ID

29188

Descripción

Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00957060

Link

https://clinicaltrials.gov/show/NCT00957060

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 NCT00957060

Inglés

Eligibility Diabetes Mellitus, Type 2 NCT00957060

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject naïve to treatment
Descripción

Study Subject Therapy naive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0919936
hba1c > 8.5 up to 11 %
Descripción

Glucohemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202054
lipid lowering therapy, antihypertensive, hormonal substitutes, thyroid hormone substitutes, and contraceptives are allowed as long as they are kept at a stable dosing
Descripción

Hypoglycemic Agents Dose Stable | Antihypertensive Agents Dose Stable | Hormone replacement therapy Dose Stable | Thyroid hormone replacement therapy Dose Stable | Contraceptive Agents Dose Stable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0282402
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C2242640
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
UMLS CUI [5,1]
C0009871
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0205360
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with any oral antidiabetics or insulin
Descripción

Antidiabetics Oral | Insulin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0021641
known type 1 diabetes mellitus
Descripción

Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
pregnant or breast feeding women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
ketoacidosis history
Descripción

Ketoacidosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220982
history of sensitivity to any of the active substances
Descripción

Hypersensitivity Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
renal dysfunction : serum creatinine > or = 1.5 mg/dl in male subjects > or = 1.4 mg/dl in female subjects
Descripción

Renal dysfunction | Creatinine measurement, serum | Gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
liver impairment (alt, ast > 3-fold the upper limit of normal range)
Descripción

Hepatic impairment | Alanine aminotransferase increased | Aspartate aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948807
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
systemic corticosteroid treatment 3 months prior to study or during the study
Descripción

CORTICOSTEROIDS FOR SYSTEMIC USE

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3653708
drug or alcohol abuse history
Descripción

Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
patients with history of acute coronary syndrome, cerebrovascular events/transient ischaemic attack in the last three months
Descripción

Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
presence of any condition (medical, psychological, social or geographic) current or previously seen that according to investigators judgment jeopardizes the safety or restricts the participation of the patient during the study
Descripción

Medical condition compromises Patient safety | Medical condition Study Subject Participation Status Limited | Mental condition compromises Patient safety | Mental condition Study Subject Participation Status Limited | Social Conditions compromise Patient safety | Social Conditions Study Subject Participation Status Limited | Geographic Factors compromise Patient safety | Geographic Factors Study Subject Participation Status Limited

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0439801
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C1113679
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C0439801
UMLS CUI [5,1]
C0037403
UMLS CUI [5,2]
C2945640
UMLS CUI [5,3]
C1113679
UMLS CUI [6,1]
C0037403
UMLS CUI [6,2]
C2348568
UMLS CUI [6,3]
C0439801
UMLS CUI [7,1]
C0017444
UMLS CUI [7,2]
C2945640
UMLS CUI [7,3]
C1113679
UMLS CUI [8,1]
C0017444
UMLS CUI [8,2]
C2348568
UMLS CUI [8,3]
C0439801
neoplasias
Descripción

Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027651
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Descripción

Study Subject Participation Status | Aspect Additional

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1879746
UMLS CUI [2,2]
C1524062
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00957060

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Therapy naive
Item
subject naïve to treatment
boolean
C0681850 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
hba1c > 8.5 up to 11 %
boolean
C0202054 (UMLS CUI [1])
Hypoglycemic Agents Dose Stable | Antihypertensive Agents Dose Stable | Hormone replacement therapy Dose Stable | Thyroid hormone replacement therapy Dose Stable | Contraceptive Agents Dose Stable
Item
lipid lowering therapy, antihypertensive, hormonal substitutes, thyroid hormone substitutes, and contraceptives are allowed as long as they are kept at a stable dosing
boolean
C0020616 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0003364 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0282402 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C2242640 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0009871 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
Item Group
C0680251 (UMLS CUI)
Antidiabetics Oral | Insulin
Item
treatment with any oral antidiabetics or insulin
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent
Item
known type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Ketoacidosis
Item
ketoacidosis history
boolean
C0220982 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs
Item
history of sensitivity to any of the active substances
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Renal dysfunction | Creatinine measurement, serum | Gender
Item
renal dysfunction : serum creatinine > or = 1.5 mg/dl in male subjects > or = 1.4 mg/dl in female subjects
boolean
C3279454 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Hepatic impairment | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
liver impairment (alt, ast > 3-fold the upper limit of normal range)
boolean
C0948807 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
CORTICOSTEROIDS FOR SYSTEMIC USE
Item
systemic corticosteroid treatment 3 months prior to study or during the study
boolean
C3653708 (UMLS CUI [1])
Substance Use Disorders
Item
drug or alcohol abuse history
boolean
C0038586 (UMLS CUI [1])
Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack
Item
patients with history of acute coronary syndrome, cerebrovascular events/transient ischaemic attack in the last three months
boolean
C0948089 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Medical condition compromises Patient safety | Medical condition Study Subject Participation Status Limited | Mental condition compromises Patient safety | Mental condition Study Subject Participation Status Limited | Social Conditions compromise Patient safety | Social Conditions Study Subject Participation Status Limited | Geographic Factors compromise Patient safety | Geographic Factors Study Subject Participation Status Limited
Item
presence of any condition (medical, psychological, social or geographic) current or previously seen that according to investigators judgment jeopardizes the safety or restricts the participation of the patient during the study
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
C0037403 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
C0037403 (UMLS CUI [6,1])
C2348568 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
C0017444 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C1113679 (UMLS CUI [7,3])
C0017444 (UMLS CUI [8,1])
C2348568 (UMLS CUI [8,2])
C0439801 (UMLS CUI [8,3])
Neoplasms
Item
neoplasias
boolean
C0027651 (UMLS CUI [1])
Study Subject Participation Status | Aspect 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])
C1879746 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
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