ID

32908

Descripción

Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00885378

Link

https://clinicaltrials.gov/show/NCT00885378

Palabras clave

Versiones (1)
  1. 19/11/18 19/11/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

19 de noviembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00885378

Inglés

Eligibility Type 2 Diabetes Mellitus NCT00885378

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
18-78 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
taking stable twice daily (bid) dosing of metformin ir (at least 1500 mg) for at least 8 weeks
Descripción

Metformin Immediate Release | Dose Stable U/day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C1708470
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C0456683
a1c: 7-10%
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
c-peptide: ≥ 0.8 ng/ml
Descripción

C-peptide measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202100
body mass index (bmi): ≤45 kg/m^2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
women of childbearing potential unable or unwilling to use acceptable birth control
Descripción

Childbearing Potential Contraceptive methods Unable | Childbearing Potential Contraceptive methods Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
women who are pregnant or breastfeeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
fasting plasma glucose (fpg) >270 mg/dl
Descripción

Plasma fasting glucose measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0583513
significant cardiovascular history
Descripción

Cardiovascular History

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1880008
symptoms of poorly controlled diabetes
Descripción

Symptoms Poorly controlled diabetes mellitus

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0554876
history of diabetic ketoacidosis or hyperosmolar nonketotic coma
Descripción

Diabetic Ketoacidosis | Hyperosmolar Nonketotic Coma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C0020457
insulin therapy within one year of screening
Descripción

Insulin regime

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0557978
cardiovascular even within the prior 6 months
Descripción

Cardiovascular Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
new york heart association stage iii/iv congestive heart failure and/or known left ventricular ejection fraction <=40%
Descripción

Congestive heart failure New York Heart Association Classification | Left ventricular ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0428772
significant history of renal or hepatic disease
Descripción

Kidney Disease | Liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
history of a psychiatric disorder, alcohol or drug abuse within the previous year
Descripción

Mental disorders | Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0038586
treatment with potent cyp3a4 inhibitors or inducers
Descripción

CYP3A4 Inhibitor | CYP3A4 Inducer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3830624
UMLS CUI [2]
C3830625
immunocompromised participants
Descripción

Immunocompromised patient

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085393
active liver disease or clinically significant abnormal hepatic, renal , endocrine, metabolic, or hematological screening tests
Descripción

Liver disease | Screening test Hepatic Abnormal | Screening test Renal Abnormal | Screening test Endocrine Abnormal | Screening test Metabolic Abnormal | Screening test Hematologic Abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0871311
UMLS CUI [2,2]
C0205054
UMLS CUI [2,3]
C0205161
UMLS CUI [3,1]
C0871311
UMLS CUI [3,2]
C0022646
UMLS CUI [3,3]
C0205161
UMLS CUI [4,1]
C0871311
UMLS CUI [4,2]
C0014136
UMLS CUI [4,3]
C0205161
UMLS CUI [5,1]
C0871311
UMLS CUI [5,2]
C0311400
UMLS CUI [5,3]
C0205161
UMLS CUI [6,1]
C0871311
UMLS CUI [6,2]
C0205488
UMLS CUI [6,3]
C0205161
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00885378

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Age
Item
18-78 years of age
boolean
C0001779 (UMLS CUI [1])
Metformin Immediate Release | Dose Stable U/day
Item
taking stable twice daily (bid) dosing of metformin ir (at least 1500 mg) for at least 8 weeks
boolean
C0025598 (UMLS CUI [1,1])
C1708470 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
Hemoglobin A1c measurement
Item
a1c: 7-10%
boolean
C0474680 (UMLS CUI [1])
C-peptide measurement
Item
c-peptide: ≥ 0.8 ng/ml
boolean
C0202100 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi): ≤45 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential Contraceptive methods Unable | Childbearing Potential Contraceptive methods Unwilling
Item
women of childbearing potential unable or unwilling to use acceptable birth control
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Plasma fasting glucose measurement
Item
fasting plasma glucose (fpg) >270 mg/dl
boolean
C0583513 (UMLS CUI [1])
Cardiovascular History
Item
significant cardiovascular history
boolean
C1880008 (UMLS CUI [1])
Symptoms Poorly controlled diabetes mellitus
Item
symptoms of poorly controlled diabetes
boolean
C1457887 (UMLS CUI [1,1])
C0554876 (UMLS CUI [1,2])
Diabetic Ketoacidosis | Hyperosmolar Nonketotic Coma
Item
history of diabetic ketoacidosis or hyperosmolar nonketotic coma
boolean
C0011880 (UMLS CUI [1])
C0020457 (UMLS CUI [2])
Insulin regime
Item
insulin therapy within one year of screening
boolean
C0557978 (UMLS CUI [1])
Cardiovascular Disease
Item
cardiovascular even within the prior 6 months
boolean
C0007222 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification | Left ventricular ejection fraction
Item
new york heart association stage iii/iv congestive heart failure and/or known left ventricular ejection fraction <=40%
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2])
Kidney Disease | Liver disease
Item
significant history of renal or hepatic disease
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
Mental disorders | Substance Use Disorders
Item
history of a psychiatric disorder, alcohol or drug abuse within the previous year
boolean
C0004936 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
CYP3A4 Inhibitor | CYP3A4 Inducer
Item
treatment with potent cyp3a4 inhibitors or inducers
boolean
C3830624 (UMLS CUI [1])
C3830625 (UMLS CUI [2])
Immunocompromised patient
Item
immunocompromised participants
boolean
C0085393 (UMLS CUI [1])
Liver disease | Screening test Hepatic Abnormal | Screening test Renal Abnormal | Screening test Endocrine Abnormal | Screening test Metabolic Abnormal | Screening test Hematologic Abnormal
Item
active liver disease or clinically significant abnormal hepatic, renal , endocrine, metabolic, or hematological screening tests
boolean
C0023895 (UMLS CUI [1])
C0871311 (UMLS CUI [2,1])
C0205054 (UMLS CUI [2,2])
C0205161 (UMLS CUI [2,3])
C0871311 (UMLS CUI [3,1])
C0022646 (UMLS CUI [3,2])
C0205161 (UMLS CUI [3,3])
C0871311 (UMLS CUI [4,1])
C0014136 (UMLS CUI [4,2])
C0205161 (UMLS CUI [4,3])
C0871311 (UMLS CUI [5,1])
C0311400 (UMLS CUI [5,2])
C0205161 (UMLS CUI [5,3])
C0871311 (UMLS CUI [6,1])
C0205488 (UMLS CUI [6,2])
C0205161 (UMLS CUI [6,3])
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