ID

32776

Descrição

Optimal Oral Hypoglycaemic Agents (OHA) for Combination With Insulin Glargine (Sulfonylurea vs. Metformin); ODM derived from: https://clinicaltrials.gov/show/NCT00708578

Link

https://clinicaltrials.gov/show/NCT00708578

Palavras-chave

Versões (1)
  1. 15/11/2018 15/11/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

15 de novembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00708578

Inglês

Eligibility Type 2 Diabetes Mellitus NCT00708578

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes for at least 6 months
Descrição

Non-Insulin-Dependent Diabetes Mellitus Disease length

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
treated with maximal, tolerable dose of metformin (≥ 1000mg/day) and sulfonylurea (glimepiride≥ 4 mg/day or equivalent dose of other su) for at least 3 months prior to the screening visit
Descrição

Metformin Maximum Tolerated Dose U/day | Sulfonylurea Maximum Tolerated Dose U/day | Glimepiride U/day

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0752079
UMLS CUI [1,3]
C0456683
UMLS CUI [2,1]
C0038766
UMLS CUI [2,2]
C0752079
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C0061323
UMLS CUI [3,2]
C0456683
7.0 < hba1c < 11 %
Descrição

Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474680
fasting serum c-peptide > 0.33 nmol/l
Descrição

Fasting C-peptide level

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2208720
bmi < 30 kg/m²
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
patients who is willing to monitor bg using smbg
Descrição

Blood Glucose Self-Monitoring Willing

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005803
UMLS CUI [1,2]
C0600109
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
clinical evidence of active liver disease, or serum alt 3 times the upper limit of the normal range
Descrição

Liver disease | Alanine aminotransferase increased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151905
serum creatinine: ≥ 1.5 mg/dl for males, ≥ 1.4 mg/dl for females
Descrição

Creatinine measurement, serum | Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)
Descrição

Proliferative diabetic retinopathy | Light Coagulation | Operative Surgical Procedures | Retinal Disease Unstable | Retinal Disease Rapidly progressive | Light Coagulation Required | Operative Surgical Procedures Required | Optic fundus observation Recommended

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0154830
UMLS CUI [2]
C0023694
UMLS CUI [3]
C0543467
UMLS CUI [4,1]
C0035309
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0035309
UMLS CUI [5,2]
C1838681
UMLS CUI [6,1]
C0023694
UMLS CUI [6,2]
C1514873
UMLS CUI [7,1]
C0543467
UMLS CUI [7,2]
C1514873
UMLS CUI [8,1]
C0423377
UMLS CUI [8,2]
C0034866
history of alcohol or other substance abuse
Descrição

Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
pregnancy or not using contraceptive in childbearing aged women
Descrição

Pregnancy | Childbearing Potential Contraceptive methods Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
breast feeding women
Descrição

Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006147
history of hypersensitivity to the study drugs or to drugs with a similar chemical structure
Descrição

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Chemical Structure Similar

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0220807
UMLS CUI [2,4]
C2348205
treatment with any medication including corticosteroid or herbal medicines that can affect blood glucose level within 3 months prior to study entry except metformin and sulfonylurea.
Descrição

Pharmaceutical Preparations Affecting Blood glucose level | Adrenal Cortex Hormones | Medicinal Herbs | Exception Metformin | Exception Sulfonylurea

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0392201
UMLS CUI [2]
C0001617
UMLS CUI [3]
C0025125
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0025598
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0038766
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Descrição

Study Subject Participation Status | Considerations Additional

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C1524062
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00708578

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Metformin Maximum Tolerated Dose U/day | Sulfonylurea Maximum Tolerated Dose U/day | Glimepiride U/day
Item
treated with maximal, tolerable dose of metformin (≥ 1000mg/day) and sulfonylurea (glimepiride≥ 4 mg/day or equivalent dose of other su) for at least 3 months prior to the screening visit
boolean
C0025598 (UMLS CUI [1,1])
C0752079 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2,1])
C0752079 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0061323 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
Hemoglobin A1c measurement
Item
7.0 < hba1c < 11 %
boolean
C0474680 (UMLS CUI [1])
Fasting C-peptide level
Item
fasting serum c-peptide > 0.33 nmol/l
boolean
C2208720 (UMLS CUI [1])
Body mass index
Item
bmi < 30 kg/m²
boolean
C1305855 (UMLS CUI [1])
Blood Glucose Self-Monitoring Willing
Item
patients who is willing to monitor bg using smbg
boolean
C0005803 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Liver disease | Alanine aminotransferase increased
Item
clinical evidence of active liver disease, or serum alt 3 times the upper limit of the normal range
boolean
C0023895 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Creatinine measurement, serum | Gender
Item
serum creatinine: ≥ 1.5 mg/dl for males, ≥ 1.4 mg/dl for females
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Proliferative diabetic retinopathy | Light Coagulation | Operative Surgical Procedures | Retinal Disease Unstable | Retinal Disease Rapidly progressive | Light Coagulation Required | Operative Surgical Procedures Required | Optic fundus observation Recommended
Item
active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)
boolean
C0154830 (UMLS CUI [1])
C0023694 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C0035309 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0035309 (UMLS CUI [5,1])
C1838681 (UMLS CUI [5,2])
C0023694 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C0543467 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C0423377 (UMLS CUI [8,1])
C0034866 (UMLS CUI [8,2])
Substance Use Disorders
Item
history of alcohol or other substance abuse
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Childbearing Potential Contraceptive methods Absent
Item
pregnancy or not using contraceptive in childbearing aged women
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Breast Feeding
Item
breast feeding women
boolean
C0006147 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Chemical Structure Similar
Item
history of hypersensitivity to the study drugs or to drugs with a similar chemical structure
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0220807 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
Pharmaceutical Preparations Affecting Blood glucose level | Adrenal Cortex Hormones | Medicinal Herbs | Exception Metformin | Exception Sulfonylurea
Item
treatment with any medication including corticosteroid or herbal medicines that can affect blood glucose level within 3 months prior to study entry except metformin and sulfonylurea.
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0392201 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2])
C0025125 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0025598 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0038766 (UMLS CUI [5,2])
Study Subject Participation Status | Considerations Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0518609 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
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