Phase
Condition
Diabetes Mellitus, Type 2
Diabetic Vitreous Hemorrhage
Diabetic Retinopathy
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Novo Nordisk Investigational Site
Porto Alegre, 90035-170
BrazilSite Not Available
Novo Nordisk Investigational Site
São Paulo, 04022-002
BrazilSite Not Available
Novo Nordisk Investigational Site
Calgary, Alberta T2N 4L7
CanadaSite Not Available
Novo Nordisk Investigational Site
Burnaby, British Columbia V5G 1T4
CanadaSite Not Available
Novo Nordisk Investigational Site
Surrey, British Columbia V3S 2N6
CanadaSite Not Available
Novo Nordisk Investigational Site
Victoria, British Columbia V8V 4A1
CanadaSite Not Available
Novo Nordisk Investigational Site
Burlington, Ontario L7M 4Y1
CanadaSite Not Available
Novo Nordisk Investigational Site
London, Ontario N5W 6A2
CanadaSite Not Available
Novo Nordisk Investigational Site
Newmarket, Ontario L3Y 5G8
CanadaSite Not Available
Novo Nordisk Investigational Site
Sarnia, Ontario N7T 4X3
CanadaSite Not Available
Novo Nordisk Investigational Site
Strathroy, Ontario N7G 1Y7
CanadaSite Not Available
Novo Nordisk Investigational Site
Trois Rivieres, Quebec G8T7A1
CanadaSite Not Available
Novo Nordisk Investigational Site
Quebec, G3K 2P8
CanadaSite Not Available
Novo Nordisk Investigational Site
Hefei, Anhui 230001
ChinaSite Not Available
Novo Nordisk Investigational Site
Beijing, Beijing 100700
ChinaSite Not Available
Novo Nordisk Investigational Site
ChongQing, Chongqing 404000
ChinaSite Not Available
Novo Nordisk Investigational Site
Chongqing, Chongqing 400016
ChinaSite Not Available
Novo Nordisk Investigational Site
Fuzhou, Fujian 350025
ChinaSite Not Available
Novo Nordisk Investigational Site
Guangzhou, Guangdong 510120
ChinaSite Not Available
Novo Nordisk Investigational Site
Nanning, Guangxi 530007
ChinaSite Not Available
Novo Nordisk Investigational Site
Guiyang, Guizhou 550004
ChinaSite Not Available
Novo Nordisk Investigational Site
Shijiazhuang, Hebei 050082
ChinaSite Not Available
Novo Nordisk Investigational Site
Harbin, Heilongjiang 150086
ChinaSite Not Available
Novo Nordisk Investigational Site
Wuhan, Hubei 430030
ChinaSite Not Available
Novo Nordisk Investigational Site
Yueyang, Hunan 414000
ChinaSite Not Available
Novo Nordisk Investigational Site
Yangzhou, Jiangsu 225001
ChinaSite Not Available
Novo Nordisk Investigational Site
Zhenjiang, Jiangsu 212001
ChinaSite Not Available
Novo Nordisk Investigational Site
Nanchang, Jiangxi 330006
ChinaSite Not Available
Novo Nordisk Investigational Site
Changchun, Jilin 130041
ChinaSite Not Available
Novo Nordisk Investigational Site
Siping, Jilin 136000
ChinaSite Not Available
Novo Nordisk Investigational Site
Shenyang, Liaoning 110021
ChinaSite Not Available
Novo Nordisk Investigational Site
Xi'an, Shaanxi 710032
ChinaSite Not Available
Novo Nordisk Investigational Site
Shanghai, Shanghai 200072
ChinaSite Not Available
Novo Nordisk Investigational Site
Kunming, Yunnan 650101
ChinaSite Not Available
Novo Nordisk Investigational Site
Hangzhou, Zhejiang 310003
ChinaSite Not Available
Novo Nordisk Investigational Site
Wenzhou, Zhejiang 325000
ChinaSite Not Available
Novo Nordisk Investigational Site
Oradea, Bihor 410469
RomaniaSite Not Available
Novo Nordisk Investigational Site
Bucharest, 020614
RomaniaSite Not Available
Novo Nordisk Investigational Site
Buzau, 120203
RomaniaSite Not Available
Novo Nordisk Investigational Site
Galati, 800578
RomaniaSite Not Available
Novo Nordisk Investigational Site
Sibiu, 550176
RomaniaSite Not Available
Novo Nordisk Investigational Site
George, Eastern Cape 6529
South AfricaSite Not Available
Novo Nordisk Investigational Site
Johannesburg, Gauteng 1812
South AfricaSite Not Available
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal 4091
South AfricaSite Not Available
Novo Nordisk Investigational Site
Dnepropetrovsk, 49038
UkraineSite Not Available
Novo Nordisk Investigational Site
Kiev, 04114
UkraineSite Not Available
Novo Nordisk Investigational Site
Mykolaiv, 54003
UkraineSite Not Available
Novo Nordisk Investigational Site
Vinnitsa, 21010
UkraineSite Not Available
Novo Nordisk Clinical Trial Call Center
Hamilton, Alabama 35570
United StatesSite Not Available
Novo Nordisk Investigational Site
Anaheim, California 92801
United StatesSite Not Available
Novo Nordisk Investigational Site
Lomita, California 90717
United StatesSite Not Available
Novo Nordisk Investigational Site
Los Angeles, California 90057
United StatesSite Not Available
Novo Nordisk Investigational Site
Golden, Colorado 80401
United StatesSite Not Available
Novo Nordisk Investigational Site
Clearwater, Florida 33765
United StatesSite Not Available
Novo Nordisk Investigational Site
Chicago, Illinois 60607
United StatesSite Not Available
Novo Nordisk Investigational Site
Crestview Hills, Kentucky 41017-3464
United StatesSite Not Available
Novo Nordisk Investigational Site
Metairie, Louisiana 70002
United StatesSite Not Available
Novo Nordisk Investigational Site
Troy, Michigan 48098
United StatesSite Not Available
Novo Nordisk Investigational Site
Chesterfield, Missouri 63017
United StatesSite Not Available
Novo Nordisk Investigational Site
Nashua, New Hampshire 03063
United StatesSite Not Available
Novo Nordisk Investigational Site
Toms River, New Jersey 08755-8050
United StatesSite Not Available
Novo Nordisk Investigational Site
Smithtown, New York 11787
United StatesSite Not Available
Novo Nordisk Investigational Site
Simpsonville, South Carolina 29681
United StatesSite Not Available
Novo Nordisk Investigational Site
Jackson, Tennessee 38305
United StatesSite Not Available
Novo Nordisk Investigational Site
Dallas, Texas 75230
United StatesSite Not Available
Novo Nordisk Investigational Site
Newport News, Virginia 23606
United StatesSite Not Available
Novo Nordisk Clinical Trial Call Center
Norfolk, Virginia 23502
United StatesSite Not Available
Novo Nordisk Investigational Site
Kenosha, Wisconsin 53142
United StatesSite Not Available
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