ID

38972

Descrição

Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01930188

Link

https://clinicaltrials.gov/show/NCT01930188

Palavras-chave

Versões (1)
  1. 17/11/2019 17/11/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

17 de novembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes NCT01930188

Inglês

Eligibility Diabetes NCT01930188

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01930188
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
japan: age minimum 20 years
Descrição

Japan | Age Minimum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022341
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C1524031
subjects diagnosed with type 2 diabetes and on stable treatment in a period of 90 days prior to screening with either metformin above or equal to 1500 mg (or maximum tolerated dose), pioglitazone above or equal to 30 mg (or maximum tolerated dose), rosiglitazone above or equal to 4 mg (or maximum tolerated dose) or a combination of either metformin/pioglitazone or metformin/rosiglitazone (doses as for individual therapies). stable is defined as unchanged medication and unchanged dose
Descrição

Diabetes Mellitus, Non-Insulin-Dependent | Treatment Stable | Metformin Dose | Metformin Maximum Tolerated Dose | Pioglitazone Dose | Pioglitazone Maximum Tolerated Dose | Rosiglitazone Dose | Rosiglitazone Maximum Tolerated Dose | Combined Modality Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0178602
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C0752079
UMLS CUI [5,1]
C0071097
UMLS CUI [5,2]
C0178602
UMLS CUI [6,1]
C0071097
UMLS CUI [6,2]
C0752079
UMLS CUI [7,1]
C0289313
UMLS CUI [7,2]
C0178602
UMLS CUI [8,1]
C0289313
UMLS CUI [8,2]
C0752079
UMLS CUI [9]
C0009429
hba1c 7.0 - 10.5 % (53 - 91 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
females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local law or practice)
Descrição

Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential Contraceptive methods Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
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 At risk Patient safety | Disease Severe At risk Patient safety | Chronic disease Protocol Compliance At risk | Disease Severe Protocol Compliance At risk

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1444641
UMLS CUI [2,4]
C1113679
UMLS CUI [3,1]
C0008679
UMLS CUI [3,2]
C0525058
UMLS CUI [3,3]
C1444641
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0525058
UMLS CUI [4,4]
C1444641
treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. an exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with inter-current illness
Descrição

Hypoglycemic Agents | Exception Inclusion criteria | Exception Insulin regime short-term | Relationship Comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0557978
UMLS CUI [3,3]
C0443303
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
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 (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2)
Descrição

Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of 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
UMLS CUI [4,1]
C4039247
UMLS CUI [4,2]
C0332307
impaired renal function defined as estimated glomerular filtration rate (egfr) below 60 ml/min/1.73 m2 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 (nyha) 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 NCT01930188

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01930188
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Japan | Age Minimum
Item
japan: age minimum 20 years
boolean
C0022341 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C1524031 (UMLS CUI [2,2])
Diabetes Mellitus, Non-Insulin-Dependent | Treatment Stable | Metformin Dose | Metformin Maximum Tolerated Dose | Pioglitazone Dose | Pioglitazone Maximum Tolerated Dose | Rosiglitazone Dose | Rosiglitazone Maximum Tolerated Dose | Combined Modality Therapy
Item
subjects diagnosed with type 2 diabetes and on stable treatment in a period of 90 days prior to screening with either metformin above or equal to 1500 mg (or maximum tolerated dose), pioglitazone above or equal to 30 mg (or maximum tolerated dose), rosiglitazone above or equal to 4 mg (or maximum tolerated dose) or a combination of either metformin/pioglitazone or metformin/rosiglitazone (doses as for individual therapies). stable is defined as unchanged medication and unchanged dose
boolean
C0011860 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0025598 (UMLS CUI [4,1])
C0752079 (UMLS CUI [4,2])
C0071097 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0071097 (UMLS CUI [6,1])
C0752079 (UMLS CUI [6,2])
C0289313 (UMLS CUI [7,1])
C0178602 (UMLS CUI [7,2])
C0289313 (UMLS CUI [8,1])
C0752079 (UMLS CUI [8,2])
C0009429 (UMLS CUI [9])
Hemoglobin A1c measurement
Item
hba1c 7.0 - 10.5 % (53 - 91 mmol/mol) (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential Contraceptive methods Absent
Item
females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local law or practice)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Chronic disease At risk Patient safety | Disease Severe At risk Patient safety | Chronic disease Protocol Compliance At risk | Disease Severe Protocol Compliance At risk
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])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C1113679 (UMLS CUI [2,4])
C0008679 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C1444641 (UMLS CUI [4,4])
Hypoglycemic Agents | Exception Inclusion criteria | Exception Insulin regime short-term | Relationship Comorbidity
Item
treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. 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])
C1705847 (UMLS CUI [3,1])
C0557978 (UMLS CUI [3,2])
C0443303 (UMLS CUI [3,3])
C0439849 (UMLS CUI [4,1])
C0009488 (UMLS CUI [4,2])
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 | Family history of multiple endocrine neoplasia Type
Item
personal or family history of medullary thyroid carcinoma (mtc) 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])
C4039247 (UMLS CUI [4,1])
C0332307 (UMLS CUI [4,2])
Renal Insufficiency | Renal function GFR estimation by MDRD
Item
impaired renal function defined as estimated glomerular filtration rate (egfr) below 60 ml/min/1.73 m2 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 (nyha) class iv
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
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