Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes

Last updated: January 8, 2020
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetic Vitreous Hemorrhage

Diabetes Prevention

Diabetic Neuropathy

Treatment

N/A

Clinical Study ID

NCT03136484
NN9535-4270
2016-000989-35
U1111-1180-3651
  • Ages > 18
  • All Genders

Study Summary

This trial is conducted in Africa, Asia, Europe, North and South America. The aim of the trial is to compare the effect of once-weekly (OW) dosing of subcutaneous semaglutide (1.0 mg) versus once-daily dosing of oral canagliflozin (300 mg) on glycaemic control in subjects with type 2 diabetes (T2D) on a background treatment of metformin

Eligibility Criteria

Inclusion

Inclusion Criteria: - Informed consent obtained before any trial-related activities.Trial-related activities are any procedures that are carried out as part of the trial,including activities to determine suitability for the trial - Male or female, age equal toor above18 years at the time of signing informed consent - Diagnosed with type 2 diabetesmellitus (T2D) - HbA1c of 7.0-10.5% (53-91 mmol/mol, both inclusive) - Stable daily dose ofmetformin (equal to or above1500 mg or maximum tolerated dose as documented in the subjectmedical record and in compliance with current local label) for at least 90 days prior to

Exclusion

the day of screening Exclusion Criteria: - Known or suspected hypersensitivity to trialproduct(s) or related products - Previous participation in this trial. Participation isdefined as signed informed consent - Female who is pregnant, breast-feeding or intends tobecome pregnant or is of child-bearing potential and not using an adequate contraceptivemethod (adequate contraceptive measure as required by local regulation or practice) -Participation in any clinical trial of an approved or non-approved investigationalmedicinal product within 90 days prior to the day of screening - Any disorder which in theinvestigator's opinion might jeopardise subject's safety or compliance with the protocol -Subject with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL) - Familyor personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.Family is defined as a first degree relative - History or presence of pancreatitis (acuteor chronic) - History of diabetic ketoacidosis (DKA) - Any of the following: myocardialinfarction (MI), stroke, hospitalization for unstable angina or transient ischaemic attackwithin the past 180 days prior to the day of screening - Subjects presently classified asbeing in New York Heart Association (NYHA) Class IV - Planned coronary, carotid orperipheral artery revascularisation known on the day of screening - Renal impairmentmeasured as eGFR below 60 ml/min/1.73 m^2 as defined by Kidney Disease Improving globaloutcomes (KDIGO 2012) classification using isotope dilution mass spectrometry (IDMS) forserum creatinine measured at screening - Treatment with any medication for the indicationof diabetes or obesity other than stated in the inclusion criteria within the past 90 daysprior to the day of screening. However, short term insulin treatment for a maximum of 14days prior to the day of screening is allowed - Proliferative retinopathy or maculopathyrequiring acute treatment. Verified by fundus photography or dilated fundoscopy performedwithin the past 90 days prior to randomisation - Presence or history of malignant neoplasmswithin the past 5 years prior to the day of screening. Basal and squamous cell skin cancerand any carcinoma in-situ is allowed - Medical history of diabetes-related lower limbamputations or signs of critical lower limb ischemia, (e.g. skin ulcer, osteomyelitis, organgrene) within the last 26 weeks prior to screening

Study Design

Total Participants: 788
Study Start date:
March 15, 2017
Estimated Completion Date:
November 16, 2018

Connect with a study center

  • Novo Nordisk Investigational Site

    Buenos Aires, C1250AAN
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Caba, C1430CKE
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Rosario, S2000CUD
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Salta, 4400
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Porto Alegre, 90035-170
    Brazil

    Site Not Available

  • Novo Nordisk Investigational Site

    Rio de Janeiro, 22271-100
    Brazil

    Site Not Available

  • Novo Nordisk Investigational Site

    Surrey, British Columbia V3S 2N6
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Brampton, Ontario L6T 0G1
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Burlington, Ontario L7M 4Y1
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    London, Ontario N5W 6A2
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Sarnia, Ontario N7T 4X3
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Toronto, Ontario M9V 4B4
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Pointe Claire, Quebec H9R 4S3
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Pointe-Claire, Quebec H9R 3J1
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Hyderabad, Andhra Pradesh 500034
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Rohtak, Haryana 124001
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Bangalore, Karnataka 560054
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Kochi, Kerala 682041
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra 400008
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Nagpur, Maharashtra 440008
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Jaipur, Rajasthan 302006
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Chennai, Tamil Nadu 600001
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Kolkata, West Bengal 700054
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Dublin, DUBLIN 15
    Ireland

    Site Not Available

  • Novo Nordisk Investigational Site

    Galway, H91 YR71
    Ireland

    Site Not Available

  • Novo Nordisk Investigational Site

    Mallow, P51Y8EC
    Ireland

    Site Not Available

  • Novo Nordisk Investigational Site

    Milano, 20100
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Achrafieh,
    Lebanon

    Site Not Available

  • Novo Nordisk Investigational Site

    Hazmieh,
    Lebanon

    Site Not Available

  • Novo Nordisk Investigational Site

    Lebanon - Beirut, 9611
    Lebanon

    Site Not Available

  • Novo Nordisk Investigational Site

    Mansourieh,
    Lebanon

    Site Not Available

  • Novo Nordisk Investigational Site

    Zgharta, 9616
    Lebanon

    Site Not Available

  • Novo Nordisk Investigational Site

    Alor Gajah, 78300
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Ipoh, 30450
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Melaka, 75400
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Penang, 10450
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Sandakan, 90000
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Seremban, 70300
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Cuernavaca, Morelos 62250
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Mexico City, México, D.F. 02230
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Monterrey, Nuevo León 64620
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Eksjö, 575 35
    Sweden

    Site Not Available

  • Novo Nordisk Investigational Site

    Kristianstad, 291 85
    Sweden

    Site Not Available

  • Novo Nordisk Investigational Site

    Lund, 221 85
    Sweden

    Site Not Available

  • Novo Nordisk Investigational Site

    Malmö, 205 02
    Sweden

    Site Not Available

  • Novo Nordisk Investigational Site

    Örebro, 701 85
    Sweden

    Site Not Available

  • Novo Nordisk Investigational Site

    Basingstoke, RG24 9GT
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Bradford-on-Avon, BA15 1DQ
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Dundee, DD1 9SY
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Haxey, DN9 2HY
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Plymouth, PL8 8DQ
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Soham, CB7 5JD
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Southampton, SO30 3JB
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Stevenage, SG1 4AB
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Torquay, TQ2 7AA
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Wellingborough, NN8 4RW
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Anaheim, California 92801
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    La Mesa, California 91942
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Los Angeles, California 90057
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Montclair, California 91763
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Diego, California 92111
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Spring Valley, California 91978
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tustin, California 92780
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Brooksville, Florida 34601
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fleming Island, Florida 32003
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hallandale Beach, Florida 33009
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Miami, Florida 33135
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Spring Hill, Florida 34609
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Conyers, Georgia 30094-5965
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Meridian, Idaho 83646
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Council Bluffs, Iowa 51501
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lake Charles, Louisiana 70601
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Metairie, Louisiana 70002
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Baltimore, Maryland 21239
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hyattsville, Maryland 20782
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Flint, Michigan 48504
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sterling Heights, Michigan 48310-3503
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Troy, Michigan 48098
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Trenton, New Jersey 08611
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Brooklyn, New York 11229
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    New Windsor, New York 12553
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Maumee, Ohio 43537
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Toledo, Ohio 43623
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Corvallis, Oregon 97330-3737
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Corpus Christi, Texas 78404
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75390-9302
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Houston, Texas 77074
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Katy, Texas 77450
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Antonio, Texas 78230
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Splendora, Texas 77372
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint George, Utah 84790
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Herndon, Virginia 20171
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Olympia, Washington 98502
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wenatchee, Washington 98801-2028
    United States

    Site Not Available

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