title
Denominators
Categories
Title
Measurements
OG000-0.67± 0.98
OG001-0.98± 1.14
OG002-1.72± 1.44
OG003-1.93± 1.87
OG004-2.37± 1.58
OG005-2.04± 1.45
OG006-2.92± 1.93
OG007-2.32± 1.04
OG008-0.43± 0.94
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG002
Oral Semaglutide 10 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG003
Oral Semaglutide 20 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG004
Oral Semaglutide 40 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG005
Oral Semaglutide 40 mg Slow Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG006
Oral Semaglutide 40 mg Fast Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
OG007
Subcutaneous Semaglutide 1 mg
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
OG008
Placebo
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
Units
Counts
Participants
OG00070
OG00170
OG00269
OG00370
OG00471
OG00570
OG00670
OG00769
OG00871
Title
Denominators
Categories
Title
Measurements
OG000142
OG001169
OG002233
OG003289
OG004230
OG005233
OG006245
OG007218
OG008127
OG001
Oral Semaglutide 5 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG002
Oral Semaglutide 10 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG003
Oral Semaglutide 20 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG004
Oral Semaglutide 40 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG005
Oral Semaglutide 40 mg Slow Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
OG006
Oral Semaglutide 40 mg Fast Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
OG007
Subcutaneous Semaglutide 1 mg
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
OG008
Placebo
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.