ID

35794

Descrição

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02054897

Link

https://clinicaltrials.gov/show/NCT02054897

Palavras-chave

Versões (1)
  1. 23/03/2019 23/03/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

23 de março de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes NCT02054897

Inglês

Eligibility Diabetes NCT02054897

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02054897
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
for japan only: male or female, age above or equal to 20 years at the time of signing inform consent
Descrição

Japan | Age | Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022341
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0021430
subjects diagnosed with type 2 diabetes and treated with diet and exercise for at least 30 days before screening
Descrição

Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0015259
hba1c 7.0 - 10.0 % (53 - 86 mmol/mol) (both inclusive)
Descrição

Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Descrição

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 adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period. united kingdom: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle)
Descrição

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Contraceptives, Oral, Hormonal | Hormonal contraception Injectable | Hormonal contraception Implantable | Intrauterine Devices | Intrauterine System | Contraception, Barrier | Female Condoms | CERVICAL CAP FOR CONTRACEPTIVE USE | Spermicidal foam/jelly/cream/film/suppository | Male sterilization | Sexual Abstinence

Tipo de dados

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]
C0009907
UMLS CUI [6,1]
C2985296
UMLS CUI [6,2]
C1828121
UMLS CUI [7,1]
C2985296
UMLS CUI [7,2]
C0021102
UMLS CUI [8]
C0021900
UMLS CUI [9]
C4293370
UMLS CUI [10]
C0004764
UMLS CUI [11]
C0221829
UMLS CUI [12]
C0493327
UMLS CUI [13]
C3843415
UMLS CUI [14]
C0024559
UMLS CUI [15]
C0036899
any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
Descrição

Chronic disease compromises Patient safety | Disease Severe compromises Patient safety | Chronic disease compromises Protocol Compliance | Disease Severe compromises Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C1113679
UMLS CUI [3,1]
C0008679
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C2945640
UMLS CUI [4,4]
C0525058
treatment with any glucose lowering agent(s) in a period of 90 days prior to screening. an exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness
Descrição

Hypoglycemic Agents | Exception Insulin regime short-term Comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0557978
UMLS CUI [2,3]
C0443303
UMLS CUI [2,4]
C0009488
history of chronic or idiopathic acute pancreatitis
Descrição

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Tipo de dados

boolean

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

Calcitonin measurement

Tipo de dados

boolean

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

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

Tipo de dados

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 egfr (epidermal growth factor receptor ) below 30 ml/min/1.73 m^2 per modification of diet in renal disease (mdrd) formula (4 variable version)
Descrição

Renal Insufficiency | Renal function GFR estimation by MDRD

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C2170215
acute coronary or cerebrovascular event within 90 days before randomisation
Descrição

Acute Coronary Syndrome | Cerebrovascular accident

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0038454
heart failure, new york heart association class iv
Descrição

Heart failure New York Heart Association Classification

Tipo de dados

boolean

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

Eligibility Diabetes NCT02054897

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02054897
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Japan | Age | Informed Consent
Item
for japan only: male or female, age above or equal to 20 years at the time of signing inform consent
boolean
C0022341 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise
Item
subjects diagnosed with type 2 diabetes and treated with diet and exercise for at least 30 days before screening
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
Hemoglobin A1c measurement
Item
hba1c 7.0 - 10.0 % (53 - 86 mmol/mol) (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Contraceptives, Oral, Hormonal | Hormonal contraception Injectable | Hormonal contraception Implantable | Intrauterine Devices | Intrauterine System | Contraception, Barrier | Female Condoms | CERVICAL CAP FOR CONTRACEPTIVE USE | Spermicidal foam/jelly/cream/film/suppository | Male sterilization | Sexual Abstinence
Item
female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period. united kingdom: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle)
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])
C0009907 (UMLS CUI [5])
C2985296 (UMLS CUI [6,1])
C1828121 (UMLS CUI [6,2])
C2985296 (UMLS CUI [7,1])
C0021102 (UMLS CUI [7,2])
C0021900 (UMLS CUI [8])
C4293370 (UMLS CUI [9])
C0004764 (UMLS CUI [10])
C0221829 (UMLS CUI [11])
C0493327 (UMLS CUI [12])
C3843415 (UMLS CUI [13])
C0024559 (UMLS CUI [14])
C0036899 (UMLS CUI [15])
Chronic disease compromises Patient safety | Disease Severe compromises Patient safety | Chronic disease compromises Protocol Compliance | Disease Severe compromises Protocol Compliance
Item
any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
boolean
C0008679 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C1113679 (UMLS CUI [2,4])
C0008679 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C2945640 (UMLS CUI [4,3])
C0525058 (UMLS CUI [4,4])
Hypoglycemic Agents | Exception Insulin regime short-term Comorbidity
Item
treatment with any glucose lowering agent(s) in a period of 90 days prior to screening. an exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0557978 (UMLS CUI [2,2])
C0443303 (UMLS CUI [2,3])
C0009488 (UMLS CUI [2,4])
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 or multiple endocrine neoplasia syndrome type 2 (men 2)
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 egfr (epidermal growth factor receptor ) 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
boolean
C0948089 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Heart failure New York Heart Association Classification
Item
heart failure, new york heart association class iv
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
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