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Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT02461589
Collaborator
(none)
706
Enrollment
150
Locations
13
Arms
12.7
Actual Duration (Months)
4.7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted globally. The aim of this trial is to investigate dose-finding of semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects with type 2 diabetes

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
706 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes
Actual Study Start Date :
Sep 21, 2015
Actual Primary Completion Date :
Oct 13, 2016
Actual Study Completion Date :
Oct 13, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Semaglutide 0.05 mg/day

Drug: semaglutide
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.
Active Comparator: Liraglutide 0.3 mg/day

Drug: liraglutide
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.
Placebo Comparator: Placebo 50 µL

Drug: placebo
Administered subcutaneously ( s.c., under the skin) once daily.
Experimental: Semaglutide 0.05/0.1 mg/day

Drug: semaglutide
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.
Active Comparator: Liraglutide 0.3/0.6 mg/day

Drug: liraglutide
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.
Placebo Comparator: Placebo 50/100 µL

Drug: placebo
Administered subcutaneously ( s.c., under the skin) once daily.
Experimental: Semaglutide 0.05/0.1/0.2 mg/day

Drug: semaglutide
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.
Active Comparator: Liraglutide 0.3/0.6/1.2 mg/day

Drug: liraglutide
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.
Placebo Comparator: Placebo 50/100/200 µL

Drug: placebo
Administered subcutaneously ( s.c., under the skin) once daily.
Experimental: Semaglutide 0.05/0.1/0.2/0.3 mg/day

Drug: semaglutide
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.
Active Comparator: Liraglutide 0.3/0.6/1.2/1.8 mg/day

Drug: liraglutide
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.
Placebo Comparator: Placebo 50/100/200/300 µL

Drug: placebo
Administered subcutaneously ( s.c., under the skin) once daily.
Experimental: Semaglutide flexible escalation from 0.05 mg/day to 0.3 mg/day

Drug: semaglutide
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.

Outcome Measures

Primary Outcome Measures

  1. Change in HbA1c (Glycosylated Haemoglobin) [Week 0, week 26]

    Estimated mean change from baseline in HbA1c at week 26. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.

Secondary Outcome Measures

  1. Change in Fasting Plasma Glucose (FPG) [Week 0, Week 26]

    Estimated mean change from baseline in FPG at week 26. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.

  2. Body Weight Change [Week 0, Week 26]

    The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.

  3. Change in Systolic and Diastolic Blood Pressure [Week 0, Week 26]

    The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male or female, age at least 18 years at the time of signing informed consent.

  • Subjects should be on stable diabetes treatment consisting of diet and exercise with or without metformin (at least 1500 mg daily or maximum tolerated dose documented in the patient medical record) for at least 90 days prior to screening

  • HbA1c (glycosylated haemoglobin): 53-86 mmol/mol (7.0-10.0%) (both inclusive)

  • BMI: 25.0 - 40.0 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Simultaneous participation in any other clinical trial of an investigational medicinal product

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods throughout the trial including the 7 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), female sterilisation, male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle)

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening (an exception is short-term insulin treatment for acute illnesses for a total of below or equal to 14 days)

  • Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on an frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)

  • History of pancreatitis (acute or chronic)

  • Screening calcitonin above or equal to 50 ng/L

  • Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)

  • Severe to moderate renal impairment defined as GFR, estimated below 60 ml/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology)

  • Within the past 180 days before screening any of the following: Myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack

  • Currently planned coronary, carotid or peripheral artery revascularisation

  • Patients presently classified as being in New York Heart Association (NYHA) Class III or IV

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Birmingham Alabama United States 35209
2 Novo Nordisk Investigational Site Birmingham Alabama United States 35294
3 Novo Nordisk Investigational Site Coronado California United States 92118
4 Novo Nordisk Investigational Site Lancaster California United States 93534
5 Novo Nordisk Investigational Site Riverside California United States 92506
6 Novo Nordisk Investigational Site Tustin California United States 92780
7 Novo Nordisk Investigational Site Van Nuys California United States 91405
8 Novo Nordisk Investigational Site Vista California United States 92083
9 Novo Nordisk Investigational Site Walnut Creek California United States 94598
10 Novo Nordisk Investigational Site Hartford Connecticut United States 06105
11 Novo Nordisk Investigational Site Boca Raton Florida United States 33433
12 Novo Nordisk Investigational Site Gainesville Florida United States 32609
13 Novo Nordisk Investigational Site Gainesville Florida United States 32653
14 Novo Nordisk Investigational Site Hialeah Florida United States 33012
15 Novo Nordisk Investigational Site Miami Florida United States 33173
16 Novo Nordisk Investigational Site Miami Florida United States 33183
17 Novo Nordisk Investigational Site Pembroke Pines Florida United States 33026
18 Novo Nordisk Investigational Site Ponte Vedra Florida United States 32081
19 Novo Nordisk Investigational Site Atlanta Georgia United States 30342
20 Novo Nordisk Investigational Site Marietta Georgia United States 30067
21 Novo Nordisk Investigational Site Evanston Illinois United States 60201-2477
22 Novo Nordisk Investigational Site Evansville Indiana United States 47714
23 Novo Nordisk Investigational Site Newton Kansas United States 67114
24 Novo Nordisk Investigational Site Louisville Kentucky United States 40206
25 Novo Nordisk Investigational Site Madisonville Kentucky United States 42431
26 Novo Nordisk Investigational Site Marrero Louisiana United States 70072
27 Novo Nordisk Investigational Site Slidell Louisiana United States 70458
28 Novo Nordisk Investigational Site Slidell Louisiana United States 70461-4231
29 Novo Nordisk Investigational Site Rockville Maryland United States 20852
30 Novo Nordisk Investigational Site Boston Massachusetts United States 02215
31 Novo Nordisk Investigational Site Buckley Michigan United States 49620
32 Novo Nordisk Investigational Site Belzoni Mississippi United States 39038
33 Novo Nordisk Investigational Site Bridgeton Missouri United States 63044
34 Novo Nordisk Investigational Site Kalispell Montana United States 59901
35 Novo Nordisk Investigational Site Elkhorn Nebraska United States 68022
36 Novo Nordisk Investigational Site Las Vegas Nevada United States 89103
37 Novo Nordisk Investigational Site Lawrenceville New Jersey United States 08648
38 Novo Nordisk Investigational Site Hopewell Junction New York United States 12553
39 Novo Nordisk Investigational Site Statesville North Carolina United States 28625
40 Novo Nordisk Investigational Site Cincinnati Ohio United States 45219
41 Novo Nordisk Investigational Site Cincinnati Ohio United States 45227
42 Novo Nordisk Investigational Site Cincinnati Ohio United States 45255
43 Novo Nordisk Investigational Site Delaware Ohio United States 43015
44 Novo Nordisk Investigational Site Dublin Ohio United States 43016
45 Novo Nordisk Investigational Site Kettering Ohio United States 45429
46 Novo Nordisk Investigational Site Mason Ohio United States 45040-6815
47 Novo Nordisk Investigational Site Oklahoma City Oklahoma United States 73112
48 Novo Nordisk Investigational Site Corvallis Oregon United States 97330-3737
49 Novo Nordisk Investigational Site Downingtown Pennsylvania United States 19335-2620
50 Novo Nordisk Investigational Site Media Pennsylvania United States 19063
51 Novo Nordisk Investigational Site Smithfield Pennsylvania United States 15478
52 Novo Nordisk Investigational Site Uniontown Pennsylvania United States 15401
53 Novo Nordisk Investigational Site Charleston South Carolina United States 29412
54 Novo Nordisk Investigational Site Hodges South Carolina United States 29653
55 Novo Nordisk Investigational Site Indian Land South Carolina United States 29707
56 Novo Nordisk Investigational Site Mount Pleasant South Carolina United States 29464
57 Novo Nordisk Investigational Site Bristol Tennessee United States 37620-7352
58 Novo Nordisk Investigational Site Chattanooga Tennessee United States 37404
59 Novo Nordisk Investigational Site Johnson City Tennessee United States 37604
60 Novo Nordisk Investigational Site Kingsport Tennessee United States 37660
61 Novo Nordisk Investigational Site Memphis Tennessee United States 38119-4806
62 Novo Nordisk Investigational Site Nashville Tennessee United States 37203
63 Novo Nordisk Investigational Site Arlington Texas United States 76012-4637
64 Novo Nordisk Investigational Site Austin Texas United States 78705
65 Novo Nordisk Investigational Site Carrollton Texas United States 75010
66 Novo Nordisk Investigational Site Dallas Texas United States 75220
67 Novo Nordisk Investigational Site Dallas Texas United States 75230
68 Novo Nordisk Investigational Site Dallas Texas United States 75251
69 Novo Nordisk Investigational Site Dallas Texas United States 75390-9302
70 Novo Nordisk Investigational Site Houston Texas United States 77008
71 Novo Nordisk Investigational Site Missouri City Texas United States 77459
72 Novo Nordisk Investigational Site New Braunfels Texas United States 78130
73 Novo Nordisk Investigational Site San Antonio Texas United States 78230
74 Novo Nordisk Investigational Site San Antonio Texas United States 78258
75 Novo Nordisk Investigational Site Sugar Land Texas United States 77479
76 Novo Nordisk Investigational Site Waco Texas United States 76710
77 Novo Nordisk Investigational Site Bountiful Utah United States 84010
78 Novo Nordisk Investigational Site Clinton Utah United States 84015
79 Novo Nordisk Investigational Site Riverton Utah United States 84065
80 Novo Nordisk Investigational Site Richmond Virginia United States 23219
81 Novo Nordisk Investigational Site Virginia Beach Virginia United States 23454
82 Novo Nordisk Investigational Site Winchester Virginia United States 22601
83 Novo Nordisk Investigational Site Renton Washington United States 98057
84 Novo Nordisk Investigational Site Spokane Washington United States 99216-1557
85 Novo Nordisk Investigational Site Graz Austria 8010
86 Novo Nordisk Investigational Site Saint Stefan Austria 8511
87 Novo Nordisk Investigational Site Wien Austria 1130
88 Novo Nordisk Investigational Site Coquitlam British Columbia Canada V3K 3P4
89 Novo Nordisk Investigational Site Moncton New Brunswick Canada E1G 1A7
90 Novo Nordisk Investigational Site Hamilton Ontario Canada L8K 3P3
91 Novo Nordisk Investigational Site Hamilton Ontario Canada L8M 1K7
92 Novo Nordisk Investigational Site Sarnia Ontario Canada N7T 4X3
93 Novo Nordisk Investigational Site Strathroy Ontario Canada N7G 1Y7
94 Novo Nordisk Investigational Site Laval Quebec Canada H7T 2P5
95 Novo Nordisk Investigational Site Pointe Claire Quebec Canada H9R 4S3
96 Novo Nordisk Investigational Site Benesov Czechia 25601
97 Novo Nordisk Investigational Site Brno Czechia 602 00
98 Novo Nordisk Investigational Site Liberec Czechia 46001
99 Novo Nordisk Investigational Site Nachod Czechia 54701
100 Novo Nordisk Investigational Site Plzeň Czechia 301 00
101 Novo Nordisk Investigational Site Police nad Metuji Czechia 54954
102 Novo Nordisk Investigational Site Praha 4 Czechia 140 46
103 Novo Nordisk Investigational Site Praha 5 Czechia 150 00
104 Novo Nordisk Investigational Site Trutnov Czechia 541 01
105 Novo Nordisk Investigational Site Eisenach Germany 99817
106 Novo Nordisk Investigational Site Friedrichsthal Germany 66299
107 Novo Nordisk Investigational Site Hamburg Germany 22607
108 Novo Nordisk Investigational Site Münster Germany 48145
109 Novo Nordisk Investigational Site Pohlheim Germany 35415
110 Novo Nordisk Investigational Site Rehlingen-Siersburg Germany 66780
111 Novo Nordisk Investigational Site Saint Ingbert-Oberwürzbach Germany 66386
112 Novo Nordisk Investigational Site Stuttgart Germany 70378
113 Novo Nordisk Investigational Site Sulzbach-Rosenberg Germany 92237
114 Novo Nordisk Investigational Site Klang, Selangor Malaysia 41200
115 Novo Nordisk Investigational Site Kota Bharu Malaysia 15586
116 Novo Nordisk Investigational Site Penang Malaysia 10450
117 Novo Nordisk Investigational Site Seremban Malaysia 70300
118 Novo Nordisk Investigational Site Seri Manjung Malaysia 32040
119 Novo Nordisk Investigational Site Dzerzhinskiy Russian Federation 140091
120 Novo Nordisk Investigational Site Kazan Russian Federation 420073
121 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 191119
122 Novo Nordisk Investigational Site Saratov Russian Federation 410031
123 Novo Nordisk Investigational Site Saratov Russian Federation 410039
124 Novo Nordisk Investigational Site Smolensk Russian Federation 214031
125 Novo Nordisk Investigational Site Syktyvkar Russian Federation 167981
126 Novo Nordisk Investigational Site Voronezh Russian Federation 394018
127 Novo Nordisk Investigational Site Belgrade Serbia 11000
128 Novo Nordisk Investigational Site Kragujevac Serbia 34000
129 Novo Nordisk Investigational Site Nis Serbia 18000
130 Novo Nordisk Investigational Site Novi Sad Serbia 21000
131 Novo Nordisk Investigational Site Zajecar Serbia 19000
132 Novo Nordisk Investigational Site Bloemfontein Free State South Africa 9301
133 Novo Nordisk Investigational Site Johannesburg Gauteng South Africa 1812
134 Novo Nordisk Investigational Site Midrand Gauteng South Africa 1685
135 Novo Nordisk Investigational Site Durban KwaZulu-Natal South Africa 4092
136 Novo Nordisk Investigational Site Durban KwaZulu-Natal South Africa 4450
137 Novo Nordisk Investigational Site Middleburg Mpumalanga South Africa 1055
138 Novo Nordisk Investigational Site Basingstoke United Kingdom RG24 9GT
139 Novo Nordisk Investigational Site Belfast United Kingdom BT16 1RH
140 Novo Nordisk Investigational Site Bexhill-on-Sea United Kingdom TN39 4SP
141 Novo Nordisk Investigational Site Blackburn United Kingdom BB2 1AX
142 Novo Nordisk Investigational Site Bristol United Kingdom BS10 5NB
143 Novo Nordisk Investigational Site Chesterfield, Derbyshire United Kingdom S40 4AA
144 Novo Nordisk Investigational Site Devon United Kingdom EX2 5DW
145 Novo Nordisk Investigational Site Harrogate, North Yorkshire United Kingdom HG2 7SX
146 Novo Nordisk Investigational Site Hinckley United Kingdom LE10 2SE
147 Novo Nordisk Investigational Site Oxford United Kingdom OX3 7LE
148 Novo Nordisk Investigational Site Plymouth United Kingdom PL8 8DQ
149 Novo Nordisk Investigational Site Sidcup United Kingdom DA14 6LT
150 Novo Nordisk Investigational Site Truro United Kingdom TR1 3LJ

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02461589
Other Study ID Numbers:
  • NN9535-4191
  • 2014-003196-39
  • U1111-1159-4923
First Posted:
Jun 3, 2015
Last Update Posted:
Jul 31, 2019
Last Verified:
Jul 1, 2019
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Liraglutide

Study Results

Participant Flow

Recruitment Details The trial was conducted at 139 sites in 10 countries as follows: Austria: 3 sites; Canada: 8 sites; Czech Republic: 9 sites; Germany: 7 sites; Malaysia: 5 sites; Russian Federation: 7 sites; Serbia: 9 sites; South Africa: 7 sites; United Kingdom: 13 sites; United States: 71 sites.
Pre-assignment Detail Of the 706 subjects randomised in the trial, 705 were exposed to trial products and 1 randomised subject withdrew prior to exposure.
Arm/Group Title Semaglutide 0.05 mg/Day Semaglutide 0.1 mg/Day Semaglutide 0.2 mg/Day Semaglutide 0.3 mg/Day Liraglutide 0.3 mg/Day Liraglutide 0.6 mg/Day Liraglutide 1.2 mg/Day Liraglutide 1.8 mg/Day Placebo Semaglutide Flexible
Arm/Group Description Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment.
Period Title: Overall Study
STARTED 64 63 65 63 64 64 64 65 129 65
Exposed 64 63 65 63 64 64 64 65 129 64
COMPLETED 58 61 60 58 62 61 58 60 123 60
NOT COMPLETED 6 2 5 5 2 3 6 5 6 5

Baseline Characteristics

Arm/Group Title Semaglutide 0.05 mg/Day Semaglutide 0.1 mg/Day Semaglutide 0.2 mg/Day Semaglutide 0.3 mg/Day Liraglutide 0.3 mg/Day Liraglutide 0.6 mg/Day Liraglutide 1.2 mg/Day Liraglutide 1.8 mg/Day Placebo Semaglutide Flexible Total
Arm/Group Description Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment. Total of all reporting groups
Overall Participants 64 63 65 63 64 64 64 65 129 64 705
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
57.53
(9.8)
57.51
(10.0)
58.37
(9.58)
54.76
(9.66)
57.20
(10.78)
59.45
(9.77)
53.73
(11.35)
55.82
(9.19)
57.08
(9.25)
54.81
(9.70)
56.67
(9.94)
Sex: Female, Male (Count of Participants)
Female
31
48.4%
28
44.4%
22
33.8%
31
49.2%
35
54.7%
32
50%
30
46.9%
32
49.2%
57
44.2%
28
43.8%
326
46.2%
Male
33
51.6%
35
55.6%
43
66.2%
32
50.8%
29
45.3%
32
50%
34
53.1%
33
50.8%
72
55.8%
36
56.3%
379
53.8%
HbA1c (glycosylated haemoglobin) (percentage of HbA1c) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of HbA1c]
7.87
(0.71)
7.91
(0.83)
7.96
(0.82)
8.23
(0.80)
8.06
(0.86)
8.12
(0.81)
8.14
(0.87)
8.07
(0.85)
8.12
(0.87)
8.10
(0.91)
8.06
(0.84)
Fasting plasma glucose (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]
9.26
(2.60)
8.97
(2.22)
9.20
(2.28)
9.67
(2.56)
9.32
(2.54)
9.34
(2.33)
9.91
(2.70)
9.18
(2.45)
9.67
(2.98)
9.82
(2.66)
9.45
(2.59)
Body weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]
93.44
(18.27)
92.40
(17.20)
98.07
(17.92)
94.82
(17.84)
92.25
(17.48)
92.68
(16.46)
96.67
(18.28)
93.40
(19.34)
93.98
(17.75)
95.29
(15.43)
94.28
(17.61)
Systolic blood pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]
133.70
(15.14)
130.97
(14.92)
131.34
(12.55)
132.08
(11.69)
134.02
(11.30)
132.41
(12.37)
134.20
(12.73)
131.02
(11.86)
132.17
(14.26)
132.70
(12.74)
132.43
(13.10)
Diastolic blood pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]
80.06
(8.90)
79.71
(8.56)
80.48
(8.87)
81.41
(8.05)
81.83
(6.98)
81.28
(6.90)
82.98
(6.94)
80.66
(7.62)
80.98
(8.00)
81.89
(8.40)
81.11
(7.96)

Outcome Measures

1. Primary Outcome
Title Change in HbA1c (Glycosylated Haemoglobin)
Description Estimated mean change from baseline in HbA1c at week 26. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.
Time Frame Week 0, week 26

Outcome Measure Data

Analysis Population Description
Full analysis set
Arm/Group Title Semaglutide 0.05 mg/Day Semaglutide 0.1 mg/Day Semaglutide 0.2 mg/Day Semaglutide 0.3 mg/Day Liraglutide 0.3 mg/Day Liraglutide 0.6 mg/Day Liraglutide 1.2 mg/Day Liraglutide 1.8 mg/Day Placebo Semaglutide Flexible
Arm/Group Description Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment.
Measure Participants 64 63 65 63 64 64 64 65 129 64
Mean (Standard Deviation) [percentage of glycosylated haemoglobin]
-0.97
(0.85)
-1.30
(1.03)
-1.65
(0.79)
-1.96
(0.95)
-0.50
(0.93)
-0.88
(0.90)
-0.86
(0.92)
-1.32
(0.78)
-0.05
(0.90)
-1.72
(0.97)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Semaglutide 0.05 mg/Day, Placebo
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -1.04
Confidence Interval (2-Sided) 95%
-1.30 to -0.77
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Semaglutide 0.1 mg/Day, Placebo
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -1.34
Confidence Interval (2-Sided) 95%
-1.61 to -1.08
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Semaglutide 0.2 mg/Day, Placebo
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -1.69
Confidence Interval (2-Sided) 95%
-1.95 to -1.42
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Semaglutide 0.3 mg/Day, Placebo
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -1.86
Confidence Interval (2-Sided) 95%
-2.12 to -1.60
Parameter Dispersion Type:
Value:
Estimation Comments
2. Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG)
Description Estimated mean change from baseline in FPG at week 26. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
Full analyses set. For "Semaglutide flexible arm", data was available only for 63 subjects.
Arm/Group Title Semaglutide 0.05 mg/Day Semaglutide 0.1 mg/Day Semaglutide 0.2 mg/Day Semaglutide 0.3 mg/Day Liraglutide 0.3 mg/Day Liraglutide 0.6 mg/Day Liraglutide 1.2 mg/Day Liraglutide 1.8 mg/Day Placebo Semaglutide Flexible
Arm/Group Description Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment.
Measure Participants 64 63 65 63 64 64 64 65 129 63
Mean (Standard Deviation) [mmol/L]
-2.09
(1.96)
-2.08
(2.23)
-2.64
(2.07)
-3.53
(2.20)
-1.33
(2.06)
-1.56
(1.74)
-1.51
(2.41)
-1.92
(2.34)
-0.54
(2.45)
-3.40
(2.84)
3. Secondary Outcome
Title Body Weight Change
Description The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
Full analysis set
Arm/Group Title Semaglutide 0.05 mg/Day Semaglutide 0.1 mg/Day Semaglutide 0.2 mg/Day Semaglutide 0.3 mg/Day Liraglutide 0.3 mg/Day Liraglutide 0.6 mg/Day Liraglutide 1.2 mg/Day Liraglutide 1.8 mg/Day Placebo Semaglutide Flexible
Arm/Group Description Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment.
Measure Participants 64 63 65 63 64 64 64 65 129 64
Mean (Standard Deviation) [kg]
-2.75
(2.82)
-4.36
(4.24)
-6.70
(4.57)
-8.23
(5.34)
-1.48
(3.06)
-1.81
(3.06)
-1.78
(3.41)
-3.68
(4.26)
-1.22
(3.42)
-6.60
(4.98)
4. Secondary Outcome
Title Change in Systolic and Diastolic Blood Pressure
Description The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.
Time Frame Week 0, Week 26

Outcome Measure Data

Analysis Population Description
Full analysis set
Arm/Group Title Semaglutide 0.05 mg/Day Semaglutide 0.1 mg/Day Semaglutide 0.2 mg/Day Semaglutide 0.3 mg/Day Liraglutide 0.3 mg/Day Liraglutide 0.6 mg/Day Liraglutide 1.2 mg/Day Liraglutide 1.8 mg/Day Placebo Semaglutide Flexible
Arm/Group Description Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment.
Measure Participants 64 63 65 63 64 64 64 65 129 64
Systolicblood pressure
-5.74
(12.30)
-2.77
(13.21)
-4.25
(12.24)
-9.85
(11.58)
-3.77
(9.79)
-3.20
(10.89)
-4.69
(12.73)
-2.99
(11.94)
-2.34
(11.40)
-6.62
(14.02)
Diastolic blood pressure
-0.60
(8.78)
0.66
(8.26)
-1.62
(9.38)
-4.02
(8.56)
-1.77
(7.37)
-1.89
(8.20)
-0.60
(6.78)
0.63
(8.13)
-0.61
(8.50)
-1.69
(8.25)

Adverse Events

Time Frame From baseline up to week 33.
Adverse Event Reporting Description Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Arm/Group Title Semaglutide 0.05 mg/Day Semaglutide 0.1 mg/Day Semaglutide 0.2 mg/Day Semaglutide 0.3 mg/Day Liraglutide 0.3 mg/Day Liraglutide 0.6 mg/Day Liraglutide 1.2 mg/Day Liraglutide 1.8 mg/Day Placebo Semaglutide Flexible
Arm/Group Description Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment.
All Cause Mortality
Semaglutide 0.05 mg/Day Semaglutide 0.1 mg/Day Semaglutide 0.2 mg/Day Semaglutide 0.3 mg/Day Liraglutide 0.3 mg/Day Liraglutide 0.6 mg/Day Liraglutide 1.2 mg/Day Liraglutide 1.8 mg/Day Placebo Semaglutide Flexible
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Semaglutide 0.05 mg/Day Semaglutide 0.1 mg/Day Semaglutide 0.2 mg/Day Semaglutide 0.3 mg/Day Liraglutide 0.3 mg/Day Liraglutide 0.6 mg/Day Liraglutide 1.2 mg/Day Liraglutide 1.8 mg/Day Placebo Semaglutide Flexible
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 7/64 (10.9%) 3/63 (4.8%) 2/65 (3.1%) 2/63 (3.2%) 1/64 (1.6%) 2/64 (3.1%) 2/64 (3.1%) 7/65 (10.8%) 0/129 (0%) 4/64 (6.3%)
Cardiac disorders
Acute myocardial infarction 1/64 (1.6%) 1 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 1/64 (1.6%) 1 1/65 (1.5%) 1 0/129 (0%) 0 0/64 (0%) 0
Atrioventricular block complete 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 1/63 (1.6%) 1 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Bundle branch block left 0/64 (0%) 0 0/63 (0%) 0 1/65 (1.5%) 1 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Coronary artery disease 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 1/65 (1.5%) 2 0/129 (0%) 0 0/64 (0%) 0
Myocardial infarction 1/64 (1.6%) 1 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Supraventricular tachycardia 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 1/65 (1.5%) 2 0/129 (0%) 0 0/64 (0%) 0
Ventricular fibrillation 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 1/64 (1.6%) 1 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Endocrine disorders
Goitre 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Eye disorders
Retinal detachment 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 1/64 (1.6%) 2 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Gastrointestinal disorders
Anal fistula 0/64 (0%) 0 1/63 (1.6%) 1 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Epiploic appendagitis 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Infections and infestations
Diverticulitis 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 1/64 (1.6%) 1
Escherichia pyelonephritis 0/64 (0%) 0 1/63 (1.6%) 1 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Gastroenteritis viral 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 1/65 (1.5%) 1 0/129 (0%) 0 0/64 (0%) 0
Pharyngitis 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Sepsis 1/64 (1.6%) 1 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Viral infection 1/64 (1.6%) 1 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Investigations
Catheterisation cardiac 0/64 (0%) 0 0/63 (0%) 0 1/65 (1.5%) 1 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Cystoscopy 0/64 (0%) 0 1/63 (1.6%) 1 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Musculoskeletal and connective tissue disorders
Back pain 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 1/65 (1.5%) 1 0/129 (0%) 0 0/64 (0%) 0
Dupuytren's contracture 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 1/64 (1.6%) 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 1/65 (1.5%) 1 0/129 (0%) 0 0/64 (0%) 0
Clear cell renal cell carcinoma 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 1/64 (1.6%) 1
Pancreatic carcinoma 1/64 (1.6%) 1 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Prostate cancer 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 1/65 (1.5%) 1 0/129 (0%) 0 0/64 (0%) 0
Spinal meningioma benign 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 1/63 (1.6%) 1 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Nervous system disorders
Carotid artery stenosis 1/64 (1.6%) 1 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Ischaemic stroke 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 1/64 (1.6%) 1
Seizure 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 1/64 (1.6%) 1 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous 1/64 (1.6%) 1 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Reproductive system and breast disorders
Endometrial hyperplasia 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 1/64 (1.6%) 1 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Uterine polyp 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 1/64 (1.6%) 1 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Pulmonary oedema 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 1/64 (1.6%) 1 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Surgical and medical procedures
Coronary revascularisation 1/64 (1.6%) 1 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Endarterectomy 1/64 (1.6%) 1 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Percutaneous coronary intervention 1/64 (1.6%) 1 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 1/64 (1.6%) 1 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Stent placement 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 1/65 (1.5%) 1 0/129 (0%) 0 0/64 (0%) 0
Vascular graft 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 1/65 (1.5%) 1 0/129 (0%) 0 0/64 (0%) 0
Vascular disorders
Arteriosclerosis 1/64 (1.6%) 1 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Orthostatic hypotension 0/64 (0%) 0 0/63 (0%) 0 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/64 (0%) 0 0/65 (0%) 0 0/129 (0%) 0 0/64 (0%) 0
Other (Not Including Serious) Adverse Events
Semaglutide 0.05 mg/Day Semaglutide 0.1 mg/Day Semaglutide 0.2 mg/Day Semaglutide 0.3 mg/Day Liraglutide 0.3 mg/Day Liraglutide 0.6 mg/Day Liraglutide 1.2 mg/Day Liraglutide 1.8 mg/Day Placebo Semaglutide Flexible
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 31/64 (48.4%) 34/63 (54%) 39/65 (60%) 42/63 (66.7%) 33/64 (51.6%) 27/64 (42.2%) 35/64 (54.7%) 35/65 (53.8%) 0/129 (0%) 44/64 (68.8%)
Gastrointestinal disorders
Abdominal discomfort 2/64 (3.1%) 2 3/63 (4.8%) 4 1/65 (1.5%) 1 2/63 (3.2%) 3 1/64 (1.6%) 1 3/64 (4.7%) 5 2/64 (3.1%) 2 4/65 (6.2%) 13 0/129 (0%) 0 4/64 (6.3%) 4
Abdominal pain 2/64 (3.1%) 4 2/63 (3.2%) 4 3/65 (4.6%) 7 5/63 (7.9%) 6 3/64 (4.7%) 3 0/64 (0%) 0 4/64 (6.3%) 4 0/65 (0%) 0 0/129 (0%) 0 4/64 (6.3%) 7
Abdominal pain upper 0/64 (0%) 0 1/63 (1.6%) 1 4/65 (6.2%) 5 4/63 (6.3%) 4 1/64 (1.6%) 2 2/64 (3.1%) 2 2/64 (3.1%) 2 3/65 (4.6%) 4 0/129 (0%) 0 6/64 (9.4%) 8
Constipation 2/64 (3.1%) 2 4/63 (6.3%) 4 6/65 (9.2%) 11 5/63 (7.9%) 7 0/64 (0%) 0 3/64 (4.7%) 3 1/64 (1.6%) 2 7/65 (10.8%) 7 0/129 (0%) 0 4/64 (6.3%) 6
Diarrhoea 7/64 (10.9%) 10 10/63 (15.9%) 13 10/65 (15.4%) 15 16/63 (25.4%) 29 5/64 (7.8%) 5 5/64 (7.8%) 9 5/64 (7.8%) 8 8/65 (12.3%) 16 0/129 (0%) 0 11/64 (17.2%) 22
Dyspepsia 1/64 (1.6%) 6 5/63 (7.9%) 7 5/65 (7.7%) 8 6/63 (9.5%) 6 2/64 (3.1%) 2 3/64 (4.7%) 3 1/64 (1.6%) 1 3/65 (4.6%) 3 0/129 (0%) 0 4/64 (6.3%) 4
Flatulence 2/64 (3.1%) 2 1/63 (1.6%) 5 4/65 (6.2%) 6 1/63 (1.6%) 1 0/64 (0%) 0 2/64 (3.1%) 3 2/64 (3.1%) 3 1/65 (1.5%) 2 0/129 (0%) 0 6/64 (9.4%) 9
Gastrooesophageal reflux disease 0/64 (0%) 0 4/63 (6.3%) 8 3/65 (4.6%) 3 3/63 (4.8%) 3 0/64 (0%) 0 2/64 (3.1%) 2 1/64 (1.6%) 1 1/65 (1.5%) 1 0/129 (0%) 0 4/64 (6.3%) 5
Nausea 11/64 (17.2%) 16 12/63 (19%) 20 14/65 (21.5%) 22 16/63 (25.4%) 22 6/64 (9.4%) 7 7/64 (10.9%) 11 7/64 (10.9%) 11 13/65 (20%) 18 0/129 (0%) 0 25/64 (39.1%) 35
Vomiting 6/64 (9.4%) 10 4/63 (6.3%) 13 6/65 (9.2%) 9 6/63 (9.5%) 8 1/64 (1.6%) 1 7/64 (10.9%) 10 1/64 (1.6%) 1 5/65 (7.7%) 8 0/129 (0%) 0 6/64 (9.4%) 8
General disorders
Fatigue 2/64 (3.1%) 2 1/63 (1.6%) 1 4/65 (6.2%) 4 1/63 (1.6%) 1 0/64 (0%) 0 4/64 (6.3%) 5 1/64 (1.6%) 1 2/65 (3.1%) 2 0/129 (0%) 0 4/64 (6.3%) 4
Infections and infestations
Bronchitis 0/64 (0%) 0 0/63 (0%) 0 1/65 (1.5%) 1 2/63 (3.2%) 2 1/64 (1.6%) 1 1/64 (1.6%) 1 2/64 (3.1%) 2 4/65 (6.2%) 4 0/129 (0%) 0 1/64 (1.6%) 1
Nasopharyngitis 7/64 (10.9%) 12 6/63 (9.5%) 7 4/65 (6.2%) 4 5/63 (7.9%) 6 4/64 (6.3%) 5 3/64 (4.7%) 3 5/64 (7.8%) 7 5/65 (7.7%) 6 0/129 (0%) 0 10/64 (15.6%) 11
Sinusitis 0/64 (0%) 0 0/63 (0%) 0 1/65 (1.5%) 1 1/63 (1.6%) 1 5/64 (7.8%) 5 2/64 (3.1%) 2 2/64 (3.1%) 2 1/65 (1.5%) 1 0/129 (0%) 0 0/64 (0%) 0
Upper respiratory tract infection 7/64 (10.9%) 8 2/63 (3.2%) 2 1/65 (1.5%) 1 7/63 (11.1%) 7 6/64 (9.4%) 6 1/64 (1.6%) 1 2/64 (3.1%) 3 5/65 (7.7%) 6 0/129 (0%) 0 4/64 (6.3%) 6
Investigations
Lipase increased 3/64 (4.7%) 3 3/63 (4.8%) 3 3/65 (4.6%) 3 3/63 (4.8%) 3 3/64 (4.7%) 4 3/64 (4.7%) 5 4/64 (6.3%) 5 7/65 (10.8%) 7 0/129 (0%) 0 5/64 (7.8%) 5
Metabolism and nutrition disorders
Decreased appetite 3/64 (4.7%) 3 7/63 (11.1%) 7 6/65 (9.2%) 6 8/63 (12.7%) 8 2/64 (3.1%) 3 1/64 (1.6%) 1 3/64 (4.7%) 3 3/65 (4.6%) 3 0/129 (0%) 0 9/64 (14.1%) 9
Musculoskeletal and connective tissue disorders
Arthralgia 3/64 (4.7%) 3 0/63 (0%) 0 3/65 (4.6%) 3 4/63 (6.3%) 4 1/64 (1.6%) 1 0/64 (0%) 0 2/64 (3.1%) 2 1/65 (1.5%) 1 0/129 (0%) 0 1/64 (1.6%) 1
Back pain 3/64 (4.7%) 3 4/63 (6.3%) 4 2/65 (3.1%) 2 2/63 (3.2%) 4 3/64 (4.7%) 3 2/64 (3.1%) 2 3/64 (4.7%) 3 4/65 (6.2%) 4 0/129 (0%) 0 4/64 (6.3%) 5
Muscle spasms 1/64 (1.6%) 1 1/63 (1.6%) 1 0/65 (0%) 0 0/63 (0%) 0 0/64 (0%) 0 4/64 (6.3%) 4 0/64 (0%) 0 1/65 (1.5%) 1 0/129 (0%) 0 1/64 (1.6%) 1
Nervous system disorders
Dizziness 2/64 (3.1%) 4 4/63 (6.3%) 6 2/65 (3.1%) 2 3/63 (4.8%) 4 0/64 (0%) 0 3/64 (4.7%) 4 1/64 (1.6%) 1 4/65 (6.2%) 5 0/129 (0%) 0 6/64 (9.4%) 8
Headache 7/64 (10.9%) 17 8/63 (12.7%) 30 4/65 (6.2%) 13 7/63 (11.1%) 11 5/64 (7.8%) 7 3/64 (4.7%) 11 10/64 (15.6%) 16 4/65 (6.2%) 8 0/129 (0%) 0 7/64 (10.9%) 14
Respiratory, thoracic and mediastinal disorders
Cough 1/64 (1.6%) 1 1/63 (1.6%) 1 0/65 (0%) 0 1/63 (1.6%) 1 3/64 (4.7%) 4 4/64 (6.3%) 5 3/64 (4.7%) 3 1/65 (1.5%) 2 0/129 (0%) 0 3/64 (4.7%) 3
Oropharyngeal pain 2/64 (3.1%) 3 2/63 (3.2%) 2 0/65 (0%) 0 1/63 (1.6%) 1 2/64 (3.1%) 2 4/64 (6.3%) 4 2/64 (3.1%) 2 0/65 (0%) 0 0/129 (0%) 0 3/64 (4.7%) 4
Vascular disorders
Hypertension 2/64 (3.1%) 2 4/63 (6.3%) 4 2/65 (3.1%) 2 0/63 (0%) 0 3/64 (4.7%) 3 0/64 (0%) 0 3/64 (4.7%) 3 3/65 (4.6%) 3 0/129 (0%) 0 1/64 (1.6%) 1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property

Results Point of Contact

Name/Title Global Clinical Registry (GCR, 1452)
Organization Novo Nordisk A/S
Phone
Email clinicaltrials@novonordisk.com
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02461589
Other Study ID Numbers:
  • NN9535-4191
  • 2014-003196-39
  • U1111-1159-4923
First Posted:
Jun 3, 2015
Last Update Posted:
Jul 31, 2019
Last Verified:
Jul 1, 2019