ID

35756

Beschreibung

Efficacy/Safety Study of Glimepiride to Type 2 Diabetes Patients Based on Metformin And Basal Insulin Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT02026310

Link

https://clinicaltrials.gov/show/NCT02026310

Stichworte

Versionen (1)
  1. 20.03.19 20.03.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. März 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02026310

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT02026310

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
understand the whole test process, voluntary and signed informed consent form
Beschreibung

Comprehension Study Protocol | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
men and women aged 35 to 70 years old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
20≤bmi<35 kg/m2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
diagnosed with type 2 diabetes
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
undergoing metformin(dose not less than 1000 mg/day)in combination with basal insulin injection once a day
Beschreibung

Metformin U/day | Combined Modality Therapy | Basal insulin Injection times/day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0456683
UMLS CUI [2]
C0009429
UMLS CUI [3,1]
C0650607
UMLS CUI [3,2]
C1828121
UMLS CUI [3,3]
C0439511
hba1c7.0－11%
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
patients should be able to self blood glucose monitoring
Beschreibung

Blood Glucose Self-Monitoring

Datentyp

boolean

Alias
UMLS CUI [1]
C0005803
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
sulfonylureas,glinides,tzds use within 3 months before the study
Beschreibung

Sulfonylureas | Glinides | Thiazolidinediones

Datentyp

boolean

Alias
UMLS CUI [1]
C0038766
UMLS CUI [2]
C3537178
UMLS CUI [3]
C1257987
pregnant or lactating women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
a history of ketoacidosis
Beschreibung

Ketoacidosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0220982
allergy to sulfonylureas or sulfa drug patients
Beschreibung

Sulfonylurea allergy | Sulfa drugs allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0571636
UMLS CUI [2]
C0038757
apparent dysfunction of liver and kidney patients(alt>2 times upper normal limit,serum creatinine>1.2 times upper normal limit)
Beschreibung

Liver Dysfunction | Renal dysfunction | Alanine aminotransferase increased | Serum creatinine raised

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C3279454
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0700225
poor blood pressure control(systolic pressure>180mmhg or diastolic blood pressure>110mmhg)
Beschreibung

Blood Pressure Poorly controlled | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C3853134
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
heart disease,cardiac insufficiency,unstable angina pectoris,ecg indicates left ventricle hypertrophy,severe anemia(hb<9.0g/d1)
Beschreibung

Heart Disease | Heart insuffiency | Angina, Unstable | ECG: left ventricular hypertrophy | Anemia, severe | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0392173
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0344398
UMLS CUI [5]
C0238644
UMLS CUI [6]
C0518015
severe diabetic nerve complications(ulcer of lower limb,neurogenic bladder)
Beschreibung

Neurologic complication of diabetes mellitus Severe | Leg Ulcer | Neurogenic Bladder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1720078
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0023223
UMLS CUI [3]
C0005697
bmi<20 orbmi≥35kg/m2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
alcohol or drug abuse ,or can't collaborate due to mental disorder
Beschreibung

Substance Use Disorders | Collaboration Unsuccessful Due to Mental disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0282116
UMLS CUI [2,2]
C1272705
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0004936
digestion and absorption function obstacle or other endocrine disorders
Beschreibung

Difficult digestion | Absorption disorder | Endocrine System Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0856712
UMLS CUI [2]
C1385930
UMLS CUI [3]
C0014130
other chronic diseases required long-term glucocorticoid treatment
Beschreibung

Chronic disease | Requirement Glucocorticoids Long-term

Datentyp

boolean

Alias
UMLS CUI [1]
C0008679
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0017710
UMLS CUI [2,3]
C0443252
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT02026310

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Comprehension Study Protocol | Informed Consent
Item
understand the whole test process, voluntary and signed informed consent form
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Age
Item
men and women aged 35 to 70 years old
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
20≤bmi<35 kg/m2
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosed with type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Metformin U/day | Combined Modality Therapy | Basal insulin Injection times/day
Item
undergoing metformin(dose not less than 1000 mg/day)in combination with basal insulin injection once a day
boolean
C0025598 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0009429 (UMLS CUI [2])
C0650607 (UMLS CUI [3,1])
C1828121 (UMLS CUI [3,2])
C0439511 (UMLS CUI [3,3])
Hemoglobin A1c measurement
Item
hba1c7.0－11%
boolean
C0474680 (UMLS CUI [1])
Blood Glucose Self-Monitoring
Item
patients should be able to self blood glucose monitoring
boolean
C0005803 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Sulfonylureas | Glinides | Thiazolidinediones
Item
sulfonylureas,glinides,tzds use within 3 months before the study
boolean
C0038766 (UMLS CUI [1])
C3537178 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Ketoacidosis
Item
a history of ketoacidosis
boolean
C0220982 (UMLS CUI [1])
Sulfonylurea allergy | Sulfa drugs allergy
Item
allergy to sulfonylureas or sulfa drug patients
boolean
C0571636 (UMLS CUI [1])
C0038757 (UMLS CUI [2])
Liver Dysfunction | Renal dysfunction | Alanine aminotransferase increased | Serum creatinine raised
Item
apparent dysfunction of liver and kidney patients(alt>2 times upper normal limit,serum creatinine>1.2 times upper normal limit)
boolean
C0086565 (UMLS CUI [1])
C3279454 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0700225 (UMLS CUI [4])
Blood Pressure Poorly controlled | Systolic Pressure | Diastolic blood pressure
Item
poor blood pressure control(systolic pressure>180mmhg or diastolic blood pressure>110mmhg)
boolean
C0005823 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Heart Disease | Heart insuffiency | Angina, Unstable | ECG: left ventricular hypertrophy | Anemia, severe | Hemoglobin measurement
Item
heart disease,cardiac insufficiency,unstable angina pectoris,ecg indicates left ventricle hypertrophy,severe anemia(hb<9.0g/d1)
boolean
C0018799 (UMLS CUI [1])
C0392173 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0344398 (UMLS CUI [4])
C0238644 (UMLS CUI [5])
C0518015 (UMLS CUI [6])
Neurologic complication of diabetes mellitus Severe | Leg Ulcer | Neurogenic Bladder
Item
severe diabetic nerve complications(ulcer of lower limb,neurogenic bladder)
boolean
C1720078 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0023223 (UMLS CUI [2])
C0005697 (UMLS CUI [3])
Body mass index
Item
bmi<20 orbmi≥35kg/m2
boolean
C1305855 (UMLS CUI [1])
Substance Use Disorders | Collaboration Unsuccessful Due to Mental disorder
Item
alcohol or drug abuse ,or can't collaborate due to mental disorder
boolean
C0038586 (UMLS CUI [1])
C0282116 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0004936 (UMLS CUI [2,4])
Difficult digestion | Absorption disorder | Endocrine System Diseases
Item
digestion and absorption function obstacle or other endocrine disorders
boolean
C0856712 (UMLS CUI [1])
C1385930 (UMLS CUI [2])
C0014130 (UMLS CUI [3])
Chronic disease | Requirement Glucocorticoids Long-term
Item
other chronic diseases required long-term glucocorticoid treatment
boolean
C0008679 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0017710 (UMLS CUI [2,2])
C0443252 (UMLS CUI [2,3])
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