Phase
Condition
Diabetic Kidney Disease
Diabetic Macular Edema
Diabetes Prevention
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including procedures to determine suitability for the trial - Male or female, age at least 18 years at the time of signing inform consent - Type 2 diabetes mellitus (clinically diagnosed) - HbA1c (glycosylated haemoglobin) above or equal to 7.5% by central laboratory analysis, with the aim of a median of 8.5%. When approximately 50% of the randomised subjects have an HbA1c above 8.5%, the remaining subjects randomised must have an HbA1c below or equal to 8.5% or when approximately 50% of the subjects randomised have an HbA1c below or equal to 8.5%, the remaining subjects randomised must have an HbA1c above 8.5% - Current treatment for at least 90 calendar days prior to screening with basal insulin plus metformin plus/minus α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones. Subjects should be on a stable dose for at least 60 calendar days prior to screening of: Basal insulin 20-50 units (U)/day (both inclusive) ( Individual fluctuations of plus/minus 5U during the 60 day period prior to the day of screening are acceptable.) on the day of screening in combination with: - Metformin (above or equal to 1500 mg or max tolerated dose) or - Metformin (above or equal to 1500 mg or max tolerated dose) and sulphonylureas (above or equal to half of the max approved dose according to local label) or - Metformin (above or equal to 1500 mg or max tolerated dose) and glinide (at least half of the max approved dose according to local label) or - Metformin (above or equal to 1500 mg or max tolerated dose) and α-glucosidase inhibitors (AGI) (at least half of the max approved dose according to local label) or - Metformin (above or equal to 1500 mg or max tolerated dose) and thiazolidinediones (at least half of the max approved dose according to local label) - Body mass index (BMI) above or equal to 24 kg/m^2 Exclusion Criteria: Current use of any antidiabetic drug (except for basal insulin, metformin, α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones) or anticipated change in concomitant medication, that in the investigator´s opinion could interfere with glucose level (e.g. systemic corticosteroids) - Treatment with glucagon like peptide -1 receptor agonists, or dipeptidyl-peptidase-4 inhibitors or insulin (except for basal insulin) within 90 days prior to Visit 1 - Impaired liver function defined as alanine aminotransferase above or equal to 2.5 times upper normal range - Impaired renal function defined as serum-creatinine above or equal to 133 μmol/L for males and above or equal to 125 μmol/L for females, or as defined according to local contraindications for metformin Screening calcitonin above or equal to 50 ng/L - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) - Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months prior to screening and/or planned coronary, carotid or peripheral artery revascularisation procedures - Severe uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mm Hg or diastolic blood pressure above or equal to 100 mm Hg) - Proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment - History of pancreatitis (acute or chronic)
Study Design
Connect with a study center
Novo Nordisk Investigational Site
Hefei, Anhui 230061
ChinaSite Not Available
Novo Nordisk Investigational Site
Beijing, Beijing 100730
ChinaSite Not Available
Novo Nordisk Investigational Site
ChongQing, Chongqing 404000
ChinaSite Not Available
Novo Nordisk Investigational Site
Fuzhou, Fujian 350001
ChinaSite Not Available
Novo Nordisk Investigational Site
Guangzhou, Guangdong 510120
ChinaSite Not Available
Novo Nordisk Investigational Site
Hengshui, Hebei 053000
ChinaSite Not Available
Novo Nordisk Investigational Site
Shijiazhuang, Hebei 050000
ChinaSite Not Available
Novo Nordisk Investigational Site
Tangshan, Hebei 063000
ChinaSite Not Available
Novo Nordisk Investigational Site
Harbin, Heilongjiang 150001
ChinaSite Not Available
Novo Nordisk Investigational Site
Yueyang, Hunan 414000
ChinaSite Not Available
Novo Nordisk Investigational Site
Huhehaote, Inner Mongolia 010020
ChinaSite Not Available
Novo Nordisk Investigational Site
Huhhot, Inner Mongolia 010050
ChinaSite Not Available
Novo Nordisk Investigational Site
Changzhou, Jiangsu 213003
ChinaSite Not Available
Novo Nordisk Investigational Site
Nanjing, Jiangsu 210011
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 130021
ChinaSite Not Available
Novo Nordisk Investigational Site
Siping, Jilin 136000
ChinaSite Not Available
Novo Nordisk Investigational Site
Dalian, Liaoning 116011
ChinaSite Not Available
Novo Nordisk Investigational Site
Yinchuan, Ningxia 750004
ChinaSite Not Available
Novo Nordisk Investigational Site
Xi'an, Shaanxi 710061
ChinaSite Not Available
Novo Nordisk Investigational Site
Shanghai, Shanghai 200240
ChinaSite Not Available
Novo Nordisk Investigational Site
Taiyuan, Shanxi 030001
ChinaSite Not Available
Novo Nordisk Investigational Site
Tianjin, Tianjin 300052
ChinaSite Not Available
Novo Nordisk Investigational Site
Kunming, Yunnan 650101
ChinaSite Not Available
Novo Nordisk Investigational Site
Shatin, New Territories,
Hong KongSite Not Available
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