The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy

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

Phase

3

Condition

Diabetic Neuropathy

Diabetic Foot Ulcers

Diabetic Kidney Disease

Treatment

N/A

Clinical Study ID

NCT01676116
NN9068-3851
2012-000209-63
U1111-1127-1321
  • Ages > 18
  • All Genders

Study Summary

This trial is conducted in Europe, Oceania and the United States of America (USA).

The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects with type 2 diabetes mellitus

  • Glycosylated haemoglobin (HbA1c) 7.0-9.0% (53-75 mmol/mol) (both inclusive)

  • Treatment with daily GLP-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg once daily (OD) Victoza® (liraglutide) or 10 microgram twice daily (BID)Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza® (liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stabledaily dose of metformin (equal to or above 1500 mg or documented maximum tolerateddose) for 90 days or more prior to screening visit (Visit 1)

  • BMI (body mass index) equal to or below 40 kg/m^2

Exclusion

Exclusion Criteria:

  • Any use of oral anti-diabetic drugs (OADs) (except for metformin, pioglitazone andsulphonylurea) for 90 days or less prior to screening visit (Visit 1)

  • Use of any drug (except metformin,pioglitazone, sulphonylurea and GLP-1 receptoragonist) which in the Investigator's opinion could interfere with the blood glucoselevel (e.g. systemic corticosteroids)

  • Treatment with any insulin regimen (short term treatment due to intercurrent illnessincluding gestational diabetes is allowed at the discretion of the Investigator)

  • Screening calcitonin equal to or above 50 ng/l

  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrineneoplasia type 2 (MEN2)

  • Cardiovascular disorders defined as: congestive heart failure (New York HeartAssociation (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebralstroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary, carotid or peripheral artery revascularisationprocedures

  • Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema)according to the Investigator's opinion

  • Subjects with a clinically significant, active (during the past 12 months) disease ofthe gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetesmellitus), neurological, genitourinary or haematological system that in the opinion ofthe Investigator may confound the results of the trial or pose additional risk inadministering trial products

  • History of chronic pancreatitis or idiopathic acute pancreatitis

Study Design

Total Participants: 438
Study Start date:
August 29, 2012
Estimated Completion Date:
March 11, 2014

Connect with a study center

  • Novo Nordisk Investigational Site

    Coffs Harbour, New South Wales 2450
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Merewether, New South Wales 2291
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Keswick, South Australia 5035
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Antibes, 06600
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Boulogne Billancourt, 92100
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    LA ROCHELLE cedex, 17019
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Montigny-les-Metz, 57950
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Narbonne, 11108
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Nimes, 30006
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Sète, 34200
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Venissieux, 69200
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Budapest, 1042
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Debrecen, 4043
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Nyíregyhaza, 4400
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Székesfehérvár, 8000
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Bratislava, 851 01
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Kosice, 040 01
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Lucenec, 98401
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Nitra, 94 911
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Presov, 080 01
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Birmingham, Alabama 35216
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Goodyear, Arizona 85395
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Mesa, Arizona 85206
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Chino, California 91710
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Concord, California 94520
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Danville, California 94526
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Encino, California 91436
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fair Oaks, California 95628
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fresno, California 93720
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greenbrae, California 94904
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Huntington Beach, California 92646
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lancaster, California 93534
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lomita, California 90717
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Long Beach, California 90806
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Montclair, California 91763
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Northridge, California 91325
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Rancho Cucamonga, California 91730-3063
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    San Mate, California 94401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Mateo, California 94401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Ramon, California 94583
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tarzana, California 91356-3551
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Van Nuys, California 91405
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    West Hills, California 91307
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Colorado Springs, Colorado 80910
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bradenton, Florida 34201
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fort Myers, Florida 33912-4343
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Miami, Florida 33136
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Miami Springs, Florida 33166
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Ocala, Florida 34471
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Orlando, Florida 32806
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Plant City, Florida 33563
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Arlington Heights, Illinois 60004-2315
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Indianapolis, Indiana 46254
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Rockville, Maryland 20852
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kalamazoo, Michigan 49048
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Troy, Michigan 48098
    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

    Omaha, Nebraska 68124
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Henderson, Nevada 89052-2649
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Reno, Nevada 89502-0111
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Nashua, New Hampshire 03063
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Flemington, New Jersey 08822-5763
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamilton, New Jersey 08619
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lawrenceville, New Jersey 08648
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Toms River, New Jersey 08753-2975
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Mineola, New York 11501
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    North Massapequa, New York 11758-1802
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    West Seneca, New York 14224
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dayton, Ohio 45439
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Altoona, Pennsylvania 16602
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pittsburgh, Pennsylvania 15243
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sumter, South Carolina 29150-1900
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jellico, Tennessee 37762
    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

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tullahoma, Tennessee 37388
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Tullahoma,, Tennessee 37388
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Arlington, Texas 76014
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Austin, Texas 78731
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75231
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fort Worth, Texas 76113
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Houston, Texas 77074
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Plano, Texas 75075
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Schertz, Texas 78154
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Sugarland, Texas 77478
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Orem, Utah 84058
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint George, Utah 84790
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    St. George, Utah 84790
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Richmond, Virginia 23219
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Seattle, Washington 98101
    United States

    Site Not Available

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