ID

24031

Descrição

Vildagliptin 100 mg Once Daily vs. Placebo as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin; ODM derived from: https://clinicaltrials.gov/show/NCT00494884

Link

https://clinicaltrials.gov/show/NCT00494884

Palavras-chave

Versões (1)
  1. 23/07/2017 23/07/2017 -
Transferido a

23 de julho 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 Diabetes Mellitus, Type 2 NCT00494884

Inglês

Eligibility Diabetes Mellitus, Type 2 NCT00494884

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male, non-fertile female or female of childbearing potential using a medically approved birth control method
Descrição

Gender | Female infertility | Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0021361
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
patients who have received metformin for at least three months prior to visit 1 and have been on a stable dose for a minimum of 8 weeks prior to visit 1
Descrição

Metformin Dose Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
agreement to maintain the same dose of metformin throughout the study
Descrição

Metformin Dose Same Maintenance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0445247
UMLS CUI [1,4]
C0024501
age in the range of 18-85 years inclusive.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
hba1c in the range of 6.5 - 8.0% (inclusive) at visit 1
Descrição

Glycosylated hemoglobin A

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019018
agreement to maintain prior diet and exercise habits during the full course of the study
Descrição

Diet Maintenance | Exercise habits Maintenance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012155
UMLS CUI [1,2]
C0024501
UMLS CUI [2,1]
C2220423
UMLS CUI [2,2]
C0024501
ability to comply with all study requirements and signed informed consent to participate in the study.
Descrição

Protocol Compliance | Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating female
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
a history of:
Descrição

Medical History

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0262926
type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. cushing's syndrome and acromegaly.
Descrição

Insulin-Dependent Diabetes Mellitus Due to Injury of pancreas | Secondary diabetes mellitus | Cushing Syndrome | Acromegaly

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0273163
UMLS CUI [2]
C0271640
UMLS CUI [3]
C0010481
UMLS CUI [4]
C0001206
acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
Descrição

Complications of Diabetes Mellitus Metabolic | Ketoacidosis | Hyperosmolar state | Coma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0311400
UMLS CUI [2]
C0220982
UMLS CUI [3]
C0236013
UMLS CUI [4]
C0009421
any of the following significant laboratory abnormalities:
Descrição

Laboratory test result abnormal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0438215
alt, ast greater than 2 times the upper limit of the normal range at visit 1.
Descrição

Alanine aminotransferase increased | Aspartate aminotransferase increased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
direct bilirubin greater than the upper limit of the normal range at visit 1.
Descrição

Direct bilirubin increased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0740434
serum creatinine levels equal to or greater than 1.5 mg/dl (132 umol/l) males, equal to or greater than 1.4 mg/dl (123 umol/l) females, or a history of abnormal creatinine clearance at visit 1.
Descrição

Creatinine measurement, serum | Gender | Creatinine clearance Abnormal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0812399
UMLS CUI [3,2]
C0205161
clinically significant tsh values outside of normal range at visit 1.
Descrição

Thyroid stimulating hormone Abnormal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0040160
UMLS CUI [1,2]
C0205161
clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycemia, hyperinsulinemia, and glycosuria at visit 1 treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1
Descrição

Laboratory test result abnormal | Hyperglycemia Excluded | Hyperinsulinism Excluded | Glycosuria Excluded | Antidiabetics Oral | Metformin Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2,1]
C0020456
UMLS CUI [2,2]
C2828389
UMLS CUI [3,1]
C0020459
UMLS CUI [3,2]
C2828389
UMLS CUI [4,1]
C0017979
UMLS CUI [4,2]
C2828389
UMLS CUI [5,1]
C0935929
UMLS CUI [5,2]
C1527415
UMLS CUI [6,1]
C0025598
UMLS CUI [6,2]
C2828389
other protocol-defined inclusion/exclusion criteria may apply
Descrição

Clinical Trial Eligibility Criteria Study Protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
Voltar ao início da página

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00494884

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Female infertility | Childbearing Potential Contraceptive methods
Item
male, non-fertile female or female of childbearing potential using a medically approved birth control method
boolean
C0079399 (UMLS CUI [1])
C0021361 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Metformin Dose Stable
Item
patients who have received metformin for at least three months prior to visit 1 and have been on a stable dose for a minimum of 8 weeks prior to visit 1
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Metformin Dose Same Maintenance
Item
agreement to maintain the same dose of metformin throughout the study
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0445247 (UMLS CUI [1,3])
C0024501 (UMLS CUI [1,4])
Age
Item
age in the range of 18-85 years inclusive.
boolean
C0001779 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hba1c in the range of 6.5 - 8.0% (inclusive) at visit 1
boolean
C0019018 (UMLS CUI [1])
Diet Maintenance | Exercise habits Maintenance
Item
agreement to maintain prior diet and exercise habits during the full course of the study
boolean
C0012155 (UMLS CUI [1,1])
C0024501 (UMLS CUI [1,2])
C2220423 (UMLS CUI [2,1])
C0024501 (UMLS CUI [2,2])
Protocol Compliance | Informed Consent
Item
ability to comply with all study requirements and signed informed consent to participate in the study.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical History
Item
a history of:
boolean
C0262926 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Due to Injury of pancreas | Secondary diabetes mellitus | Cushing Syndrome | Acromegaly
Item
type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. cushing's syndrome and acromegaly.
boolean
C0011854 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0273163 (UMLS CUI [1,3])
C0271640 (UMLS CUI [2])
C0010481 (UMLS CUI [3])
C0001206 (UMLS CUI [4])
Complications of Diabetes Mellitus Metabolic | Ketoacidosis | Hyperosmolar state | Coma
Item
acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
boolean
C0342257 (UMLS CUI [1,1])
C0311400 (UMLS CUI [1,2])
C0220982 (UMLS CUI [2])
C0236013 (UMLS CUI [3])
C0009421 (UMLS CUI [4])
Laboratory test result abnormal
Item
any of the following significant laboratory abnormalities:
boolean
C0438215 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
alt, ast greater than 2 times the upper limit of the normal range at visit 1.
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Direct bilirubin increased
Item
direct bilirubin greater than the upper limit of the normal range at visit 1.
boolean
C0740434 (UMLS CUI [1])
Creatinine measurement, serum | Gender | Creatinine clearance Abnormal
Item
serum creatinine levels equal to or greater than 1.5 mg/dl (132 umol/l) males, equal to or greater than 1.4 mg/dl (123 umol/l) females, or a history of abnormal creatinine clearance at visit 1.
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0812399 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
Thyroid stimulating hormone Abnormal
Item
clinically significant tsh values outside of normal range at visit 1.
boolean
C0040160 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Laboratory test result abnormal | Hyperglycemia Excluded | Hyperinsulinism Excluded | Glycosuria Excluded | Antidiabetics Oral | Metformin Excluded
Item
clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycemia, hyperinsulinemia, and glycosuria at visit 1 treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1
boolean
C0438215 (UMLS CUI [1])
C0020456 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0020459 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
C0017979 (UMLS CUI [4,1])
C2828389 (UMLS CUI [4,2])
C0935929 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
C0025598 (UMLS CUI [6,1])
C2828389 (UMLS CUI [6,2])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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