ID

33034

Description

Impact of Benfluorex Versus Metformin on Glucose Control and Insulin Secretion in Chinese Type 2 Diabetic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00544518

Link

https://clinicaltrials.gov/show/NCT00544518

Keywords

Versions (1)
  1. 11/23/18 11/23/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 23, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00544518

English

Eligibility Type 2 Diabetes NCT00544518

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
for inclusion in the study, participants will be；① antidiabetic drugs naïve type 2 diabetes mellitus（who standard） with diet control more than 2 weeks; ②or diagnosed type 2 diabetes mellitus with no oral antidiabetic drugs more than 6months; ③or type 2 diabetes mellitus treated with insulin secretagogues more than 1 month; all patients have hba1c between 7.0-10.0% and fasting glucose between 7.0mmol/l～13.0mmol/l.
Description

Antidiabetics Absent | Diabetes Mellitus, Non-Insulin-Dependent | Dietary control | Antidiabetics Oral Absent | Pills Insulin Release | Hemoglobin A1c measurement | Glucose measurement, fasting

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0743195
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C1527415
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C0994475
UMLS CUI [5,2]
C0021641
UMLS CUI [5,3]
C1283071
UMLS CUI [6]
C0474680
UMLS CUI [7]
C0202045
ages eligible for study: 18 years --70 years, genders:both
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
bmi: 23～40kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
no using insulin before 3 months
Description

Insulin Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332197
consent to do birth control to women of child-bearing age
Description

Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
volunteer to join and sign information consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with ketoacidosis、hyperglycemic hyperosmolar syndrome.
Description

Ketoacidosis | Hyperosmolar Hyperglycemic Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0220982
UMLS CUI [2]
C3888846
patients with severe diabetic complications
Description

Complications of Diabetes Mellitus Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0205082
patient with acute cardiovascular diseases，acute cerebrovascular diseases，with vitamin b12、folic acid and iron deficiency，with severe trauma or surgery，severe infection diseases.
Description

Cardiovascular Diseases | Cerebrovascular Disorders | Vitamin B 12 Deficiency | Folic Acid Deficiency | Iron deficiency | Trauma Severe | Operative Surgical Procedures Severe | Communicable Diseases Severe

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0007820
UMLS CUI [3]
C0042847
UMLS CUI [4]
C0016412
UMLS CUI [5]
C0240066
UMLS CUI [6,1]
C3714660
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C0543467
UMLS CUI [7,2]
C0205082
UMLS CUI [8,1]
C0009450
UMLS CUI [8,2]
C0205082
allergy to benfluorex or metformin
Description

Hypersensitivity Benfluorex | Metformin allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0053105
UMLS CUI [2]
C0571648
alt、ast> 2 times of upper normal limit，cr> upper normal limit.
Description

Alanine aminotransferase increased | Aspartate aminotransferase increased | Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0700225
having used benfluorex within 3 months before recruiting.
Description

benfluorex

Data type

boolean

Alias
UMLS CUI [1]
C0053105
patients accepting steroid hormones or malignant tumor treatment
Description

Steroid hormone | Cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0301818
UMLS CUI [2]
C0920425
patients with drug abuse or bibulous history.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
patients with severe unconscious low blood glucose history，severe mental illness history and family history
Description

Unconscious State Severe | Hypoglycemia | Mental Disorders, Severe | Family history of mental disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0041657
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0020615
UMLS CUI [3]
C4046029
UMLS CUI [4]
C0455379
severe hypertensive patients（sbp>160 mmhg，dbp>95mmhg）
Description

Hypertensive disease Severe | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
patient with pancreas diseases.
Description

Pancreatic Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0030286
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Similar models

Eligibility Type 2 Diabetes NCT00544518

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Antidiabetics Absent | Diabetes Mellitus, Non-Insulin-Dependent | Dietary control | Antidiabetics Oral Absent | Pills Insulin Release | Hemoglobin A1c measurement | Glucose measurement, fasting
Item
for inclusion in the study, participants will be；① antidiabetic drugs naïve type 2 diabetes mellitus（who standard） with diet control more than 2 weeks; ②or diagnosed type 2 diabetes mellitus with no oral antidiabetic drugs more than 6months; ③or type 2 diabetes mellitus treated with insulin secretagogues more than 1 month; all patients have hba1c between 7.0-10.0% and fasting glucose between 7.0mmol/l～13.0mmol/l.
boolean
C0935929 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2])
C0743195 (UMLS CUI [3])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0994475 (UMLS CUI [5,1])
C0021641 (UMLS CUI [5,2])
C1283071 (UMLS CUI [5,3])
C0474680 (UMLS CUI [6])
C0202045 (UMLS CUI [7])
Age
Item
ages eligible for study: 18 years --70 years, genders:both
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
bmi: 23～40kg/m2
boolean
C1305855 (UMLS CUI [1])
Insulin Absent
Item
no using insulin before 3 months
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods
Item
consent to do birth control to women of child-bearing age
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
volunteer to join and sign information consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Ketoacidosis | Hyperosmolar Hyperglycemic Syndrome
Item
patients with ketoacidosis、hyperglycemic hyperosmolar syndrome.
boolean
C0220982 (UMLS CUI [1])
C3888846 (UMLS CUI [2])
Complications of Diabetes Mellitus Severe
Item
patients with severe diabetic complications
boolean
C0342257 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Cardiovascular Diseases | Cerebrovascular Disorders | Vitamin B 12 Deficiency | Folic Acid Deficiency | Iron deficiency | Trauma Severe | Operative Surgical Procedures Severe | Communicable Diseases Severe
Item
patient with acute cardiovascular diseases，acute cerebrovascular diseases，with vitamin b12、folic acid and iron deficiency，with severe trauma or surgery，severe infection diseases.
boolean
C0007222 (UMLS CUI [1])
C0007820 (UMLS CUI [2])
C0042847 (UMLS CUI [3])
C0016412 (UMLS CUI [4])
C0240066 (UMLS CUI [5])
C3714660 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0543467 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0009450 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
Hypersensitivity Benfluorex | Metformin allergy
Item
allergy to benfluorex or metformin
boolean
C0020517 (UMLS CUI [1,1])
C0053105 (UMLS CUI [1,2])
C0571648 (UMLS CUI [2])
Alanine aminotransferase increased | Aspartate aminotransferase increased | Serum creatinine raised
Item
alt、ast> 2 times of upper normal limit，cr> upper normal limit.
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0700225 (UMLS CUI [3])
benfluorex
Item
having used benfluorex within 3 months before recruiting.
boolean
C0053105 (UMLS CUI [1])
Steroid hormone | Cancer treatment
Item
patients accepting steroid hormones or malignant tumor treatment
boolean
C0301818 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
Substance Use Disorders
Item
patients with drug abuse or bibulous history.
boolean
C0038586 (UMLS CUI [1])
Unconscious State Severe | Hypoglycemia | Mental Disorders, Severe | Family history of mental disorder
Item
patients with severe unconscious low blood glucose history，severe mental illness history and family history
boolean
C0041657 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0020615 (UMLS CUI [2])
C4046029 (UMLS CUI [3])
C0455379 (UMLS CUI [4])
Hypertensive disease Severe | Systolic Pressure | Diastolic blood pressure
Item
severe hypertensive patients（sbp>160 mmhg，dbp>95mmhg）
boolean
C0020538 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Pancreatic Diseases
Item
patient with pancreas diseases.
boolean
C0030286 (UMLS CUI [1])
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