ID

23245

Descrição

Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Being Treated With Sulfonylurea; ODM derived from: https://clinicaltrials.gov/show/NCT00327626

Link

https://clinicaltrials.gov/show/NCT00327626

Palavras-chave

Versões (1)
  1. 30/06/2017 30/06/2017 -
Transferido a

30 de junho de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Type 2 Diabetes Mellitus NCT00327626

Inglês

Eligibility Type 2 Diabetes Mellitus NCT00327626

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female (post-menopausal and/or surgically sterile)
Descrição

Gender | Postmenopausal state | Female Sterilization

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
aged 18 to 70 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed with type 2 diabetes mellitus of eight years or less in duration
Descrição

Non-Insulin-Dependent Diabetes Mellitus disease length

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
being treated with oad at stable maximum doses [defined as at least 10 mg/day glibenclamide (preferred), or 20 mg/day glipizide, with or without at least 1,500 mg/day metformin] for at least three months prior to screening
Descrição

Oral antibiotic therapy Dose Maximum Stable | Glyburide U/day | Glipizide U/day | Metformin U/day

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0559681
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0806909
UMLS CUI [1,4]
C0205360
UMLS CUI [2,1]
C0017628
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0017642
UMLS CUI [3,2]
C0456683
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C0456683
having fasting plasma glucose levels of 150-270 mg/dl and hba1c levels of 7.5-11.0%
Descrição

Plasma fasting glucose measurement | Glycosylated hemoglobin A

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0583513
UMLS CUI [2]
C0019018
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
greater than 3 severe hypoglycemic episodes within six months of screen
Descrição

Hypoglycaemic episode Severe Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0745153
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1265611
pregnant, breastfeeding, or intends to become pregnant
Descrição

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
clinical signs or symptoms of liver disease, acute, or chronic hepatitis, or alt greater than the upper limit of normal
Descrição

Sign or Symptom Liver diseases | Hepatitis | Hepatitis, Chronic | Alanine aminotransferase increased

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0023895
UMLS CUI [2]
C0019158
UMLS CUI [3]
C0019189
UMLS CUI [4]
C0151905
positive hepatitis b surface antigen, hepatitis c antibody, or hiv test
Descrição

Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV Seropositivity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0019699
patients with history of renal transplantation or renal dialysis or microalbuminuria defined as urine albumin > 200 mg/day
Descrição

Kidney Transplantation | Dialysis | Microalbuminuria | Urine albumin level

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022671
UMLS CUI [2]
C0011946
UMLS CUI [3]
C0730345
UMLS CUI [4]
C0587185
history of insulin use within three months of screen
Descrição

Insulin use

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0240016
history of diabetic ketoacidosis
Descrição

Diabetic Ketoacidosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011880
treatment with any thiazolidinedione (e.g., rosiglitazone) within three months of screen
Descrição

Thiazolidinediones | rosiglitazone

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C0289313
history of lactic acidosis while on metformin therapy
Descrição

Acidosis, Lactic | Metformin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001125
UMLS CUI [2]
C0025598
complications of diabetes (e.g., neuropathy, nephropathy, and retinopathy)
Descrição

Complications of Diabetes Mellitus | Neuropathy | Kidney Diseases | Retinal Diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0342257
UMLS CUI [2]
C0442874
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0035309
clinically significant and currently active diseases
Descrição

Disease Clinical Significance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
clinical significant abnormalities in medical history, physical examination, or laboratory examination
Descrição

Abnormality Medical History | Abnormality Physical Examination | Laboratory test result abnormal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0031809
UMLS CUI [3]
C0438215
Voltar ao início da página

Similar models

Eligibility Type 2 Diabetes Mellitus NCT00327626

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Postmenopausal state | Female Sterilization
Item
male or female (post-menopausal and/or surgically sterile)
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
Age
Item
aged 18 to 70 years
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus disease length
Item
diagnosed with type 2 diabetes mellitus of eight years or less in duration
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Oral antibiotic therapy Dose Maximum Stable | Glyburide U/day | Glipizide U/day | Metformin U/day
Item
being treated with oad at stable maximum doses [defined as at least 10 mg/day glibenclamide (preferred), or 20 mg/day glipizide, with or without at least 1,500 mg/day metformin] for at least three months prior to screening
boolean
C0559681 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0017628 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0017642 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0025598 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
Plasma fasting glucose measurement | Glycosylated hemoglobin A
Item
having fasting plasma glucose levels of 150-270 mg/dl and hba1c levels of 7.5-11.0%
boolean
C0583513 (UMLS CUI [1])
C0019018 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hypoglycaemic episode Severe Quantity
Item
greater than 3 severe hypoglycemic episodes within six months of screen
boolean
C0745153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant, breastfeeding, or intends to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Sign or Symptom Liver diseases | Hepatitis | Hepatitis, Chronic | Alanine aminotransferase increased
Item
clinical signs or symptoms of liver disease, acute, or chronic hepatitis, or alt greater than the upper limit of normal
boolean
C3540840 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C0019158 (UMLS CUI [2])
C0019189 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV Seropositivity
Item
positive hepatitis b surface antigen, hepatitis c antibody, or hiv test
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Kidney Transplantation | Dialysis | Microalbuminuria | Urine albumin level
Item
patients with history of renal transplantation or renal dialysis or microalbuminuria defined as urine albumin > 200 mg/day
boolean
C0022671 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
C0730345 (UMLS CUI [3])
C0587185 (UMLS CUI [4])
Insulin use
Item
history of insulin use within three months of screen
boolean
C0240016 (UMLS CUI [1])
Diabetic Ketoacidosis
Item
history of diabetic ketoacidosis
boolean
C0011880 (UMLS CUI [1])
Thiazolidinediones | rosiglitazone
Item
treatment with any thiazolidinedione (e.g., rosiglitazone) within three months of screen
boolean
C1257987 (UMLS CUI [1])
C0289313 (UMLS CUI [2])
Acidosis, Lactic | Metformin
Item
history of lactic acidosis while on metformin therapy
boolean
C0001125 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
Complications of Diabetes Mellitus | Neuropathy | Kidney Diseases | Retinal Diseases
Item
complications of diabetes (e.g., neuropathy, nephropathy, and retinopathy)
boolean
C0342257 (UMLS CUI [1])
C0442874 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0035309 (UMLS CUI [4])
Disease Clinical Significance
Item
clinically significant and currently active diseases
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Abnormality Medical History | Abnormality Physical Examination | Laboratory test result abnormal
Item
clinical significant abnormalities in medical history, physical examination, or laboratory examination
boolean
C1704258 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C0438215 (UMLS CUI [3])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial