A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes

Last updated: March 9, 2017
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetic Vitreous Hemorrhage

Diabetic Retinopathy

Treatment

N/A

Clinical Study ID

NCT01849289
NN1250-3587
U1111-1121-5325
  • Ages > 18
  • All Genders

Study Summary

This trial was conducted in Africa, Asia, Europe, North and South America. The aim of the trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin naïve subjects with type 2 diabetes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • Insulin naïve subjects (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), dipeptidyl peptidase IV (DPP-IV)inhibitor, alfa-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3months prior to randomisation (Visit 2) with the minimum doses stated: metformin:alone or in combination (including fixed combination) 1500 mg daily, or maximumtolerated dose (at least 1000 mg daily), insulin secretagogue (sulfonylurea orglinide): minimum half of the daily maximal dose according to local labelling, DPP-IVinhibitor: minimum 100 mg daily or according to local labelling,alfa-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose ormaximum tolerated dose

  • HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive) by central laboratoryanalysis

  • BMI (Body Mass Index) below or equal to 40.0 kg/m^2

Exclusion

Exclusion Criteria:

  • Treatment with TZDs (thiazoledinedione), or GLP-1 (glucagon-like peptide 1) receptoragonists within the last 3 months prior to Visit 1 (screening)

  • Anticipated change in concomitant medication known to interfere significantly withglucose metabolism, such as systemic corticosteroids, beta-blockers, MAO (monoamineoxidase) inhibitors

  • Cardiovascular disease within the last 6 months prior to Visit 1 (screening) definedas stroke; decompensated heart failure NYHA (New York Heart Association) class III orIV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graftor angioplasty

  • Any clinically significant disease or disorder, except for conditions associated withtype 2 diabetes mellitus, which in the Investigator's opinion could interfere with theresults of the trial

  • Previous participation in this trial. Participation is defined as randomised.Re-screening of screening failures is allowed only once within the limits of therecruitment period

  • Known or suspected hypersensitivity to trial product(s) or related products

Study Design

Total Participants: 833
Study Start date:
June 02, 2013
Estimated Completion Date:
May 15, 2014

Connect with a study center

  • Novo Nordisk Investigational Site

    Porto Alegre, 90035-170
    Brazil

    Site Not Available

  • Novo Nordisk Investigational Site

    São Paulo, 04022-002
    Brazil

    Site Not Available

  • Novo Nordisk Investigational Site

    Calgary, Alberta T2N 4L7
    Canada

    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 4A1
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Burlington, Ontario L7M 4Y1
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    London, Ontario N5W 6A2
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Newmarket, Ontario L3Y 5G8
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Sarnia, Ontario N7T 4X3
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Strathroy, Ontario N7G 1Y7
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Trois Rivieres, Quebec G8T7A1
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Quebec, G3K 2P8
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Hefei, Anhui 230001
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Beijing, Beijing 100700
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    ChongQing, Chongqing 404000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Chongqing, Chongqing 400016
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Fuzhou, Fujian 350025
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Nanning, Guangxi 530007
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Guiyang, Guizhou 550004
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Shijiazhuang, Hebei 050082
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Harbin, Heilongjiang 150086
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Yueyang, Hunan 414000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Yangzhou, Jiangsu 225001
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Zhenjiang, Jiangsu 212001
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Changchun, Jilin 130041
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Siping, Jilin 136000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Shenyang, Liaoning 110021
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Xi'an, Shaanxi 710032
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Shanghai, Shanghai 200072
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Kunming, Yunnan 650101
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Oradea, Bihor 410469
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Bucharest, 020614
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Buzau, 120203
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Galati, 800578
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Sibiu, 550176
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    George, Eastern Cape 6529
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng 1812
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal 4091
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Dnepropetrovsk, 49038
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Kiev, 04114
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Mykolaiv, 54003
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Vinnitsa, 21010
    Ukraine

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Hamilton, Alabama 35570
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Anaheim, California 92801
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lomita, California 90717
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Los Angeles, California 90057
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Golden, Colorado 80401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Crestview Hills, Kentucky 41017-3464
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Metairie, Louisiana 70002
    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

    Nashua, New Hampshire 03063
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Toms River, New Jersey 08755-8050
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Smithtown, New York 11787
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Simpsonville, South Carolina 29681
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75230
    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

    Kenosha, Wisconsin 53142
    United States

    Site Not Available

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