ID

35795

Descrizione

A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02207374

collegamento

https://clinicaltrials.gov/show/NCT02207374

Keywords

versioni (1)
  1. 23/03/19 23/03/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

23 marzo 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Diabetes NCT02207374

Inglese

Eligibility Diabetes NCT02207374

1 moduli  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02207374
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, age at least 20 years at the time of signing informed consent
Descrizione

Age | Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
hba1c (glycosylated haemoglobin a1c) between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive)
Descrizione

Hemoglobin A1c measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0474680
japanese subjects with type 2 diabetes mellitus (diagnosed clinically) and on stable treatment (defined as unchanged medication and unchanged dose) who are: a) on diet and exercise therapy for at least 30 days before visit 1 (week -2). or b) on oad monotherapy (either of su (sulfonylurea), glinide, a-gi (a-glucosidase inhibitor) or tzd (thiazolidinediones)) within approved japanese labelling in addition to diet and exercise therapy for at least 60 days before visit 1 (week -2)
Descrizione

Study Subject Japanese | Treatment Stable Non-Insulin-Dependent Diabetes Mellitus | Diet therapy | Exercise | Antidiabetics Oral | Sulfonylurea | Glinide | alpha-Glucosidase Inhibitors | Thiazolidinediones

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1556094
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C0011860
UMLS CUI [3]
C0012159
UMLS CUI [4]
C0015259
UMLS CUI [5,1]
C0935929
UMLS CUI [5,2]
C1527415
UMLS CUI [6]
C0038766
UMLS CUI [7]
C2266929
UMLS CUI [8]
C1299007
UMLS CUI [9]
C1257987
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (e.g., abstinence [not having sex], diaphragm, condom [by the partner], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5 week follow-up period
Descrizione

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Sexual Abstinence | Vaginal contraceptive diaphragm | Male Condom Partner | Intrauterine Devices | Contraceptive Sponge | Vaginal Spermicides | Contraceptives, Oral

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
UMLS CUI [5]
C0036899
UMLS CUI [6]
C0042241
UMLS CUI [7,1]
C0009653
UMLS CUI [7,2]
C0682323
UMLS CUI [8]
C0021900
UMLS CUI [9]
C0183461
UMLS CUI [10]
C0087145
UMLS CUI [11]
C0009905
treatment with glucose lowering agent(s) other than stated in the inclusion criteria within 60 days before visit 1 (week -2) and treatment with once weekly glucagon-like peptide-1 (glp-1) receptor agonists within 90 days before visit 1 (week -2). an exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with inter-current illness
Descrizione

Hypoglycemic Agents | Exception Inclusion criteria | GLP-1 Receptor Agonist times/week | Exception Insulin regime short-term Comorbidity

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
UMLS CUI [3,1]
C2917359
UMLS CUI [3,2]
C0456698
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0557978
UMLS CUI [4,3]
C0443303
UMLS CUI [4,4]
C0009488
any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
Descrizione

Disease compromises Patient safety | Disease compromises Protocol Compliance

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0525058
history of chronic or idiopathic acute pancreatitis
Descrizione

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0149521
UMLS CUI [2]
C0341461
screening calcitonin value above or equal to 50 ng/l (pg/ml)
Descrizione

Calcitonin measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201924
personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men2)
Descrizione

Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2]
C1833921
UMLS CUI [3,1]
C0027662
UMLS CUI [3,2]
C0332307
impaired renal function defined as estimated glomerular filtration rate (egfr) below 30 ml/min/1.73 m^2 per modification of diet in renal disease (mdrd) formula (4 variable version)
Descrizione

Renal Insufficiency | Renal function GFR estimation by MDRD

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C2170215
acute coronary or cerebrovascular event within 90 days before randomisation (visit 2 [week 0])
Descrizione

Acute Coronary Syndrome | Cerebrovascular accident

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0038454
heart failure, new york heart association (nyha) class iv
Descrizione

Heart failure New York Heart Association Classification

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
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Similar models

Eligibility Diabetes NCT02207374

1 moduli
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02207374
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
male or female, age at least 20 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin a1c) between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Study Subject Japanese | Treatment Stable Non-Insulin-Dependent Diabetes Mellitus | Diet therapy | Exercise | Antidiabetics Oral | Sulfonylurea | Glinide | alpha-Glucosidase Inhibitors | Thiazolidinediones
Item
japanese subjects with type 2 diabetes mellitus (diagnosed clinically) and on stable treatment (defined as unchanged medication and unchanged dose) who are: a) on diet and exercise therapy for at least 30 days before visit 1 (week -2). or b) on oad monotherapy (either of su (sulfonylurea), glinide, a-gi (a-glucosidase inhibitor) or tzd (thiazolidinediones)) within approved japanese labelling in addition to diet and exercise therapy for at least 60 days before visit 1 (week -2)
boolean
C0681850 (UMLS CUI [1,1])
C1556094 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0011860 (UMLS CUI [2,3])
C0012159 (UMLS CUI [3])
C0015259 (UMLS CUI [4])
C0935929 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
C0038766 (UMLS CUI [6])
C2266929 (UMLS CUI [7])
C1299007 (UMLS CUI [8])
C1257987 (UMLS CUI [9])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Sexual Abstinence | Vaginal contraceptive diaphragm | Male Condom Partner | Intrauterine Devices | Contraceptive Sponge | Vaginal Spermicides | Contraceptives, Oral
Item
female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (e.g., abstinence [not having sex], diaphragm, condom [by the partner], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5 week follow-up period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0036899 (UMLS CUI [5])
C0042241 (UMLS CUI [6])
C0009653 (UMLS CUI [7,1])
C0682323 (UMLS CUI [7,2])
C0021900 (UMLS CUI [8])
C0183461 (UMLS CUI [9])
C0087145 (UMLS CUI [10])
C0009905 (UMLS CUI [11])
Hypoglycemic Agents | Exception Inclusion criteria | GLP-1 Receptor Agonist times/week | Exception Insulin regime short-term Comorbidity
Item
treatment with glucose lowering agent(s) other than stated in the inclusion criteria within 60 days before visit 1 (week -2) and treatment with once weekly glucagon-like peptide-1 (glp-1) receptor agonists within 90 days before visit 1 (week -2). an exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with inter-current illness
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C2917359 (UMLS CUI [3,1])
C0456698 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0557978 (UMLS CUI [4,2])
C0443303 (UMLS CUI [4,3])
C0009488 (UMLS CUI [4,4])
Disease compromises Patient safety | Disease compromises Protocol Compliance
Item
any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
boolean
C0012634 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
Calcitonin measurement
Item
screening calcitonin value above or equal to 50 ng/l (pg/ml)
boolean
C0201924 (UMLS CUI [1])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type
Item
personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men2)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
Renal Insufficiency | Renal function GFR estimation by MDRD
Item
impaired renal function defined as estimated glomerular filtration rate (egfr) below 30 ml/min/1.73 m^2 per modification of diet in renal disease (mdrd) formula (4 variable version)
boolean
C1565489 (UMLS CUI [1])
C2170215 (UMLS CUI [2])
Acute Coronary Syndrome | Cerebrovascular accident
Item
acute coronary or cerebrovascular event within 90 days before randomisation (visit 2 [week 0])
boolean
C0948089 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Heart failure New York Heart Association Classification
Item
heart failure, new york heart association (nyha) class iv
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
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