Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes

Last updated: January 20, 2017
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes And Hypertension

Diabetic Macular Edema

Diabetic Foot Ulcers

Treatment

N/A

Clinical Study ID

NCT01068665
NN1250-3672
2009-010662-28
U1111-1112-8977
  • Ages > 18
  • All Genders

Study Summary

This trial is conducted in South Africa, Europe and North America. The aim of this trial is to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or dipeptyl peptidase 4 (DPP-4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs) qualifying for intensified treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Insulin naïve subject (allowed are: previous short term insulin treatment up to 14days; Treatment during hospitalisation or during gestational diabetes is allowed forperiods longer than 14 days)

  • Current treatment: metformin monotherapy or metformin in any combination with aninsulin secretagogue (sulfonylurea or glinide), DPP-4 inhibitor,alpha-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 monthsprior to visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000mg daily) -Insulin secretagogue (sulfonylurea or glinide): minimum half of the dailymaximal dose according to local labelling -DPP-4 inhibitor: minimum half of the dailymaximal dose according to local labelling - alpha-glucosidase-inhibitors (acarbose):minimum half of the daily maximal dose or maximum tolerated dose

  • HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis

  • Body Mass Index (BMI) maximum 45.0 kg/m^2

  • Type 2 diabetes (diagnosed clinically) for at least 6 months

  • Ability and willingness to adhere to the protocol including performance of selfmonitored plasma glucose (SMPG) profiles according to the protocol

Exclusion

Exclusion Criteria:

  • Use within the last 3 months prior to Visit 1 of: thiazoledinediones (TZDs), exenatideor liraglutide

  • Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke;decompensated heart failure New York Heart Association (NYHA) class III or IV;myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft orangioplasty

  • Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)

  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequatecontraceptive measures according to local requirements [for UK: adequate contraceptivemeasures are defined as established use of oral, injected or implanted hormonalmethods of contraception, sterilisation, intrauterine device or intrauterine system,or consistent use of barrier methods]

  • Cancer and medical history of cancer hereof (except basal cell skin cancer or squamouscell skin cancer)

Study Design

Total Participants: 460
Study Start date:
March 01, 2010
Estimated Completion Date:
November 30, 2010

Connect with a study center

  • Novo Nordisk Investigational Site

    Calgary, Alberta T2H 2G4
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Edmonton, Alberta T5J 3N4
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Langley, British Columbia V3A 4H9
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Cambridge, Ontario N1R 7L6
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Cornwall, Ontario K6H 4M4
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamilton, Ontario L8L 5G8
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Mississauga, Ontario L5B 4A2
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Sudbury, Ontario P3C 5K7
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    St. Romuald, Quebec G6W 5M6
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Antibes, 06600
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Besancon, 25030
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Narbonne, 11108
    France

    Site Not Available

  • empty

    Pointe à Pitre, 97159
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Pointe à Pitre, 97159
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Rennes, 35056
    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

    Dublin, DUBLIN 7
    Ireland

    Site Not Available

  • Novo Nordisk Investigational Site

    Ekaterinburg, 620102
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Kemerovo, 650099
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Krasnoyarsk, 660062
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Moscow, 121356
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint-Petersburg, 199034
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Voronezh, 394018
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    East London, Eastern Cape 5201
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Port Elizabeth, Eastern Cape 6045
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal 4000
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Alberton, 1449
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Kiev, 04114
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Abergavenny, NP7 7EG
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Ashton-Under-Lyne, OL6 9RW
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Atherstone, CV9 1EU
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Ayr, KA6 6DX
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Bath, BA2 1NH
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Bolton, BL3 6TL
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Chester, CH2 1UL
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Chorley, PR7 1PP
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Coventry, CV2 2DX
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Epworth, DN9 1EP
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Harrogate, HG1 5JP
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Letchworth, SG6 4UB
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Livingstone, EH54 6PP
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Llantrisant, CF72 8XR
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Maidstone, ME16 9QQ
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Oldham, OL1 2JH
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Rugby, CV22 5PX
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Trowbridge, BA14 8QA
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Whitby, YO21 1SD
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Wrexham, LL13 7TD
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Gilbert, Arizona 85295
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tucson, Arizona 85741
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Anaheim, California 92801
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Chino, California 91710
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Huntington Beach, California 92648
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Mission Hills, California 91345
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Montclair, California 91763
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    National City, California 91950
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Norco, California 92860
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Diego, California 92111
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Valencia, California 91355
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Aurora, Colorado 80045-7402
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jacksonville, Florida 32209-6511
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Longwood, Florida 32779
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Ocala, Florida 34471
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Ponte Vedra, Florida 32081
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Vero Beach, Florida 32960
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lawrenceville, Georgia 30046
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Crystal Lake, Illinois 60012
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Evansville, Indiana 47714
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greenfield, Indiana 46140
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Des Moines, Iowa 50314-2610
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Madisonville, Kentucky 42431
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Slidell, Louisiana 70461-4231
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greenbelt, Maryland 20770
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Brockton, Massachusetts 02301
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Southfield, Michigan 48075
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Troy, Michigan 48098
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Minneapolis, Minnesota 55416
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Biloxi, Mississippi 39531-4535
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    St. Louis, Missouri 63104
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Billings, Montana 59102
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Brick, New Jersey 08724
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Mine Hill, New Jersey 07803
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Brooklyn, New York 11203-2711
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    New York, New York 10025
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Asheboro, North Carolina 27203
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chapel Hill, North Carolina 27517
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Durham, North Carolina 27713
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Franklin, Ohio 45005
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Beaver, Pennsylvania 15009
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Melrose Park, Pennsylvania 19027
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Norristown, Pennsylvania 19401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Peak, South Carolina 29122
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Desoto, Texas 75115
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    El Paso, Texas 79912
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Killeen, Texas 76543
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Plano, Texas 75093
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    St. George, Utah 84790
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Renton, Washington 98057
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Milwaukee, Wisconsin 53209
    United States

    Site Not Available

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