ID

38921

Beschrijving

Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone; ODM derived from: https://clinicaltrials.gov/show/NCT01512108

Link

https://clinicaltrials.gov/show/NCT01512108

Trefwoorden

Versies (1)
  1. 13-11-19 13-11-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

13 november 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes NCT01512108

Engels

Eligibility Diabetes NCT01512108

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01512108
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject.)
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
japanese subjects with type 2 diabetes on monotherapy with an oad (either glinide, metformin, a-glucosidase inhibitor or thiazolidinedione) within approved japanese labelling in addition to diet and exercise therapy. total daily dose and type of drug should have remained unchanged for at least 8 weeks prior to visit 1
Beschrijving

Japanese | Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral | Glinide | Metformin | alpha-Glucosidase Inhibitors | Thiazolidinediones | Diet therapy | Exercise | Cumulative Dose Daily unchanged | Pharmaceutical Preparations Type unchanged

Datatype

boolean

Alias
UMLS CUI [1]
C1556094
UMLS CUI [2]
C0011860
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [4]
C2266929
UMLS CUI [5]
C0025598
UMLS CUI [6]
C1299007
UMLS CUI [7]
C1257987
UMLS CUI [8]
C0012159
UMLS CUI [9]
C0015259
UMLS CUI [10,1]
C2986497
UMLS CUI [10,2]
C0332173
UMLS CUI [10,3]
C0442739
UMLS CUI [11,1]
C0013227
UMLS CUI [11,2]
C0332307
UMLS CUI [11,3]
C0442739
type 2 diabetes mellitus (clinically diagnosed) for at least 6 months
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
hba1c between 7.0-10.0% (both inclusive)
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) below 40.0 kg/m^2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
outpatients who have no plans for an educational hospitalisation for the purpose of glycaemic control. however, hospitalisation for training of self-injection from visit 2 that is for no longer than one week is allowed
Beschrijving

Outpatients | Absence Hospitalization Education Glycaemia control

Datatype

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0019993
UMLS CUI [2,3]
C0030688
UMLS CUI [2,4]
C3267174
subjects able and willing to perform self-monitoring of plasma glucose (smpg)
Beschrijving

Plasma Glucose Measurement Self Perform

Datatype

boolean

Alias
UMLS CUI [1,1]
C0202042
UMLS CUI [1,2]
C0036588
UMLS CUI [1,3]
C0884358
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with known or previous malignant tumor and are strongly suspected of recurrence (except basal cell skin cancer or squamous cell skin cancer)
Beschrijving

Malignant Neoplasms | Recurrence Suspected | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0034897
UMLS CUI [2,2]
C0750491
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
calcitonin above or equal to 160 pg/ml
Beschrijving

Calcitonin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201924
personal history of non-familial medullary thyroid carcinoma
Beschrijving

Medullary carcinoma of thyroid

Datatype

boolean

Alias
UMLS CUI [1]
C0238462
family or personal history of multiple endocrine neoplasia type 2 (men-2) or familial medullary thyroid carcinoma (fmtc)
Beschrijving

Family history of multiple endocrine neoplasia Type | Multiple Endocrine Neoplasia Type | Familial medullary thyroid carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C4039247
UMLS CUI [1,2]
C0332307
UMLS CUI [2,1]
C0027662
UMLS CUI [2,2]
C0332307
UMLS CUI [3]
C1833921
history of chronic pancreatitis or idiopathic acute pancreatitis
Beschrijving

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Datatype

boolean

Alias
UMLS CUI [1]
C0149521
UMLS CUI [2]
C0341461
recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Beschrijving

Recurrent severe hypoglycemia | Hypoglycaemic episode Severe Quantity | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis

Datatype

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2,1]
C0745153
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0342317
UMLS CUI [4,1]
C0019993
UMLS CUI [4,2]
C0011880
treatment with glp-1 receptor agonist or dipeptidyl peptidase 4 (dpp-4) inhibitor within 12 weeks prior to visit 1
Beschrijving

GLP-1 Receptor Agonist | Dipeptidyl Peptidase 4 Inhibitors

Datatype

boolean

Alias
UMLS CUI [1]
C2917359
UMLS CUI [2]
C2917254
having contraindications to liraglutide and any of the oads (according to japanese labelling)
Beschrijving

Medical contraindication Liraglutide | Medical contraindication Antidiabetics Oral

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1456408
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0935929
UMLS CUI [2,3]
C1527415
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Similar models

Eligibility Diabetes NCT01512108

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01512108
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject.)
boolean
C0021430 (UMLS CUI [1])
Japanese | Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral | Glinide | Metformin | alpha-Glucosidase Inhibitors | Thiazolidinediones | Diet therapy | Exercise | Cumulative Dose Daily unchanged | Pharmaceutical Preparations Type unchanged
Item
japanese subjects with type 2 diabetes on monotherapy with an oad (either glinide, metformin, a-glucosidase inhibitor or thiazolidinedione) within approved japanese labelling in addition to diet and exercise therapy. total daily dose and type of drug should have remained unchanged for at least 8 weeks prior to visit 1
boolean
C1556094 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C2266929 (UMLS CUI [4])
C0025598 (UMLS CUI [5])
C1299007 (UMLS CUI [6])
C1257987 (UMLS CUI [7])
C0012159 (UMLS CUI [8])
C0015259 (UMLS CUI [9])
C2986497 (UMLS CUI [10,1])
C0332173 (UMLS CUI [10,2])
C0442739 (UMLS CUI [10,3])
C0013227 (UMLS CUI [11,1])
C0332307 (UMLS CUI [11,2])
C0442739 (UMLS CUI [11,3])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus (clinically diagnosed) for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c between 7.0-10.0% (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Outpatients | Absence Hospitalization Education Glycaemia control
Item
outpatients who have no plans for an educational hospitalisation for the purpose of glycaemic control. however, hospitalisation for training of self-injection from visit 2 that is for no longer than one week is allowed
boolean
C0029921 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0019993 (UMLS CUI [2,2])
C0030688 (UMLS CUI [2,3])
C3267174 (UMLS CUI [2,4])
Plasma Glucose Measurement Self Perform
Item
subjects able and willing to perform self-monitoring of plasma glucose (smpg)
boolean
C0202042 (UMLS CUI [1,1])
C0036588 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Recurrence Suspected | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
subjects with known or previous malignant tumor and are strongly suspected of recurrence (except basal cell skin cancer or squamous cell skin cancer)
boolean
C0006826 (UMLS CUI [1])
C0034897 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
Calcitonin measurement
Item
calcitonin above or equal to 160 pg/ml
boolean
C0201924 (UMLS CUI [1])
Medullary carcinoma of thyroid
Item
personal history of non-familial medullary thyroid carcinoma
boolean
C0238462 (UMLS CUI [1])
Family history of multiple endocrine neoplasia Type | Multiple Endocrine Neoplasia Type | Familial medullary thyroid carcinoma
Item
family or personal history of multiple endocrine neoplasia type 2 (men-2) or familial medullary thyroid carcinoma (fmtc)
boolean
C4039247 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0027662 (UMLS CUI [2,1])
C0332307 (UMLS CUI [2,2])
C1833921 (UMLS CUI [3])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic pancreatitis or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
Recurrent severe hypoglycemia | Hypoglycaemic episode Severe Quantity | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis
Item
recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
boolean
C0342316 (UMLS CUI [1])
C0745153 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0342317 (UMLS CUI [3])
C0019993 (UMLS CUI [4,1])
C0011880 (UMLS CUI [4,2])
GLP-1 Receptor Agonist | Dipeptidyl Peptidase 4 Inhibitors
Item
treatment with glp-1 receptor agonist or dipeptidyl peptidase 4 (dpp-4) inhibitor within 12 weeks prior to visit 1
boolean
C2917359 (UMLS CUI [1])
C2917254 (UMLS CUI [2])
Medical contraindication Liraglutide | Medical contraindication Antidiabetics Oral
Item
having contraindications to liraglutide and any of the oads (according to japanese labelling)
boolean
C1301624 (UMLS CUI [1,1])
C1456408 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0935929 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
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