ID

29253

Descripción

Comparison of Repaglinide and Gliclazide in Chinese Subjects With Type 2 Diabetes Never Received Oral Antidiabetic Drug Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT01022762

Link

https://clinicaltrials.gov/show/NCT01022762

Palabras clave

Versiones (1)
  1. 12/3/18 12/3/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

12 de marzo de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes NCT01022762

Inglés

Eligibility Diabetes NCT01022762

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01022762
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
oral anti-diabetic drug (oad) naïve (unsystematic oad treatment 6 months prior to this trial is allowed)
Descripción

Antidiabetics Oral naive | Antidiabetics Oral Irregular allowed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0919936
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0205271
UMLS CUI [2,4]
C0683607
insulin naïve (less than 1 week of daily use of insulin therapy before trial start is allowed)
Descripción

Insulin naive | Insulin regime short-term allowed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0443303
UMLS CUI [2,3]
C0683607
lipid-lowing agent naïve
Descripción

Hypoglycemic Agents naive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C0919936
hba1c: 6.5-8.5%
Descripción

Glucohemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202054
fasting glucose: 6.1-13.0 mmol/l (110-234 mg/dl)
Descripción

Glucose measurement, fasting

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202045
body mass index (bmi): 20-35 kg/m^2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
be able and willing to perform self-monitored plasma glucose (smpg)
Descripción

Plasma Glucose Self Monitoring Able | Plasma Glucose Self Monitoring Willing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0202042
UMLS CUI [1,2]
C0588436
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0202042
UMLS CUI [2,2]
C0588436
UMLS CUI [2,3]
C0600109
be able and willing to eat 3 main meals per day
Descripción

Meal Main Quantity per day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C1542147
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0439505
only applicable to subjects who will participate in the subgroup study: be able and willing to perform and complete ivgtt (intravenous glucose tolerance test) at additional visits
Descripción

Subgroup Clinical Trial | Intravenous Glucose Tolerance Test Completion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515021
UMLS CUI [1,2]
C0008976
UMLS CUI [2,1]
C0021911
UMLS CUI [2,2]
C0205197
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected allergy to repaglinide, gliclazide, or related products (for example sulfonamide or other sulphonylureas (sus)), or any of the excipients in the study drugs
Descripción

Hypersensitivity repaglinide | Hypersensitivity Suspected repaglinide | Gliclazide allergy | Hypersensitivity Suspected Gliclazide | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related | Hypersensitivity Sulfonamides | Hypersensitivity Suspected Sulfonamides | Hypersensitivity Sulfonylurea | Hypersensitivity Suspected Sulfonylurea | Hypersensitivity Investigational New Drugs Excipient | Hypersensitivity Suspected Investigational New Drugs Excipient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0246689
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0246689
UMLS CUI [3]
C0571641
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0017631
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0013227
UMLS CUI [5,3]
C0439849
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0750491
UMLS CUI [6,3]
C0013227
UMLS CUI [6,4]
C0439849
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0038760
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0750491
UMLS CUI [8,3]
C0038760
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0038766
UMLS CUI [10,1]
C0020517
UMLS CUI [10,2]
C0750491
UMLS CUI [10,3]
C0038766
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C0013230
UMLS CUI [11,3]
C0015237
UMLS CUI [12,1]
C0020517
UMLS CUI [12,2]
C0750491
UMLS CUI [12,3]
C0013230
UMLS CUI [12,4]
C0015237
previous participation in this study
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
participation in a study of another investigational drug within 1 month prior to study start
Descripción

Study Subject Participation Status | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility Diabetes NCT01022762

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01022762
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])
Antidiabetics Oral naive | Antidiabetics Oral Irregular allowed
Item
oral anti-diabetic drug (oad) naïve (unsystematic oad treatment 6 months prior to this trial is allowed)
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0919936 (UMLS CUI [1,3])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0205271 (UMLS CUI [2,3])
C0683607 (UMLS CUI [2,4])
Insulin naive | Insulin regime short-term allowed
Item
insulin naïve (less than 1 week of daily use of insulin therapy before trial start is allowed)
boolean
C0021641 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Hypoglycemic Agents naive
Item
lipid-lowing agent naïve
boolean
C0020616 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
hba1c: 6.5-8.5%
boolean
C0202054 (UMLS CUI [1])
Glucose measurement, fasting
Item
fasting glucose: 6.1-13.0 mmol/l (110-234 mg/dl)
boolean
C0202045 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi): 20-35 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Plasma Glucose Self Monitoring Able | Plasma Glucose Self Monitoring Willing
Item
be able and willing to perform self-monitored plasma glucose (smpg)
boolean
C0202042 (UMLS CUI [1,1])
C0588436 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0202042 (UMLS CUI [2,1])
C0588436 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Meal Main Quantity per day
Item
be able and willing to eat 3 main meals per day
boolean
C1998602 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0439505 (UMLS CUI [1,4])
Subgroup Clinical Trial | Intravenous Glucose Tolerance Test Completion
Item
only applicable to subjects who will participate in the subgroup study: be able and willing to perform and complete ivgtt (intravenous glucose tolerance test) at additional visits
boolean
C1515021 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0021911 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity repaglinide | Hypersensitivity Suspected repaglinide | Gliclazide allergy | Hypersensitivity Suspected Gliclazide | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related | Hypersensitivity Sulfonamides | Hypersensitivity Suspected Sulfonamides | Hypersensitivity Sulfonylurea | Hypersensitivity Suspected Sulfonylurea | Hypersensitivity Investigational New Drugs Excipient | Hypersensitivity Suspected Investigational New Drugs Excipient
Item
known or suspected allergy to repaglinide, gliclazide, or related products (for example sulfonamide or other sulphonylureas (sus)), or any of the excipients in the study drugs
boolean
C0020517 (UMLS CUI [1,1])
C0246689 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0246689 (UMLS CUI [2,3])
C0571641 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0017631 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
C0439849 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C0013227 (UMLS CUI [6,3])
C0439849 (UMLS CUI [6,4])
C0020517 (UMLS CUI [7,1])
C0038760 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0750491 (UMLS CUI [8,2])
C0038760 (UMLS CUI [8,3])
C0020517 (UMLS CUI [9,1])
C0038766 (UMLS CUI [9,2])
C0020517 (UMLS CUI [10,1])
C0750491 (UMLS CUI [10,2])
C0038766 (UMLS CUI [10,3])
C0020517 (UMLS CUI [11,1])
C0013230 (UMLS CUI [11,2])
C0015237 (UMLS CUI [11,3])
C0020517 (UMLS CUI [12,1])
C0750491 (UMLS CUI [12,2])
C0013230 (UMLS CUI [12,3])
C0015237 (UMLS CUI [12,4])
Study Subject Participation Status
Item
previous participation in this study
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
participation in a study of another investigational drug within 1 month prior to study start
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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