ID

20618

Descrição

Local Registration Trial in China Humalog Mix 50; ODM derived from: https://clinicaltrials.gov/show/NCT00191581

Link

https://clinicaltrials.gov/show/NCT00191581

Palavras-chave

Versões (1)
  1. 06/03/2017 06/03/2017 -
Transferido a

6 de março 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 1 NCT00191581

Inglês

Eligibility Diabetes Mellitus, Type 1 NCT00191581

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men and women who have had either type 1 or type 2 diabetes (world health organization[who]classification)for at least 2 months and are between the ages of 18 and 70 (inclusive) at the signing of the informed consent.
Descrição

Age | Insulin-Dependent Diabetes Mellitus disease length | Non-Insulin-Dependent Diabetes Mellitus disease length

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0011854
UMLS CUI [2,2]
C0872146
UMLS CUI [3,1]
C0011860
UMLS CUI [3,2]
C0872146
2. have been treated with commercially available human insulin mix 50/50 or human insulin mix 30/70 twice daily as the only pharmacological treatment for their diabetes for at least 2 months prior to entering the study.
Descrição

Insulin regime

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0557978
3. have an hba1c between 1.1 and 1.7 times the upper limit of the normal reference rang(inclusive) as determined by a local laboratory within 2 weeks prior to or at visit 1.
Descrição

Increased HbA1c levels

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4073162
4. have achieved compliance with their diets and insulin therapies as determined by the investigators and perform regular blood glucose monitoring.
Descrição

Compliance behavior | Diet therapy | Insulin regime | Blood Glucose Self-Monitoring

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0557978
UMLS CUI [4]
C0005803
5. have given informed consent to participate in this study in accordance with local regulations.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
{1] have used oral antidiabetic agents, including biguanides, sulfonylureas, glucosidase inhibitors, and insulin-sensitivity enhancers within 30 days prior to entry into the study.
Descrição

Antidiabetics Oral | Biguanides | Sulfonylurea Compounds | Glucosidase Inhibitor | Enhanced insulin sensitivity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0005382
UMLS CUI [3]
C0038766
UMLS CUI [4]
C1512211
UMLS CUI [5]
C3549878
[2] receive a total daily dose of insulin >2 units/kg.
Descrição

Insulin Cumulative Dose Unit/kilogram/day

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C2986497
UMLS CUI [1,3]
C1532634
[3] have had more than two episodes of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entry into the study.
Descrição

Hypoglycemia Severe Episode Quantity | Hypoglycemia Disabling Requirement Assistance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332189
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C0020615
UMLS CUI [2,2]
C4061999
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C1269765
[4] have a body mass index >35 kg/m2.
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
[5] have serum creatinine > the upper limit of normal (uln), as determined by a local laboratory.
Descrição

Serum creatinine raised

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0700225
Voltar ao início da página

Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00191581

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age | Insulin-Dependent Diabetes Mellitus disease length | Non-Insulin-Dependent Diabetes Mellitus disease length
Item
1. men and women who have had either type 1 or type 2 diabetes (world health organization[who]classification)for at least 2 months and are between the ages of 18 and 70 (inclusive) at the signing of the informed consent.
boolean
C0001779 (UMLS CUI [1])
C0011854 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
C0011860 (UMLS CUI [3,1])
C0872146 (UMLS CUI [3,2])
Insulin regime
Item
2. have been treated with commercially available human insulin mix 50/50 or human insulin mix 30/70 twice daily as the only pharmacological treatment for their diabetes for at least 2 months prior to entering the study.
boolean
C0557978 (UMLS CUI [1])
Increased HbA1c levels
Item
3. have an hba1c between 1.1 and 1.7 times the upper limit of the normal reference rang(inclusive) as determined by a local laboratory within 2 weeks prior to or at visit 1.
boolean
C4073162 (UMLS CUI [1])
Compliance behavior | Diet therapy | Insulin regime | Blood Glucose Self-Monitoring
Item
4. have achieved compliance with their diets and insulin therapies as determined by the investigators and perform regular blood glucose monitoring.
boolean
C1321605 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0557978 (UMLS CUI [3])
C0005803 (UMLS CUI [4])
Informed Consent
Item
5. have given informed consent to participate in this study in accordance with local regulations.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antidiabetics Oral | Biguanides | Sulfonylurea Compounds | Glucosidase Inhibitor | Enhanced insulin sensitivity
Item
{1] have used oral antidiabetic agents, including biguanides, sulfonylureas, glucosidase inhibitors, and insulin-sensitivity enhancers within 30 days prior to entry into the study.
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0005382 (UMLS CUI [2])
C0038766 (UMLS CUI [3])
C1512211 (UMLS CUI [4])
C3549878 (UMLS CUI [5])
Insulin Cumulative Dose Unit/kilogram/day
Item
[2] receive a total daily dose of insulin >2 units/kg.
boolean
C0021641 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C1532634 (UMLS CUI [1,3])
Hypoglycemia Severe Episode Quantity | Hypoglycemia Disabling Requirement Assistance
Item
[3] have had more than two episodes of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entry into the study.
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0020615 (UMLS CUI [2,1])
C4061999 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C1269765 (UMLS CUI [2,4])
Body mass index
Item
[4] have a body mass index >35 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Serum creatinine raised
Item
[5] have serum creatinine > the upper limit of normal (uln), as determined by a local laboratory.
boolean
C0700225 (UMLS CUI [1])
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