ID

33089

Descripción

Comparison of the Effects of Repaglinide and Metformin on Glucose Excursions; ODM derived from: https://clinicaltrials.gov/show/NCT00832481

Link

https://clinicaltrials.gov/show/NCT00832481

Palabras clave

Versiones (1)
  1. 26/11/18 26/11/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

26 de noviembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00832481

Inglés

Eligibility Type 2 Diabetes NCT00832481

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. informed consent obtained before any trial-related activities. (trial- related activities are any procedure that would not have been performed during normal management of the subject.)
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
2. ages between 20-90 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
3. bmi between 18.5 and 30 kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
4. newly diagnosed type 2 diabetes. type 2 diabetes is in accordance with who criteria 1999
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
5. the history of diabetes less than 6 months
Descripción

Diabetes Mellitus Disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0872146
6. hba1c <10%.
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
7. only on diet and/or exercise, oad or insulin naïve subjects
Descripción

Diet therapy | Exercise | Antidiabetics Oral Absent | Insulin Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C0015259
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0021641
UMLS CUI [4,2]
C0332197
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any history of oad or insulin therapy preceding this trial.
Descripción

Antidiabetics Oral | Insulin regime

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0557978
2. type 1 diabetic subjects, including lada
Descripción

Diabetes Mellitus, Insulin-Dependent | Latent Autoimmune Diabetes in Adults

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C1739108
3. pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (adequate contraceptive measures are sterilisation, iud, oral contraceptives or barrier methods) before and/or during the trial.
Descripción

Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent | Female Sterilization | Intrauterine Devices | Contraceptives, Oral | Contraception, Barrier

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C0015787
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0009905
UMLS CUI [8]
C0004764
4. impaired hepatic function (alt > 2.5 times upper limit of local laboratories normal ranges)
Descripción

Liver Dysfunction | Alanine aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
5. impaired renal function, defined as serum creatinine ≥ 1.5 mg/dl.
Descripción

Renal Insufficiency | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
6. use of systemic or inhaled glucocorticoids or other medication known to interfere with glucose metabolism.
Descripción

Glucocorticoids, Systemic | Glucocorticoids Inhalation | Pharmaceutical Preparations Interferes with Glucose metabolism

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3540777
UMLS CUI [2,1]
C0017710
UMLS CUI [2,2]
C0205535
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0596620
7. recently had acute diabetic complications
Descripción

Acute complication with diabetes mellitus

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4546244
8. mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Descripción

Mental handicap Comprehension Excluded | Comprehension Unwilling | Language Barriers Comprehension Excluded | Mental handicap Cooperation Excluded | Cooperation Unwilling | Language Barriers Cooperation Excluded

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1306341
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C0237167
UMLS CUI [3,2]
C0162340
UMLS CUI [3,3]
C0332196
UMLS CUI [4,1]
C1306341
UMLS CUI [4,2]
C0392337
UMLS CUI [4,3]
C0332196
UMLS CUI [5,1]
C0392337
UMLS CUI [5,2]
C0558080
UMLS CUI [6,1]
C0237167
UMLS CUI [6,2]
C0392337
UMLS CUI [6,3]
C0332196
9. recently had operation, injury, inflammation and other stress conditions.
Descripción

Operative Surgical Procedures | Injury | Inflammation | Stress

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C3263723
UMLS CUI [3]
C0021368
UMLS CUI [4]
C0038435
10. recently had cardiac disease as following:
Descripción

Heart Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018799
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Similar models

Eligibility Type 2 Diabetes NCT00832481

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. informed consent obtained before any trial-related activities. (trial- related activities are any procedure that would not have been performed during normal management of the subject.)
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. ages between 20-90 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
3. bmi between 18.5 and 30 kg/m2
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
4. newly diagnosed type 2 diabetes. type 2 diabetes is in accordance with who criteria 1999
boolean
C0011860 (UMLS CUI [1])
Diabetes Mellitus Disease length
Item
5. the history of diabetes less than 6 months
boolean
C0011849 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
6. hba1c <10%.
boolean
C0474680 (UMLS CUI [1])
Diet therapy | Exercise | Antidiabetics Oral Absent | Insulin Absent
Item
7. only on diet and/or exercise, oad or insulin naïve subjects
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0021641 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Antidiabetics Oral | Insulin regime
Item
1. any history of oad or insulin therapy preceding this trial.
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent | Latent Autoimmune Diabetes in Adults
Item
2. type 1 diabetic subjects, including lada
boolean
C0011854 (UMLS CUI [1])
C1739108 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent | Female Sterilization | Intrauterine Devices | Contraceptives, Oral | Contraception, Barrier
Item
3. pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (adequate contraceptive measures are sterilisation, iud, oral contraceptives or barrier methods) before and/or during the trial.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0015787 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0009905 (UMLS CUI [7])
C0004764 (UMLS CUI [8])
Liver Dysfunction | Alanine aminotransferase increased
Item
4. impaired hepatic function (alt > 2.5 times upper limit of local laboratories normal ranges)
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Renal Insufficiency | Creatinine measurement, serum
Item
5. impaired renal function, defined as serum creatinine ≥ 1.5 mg/dl.
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Glucocorticoids, Systemic | Glucocorticoids Inhalation | Pharmaceutical Preparations Interferes with Glucose metabolism
Item
6. use of systemic or inhaled glucocorticoids or other medication known to interfere with glucose metabolism.
boolean
C3540777 (UMLS CUI [1])
C0017710 (UMLS CUI [2,1])
C0205535 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0596620 (UMLS CUI [3,3])
Acute complication with diabetes mellitus
Item
7. recently had acute diabetic complications
boolean
C4546244 (UMLS CUI [1])
Mental handicap Comprehension Excluded | Comprehension Unwilling | Language Barriers Comprehension Excluded | Mental handicap Cooperation Excluded | Cooperation Unwilling | Language Barriers Cooperation Excluded
Item
8. mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
boolean
C1306341 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0162340 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0237167 (UMLS CUI [3,1])
C0162340 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
C1306341 (UMLS CUI [4,1])
C0392337 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
C0392337 (UMLS CUI [5,1])
C0558080 (UMLS CUI [5,2])
C0237167 (UMLS CUI [6,1])
C0392337 (UMLS CUI [6,2])
C0332196 (UMLS CUI [6,3])
Operative Surgical Procedures | Injury | Inflammation | Stress
Item
9. recently had operation, injury, inflammation and other stress conditions.
boolean
C0543467 (UMLS CUI [1])
C3263723 (UMLS CUI [2])
C0021368 (UMLS CUI [3])
C0038435 (UMLS CUI [4])
Heart Disease
Item
10. recently had cardiac disease as following:
boolean
C0018799 (UMLS CUI [1])
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