ID

32931

Descripción

Galvus on Met Phase 4 Study : Study to Evaluate the Efficacy and Safety of Early Combination of Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00975065

Link

https://clinicaltrials.gov/show/NCT00975065

Palabras clave

Versiones (1)
  1. 20/11/18 20/11/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

20 de noviembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00975065

Inglés

Eligibility Type 2 Diabetes Mellitus NCT00975065

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with type 2 diabetes mellitus who were inadequately controlled (baseline a1c of 7.0~11.0%)on metformin monotherapy (1500mg metformin)for ≥ 2 months before baseline visit
Descripción

Non-Insulin-Dependent Diabetes Mellitus Poorly controlled | Hemoglobin A1c measurement | Metformin Dosage

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C3853134
UMLS CUI [2]
C0474680
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0178602
age of 18-80 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
body mass index of 18-40 kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 of diabetes
Descripción

Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
myocardial infarction, unstable angina, or coronary artery bypass graft within the 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
congestive heart failure (iii or nyha class iv)
Descripción

Congestive heart failure New York Heart Association Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
liver disease such as cirrhosis or chronic active hepatitis
Descripción

Liver disease | Liver Cirrhosis | Hepatitis, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0023890
UMLS CUI [3]
C0019189
history of lacticacidemia
Descripción

Lactic acidemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0347959
use of any oral anti-diabetic drug other than metformin within the 2 months
Descripción

Antidiabetics Oral | Exception Metformin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
use of insulin before screening visit
Descripción

Insulin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021641
alt or ast >3 times the upper limit of normal range
Descripción

Alanine aminotransferase increased | Aspartate aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
creatinine >1.5 mg/dl
Descripción

Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
other situation (pregnant or lactating females, history of drug or alcohol abuse, night-shift workers, clinically significant laboratory abnormality on screening or any medical condition that would affect the completion or outcome of the study)
Descripción

Pregnancy | Breast Feeding | Substance Use Disorders | Night shift worker | Laboratory test result abnormal | Medical condition Affecting Completion of clinical trial | Medical condition Affecting Research results

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0038586
UMLS CUI [4]
C0555008
UMLS CUI [5]
C0438215
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0392760
UMLS CUI [6,3]
C2732579
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C0392760
UMLS CUI [7,3]
C0683954
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00975065

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Poorly controlled | Hemoglobin A1c measurement | Metformin Dosage
Item
patients with type 2 diabetes mellitus who were inadequately controlled (baseline a1c of 7.0~11.0%)on metformin monotherapy (1500mg metformin)for ≥ 2 months before baseline visit
boolean
C0011860 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
Age
Item
age of 18-80 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index of 18-40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 of diabetes
boolean
C0011854 (UMLS CUI [1])
Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery
Item
myocardial infarction, unstable angina, or coronary artery bypass graft within the previous 6 months
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
Congestive heart failure New York Heart Association Classification
Item
congestive heart failure (iii or nyha class iv)
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Liver disease | Liver Cirrhosis | Hepatitis, Chronic
Item
liver disease such as cirrhosis or chronic active hepatitis
boolean
C0023895 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C0019189 (UMLS CUI [3])
Lactic acidemia
Item
history of lacticacidemia
boolean
C0347959 (UMLS CUI [1])
Antidiabetics Oral | Exception Metformin
Item
use of any oral anti-diabetic drug other than metformin within the 2 months
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Insulin
Item
use of insulin before screening visit
boolean
C0021641 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
alt or ast >3 times the upper limit of normal range
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Creatinine measurement, serum
Item
creatinine >1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Pregnancy | Breast Feeding | Substance Use Disorders | Night shift worker | Laboratory test result abnormal | Medical condition Affecting Completion of clinical trial | Medical condition Affecting Research results
Item
other situation (pregnant or lactating females, history of drug or alcohol abuse, night-shift workers, clinically significant laboratory abnormality on screening or any medical condition that would affect the completion or outcome of the study)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
C0555008 (UMLS CUI [4])
C0438215 (UMLS CUI [5])
C3843040 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C2732579 (UMLS CUI [6,3])
C3843040 (UMLS CUI [7,1])
C0392760 (UMLS CUI [7,2])
C0683954 (UMLS CUI [7,3])
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