ID

38845

Description

Comparison of the Blood Sugar Lowering Effect Between Repaglinide Plus Metformin and Repaglinide Alone in Type 2 Diabetics Not Previously Treated With Oral Sugar-lowering Drugs; ODM derived from: https://clinicaltrials.gov/show/NCT00819741

Link

https://clinicaltrials.gov/show/NCT00819741

Keywords

Versions (1)
  1. 11/9/19 11/9/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 9, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT00819741

English

Eligibility Diabetes NCT00819741

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00819741
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
never taken oral antidiabetic drugs before
Description

Antidiabetics Oral Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0332197
hba1c greater than 8.5 %
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
bmi (body mass index) less than or equal to 35 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected allergy to repaglinide, metformin, or any of the excipients in the medications
Description

Hypersensitivity Repaglinide | Hypersensitivity Suspected Repaglinide | Metformin allergy | Metformin allergy Suspected | Hypersensitivity Repaglinide Excipient | Hypersensitivity Suspected Repaglinide Excipient | Hypersensitivity Metformin Excipient | Hypersensitivity Suspected Metformin Excipient

Data type

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]
C0571648
UMLS CUI [4,1]
C0571648
UMLS CUI [4,2]
C0750491
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0246689
UMLS CUI [5,3]
C0015237
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0750491
UMLS CUI [6,3]
C0246689
UMLS CUI [6,4]
C0015237
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0025598
UMLS CUI [7,3]
C0015237
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0750491
UMLS CUI [8,3]
C0025598
UMLS CUI [8,4]
C0015237
taken an investigational drug in another clinical trial within 4 weeks prior to this trial
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
impaired liver function, defined as asat (aspartate aminotransferase) or alat (alanine aminotransferase) equal to or greater than 2 times upper normal limit
Description

Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
have a clinically significant, active disease of the gastrointestinal, pulmonary, neurological, renal, genitourinary, and haematological systems
Description

Gastrointestinal Disease | Lung disease | Nervous system disorder | Kidney Disease | Disorder of the genitourinary system | Hematological Disease

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0024115
UMLS CUI [3]
C0027765
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0080276
UMLS CUI [6]
C0018939
severe uncontrolled or untreated hypertension (sitting diastolic blood pressure (bp) equal to or greater than 100 mmhg or systolic bp equal to or greater than 180 mmhg)
Description

Uncontrolled hypertension Severe | Severe hypertension untreated | Sitting diastolic blood pressure | Sitting systolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C4013784
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C1319894
UMLS CUI [4]
C1319893
impaired renal function
Description

Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1565489
acute or chronic acidosis or if there are plans to have a radiographic material containing iodine
Description

Acidosis | Chronic acidosis | Radiographic contrast material Containing Iodine

Data type

boolean

Alias
UMLS CUI [1]
C0001122
UMLS CUI [2]
C1735903
UMLS CUI [3,1]
C0009924
UMLS CUI [3,2]
C0332256
UMLS CUI [3,3]
C0021968
have a clinically significant, active cardiovascular disease, or decompensated heart failure
Description

Cardiovascular Disease | Decompensated cardiac failure

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0581377
treatment with systemic corticosteroids within the past two months prior to screening
Description

CORTICOSTEROIDS FOR SYSTEMIC USE

Data type

boolean

Alias
UMLS CUI [1]
C3653708
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Similar models

Eligibility Diabetes NCT00819741

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00819741
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosed with type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Antidiabetics Oral Absent
Item
never taken oral antidiabetic drugs before
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Hemoglobin A1c measurement
Item
hba1c greater than 8.5 %
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) less than or equal to 35 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Repaglinide | Hypersensitivity Suspected Repaglinide | Metformin allergy | Metformin allergy Suspected | Hypersensitivity Repaglinide Excipient | Hypersensitivity Suspected Repaglinide Excipient | Hypersensitivity Metformin Excipient | Hypersensitivity Suspected Metformin Excipient
Item
known or suspected allergy to repaglinide, metformin, or any of the excipients in the medications
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])
C0571648 (UMLS CUI [3])
C0571648 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0246689 (UMLS CUI [5,2])
C0015237 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C0246689 (UMLS CUI [6,3])
C0015237 (UMLS CUI [6,4])
C0020517 (UMLS CUI [7,1])
C0025598 (UMLS CUI [7,2])
C0015237 (UMLS CUI [7,3])
C0020517 (UMLS CUI [8,1])
C0750491 (UMLS CUI [8,2])
C0025598 (UMLS CUI [8,3])
C0015237 (UMLS CUI [8,4])
Study Subject Participation Status | Investigational New Drugs
Item
taken an investigational drug in another clinical trial within 4 weeks prior to this trial
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
impaired liver function, defined as asat (aspartate aminotransferase) or alat (alanine aminotransferase) equal to or greater than 2 times upper normal limit
boolean
C0086565 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Gastrointestinal Disease | Lung disease | Nervous system disorder | Kidney Disease | Disorder of the genitourinary system | Hematological Disease
Item
have a clinically significant, active disease of the gastrointestinal, pulmonary, neurological, renal, genitourinary, and haematological systems
boolean
C0017178 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0080276 (UMLS CUI [5])
C0018939 (UMLS CUI [6])
Uncontrolled hypertension Severe | Severe hypertension untreated | Sitting diastolic blood pressure | Sitting systolic blood pressure
Item
severe uncontrolled or untreated hypertension (sitting diastolic blood pressure (bp) equal to or greater than 100 mmhg or systolic bp equal to or greater than 180 mmhg)
boolean
C1868885 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C4013784 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3])
C1319893 (UMLS CUI [4])
Renal Insufficiency
Item
impaired renal function
boolean
C1565489 (UMLS CUI [1])
Acidosis | Chronic acidosis | Radiographic contrast material Containing Iodine
Item
acute or chronic acidosis or if there are plans to have a radiographic material containing iodine
boolean
C0001122 (UMLS CUI [1])
C1735903 (UMLS CUI [2])
C0009924 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C0021968 (UMLS CUI [3,3])
Cardiovascular Disease | Decompensated cardiac failure
Item
have a clinically significant, active cardiovascular disease, or decompensated heart failure
boolean
C0007222 (UMLS CUI [1])
C0581377 (UMLS CUI [2])
CORTICOSTEROIDS FOR SYSTEMIC USE
Item
treatment with systemic corticosteroids within the past two months prior to screening
boolean
C3653708 (UMLS CUI [1])
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