Englisch

Eligibility Diabetes Mellitus, Type 2 NCT00744367

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, 18-75 years age;
Beschreibung

Adult | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
type 2 diabetes receiving pioglitazone (>= 30 mg/day) and metformin (>= 1500 mg/day) for at least 12 weeks prior to screening;
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Pioglitazone U/day | Metformin U/day

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0071097
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0456683
hba1c >=7.0% and <=10.0% at screening;
Beschreibung

Glucohemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202054
bmi >= 25 (>23 for asians) and <=45 kg/m2 at screening;
Beschreibung

Body mass index | Asians

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0078988
stable weight +/-5% for at least 12 weeks prior to screening.
Beschreibung

Stable body weight Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0517386
UMLS CUI [1,2]
C0449238
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Complications of Diabetes Mellitus Metabolic | Ketoacidosis | Hyperosmolar Coma

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0342257
UMLS CUI [2,2]
C0311400
UMLS CUI [3]
C0220982
UMLS CUI [4]
C0020457
evidence of clinically significant diabetic complications;
Beschreibung

Complications of Diabetes Mellitus Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C2826293
clinically symptomatic gastrointestinal disease;
Beschreibung

Gastrointestinal Disease Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0231220
myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
Beschreibung

Myocardial Infarction | Coronary Artery Bypass Surgery | Cardiomyopathy Post Transplantation | Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0010055
UMLS CUI [3,1]
C0878544
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0040732
UMLS CUI [4]
C0038454
known hemoglobinopathy or chronic anemia.
Beschreibung

Hemoglobinopathy | Chronic anemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0019045
UMLS CUI [2]
C0581384
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT00744367

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, 18-75 years age;
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent | Pioglitazone U/day | Metformin U/day
Item
type 2 diabetes receiving pioglitazone (>= 30 mg/day) and metformin (>= 1500 mg/day) for at least 12 weeks prior to screening;
boolean
C0011860 (UMLS CUI [1])
C0071097 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
Glucohemoglobin measurement
Item
hba1c >=7.0% and <=10.0% at screening;
boolean
C0202054 (UMLS CUI [1])
Body mass index | Asians
Item
bmi >= 25 (>23 for asians) and <=45 kg/m2 at screening;
boolean
C1305855 (UMLS CUI [1])
C0078988 (UMLS CUI [2])
Stable body weight Duration
Item
stable weight +/-5% for at least 12 weeks prior to screening.
boolean
C0517386 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Complications of Diabetes Mellitus Metabolic | Ketoacidosis | Hyperosmolar Coma
Item
history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
boolean
C0011854 (UMLS CUI [1])
C0342257 (UMLS CUI [2,1])
C0311400 (UMLS CUI [2,2])
C0220982 (UMLS CUI [3])
C0020457 (UMLS CUI [4])
Complications of Diabetes Mellitus Clinical Significance
Item
evidence of clinically significant diabetic complications;
boolean
C0342257 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Gastrointestinal Disease Symptomatic
Item
clinically symptomatic gastrointestinal disease;
boolean
C0017178 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Myocardial Infarction | Coronary Artery Bypass Surgery | Cardiomyopathy Post Transplantation | Cerebrovascular accident
Item
myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
boolean
C0027051 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C0878544 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0040732 (UMLS CUI [3,3])
C0038454 (UMLS CUI [4])
Hemoglobinopathy | Chronic anemia
Item
known hemoglobinopathy or chronic anemia.
boolean
C0019045 (UMLS CUI [1])
C0581384 (UMLS CUI [2])
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