ID

32910

Description

Study of LX4211 in Subjects With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00962065

Link

https://clinicaltrials.gov/show/NCT00962065

Keywords

Versions (1)
  1. 11/19/18 11/19/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 19, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00962065

English

Eligibility Type 2 Diabetes Mellitus NCT00962065

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females (non-childbearing potential), aged 18-65 years
Description

Gender | Female infertility | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0021361
UMLS CUI [3]
C0001779
diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
fasting plasma glucose ≤ 240 mg/dl prior to metformin washout
Description

Plasma fasting glucose measurement | Status pre- Metformin Washout

Data type

boolean

Alias
UMLS CUI [1]
C0583513
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0025598
UMLS CUI [2,3]
C1710661
body mass index < 42 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
hba1c value of 7 to 11%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
c-peptide ≥ 1.0 ng/ml
Description

C-peptide measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202100
ability to provide written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, incontinence, or nocturia
Description

Diabetes Mellitus, Insulin-Dependent | Diabetic Ketoacidosis | Hyperglycaemic hyperosmolar nonketotic syndrome | Incontinence | Nocturia

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011880
UMLS CUI [3]
C1504377
UMLS CUI [4]
C0021167
UMLS CUI [5]
C0028734
use of any blood glucose lowering agent other than metformin
Description

Hypoglycemic Agents | Exception Metformin

Data type

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
prior exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening
Description

Exposure to Insulin | Exposure to Thiazides | Exposure to Loop Diuretics

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0021641
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0541746
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C0354100
laboratory or electrocardiogram abnormalities deemed significant by the sponsor or the investigator
Description

Laboratory test result abnormal | Electrocardiogram abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0522055
positive test result for glutamic acid decarboxylase (gad) antibody
Description

Anti-GAD antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C1167896
surgery within 6 months of screening
Description

Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C0543467
exposure to any investigational agent or participation in any investigational trial within 30 days prior to day 1
Description

Exposure to Investigational New Drugs | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0013230
UMLS CUI [2]
C2348568
hypersensitivity to an sglt2 inhibitor
Description

Hypersensitivity SGLT2 Inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3273807
history of drug or alcohol abuse within the last 12 months
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00962065

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Female infertility | Age
Item
males and females (non-childbearing potential), aged 18-65 years
boolean
C0079399 (UMLS CUI [1])
C0021361 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Plasma fasting glucose measurement | Status pre- Metformin Washout
Item
fasting plasma glucose ≤ 240 mg/dl prior to metformin washout
boolean
C0583513 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1710661 (UMLS CUI [2,3])
Body mass index
Item
body mass index < 42 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c value of 7 to 11%
boolean
C0474680 (UMLS CUI [1])
C-peptide measurement
Item
c-peptide ≥ 1.0 ng/ml
boolean
C0202100 (UMLS CUI [1])
Informed Consent
Item
ability to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetic Ketoacidosis | Hyperglycaemic hyperosmolar nonketotic syndrome | Incontinence | Nocturia
Item
history of type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, incontinence, or nocturia
boolean
C0011854 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
C1504377 (UMLS CUI [3])
C0021167 (UMLS CUI [4])
C0028734 (UMLS CUI [5])
Hypoglycemic Agents | Exception Metformin
Item
use of any blood glucose lowering agent other than metformin
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Exposure to Insulin | Exposure to Thiazides | Exposure to Loop Diuretics
Item
prior exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening
boolean
C0332157 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0541746 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C0354100 (UMLS CUI [3,2])
Laboratory test result abnormal | Electrocardiogram abnormal
Item
laboratory or electrocardiogram abnormalities deemed significant by the sponsor or the investigator
boolean
C0438215 (UMLS CUI [1])
C0522055 (UMLS CUI [2])
Anti-GAD antibody positive
Item
positive test result for glutamic acid decarboxylase (gad) antibody
boolean
C1167896 (UMLS CUI [1])
Operative Surgical Procedures
Item
surgery within 6 months of screening
boolean
C0543467 (UMLS CUI [1])
Exposure to Investigational New Drugs | Study Subject Participation Status
Item
exposure to any investigational agent or participation in any investigational trial within 30 days prior to day 1
boolean
C0332157 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])
Hypersensitivity SGLT2 Inhibitor
Item
hypersensitivity to an sglt2 inhibitor
boolean
C0020517 (UMLS CUI [1,1])
C3273807 (UMLS CUI [1,2])
Substance Use Disorders
Item
history of drug or alcohol abuse within the last 12 months
boolean
C0038586 (UMLS CUI [1])
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