Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes

Last updated: May 28, 2019
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetic Macular Edema

Diabetic Retinopathy

Diabetic Gastroparesis

Treatment

N/A

Clinical Study ID

NCT01885208
NN9535-3624
U1111-1135-8647
2012-004826-92
  • Ages > 18
  • All Genders

Study Summary

This trial is conducted in Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes.

Eligibility Criteria

Inclusion

Inclusion Criteria: - Subjects diagnosed with type 2 diabetes and on stable diabetestreatment with 1-2 OADs (Metformin equal to or above 1500 mg or maximum tolerated doseand/or thiazolidinedione (TZD) and sulfonylureas (SUs) equal to or above half of maximumdose allowed according to national label) for at least 90 days prior to screening. Stableis defined as unchanged medication and unchanged dose - HbA1c 7.0 - 10.5 % (53 - 91

Exclusion

mmol/mol) (both inclusive) Exclusion Criteria: - Females of childbearing potential who arepregnant, breast-feeding or intend to become pregnant or are not using an adequatecontraceptive method throughout the trial including the 5 week follow-up period (adequatecontraceptive measures as required by local law or practice) - Any chronic disorder orsevere disease which, in the opinion of the investigator, might jeopardise subject's safetyor compliance with the protocol - Treatment with glucose lowering agent(s) other thanstated in the inclusion criteria in a period of 90 days before screening. An exception isshort-term treatment (7 days or less in total) with insulin in connection withinter-current illness - History of chronic or idiopathic acute pancreatitis - Screeningcalcitonin value equal to or above 50 ng/L (pg/mL) - Personal or family history ofmedullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) -Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60ml/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variableversion) - Acute coronary or cerebrovascular event within 90 days before randomisation -Heart failure, New York Heart Association (NYHA) class IV

Study Design

Total Participants: 813
Study Start date:
December 02, 2013
Estimated Completion Date:
July 13, 2015

Connect with a study center

  • Novo Nordisk Investigational Site

    Buenos Aires, C1250AAN
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Caba, C1179AAB
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Lanus Este, B1824KAJ
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Mar del Plata, B7600GWV
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Karlovac, 47000
    Croatia

    Site Not Available

  • Novo Nordisk Investigational Site

    Osijek, 31 000
    Croatia

    Site Not Available

  • Novo Nordisk Investigational Site

    Slavonski Brod, 35 000
    Croatia

    Site Not Available

  • Novo Nordisk Investigational Site

    Virovitica, 33000
    Croatia

    Site Not Available

  • Novo Nordisk Investigational Site

    Zagreb, 10 000
    Croatia

    Site Not Available

  • Novo Nordisk Investigational Site

    Helsinki, FI-00100
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Kerava, FI-04200
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Oulu, 90220
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Turku, 20520
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Chalons-en-Champagne Cedex, 51005
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Corbeil Essonnes, 91106
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    LA ROCHELLE cedex, 17019
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Le Creusot, 71200
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Nanterre, 92014
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Roubaix, 59100
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Strasbourg, 67000
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Venissieux, 69200
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Dresden, 01219
    Germany

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  • Novo Nordisk Investigational Site

    Duisburg, 47051
    Germany

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  • Novo Nordisk Investigational Site

    Hohenmölsen, 06679
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Mannheim, 68163
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Oldenburg, 23758
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Rehlingen-Siersburg, 66780
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Völklingen, 66333
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Athens, GR-14233
    Greece

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    Piraeus, GR-18536
    Greece

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  • Novo Nordisk Investigational Site

    Thessaloniki, GR-57010
    Greece

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  • Novo Nordisk Investigational Site

    Bologna, 40138
    Italy

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  • Novo Nordisk Investigational Site

    Città di Castello, 06012
    Italy

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  • Novo Nordisk Investigational Site

    Milano, 20132
    Italy

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  • Novo Nordisk Investigational Site

    Palermo, 90127
    Italy

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  • Novo Nordisk Investigational Site

    Pavia, 27100
    Italy

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  • Novo Nordisk Investigational Site

    Roma, 00161
    Italy

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  • Novo Nordisk Investigational Site

    Siena, 53100
    Italy

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  • Novo Nordisk Investigational Site

    Amsterdam, 1066 EC
    Netherlands

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  • Novo Nordisk Investigational Site

    Apeldoorn, 7334 DZ
    Netherlands

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  • Novo Nordisk Investigational Site

    Delft, 2625 AD
    Netherlands

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  • Novo Nordisk Investigational Site

    Hoofddorp, 2134 TM
    Netherlands

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  • Novo Nordisk Investigational Site

    Leeuwarden, 8934 AD
    Netherlands

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  • Novo Nordisk Investigational Site

    Rotterdam, 3039 BD
    Netherlands

    Site Not Available

  • Novo Nordisk Investigational Site

    Venlo, 5912 BL
    Netherlands

    Site Not Available

  • Novo Nordisk Investigational Site

    Zoetermeer, 2725 NA
    Netherlands

    Site Not Available

  • Novo Nordisk Investigational Site

    Caguas, 00725
    Puerto Rico

    Site Not Available

  • Novo Nordisk Investigational Site

    Manati, 00674
    Puerto Rico

    Site Not Available

  • Novo Nordisk Investigational Site

    Belgrade, 11000
    Serbia

    Site Not Available

  • Novo Nordisk Investigational Site

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Novo Nordisk Investigational Site

    Novi Sad, 21000
    Serbia

    Site Not Available

  • Novo Nordisk Investigational Site

    Basel, 4031
    Switzerland

    Site Not Available

  • Novo Nordisk Investigational Site

    Genève 14, 1211
    Switzerland

    Site Not Available

  • Novo Nordisk Investigational Site

    Luzern 16, 6000
    Switzerland

    Site Not Available

  • Novo Nordisk Investigational Site

    St. Gallen, 9007
    Switzerland

    Site Not Available

  • Novo Nordisk Investigational Site

    Zollikerberg, 8125
    Switzerland

    Site Not Available

  • Novo Nordisk Investigational Site

    Ayr, KA6 6DX
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Bath, BA1 3NG
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Bradford-on-Avon, BA15 1DQ
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Haxey, DN9 2HY
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Headington, OX3 7LE
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Rotherham, S651DA
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Anniston, Alabama 36207
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Birmingham, Alabama 35216
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pell City, Alabama 35128
    United States

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  • Novo Nordisk Investigational Site

    Glendale, Arizona 85306-4652
    United States

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    Mesa, Arizona 85213
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Phoenix, Arizona 85027
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Burbank, California 91505
    United States

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  • Novo Nordisk Investigational Site

    Hawaiian Gardens, California 90716
    United States

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  • Novo Nordisk Investigational Site

    Lomita, California 90717
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Los Angeles, California 90022
    United States

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  • Novo Nordisk Investigational Site

    Northridge, California 91325
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Diego, California 92108
    United States

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  • Novo Nordisk Investigational Site

    Tustin, California 92780
    United States

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  • Novo Nordisk Investigational Site

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bradenton, Florida 34201
    United States

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  • Novo Nordisk Investigational Site

    Brandon, Florida 33511
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jacksonville, Florida 32207
    United States

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  • Novo Nordisk Investigational Site

    Miami, Florida 33144
    United States

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  • Novo Nordisk Investigational Site

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Plantation, Florida 33324
    United States

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  • Novo Nordisk Investigational Site

    Savannah, Georgia 31406
    United States

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  • Novo Nordisk Investigational Site

    Chicago, Illinois 60634
    United States

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  • Novo Nordisk Investigational Site

    Franklin, Indiana 46131
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greenfield, Indiana 46140
    United States

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  • Novo Nordisk Investigational Site

    Muncie, Indiana 47304
    United States

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  • Novo Nordisk Investigational Site

    Crestview Hills, Kentucky 41017-3464
    United States

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  • Novo Nordisk Investigational Site

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Madisonville, Kentucky 42431
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hyattsville, Maryland 20782
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kalamazoo, Michigan 49009
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada 89103
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Mine Hill, New Jersey 07803
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    North Massapequa, New York 11758-1802
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Syracuse, New York 13210
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    West Seneca, New York 14224
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hickory, North Carolina 28601
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Whiteville, North Carolina 28472
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Akron, Ohio 44311
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio 45255
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Delaware, Ohio 43015
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Corvallis, Oregon 97330-3737
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Portland, Oregon 97210
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lansdale, Pennsylvania 19446-1002
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Norristown, Pennsylvania 19401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Mt. Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Murrells Inlet, South Carolina 29576
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Austin, Texas 78731
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Carrollton, Texas 75010
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75390-8858
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fort Worth, Texas 76117
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Houston, Texas 77072
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Irving, Texas 75039
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Katy, Texas 77450
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Antonio, Texas 78245
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sugar Land, Texas 77479
    United States

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  • Novo Nordisk Investigational Site

    Sugarland, Texas 77478
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Alexandria, Virginia 22304
    United States

    Site Not Available

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