The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy

Last updated: September 26, 2017
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetic Kidney Disease

Diabetic Macular Edema

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT01618162
NN9068-3951
2012-000140-97
U1111-1126-9776
  • Ages > 18
  • All Genders

Study Summary

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in combination with metformin. All subjects will continue their pre-trial SU treatment with or without metformin treatment without changing the frequency or dose throughout the trial.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects with type 2 diabetes mellitus

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

  • Subjects on stable daily dose of sulphonylurea (above or equal to half of the maxapproved dose according to local label) with or without metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (Visit 1)

  • Body Mass Index (BMI) below or equal to 40 kg/m^2

Exclusion

Exclusion Criteria:

  • Any use of oral anti-diabetic drugs (OADs) (other than SU in monotherapy or incombinationwith metformin) below or equal to 90 days prior to screening visit (Visit
  • Use of any drug (other than SU in monotherapy or in combination with metformin), whichin the Investigators opinion could interfere with the blood glucose level (e.g.systemic corticosteroids)

  • Previous treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (e.g.exenatide, liraglutide)

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

  • Screening calcitonin above or equal to 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 clinical 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 product

  • History of chronic pancreatitis or idiopathic acute pancreatitis

Study Design

Total Participants: 435
Study Start date:
August 29, 2012
Estimated Completion Date:
October 23, 2013

Connect with a study center

  • Novo Nordisk Investigational Site

    Lukovit, 5770
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Ruse, 7000
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Sofia, 1324
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Burnaby, British Columbia V5G 1T4
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Surrey, British Columbia V3S 2N6
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Victoria, British Columbia V8V 3N7
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Cambridge, Ontario N1R 7L6
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    London, Ontario N6G 2M1
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Toronto, Ontario M4S 1Y2
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Mirabel, Quebec J7J 2K8
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Pointe Claire, Quebec H9R 4S3
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Sherbrooke, Quebec J1G 5K2
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Quebec, G1N 4V3
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Esslingen, 73728
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamburg, 22607
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Hohenmölsen, 06679
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Münster, 48145
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Pohlheim, 35415
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Rehlingen-Siersburg, 66780
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Sulzbach-Rosenberg, 92237
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Guwahati, Assam
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Bangalore, Karnataka 560043
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Belgaum, Karnataka 590001
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra 400008
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Pune, Maharashtra 411030
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Delhi, New Delhi 110002
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Hyderabad, 600034
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Haifa, 35152
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Holon, 58100
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Jerusalem, 91120
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Kfar Saba, 44281
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Petah-Tikva, 49100
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Tel Hashomer, 52621
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Tel-Aviv, 64239
    Israel

    Site Not Available

  • empty

    Skopje, 1000
    Macedonia, The Former Yugoslav Republic of

    Site Not Available

  • Novo Nordisk Investigational Site

    Manati, 00674
    Puerto Rico

    Site Not Available

  • Novo Nordisk Investigational Site

    Ankara, 06110
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Antalya, 07058
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Gaziantep, 27070
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Istanbul, 34752
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Izmir, 35100
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Anaheim, California 92801
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Garden Grove, California 92844
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    La Jolla, California 92037
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Long Beach, California 90807
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Los Angeles, California 90057
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Monterey, California 93940
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Poway, California 92064
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    San Diego, California 92111
    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

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Melbourne, Florida 32934
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Miami, Florida 33136
    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

    Meridian, Idaho 83646
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Crestview Hills, Kentucky 41017-3464
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Rockville, Maryland 20852
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Troy, Michigan 48098
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Charles, Missouri 63303
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    St. Charles, Missouri 63303
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Nashua, New Hampshire 03063
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lodi, New Jersey 076444
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    West Seneca, New York 14224
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tabor City, North Carolina 28463
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio 45220-2213
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Franklin, Ohio 45005
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Mason, Ohio 45040-6815
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma 73104-5020
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Beaver, Pennsylvania 15009
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania 19152
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pelzer, South Carolina 29669
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Simpsonville, South Carolina 29681
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Brentwood, Tennessee 37027
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75251
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hurst, Texas 76054
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Newport News, Virginia 23606
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Richmond, Virginia 23219
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.