ID

35792

Descripción

A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02030600

Link

https://clinicaltrials.gov/show/NCT02030600

Palabras clave

Versiones (1)
  1. 23/03/2019 23/03/2019 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

23 de março de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes NCT02030600

Inglés

Eligibility Diabetes NCT02030600

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02030600
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, age at least 18 years at the time of signing informed consent
Descripción

Age | Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
subjects fulfilling at least one of the below criteria: a) experienced at least one severe hypoglycaemic episode within last year (according to the ada (american diabetes association) definition, april 2013), b) moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 ml/min/1.73 m^2 per ckd-epi (chronic kidney disease epidemiology collaboration) by central laboratory analysis, c) hypoglycaemic symptom unawareness, d) exposed to insulin for more than 5 years, e) recent episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70 mg/dl [below or equal to 3.9 mmol/l])) within the last 12 weeks prior to visit 1 (screening)
Descripción

Hypoglycaemic episode Severe Quantity | Chronic Kidney Failure Moderate | Glomerular Filtration Rate | Loss of hypoglycemic warning | Exposure to Insulin | Episode of Hypoglycemia | Symptoms Hypoglycemia | Episode Glucose low

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0745153
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0022661
UMLS CUI [2,2]
C0205081
UMLS CUI [3]
C0017654
UMLS CUI [4]
C0342317
UMLS CUI [5,1]
C0332157
UMLS CUI [5,2]
C0021641
UMLS CUI [6,1]
C0332189
UMLS CUI [6,2]
C0020615
UMLS CUI [7,1]
C1457887
UMLS CUI [7,2]
C0020615
UMLS CUI [8,1]
C0332189
UMLS CUI [8,2]
C0860801
type 2 diabetes mellitus (diagnosed clinically) for at least 26 weeks prior to visit 1
Descripción

Non-Insulin-Dependent Diabetes Mellitus Disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
current treatment with any basal insulin (od or bid) ± any combination of oads (metformin, dpp-4 inhibitor, alpha-glucosidase inhibitor, thiazolidinediones, and sglt2-inhibitor) for 26 weeks or longer prior to visit 1 for subjects on bid the total daily dose should be below 75 units
Descripción

Basal insulin | Antidiabetics Oral | Combined Modality Therapy | Metformin | Dipeptidyl Peptidase-4 Inhibitor | alpha-Glucosidase Inhibitors | Thiazolidinediones | SGLT2 Inhibitor

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0650607
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [3]
C0009429
UMLS CUI [4]
C0025598
UMLS CUI [5]
C3537225
UMLS CUI [6]
C1299007
UMLS CUI [7]
C1257987
UMLS CUI [8]
C3273807
hba1c (glycosylated haemoglobin) below or equal to 9.5 % by central laboratory analysis
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
bmi (body mass index) below or equal to 45 kg/m^2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with a bolus insulin separately or contained in an insulin mix product within the last 26 weeks prior to visit 1
Descripción

Bolus Insulin | Insulin Product Mixed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1705509
UMLS CUI [1,2]
C0021641
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C1514468
UMLS CUI [2,3]
C0205430
use of any other anti-diabetic agent(s) than those stated in the inclusion criteria within the last 26 weeks prior to visit 1
Descripción

Antidiabetics | Exception Inclusion criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
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Similar models

Eligibility Diabetes NCT02030600

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02030600
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
male or female, age at least 18 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Hypoglycaemic episode Severe Quantity | Chronic Kidney Failure Moderate | Glomerular Filtration Rate | Loss of hypoglycemic warning | Exposure to Insulin | Episode of Hypoglycemia | Symptoms Hypoglycemia | Episode Glucose low
Item
subjects fulfilling at least one of the below criteria: a) experienced at least one severe hypoglycaemic episode within last year (according to the ada (american diabetes association) definition, april 2013), b) moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 ml/min/1.73 m^2 per ckd-epi (chronic kidney disease epidemiology collaboration) by central laboratory analysis, c) hypoglycaemic symptom unawareness, d) exposed to insulin for more than 5 years, e) recent episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70 mg/dl [below or equal to 3.9 mmol/l])) within the last 12 weeks prior to visit 1 (screening)
boolean
C0745153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0022661 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0017654 (UMLS CUI [3])
C0342317 (UMLS CUI [4])
C0332157 (UMLS CUI [5,1])
C0021641 (UMLS CUI [5,2])
C0332189 (UMLS CUI [6,1])
C0020615 (UMLS CUI [6,2])
C1457887 (UMLS CUI [7,1])
C0020615 (UMLS CUI [7,2])
C0332189 (UMLS CUI [8,1])
C0860801 (UMLS CUI [8,2])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus (diagnosed clinically) for at least 26 weeks prior to visit 1
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin | Antidiabetics Oral | Combined Modality Therapy | Metformin | Dipeptidyl Peptidase-4 Inhibitor | alpha-Glucosidase Inhibitors | Thiazolidinediones | SGLT2 Inhibitor
Item
current treatment with any basal insulin (od or bid) ± any combination of oads (metformin, dpp-4 inhibitor, alpha-glucosidase inhibitor, thiazolidinediones, and sglt2-inhibitor) for 26 weeks or longer prior to visit 1 for subjects on bid the total daily dose should be below 75 units
boolean
C0650607 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0009429 (UMLS CUI [3])
C0025598 (UMLS CUI [4])
C3537225 (UMLS CUI [5])
C1299007 (UMLS CUI [6])
C1257987 (UMLS CUI [7])
C3273807 (UMLS CUI [8])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) below or equal to 9.5 % by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) below or equal to 45 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Bolus Insulin | Insulin Product Mixed
Item
treatment with a bolus insulin separately or contained in an insulin mix product within the last 26 weeks prior to visit 1
boolean
C1705509 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C1514468 (UMLS CUI [2,2])
C0205430 (UMLS CUI [2,3])
Antidiabetics | Exception Inclusion criteria
Item
use of any other anti-diabetic agent(s) than those stated in the inclusion criteria within the last 26 weeks prior to visit 1
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
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