Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes (PIONEER 3)

July 11, 2022 updated by: Novo Nordisk A/S
This trial is conducted globally. The aim of the trial is to investigate efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1864

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Caba, Argentina, C1179AAB
        • Novo Nordisk Investigational Site
      • Caba, Argentina, C1060ABA
        • Novo Nordisk Investigational Site
      • Caba, Argentina, 1425
        • Novo Nordisk Investigational Site
      • Capital Federal, Argentina, C1056ABJ
        • Novo Nordisk Investigational Site
      • Cordoba, Argentina, 5000
        • Novo Nordisk Investigational Site
      • Córdoba, Argentina, 5008
        • Novo Nordisk Investigational Site
  • Brazil
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 01228-200
        • Novo Nordisk Investigational Site
  • France
      • Angers, France, 49000
        • Novo Nordisk Investigational Site
      • Chalons-en-Champagne Cedex, France, 51005
        • Novo Nordisk Investigational Site
      • DIJON cedex, France, 21079
        • Novo Nordisk Investigational Site
      • LA ROCHE-sur-YON cedex 9, France, 85295
        • Novo Nordisk Investigational Site
      • LA ROCHELLE cedex, France, 17019
        • Novo Nordisk Investigational Site
      • Le Creusot, France, 71200
        • Novo Nordisk Investigational Site
      • Limoges, France, 87000
        • Novo Nordisk Investigational Site
      • Marseille, France, 13006
        • Novo Nordisk Investigational Site
      • Nanterre, France, 92014
        • Novo Nordisk Investigational Site
      • Nantes, France, 44200
        • Novo Nordisk Investigational Site
      • Nantes Cedex 01, France, 448093
        • Novo Nordisk Investigational Site
      • Narbonne, France, 11108
        • Novo Nordisk Investigational Site
      • PERPIGNAN cedex, France, 66046
        • Novo Nordisk Investigational Site
      • Paris, France, 75877
        • Novo Nordisk Investigational Site
      • Périgueux, France, 24019
        • Novo Nordisk Investigational Site
      • Venissieux, France, 69200
        • Novo Nordisk Investigational Site
  • Germany
      • Bad Mergentheim, Germany, 97980
        • Novo Nordisk Investigational Site
      • Berlin, Germany, 12163
        • Novo Nordisk Investigational Site
      • Dresden, Germany, 01307
        • Novo Nordisk Investigational Site
      • Elsterwerda, Germany, 04910
        • Novo Nordisk Investigational Site
      • Essen, Germany, 45219
        • Novo Nordisk Investigational Site
      • Falkensee, Germany, 14612
        • Novo Nordisk Investigational Site
      • Friedrichsthal, Germany, 66299
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 22607
        • Novo Nordisk Investigational Site
      • Leipzig, Germany, 04103
        • Novo Nordisk Investigational Site
      • Münster, Germany, 48145
        • Novo Nordisk Investigational Site
      • Saint Ingbert-Oberwürzbach, Germany, 66386
        • Novo Nordisk Investigational Site
      • Stuttgart, Germany, 70378
        • Novo Nordisk Investigational Site
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500072
        • Novo Nordisk Investigational Site
      • Hyderabad, Andhra Pradesh, India, 500034
        • Novo Nordisk Investigational Site
    • Haryana
      • Gurgaon, Haryana, India, 122001
        • Novo Nordisk Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 017
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400008
        • Novo Nordisk Investigational Site
      • Mumbai, Maharashtra, India, 4000016
        • Novo Nordisk Investigational Site
      • Pune, Maharashtra, India, 411040
        • Novo Nordisk Investigational Site
    • New Delhi
      • New Dehli, New Delhi, India, 110029
        • Novo Nordisk Investigational Site
    • Orissa
      • Bhubaneshwar, Orissa, India, 751003
        • Novo Nordisk Investigational Site
    • Punjab
      • Chandigarh, Punjab, India, 160012
        • Novo Nordisk Investigational Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • Novo Nordisk Investigational Site
      • Jaipur, Rajasthan, India, 302006
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
        • Novo Nordisk Investigational Site
      • Chennai, Tamil Nadu, India, 600 013
        • Novo Nordisk Investigational Site
      • Vellore, Tamil Nadu, India, 632004
        • Novo Nordisk Investigational Site
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • Novo Nordisk Investigational Site
      • Kolkata, West Bengal, India, 700064
        • Novo Nordisk Investigational Site
      • Kolkata, West Bengal, India, 700014
        • Novo Nordisk Investigational Site
  • Israel
      • Haifa, Israel, 31096
        • Novo Nordisk Investigational Site
      • Holon, Israel, 58100
        • Novo Nordisk Investigational Site
      • Jerusalem, Israel, 91120
        • Novo Nordisk Investigational Site
      • Kfar Saba, Israel, 44281
        • Novo Nordisk Investigational Site
      • Petah-Tikva, Israel, 49100
        • Novo Nordisk Investigational Site
      • Ra'anana, Israel, 43452
        • Novo Nordisk Investigational Site
      • Tel Aviv, Israel, 6937947
        • Novo Nordisk Investigational Site
      • Tel-Aviv, Israel, 64239
        • Novo Nordisk Investigational Site
  • Japan
      • Asahikawa-shi, Hokkaido, Japan, 070-0002
        • Novo Nordisk Investigational Site
      • Gunma, Japan, 373-0036
        • Novo Nordisk Investigational Site
      • Hokkaido, Japan, 060-0062
        • Novo Nordisk Investigational Site
      • Ibaraki, Japan, 311-0113
        • Novo Nordisk Investigational Site
      • Iruma-shi, Saitama, Japan, 358-0011
        • Novo Nordisk Investigational Site
      • Kanagawa, Japan, 235-0045
        • Novo Nordisk Investigational Site
      • Kashiwara-shi, Osaka, Japan, 582-0005
        • Novo Nordisk Investigational Site
      • Kyoto-shi, Kyoto, Japan, 601-1495
        • Novo Nordisk Investigational Site
      • Kyoto-shi, Kyoto, Japan, 615-0035
        • Novo Nordisk Investigational Site
      • Miyazaki, Japan, 880-0034
        • Novo Nordisk Investigational Site
      • Osaka, Japan, 569-1045
        • Novo Nordisk Investigational Site
      • Shinjuku-ku, Tokyo, Japan, 162-8655
        • Novo Nordisk Investigational Site
      • Shizuoka-shi, Shizuoka, Japan, 424-0853
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 103-0027
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 103-0028
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 113-8431
        • Novo Nordisk Investigational Site
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Novo Nordisk Investigational Site
      • San Luis Potosi, Mexico, 78200
        • Novo Nordisk Investigational Site
    • Estado De México
      • Toluca, Estado De México, Mexico, 50130
        • Novo Nordisk Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Novo Nordisk Investigational Site
    • Tamaulipas
      • Ciudad Madero, Tamaulipas, Mexico, 89440
        • Novo Nordisk Investigational Site
  • Romania
      • Bucharest, Romania, 020475
        • Novo Nordisk Investigational Site
      • Bucharest, Romania, 020359
        • Novo Nordisk Investigational Site
      • Iasi, Romania, 700111
        • Novo Nordisk Investigational Site
      • Iasi, Romania, 700469
        • Novo Nordisk Investigational Site
      • Satu Mare, Romania, 440055
        • Novo Nordisk Investigational Site
      • Timisoara, Romania, 300736
        • Novo Nordisk Investigational Site
    • Arges
      • Pitesti, Arges, Romania, 110084
        • Novo Nordisk Investigational Site
    • Bihor
      • Oradea, Bihor, Romania, 410025
        • Novo Nordisk Investigational Site
    • Dolj
      • Craiova, Dolj, Romania, 200642
        • Novo Nordisk Investigational Site
    • Maramures
      • Baia Mare, Maramures, Romania, 430222
        • Novo Nordisk Investigational Site
    • Mures
      • Targu Mures, Mures, Romania, 540098
        • Novo Nordisk Investigational Site
    • Prahova
      • Ploiesti, Prahova, Romania, 100342
        • Novo Nordisk Investigational Site
    • Timis
      • Timisoara, Timis, Romania, 300125
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Barnaul, Russian Federation, 656045
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 117292
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 119435
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 117036
        • Novo Nordisk Investigational Site
      • Novosibirsk, Russian Federation, 630047
        • Novo Nordisk Investigational Site
      • Penza, Russian Federation, 440026
        • Novo Nordisk Investigational Site
      • Tomsk, Russian Federation, 634050
        • Novo Nordisk Investigational Site
      • Tomsk, Russian Federation, 634041
        • Novo Nordisk Investigational Site
      • Yaroslavl, Russian Federation, 150062
        • Novo Nordisk Investigational Site
  • South Africa
      • Cape Town, South Africa, 7530
        • Novo Nordisk Investigational Site
      • Pretoria, South Africa, 0101
        • Novo Nordisk Investigational Site
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6045
        • Novo Nordisk Investigational Site
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Novo Nordisk Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1829
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, South Africa, 2001
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, South Africa, 1818
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, South Africa, 2198
        • Novo Nordisk Investigational Site
      • Krugersdorp, Gauteng, South Africa, 1739
        • Novo Nordisk Investigational Site
      • Pretoria, Gauteng, South Africa, 0122
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4120
        • Novo Nordisk Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7130
        • Novo Nordisk Investigational Site
  • Turkey
      • Ankara, Turkey, 06100
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34722
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34718
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34371
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34890
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34147
        • Novo Nordisk Investigational Site
      • Izmir, Turkey, 35340
        • Novo Nordisk Investigational Site
      • Samsun, Turkey, 55139
        • Novo Nordisk Investigational Site
      • İstanbul, Turkey, 34752
        • Novo Nordisk Investigational Site
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Novo Nordisk Investigational Site
      • Ivano-Frankivsk, Ukraine, 76018
        • Novo Nordisk Investigational Site
      • Kyiv, Ukraine, 04114
        • Novo Nordisk Investigational Site
      • Mykolaiv, Ukraine, 54003
        • Novo Nordisk Investigational Site
      • Odesa, Ukraine, 65025
        • Novo Nordisk Investigational Site
      • Ternopil, Ukraine, 46002
        • Novo Nordisk Investigational Site
      • Zaporizhia, Ukraine, 69600
        • Novo Nordisk Investigational Site
      • Zhytomyr, Ukraine, 10002
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9GT
        • Novo Nordisk Investigational Site
      • Cardiff, United Kingdom, CF5 4AD
        • Novo Nordisk Investigational Site
      • Chester, United Kingdom, CH2 1UL
        • Novo Nordisk Investigational Site
      • Crewe, United Kingdom, CW5 5NX
        • Novo Nordisk Investigational Site
      • Doncaster, United Kingdom, DN9 2HY
        • Novo Nordisk Investigational Site
      • Leicester, United Kingdom, LE5 4PW
        • Novo Nordisk Investigational Site
      • Plymouth, United Kingdom, PL6 8DH
        • Novo Nordisk Investigational Site
      • Preston, United Kingdom, PR2 9HT
        • Novo Nordisk Investigational Site
      • Rotherham, United Kingdom, S651DA
        • Novo Nordisk Investigational Site
      • Sidcup, United Kingdom, DA14 6LT
        • Novo Nordisk Investigational Site
      • Soham, United Kingdom, CB7 5JD
        • Novo Nordisk Investigational Site
      • Swansea, United Kingdom, SA2 8PP
        • Novo Nordisk Investigational Site
      • Taunton, United Kingdom, TA1 5DA
        • Novo Nordisk Investigational Site
      • Torquay, United Kingdom, TQ2 7AA
        • Novo Nordisk Investigational Site
      • Wellingborough, United Kingdom, NN8 4RW
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Novo Nordisk Investigational Site
      • Birmingham, Alabama, United States, 35211
        • Novo Nordisk Investigational Site
      • Tuscumbia, Alabama, United States, 35674
        • Novo Nordisk Investigational Site
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Novo Nordisk Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72212
        • Novo Nordisk Investigational Site
    • California
      • Carmichael, California, United States, 95608
        • Novo Nordisk Investigational Site
      • Coronado, California, United States, 92118
        • Novo Nordisk Investigational Site
      • Encino, California, United States, 91436
        • Novo Nordisk Investigational Site
      • Fresno, California, United States, 93720
        • Novo Nordisk Investigational Site
      • Los Alamitos, California, United States, 90720
        • Novo Nordisk Investigational Site
      • Palm Springs, California, United States, 92262
        • Novo Nordisk Investigational Site
      • Poway, California, United States, 92064
        • Novo Nordisk Investigational Site
      • Walnut Creek, California, United States, 94598
        • Novo Nordisk Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80220
        • Novo Nordisk Investigational Site
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Novo Nordisk Investigational Site
      • New Port Richey, Florida, United States, 34652
        • Novo Nordisk Investigational Site
      • Palm Harbor, Florida, United States, 34684
        • Novo Nordisk Investigational Site
      • Plantation, Florida, United States, 33324
        • Novo Nordisk Investigational Site
      • Port Charlotte, Florida, United States, 33952
        • Novo Nordisk Investigational Site
      • Spring Hill, Florida, United States, 34609
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33607
        • Novo Nordisk Investigational Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Novo Nordisk Investigational Site
      • Perry, Georgia, United States, 31069
        • Novo Nordisk Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Novo Nordisk Investigational Site
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Novo Nordisk Investigational Site
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Novo Nordisk Investigational Site
      • Peoria, Illinois, United States, 61602
        • Novo Nordisk Investigational Site
      • Peoria, Illinois, United States, 61603
        • Novo Nordisk Investigational Site
    • Indiana
      • Avon, Indiana, United States, 46123
        • Novo Nordisk Investigational Site
    • Kansas
      • Park City, Kansas, United States, 67219
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Novo Nordisk Investigational Site
      • Louisville, Kentucky, United States, 40213
        • Novo Nordisk Investigational Site
      • Paducah, Kentucky, United States, 42001
        • Novo Nordisk Investigational Site
      • Paducah, Kentucky, United States, 42003
        • Novo Nordisk Investigational Site
    • Louisiana
      • Metairie, Louisiana, United States, 70002
        • Novo Nordisk Investigational Site
      • Natchitoches, Louisiana, United States, 71457-5881
        • Novo Nordisk Investigational Site
      • Shreveport, Louisiana, United States, 71105
        • Novo Nordisk Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Waltham, Massachusetts, United States, 02453
        • Novo Nordisk Investigational Site
    • Michigan
      • Flint, Michigan, United States, 48532
        • Novo Nordisk Investigational Site
      • Sterling Heights, Michigan, United States, 48310-3503
        • Novo Nordisk Investigational Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Novo Nordisk Investigational Site
    • Montana
      • Butte, Montana, United States, 59701-1652
        • Novo Nordisk Investigational Site
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Novo Nordisk Investigational Site
      • Trenton, New Jersey, United States, 08611
        • Novo Nordisk Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Novo Nordisk Investigational Site
    • New York
      • New Windsor, New York, United States, 12553
        • Novo Nordisk Investigational Site
      • Rochester, New York, United States, 14607
        • Novo Nordisk Investigational Site
      • West Seneca, New York, United States, 14224
        • Novo Nordisk Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Novo Nordisk Investigational Site
      • High Point, North Carolina, United States, 27265
        • Novo Nordisk Investigational Site
      • Statesville, North Carolina, United States, 28625
        • Novo Nordisk Investigational Site
      • Whiteville, North Carolina, United States, 28472
        • Novo Nordisk Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • Novo Nordisk Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Novo Nordisk Investigational Site
      • Cincinnati, Ohio, United States, 45236
        • Novo Nordisk Investigational Site
      • Columbus, Ohio, United States, 43203
        • Novo Nordisk Investigational Site
      • Columbus, Ohio, United States, 43213
        • Novo Nordisk Investigational Site
      • Franklin, Ohio, United States, 45005
        • Novo Nordisk Investigational Site
      • Maumee, Ohio, United States, 43537
        • Novo Nordisk Investigational Site
      • Toledo, Ohio, United States, 43623
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Novo Nordisk Investigational Site
    • Oregon
      • Corvallis, Oregon, United States, 97330-3737
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Jersey Shore, Pennsylvania, United States, 17740
        • Novo Nordisk Investigational Site
      • McMurray, Pennsylvania, United States, 15317
        • Novo Nordisk Investigational Site
    • South Carolina
      • Gaffney, South Carolina, United States, 29341
        • Novo Nordisk Investigational Site
      • Greer, South Carolina, United States, 29651
        • Novo Nordisk Investigational Site
      • Pelzer, South Carolina, United States, 29669
        • Novo Nordisk Investigational Site
      • Summerville, South Carolina, United States, 29485
        • Novo Nordisk Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620-7352
        • Novo Nordisk Investigational Site
      • Humboldt, Tennessee, United States, 38343
        • Novo Nordisk Investigational Site
      • Jackson, Tennessee, United States, 38305
        • Novo Nordisk Investigational Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75390-9302
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75226
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75246
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77074
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77081
        • Novo Nordisk Investigational Site
      • Longview, Texas, United States, 75605
        • Novo Nordisk Investigational Site
      • Plano, Texas, United States, 75093
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78224
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78209
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77478
        • Novo Nordisk Investigational Site
      • Waco, Texas, United States, 76710
        • Novo Nordisk Investigational Site
    • Utah
      • Murray, Utah, United States, 84123
        • Novo Nordisk Investigational Site
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • Novo Nordisk Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Novo Nordisk Investigational Site
    • Washington
      • Olympia, Washington, United States, 98502
        • Novo Nordisk Investigational Site
      • Renton, Washington, United States, 98057
        • Novo Nordisk Investigational Site
      • Spokane, Washington, United States, 99218
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53202
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, age at least 18 years at the time of signing informed consent For Japan only: Male or female, age at least 20 years at the time of signing informed consent
  • Diagnosed with T2DM (type 2 diabetes mellitus) for at least 90 days prior to day of screening
  • HbA1c (glycosylated haemoglobin) 7.0-10.5 % (53-91 mmol/mol) (both inclusive).
  • Stable daily dose of metformin (equal or above 1500 mg or maximum tolerated dose as documented in subject medical record) alone or in combination with SU (= half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) within 90 days prior to the day of screening

Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). For certain specific countries: Additional specific requirements apply
  • Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC)
  • History of pancreatitis (acute or chronic)
  • History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
  • Any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack within the past 180 days prior to the day of screening
  • Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
  • Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
  • Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 60 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
  • History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sitagliptin 100 mg
Drug: placebo
Oral administration once-daily
Drug: sitagliptin
Oral administration once-daily
Experimental: Semaglutide 3 mg
Drug: semaglutide
Oral administration once-daily
Drug: placebo
Oral administration once-daily
Experimental: Semaglutide 7 mg
Drug: semaglutide
Oral administration once-daily
Drug: placebo
Oral administration once-daily
Experimental: Semaglutide 14 mg
Drug: semaglutide
Oral administration once-daily
Drug: placebo
Oral administration once-daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c: Week 26
Time Frame: Week 0, week 26
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on the data from 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. The endpoint was also 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight: Week 26
Time Frame: Week 0, week 26
Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from 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. The endpoint was also 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 HbA1c: Weeks 52 and 78
Time Frame: Week 0, week 52, week 78
Change from baseline (week 0) in HbA1c was evaluated at weeks 52 and 78. Results are based on the data from 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.
Week 0, week 52, week 78
Change in Body Weight (kg): Weeks 52 and 78
Time Frame: Week 0, week 52, week 78
Change from baseline (week 0) in body weight was evaluated at weeks 52 and 78. Results are based on the data from 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.
Week 0, week 52, week 78
Change in Body Weight (%)
Time Frame: Week 0, week 26, week 52, week 78
Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26, 52 and 78. Results are based on the data from 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.
Week 0, week 26, week 52, week 78
Change in FPG
Time Frame: Week 0, week 26, week 52, week 78
Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26, 52 and 78. Results are based on the data from 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.
Week 0, week 26, week 52, week 78
Change in BMI
Time Frame: Week 0, week 26, week 52, week 78
Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26, 52 and 78. Results are based on the data from 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.
Week 0, week 26, week 52, week 78
Change in Waist Circumference
Time Frame: Week 0, week 26, week 52, week 78
Change from baseline (week 0) in waist circumference was evaluated at weeks 26, 52 and 78. Results are based on the data from 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.
Week 0, week 26, week 52, week 78
Change in Total Cholesterol (Ratio to Baseline)
Time Frame: Week 0, week 26, week 52, week 78
Change from baseline (week 0) in total cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from 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.
Week 0, week 26, week 52, week 78
Change in LDL Cholesterol (Ratio to Baseline)
Time Frame: Week 0, week 26, week 52, week 78
Change from baseline (week 0) in low-density lipoprotein (LDL) cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from 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.
Week 0, week 26, week 52, week 78
Change in VLDL Cholesterol (Ratio to Baseline)
Time Frame: Week 0, week 26, week 52, week 78
Change from baseline (week 0) in very-low-density lipoprotein (VLDL) cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from 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.
Week 0, week 26, week 52, week 78
Change in HDL Cholesterol (Ratio to Baseline)
Time Frame: Week 0, week 26, week 52, week 78
Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from 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.
Week 0, week 26, week 52, week 78
Change in Triglycerides (Ratio to Baseline)
Time Frame: Week 0, week 26, week 52, week 78
Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from 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.
Week 0, week 26, week 52, week 78
Change in Free Fatty Acids (Ratio to Baseline)
Time Frame: Week 0, week 26, week 52, week 78
Change from baseline (week 0) in free fatty acids (FFA) (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from 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. Because of an issue with the handling of the blood samples for FFA, all FFA data were considered invalid for this trial; thus, no conclusion with regards to FFA levels can be made based on the data presented here.
Week 0, week 26, week 52, week 78
Change in SMPG - Mean 7-point Profile
Time Frame: Week 0, week 26, week 52, week 78
Change from baseline (week 0) in mean 7-point self-measured plasma glucose (SMPG) profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the data from 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.
Week 0, week 26, week 52, week 78
Change in SMPG - Mean Postprandial Increment Over All Meals
Time Frame: Week 0, week 26, week 52, week 78
Change from baseline (week 0) in the average of the post-prandial increments over all meals was evaluated at weeks 26, 52 and 78. Results are based on the data from 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.
Week 0, week 26, week 52, week 78
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)
Time Frame: Week 26, week 52, week 78
Participants who achieved HbA1c <7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at weeks 26, 52 and 78. Results are based on the data from 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.
Week 26, week 52, week 78
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)
Time Frame: Week 26, week 52, week 78
Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at weeks 26, 52 and 78 are presented. Results are based on the data from 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.
Week 26, week 52, week 78
Participants Who Achieve Weight Loss ≥5% (Yes/no)
Time Frame: Week 26, week 52, week 78
Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 26, 52 and 78 are presented. Results are based on the data from 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.
Week 26, week 52, week 78
Participants Who Achieve Weight Loss ≥10% (Yes/no)
Time Frame: Week 26, week 52, week 78
Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at weeks 26, 52 and 78 are presented. Results are based on the data from 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.
Week 26, week 52, week 78
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)
Time Frame: Week 26, week 52, week 78
Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26, 52 and 78 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from 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.
Week 26, week 52, week 78
Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)
Time Frame: Week 26, week 52, week 78
Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26, 52 and 78 are presented. Results are based on the data from 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.
Week 26, week 52, week 78
Time to Additional Anti-diabetic Medication
Time Frame: Weeks 0-78
Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26, week 0 to week 52 and week 0 to week 78. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 78), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from 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.
Weeks 0-78
Time to Rescue Medication
Time Frame: Weeks 0-78
Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26, week 0 to week 52 and week 0 to week 78. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are 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.
Weeks 0-78
Number of TEAEs During Exposure to Trial Product
Time Frame: Weeks 0-83
Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 83 (78-week treatment period plus the 5-week 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 0-83
Change in Amylase (Ratio to Baseline)
Time Frame: Week 0, week 26, week 52, week 78
Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Week 0, week 26, week 52, week 78
Change in Lipase (Ratio to Baseline)
Time Frame: Week 0, week 26, week 52, week 78
Change from baseline (week 0) in lipase (U/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Week 0, week 26, week 52, week 78
Change in Pulse Rate
Time Frame: Week 0, week 26, week 52, week 78
Change from baseline (week 0) in pulse rate was evaluated at weeks 26, 52 and 78. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Week 0, week 26, week 52, week 78
Change in SBP and DBP
Time Frame: Week 0, week 26, week 52, week 78
Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at weeks 26, 52 and 78. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Week 0, week 26, week 52, week 78
Change in ECG Evaluation
Time Frame: Week 0, week 26, week 52, week 78
Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26, 52 and 78. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26, 52 and 78. Results are based on the data from 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.
Week 0, week 26, week 52, week 78
Change in Physical Examination
Time Frame: Week -2, week 52, week 78
Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2), weeks 52 and 78 are presented. Results are based on the data from 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. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.
Week -2, week 52, week 78
Change in Eye Examination Category
Time Frame: Week -2, week 52, week 78
Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2), week 52 and week 78 are presented. Results are based on the data from 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.
Week -2, week 52, week 78
Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)
Time Frame: Weeks 0-83
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (weeks 0-83) are presented. Results are based on the data from 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.
Weeks 0-83
Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)
Time Frame: Weeks 0-83
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (weeks 0-83) are presented. Results are based on the data from 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.
Weeks 0-83
Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)
Time Frame: Weeks 0-83
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (weeks 0-83) are presented. Results are based on the data from 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.
Weeks 0-83
Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)
Time Frame: Weeks 0-83
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (weeks 0-83) are presented. Results are based on the data from 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.
Weeks 0-83
Anti-semaglutide Binding Antibody Levels
Time Frame: Weeks 0-83
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-83). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from 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.
Weeks 0-83
Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes
Time Frame: Weeks 0-83
Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-83 (78-week treatment period plus the 5-week 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. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Weeks 0-83
Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes
Time Frame: Weeks 0-83
Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 83 (78-week treatment period plus the 5-week 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. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Weeks 0-83
Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses
Time Frame: Weeks 0-83
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Semaglutide plasma concentrations for participants in the pharmacokinetic (PK) subpopulation are presented. The PK subpopulation consisted of participants from sites in Germany, Japan and the United States receiving oral semaglutide (3 mg, 7 mg or 14 mg). Results are based on the data from the on-treatment observation period and follow-up period. The on-treatment observation period was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Weeks 0-83
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)
Time Frame: Week 0, week 26, week 52, week 78
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26, 52 and 78. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.
Week 0, week 26, week 52, week 78
Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains
Time Frame: Week 0, week 26, week 52, week 78
The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. The items of the IWQOL-Lite-CT pertain to physical functioning (physical, physical function and pain/discomfort) and psychosocial domains and all items employ a 5-point graded response scale (never, rarely, sometimes, usually, always; or not at all true, a little true, moderately true, mostly true, completely true). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. Results are based on the data from 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.
Week 0, week 26, week 52, week 78
Change in CoEQ: Scores From the 4 Domains and the 19 Items
Time Frame: Week 0, week 26, week 52, week 78
Change from baseline (week 0) in Control of Eating Questionnaire (CoEQ) was evaluated at weeks (wk) 26, 52 and 78. The CoEQ comprised 19 items to assess the intensity and type of food cravings, as well as subjective sensation of appetite and mood, with the 4 domains: 'craving control' (items 9-12, 19), 'positive mood' (items 5-8), 'craving for savoury' (items 4, 16-18) and 'craving for sweet' (items 3, 13-15). The 19 items were scored on an 11-point graded response scale ranging from 10 to 0, with items relating to each of the 4 domains being averaged to create a final score. A low score in the domains 'craving for sweet and 'craving for savoury' represents a low level of craving; whereas a high score in the domains 'craving control' and 'positive mood' represents good control and a good mood, respectively. Results are based on the data from the in-trial observation period.
Week 0, week 26, week 52, week 78

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2016

Primary Completion (Actual)

February 14, 2017

Study Completion (Actual)

March 28, 2018

Study Registration Dates

First Submitted

November 10, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimate)

November 18, 2015

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9924-4222
  • 2015-001351-71 (EudraCT Number)
  • U1111-1168-4339 (Other Identifier: WHO)
  • JAPIC (Other Identifier: JapicCTI-163174)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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