ID

29192

Descripción

Glucose Reduction by Early Acarbose Treatment in Basal Insulin; ODM derived from: https://clinicaltrials.gov/show/NCT00970528

Link

https://clinicaltrials.gov/show/NCT00970528

Palabras clave

Versiones (1)
  1. 5/3/18 5/3/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de marzo de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00970528

Inglés

Eligibility Diabetes Mellitus, Type 2 NCT00970528

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged 18-79 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes inadequately controlled with insulin glargine alone or in combination with metformin
Descripción

Non-Insulin-Dependent Diabetes Mellitus Controlled Inadequate | Insulin Glargine | Metformin | Combined Modality Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C2587213
UMLS CUI [1,3]
C0205412
UMLS CUI [2]
C0907402
UMLS CUI [3]
C0025598
UMLS CUI [4]
C0009429
diagnosed of type 2 diabetes for at least 6 months prior to screening
Descripción

Non-Insulin-Dependent Diabetes Mellitus Disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
treated with tolerable, stable dose of insulin glargine and/or metformin for at least 3 months prior to screening
Descripción

Insulin Glargine Dose Stable | Metformin Dose Stable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0907402
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
hba1c > 7.0 and </= 10.0% at screening
Descripción

Glucohemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202054
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes patients
Descripción

Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
myocardial infarction, unstable angina or coronary artery bypass surgery within previous 6 months
Descripción

Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0010055
clinical evidence of active liver disease, or serum alt or ast 3 times the upper limit of the normal (uln) range
Descripción

Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
serum creatinine >/= 1.5 mg/dl for males, >/= 1.4 mg/dl for females
Descripción

Creatinine measurement, serum | Gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
active proliferative diabetic retinopathy
Descripción

Proliferative diabetic retinopathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0154830
any other anti-diabetic medications except insulin glargine and metformin within 4 weeks prior to study entry
Descripción

Antidiabetics | Exception Insulin Glargine | Exception Metformin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0907402
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0025598
gastrointestinal diseases that are likely to be associated with abnormal intestinal motility or altered absorption of nutrients (e.g. gastroparesis, malabsorption syndrome, chronic diarrhea states, enteropathies, inflammatory bowel disease, partial intestinal obstruction, and large hernias)
Descripción

Gastrointestinal Diseases Associated with Deranged intestinal motility | Gastrointestinal Diseases Associated with Nutrient absorption altered | Gastroparesis | Malabsorption Syndrome | Chronic diarrhea | Intestinal Diseases | Inflammatory Bowel Diseases | Partial bowel obstruction | Hernia Large

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0232673
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C1961155
UMLS CUI [2,4]
C0392747
UMLS CUI [3]
C0152020
UMLS CUI [4]
C0024523
UMLS CUI [5]
C0401151
UMLS CUI [6]
C0021831
UMLS CUI [7]
C0021390
UMLS CUI [8]
C1328480
UMLS CUI [9,1]
C0019270
UMLS CUI [9,2]
C0549177
galactose intolerance
Descripción

Galactosemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0016952
pregnancy
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
delivery, abortion, or lactation within less than three cycles before the start of treatment
Descripción

Birth | Abortion | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005615
UMLS CUI [2]
C0156543
UMLS CUI [3]
C0006147
no use of contraceptive in childbearing aged. women of childbearing potential must agree to use adequate contraception (barrier method of birth control) since signing of the informed consent form until at least 30 days after the last study drug administration.
Descripción

Childbearing Potential Contraceptive methods Absent | Childbearing Potential Barrier Contraception

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0004764
hypersensitivity to the active substances or any of gradient of the study drug ingredients
Descripción

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Ingredient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1550600
treatment with any medication including corticosteroid or herb medication that can affect blood glucose level in the 3 months prior to study entry
Descripción

Pharmaceutical Preparations Affecting Blood glucose level | Adrenal Cortex Hormones Affecting Blood glucose level | Herbal medicine Affecting Blood glucose level

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0428554
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0428554
UMLS CUI [3,1]
C2240391
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0428554
any disease or condition that in the opinion of the investigator may interfere with completion of the study
Descripción

Disease Interferes with Completion of clinical trial | Condition Interferes with Completion of clinical trial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2732579
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00970528

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged 18-79 years
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Controlled Inadequate | Insulin Glargine | Metformin | Combined Modality Therapy
Item
type 2 diabetes inadequately controlled with insulin glargine alone or in combination with metformin
boolean
C0011860 (UMLS CUI [1,1])
C2587213 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0907402 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
C0009429 (UMLS CUI [4])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosed of type 2 diabetes for at least 6 months prior to screening
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin Glargine Dose Stable | Metformin Dose Stable
Item
treated with tolerable, stable dose of insulin glargine and/or metformin for at least 3 months prior to screening
boolean
C0907402 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Glucohemoglobin measurement
Item
hba1c > 7.0 and </= 10.0% at screening
boolean
C0202054 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes patients
boolean
C0011854 (UMLS CUI [1])
Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery
Item
myocardial infarction, unstable angina or coronary artery bypass surgery within previous 6 months
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
clinical evidence of active liver disease, or serum alt or ast 3 times the upper limit of the normal (uln) range
boolean
C0023895 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
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
Item
active proliferative diabetic retinopathy
boolean
C0154830 (UMLS CUI [1])
Antidiabetics | Exception Insulin Glargine | Exception Metformin
Item
any other anti-diabetic medications except insulin glargine and metformin within 4 weeks prior to study entry
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0907402 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])
Gastrointestinal Diseases Associated with Deranged intestinal motility | Gastrointestinal Diseases Associated with Nutrient absorption altered | Gastroparesis | Malabsorption Syndrome | Chronic diarrhea | Intestinal Diseases | Inflammatory Bowel Diseases | Partial bowel obstruction | Hernia Large
Item
gastrointestinal diseases that are likely to be associated with abnormal intestinal motility or altered absorption of nutrients (e.g. gastroparesis, malabsorption syndrome, chronic diarrhea states, enteropathies, inflammatory bowel disease, partial intestinal obstruction, and large hernias)
boolean
C0017178 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0232673 (UMLS CUI [1,3])
C0017178 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C1961155 (UMLS CUI [2,3])
C0392747 (UMLS CUI [2,4])
C0152020 (UMLS CUI [3])
C0024523 (UMLS CUI [4])
C0401151 (UMLS CUI [5])
C0021831 (UMLS CUI [6])
C0021390 (UMLS CUI [7])
C1328480 (UMLS CUI [8])
C0019270 (UMLS CUI [9,1])
C0549177 (UMLS CUI [9,2])
Galactosemia
Item
galactose intolerance
boolean
C0016952 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Birth | Abortion | Breast Feeding
Item
delivery, abortion, or lactation within less than three cycles before the start of treatment
boolean
C0005615 (UMLS CUI [1])
C0156543 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Childbearing Potential Contraceptive methods Absent | Childbearing Potential Barrier Contraception
Item
no use of contraceptive in childbearing aged. women of childbearing potential must agree to use adequate contraception (barrier method of birth control) since signing of the informed consent form until at least 30 days after the last study drug administration.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0004764 (UMLS CUI [2,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Ingredient
Item
hypersensitivity to the active substances or any of gradient of the study drug ingredients
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
Pharmaceutical Preparations Affecting Blood glucose level | Adrenal Cortex Hormones Affecting Blood glucose level | Herbal medicine Affecting Blood glucose level
Item
treatment with any medication including corticosteroid or herb medication that can affect blood glucose level in the 3 months prior to study entry
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0428554 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0428554 (UMLS CUI [2,3])
C2240391 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0428554 (UMLS CUI [3,3])
Disease Interferes with Completion of clinical trial | Condition Interferes with Completion of clinical trial
Item
any disease or condition that in the opinion of the investigator may interfere with completion of the study
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
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