A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus

Last updated: December 7, 2018
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes Prevention

Diabetic Foot Ulcers

Diabetic Neuropathy

Treatment

N/A

Clinical Study ID

NCT01952145
NN9068-3952
U1111-1135-1003
2012-004413-14
  • Ages > 18
  • All Genders

Study Summary

This trial is conducted globally. The aim of the trial is to compare the efficacy and safety of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes mellitus.

Eligibility Criteria

Inclusion

Inclusion Criteria: - Type 2 diabetes mellitus - HbA1c 7.0-10.0% [53-86 mmol/mol] (bothinclusive) by central laboratory analysis - Current treatment with insulin glargine for atleast 90 days prior to screening - Stable daily dose of insulin glargine between 20 unitsand 50 units (both inclusive) for at least 56 days prior to screening. Total daily doseshould be within the range of 20-50 units, both inclusive, on the day of screening, butindividual fluctuations of plus/minus 10 procent within the 56 days prior to screening areacceptable - Stable daily dose of metformin (above or equal to 1500 mg or max tolerateddose) for at least 90 days prior to screening - Body mass index (BMI) below or equal to 40

Exclusion

kg/m^2 Exclusion Criteria: - Any use of oral antidiabetic agents (OADs) (except formetformin) within 90 days prior to Visit 1 (screening) - Current use of any drug (exceptmetformin and insulin glargine) or anticipated change inconcomitant medication, which inthe investigator's opinion could interfere with the glucose metabolism (e.g. systemiccorticosteroids) - Previous and/or current treatment with any insulin regimen other thanbasal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrentillness includinggestational diabetes is allowed at the discretion of the investigator) -Previous and/or current treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide) - Impaired liver function, defined as ALAT (alanineaminotransferase) above or equal to 2.5 times upper normal range (UNR) - Impaired renalfunction defined as serum-creatinine above or equal to 133 micromol/L (above or equal to 1.5 mg/dL) for males and above or equal to 125 micromol/L (1.4 mg/dL) for females, or asallowed according to local contraindications for metformin - Screening calcitonin above orequal to 50 ng/L - Personal or family history of medullary thyroid carcinoma (MTC) ormultiple endocrine neoplasia type 2 (MEN2) - History of chronic pancreatitis or idiopathicacute pancreatitis

Study Design

Total Participants: 557
Study Start date:
September 20, 2013
Estimated Completion Date:
November 04, 2014

Connect with a study center

  • Novo Nordisk Investigational Site

    Buenos Aires, B1704ETD
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Capital Federal, C1056ABJ
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Corrientes, 3400
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Salta, 4400
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Zarate, B2800DGH
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Blacktown, New South Wales 2148
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Wollongong, New South Wales 2500
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Herston, Queensland 4029
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Ipswich, Queensland 4305
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Robina, Queensland 4226
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    East Ringwood, Victoria 3135
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Athens, GR-14233
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Ioannina, 45500
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Larissa, GR-41110
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Thessaloniki, GR-57001
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Budapest, H-1134
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Eger, 3300
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Gyor, 9024
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Gyula, 5700
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Miskolc, 3526
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Pachuca, Hidalgo 42084
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Cuernavaca, Morelos 62250
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Mexico City, México, D.F. 03300
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Durango, 34000
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Monterrey, 64460
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Kazan, 420073
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Kirov, 610014
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Moscow, 123448
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Novosibirsk, 630117
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint-Petersburg, 199034
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    St. Petersburg, 194354
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Tomsk, 634050
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Volgograd, 400131
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Vsevolozhsk, 188643
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Bardejov, 08501
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Dolny Kubin, 02601
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Kosice, 040 11
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Levice, 93401
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Lubochna, 03491
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Poprad, 05801
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Povazska Bystrica, 01701
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Prievidza, 97101
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Trnava, 91701
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Velky Meder, 93201
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Midrand, Gauteng 1685
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal 4450
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Alberton, 1449
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Almería, 04001
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Granada, 18012
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Palma de Mallorca, 07014
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Sevilla, 41010
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Valencia, 46026
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Fresno, California 93720
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Palm Springs, California 92262
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Diego, California 92111
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Colorado Springs, Colorado 80906
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bradenton, Florida 34201
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fort Lauderdale, Florida 33316
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Miami, Florida 33165
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pembroke Pines, Florida 33027
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tampa, Florida 33603
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Evansville, Indiana 47725
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Michigan City, Indiana 46360
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Slidell, Louisiana 70461-4231
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Charles, Missouri 63303
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    St. Charles, Missouri 63303
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Franklin, Ohio 45005
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Altoona, Pennsylvania 16602
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tipton, Pennsylvania 16684
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Collierville, Tennessee 38017
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Johnson City, Tennessee 37604
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75390-9302
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Antonio, Texas 78224
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    West Jordan, Utah 84088-8871
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Renton, Washington 98057
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Spokane, Washington 99218
    United States

    Site Not Available

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