ID

38781

Descrição

A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01789788

Link

https://clinicaltrials.gov/show/NCT01789788

Palavras-chave

Versões (1)
  1. 03/11/2019 03/11/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

3 de novembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01789788

Inglês

Eligibility Diabetes Mellitus, Type 2 NCT01789788

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, 18 to 65 years of age, inclusive
Descrição

Adult | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
type 2 diabetes mellitus according to who criteria diagnosed for at least 3 months prior to screening
Descrição

Non-Insulin-Dependent Diabetes Mellitus WHO classification | Non-Insulin-Dependent Diabetes Mellitus Disease length

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C4267671
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0872146
on stable dose of metformin for at least 2 months prior to screening
Descrição

Metformin Dose Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
fasting plasma glucose during the screening period </= 240 mg/dl
Descrição

Plasma fasting glucose measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0583513
hemoglobin a1c (hba1c) levels at screening >/= 6.5% and </= 10.5%
Descrição

Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474680
evidence of insulin secretory capacity at screening
Descrição

Insulin Capacity secretory

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C1516240
UMLS CUI [1,3]
C1327616
body mass index (bmi) 27 to 42 kg/m2, inclusive
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol
Descrição

Childbearing Potential Contraceptive methods | Gender Partner Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C3831118
UMLS CUI [2,4]
C0700589
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes
Descrição

Diabetes Mellitus, Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
acquired or secondary forms of diabetes such as those resulting from pancreatic surgery/injury, cystic fibrosis related diabetes
Descrição

Diabetes Mellitus Acquired | Secondary diabetes mellitus | Diabetes Mellitus Due to Pancreatic surgery | Diabetes Mellitus Due to Injury of pancreas | Cystic fibrosis related diabetes

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0439661
UMLS CUI [2]
C0271640
UMLS CUI [3,1]
C0011849
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C2033062
UMLS CUI [4,1]
C0011849
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0273163
UMLS CUI [5]
C2242728
history of acute metabolic complications such as diabetic ketoacidosis or state of hyperosmolar hyperglycemia
Descrição

Complications Metabolic | Diabetic Ketoacidosis | Hyperglycemia hyperosmolar

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0311400
UMLS CUI [2]
C0011880
UMLS CUI [3]
C0745095
evidence or history of clinically significant diabetic complications such as clinically severe diabetic peripheral neuropathy, clinically significant nephropathy as judged by the investigator, or pre-proliferative/proliferative diabetic retinopathy as judged by the investigator
Descrição

Complications of Diabetes Mellitus | Diabetic peripheral neuropathy Severe | Kidney Disease | Preproliferative diabetic retinopathy | Proliferative diabetic retinopathy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0342257
UMLS CUI [2,1]
C0740447
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0339473
UMLS CUI [5]
C0154830
history of severe symptomatic hypoglycemia (requiring assistances of a third party) within 6 months prior to screening
Descrição

Hypoglycemia Severe Symptomatic | Assistance Required

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0231220
UMLS CUI [2,1]
C1269765
UMLS CUI [2,2]
C1514873
history or presence of clinically significant concomitant disease or disorder
Descrição

Comorbidity Clinical Significance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2826293
hemoglobin level below the lower limit of reference range at screening
Descrição

Hemoglobin low

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0162119
pregnant or lactating women
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of anaphylaxis or severe systemic hypersensitivity or allergic reactions
Descrição

Anaphylaxis | Severe allergy Systemic | Allergic Reaction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002792
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C1527304
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01789788

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, 18 to 65 years of age, inclusive
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Non-Insulin-Dependent Diabetes Mellitus WHO classification | Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus according to who criteria diagnosed for at least 3 months prior to screening
boolean
C0011860 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
Metformin Dose Stable
Item
on stable dose of metformin for at least 2 months prior to screening
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Plasma fasting glucose measurement
Item
fasting plasma glucose during the screening period </= 240 mg/dl
boolean
C0583513 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hemoglobin a1c (hba1c) levels at screening >/= 6.5% and </= 10.5%
boolean
C0474680 (UMLS CUI [1])
Insulin Capacity secretory
Item
evidence of insulin secretory capacity at screening
boolean
C0021641 (UMLS CUI [1,1])
C1516240 (UMLS CUI [1,2])
C1327616 (UMLS CUI [1,3])
Body mass index
Item
body mass index (bmi) 27 to 42 kg/m2, inclusive
boolean
C1305855 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Gender Partner Childbearing Potential Contraceptive methods
Item
females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C0700589 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Diabetes Mellitus Acquired | Secondary diabetes mellitus | Diabetes Mellitus Due to Pancreatic surgery | Diabetes Mellitus Due to Injury of pancreas | Cystic fibrosis related diabetes
Item
acquired or secondary forms of diabetes such as those resulting from pancreatic surgery/injury, cystic fibrosis related diabetes
boolean
C0011849 (UMLS CUI [1,1])
C0439661 (UMLS CUI [1,2])
C0271640 (UMLS CUI [2])
C0011849 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C2033062 (UMLS CUI [3,3])
C0011849 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0273163 (UMLS CUI [4,3])
C2242728 (UMLS CUI [5])
Complications Metabolic | Diabetic Ketoacidosis | Hyperglycemia hyperosmolar
Item
history of acute metabolic complications such as diabetic ketoacidosis or state of hyperosmolar hyperglycemia
boolean
C0009566 (UMLS CUI [1,1])
C0311400 (UMLS CUI [1,2])
C0011880 (UMLS CUI [2])
C0745095 (UMLS CUI [3])
Complications of Diabetes Mellitus | Diabetic peripheral neuropathy Severe | Kidney Disease | Preproliferative diabetic retinopathy | Proliferative diabetic retinopathy
Item
evidence or history of clinically significant diabetic complications such as clinically severe diabetic peripheral neuropathy, clinically significant nephropathy as judged by the investigator, or pre-proliferative/proliferative diabetic retinopathy as judged by the investigator
boolean
C0342257 (UMLS CUI [1])
C0740447 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0022658 (UMLS CUI [3])
C0339473 (UMLS CUI [4])
C0154830 (UMLS CUI [5])
Hypoglycemia Severe Symptomatic | Assistance Required
Item
history of severe symptomatic hypoglycemia (requiring assistances of a third party) within 6 months prior to screening
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
C1269765 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Comorbidity Clinical Significance
Item
history or presence of clinically significant concomitant disease or disorder
boolean
C0009488 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Hemoglobin low
Item
hemoglobin level below the lower limit of reference range at screening
boolean
C0162119 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Anaphylaxis | Severe allergy Systemic | Allergic Reaction
Item
history of anaphylaxis or severe systemic hypersensitivity or allergic reactions
boolean
C0002792 (UMLS CUI [1])
C2945656 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C1527304 (UMLS CUI [3])
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