ID

37291

Description

Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C; ODM derived from: https://clinicaltrials.gov/show/NCT02383940

Link

https://clinicaltrials.gov/show/NCT02383940

Keywords

Versions (1)
  1. 7/14/19 7/14/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 14, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 1 Diabetes Mellitus NCT02383940

English

Eligibility Type 1 Diabetes Mellitus NCT02383940

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient has given written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
young adult patients ≥18 to ≤30 years old at screening, with a confirmed diagnosis of t1dm made at least 1 year prior to informed consent
Description

Adult | Age | Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0011854
UMLS CUI [3,2]
C0872146
patients are being treated with insulin or insulin analogue delivered via csii or mdi
Description

Insulin | Insulin Analog | Continuous subcutaneous infusion of insulin | Insulin injection multiple daily

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C2825028
UMLS CUI [3]
C0393124
UMLS CUI [4,1]
C0199782
UMLS CUI [4,2]
C0439064
UMLS CUI [4,3]
C0332173
at screening, must have a1c ≥9.0%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
must be willing and able to perform smbg and complete the study diary
Description

Blood Glucose Self-Monitoring | Subject Diary Completion

Data type

boolean

Alias
UMLS CUI [1]
C0005803
UMLS CUI [2,1]
C3890583
UMLS CUI [2,2]
C0205197
females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test
Description

Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any prior use of lx4211/sotagliflozin
Description

LX4211 | Sotagliflozin

Data type

boolean

Alias
UMLS CUI [1]
C3502472
UMLS CUI [2]
C3502471
use of antidiabetic agent other than insulin or insulin analogue at the time of screening
Description

Antidiabetics | Exception Insulin | Exception Insulin Analogue

Data type

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021641
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2825028
use of sglt inhibitors within 8 weeks prior to start of the placebo run-in period
Description

Sodium-Glucose Transporter Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C3665045
chronic systemic corticosteroid use
Description

Corticosteroids for systemic use chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C3653708
UMLS CUI [1,2]
C0205191
type 2 diabetes, or severely uncontrolled diabetes mellitus as determined by the investigator
Description

Diabetes Mellitus, Non-Insulin-Dependent | Diabetes mellitus uncontrolled Severe

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0421258
UMLS CUI [2,2]
C0205082
history of dka or nonketotic hyperosmolar state within 6 months prior to the screening visit
Description

Diabetic Ketoacidosis | Diabetic hyperosmolar non-ketotic state

Data type

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C0553772
history of severe hypoglycemic event within 1 month prior to screening visit
Description

Hypoglycemia Event Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C0205082
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Similar models

Eligibility Type 1 Diabetes Mellitus NCT02383940

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
patient has given written informed consent
boolean
C0021430 (UMLS CUI [1])
Adult | Age | Insulin-Dependent Diabetes Mellitus Disease length
Item
young adult patients ≥18 to ≤30 years old at screening, with a confirmed diagnosis of t1dm made at least 1 year prior to informed consent
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0011854 (UMLS CUI [3,1])
C0872146 (UMLS CUI [3,2])
Insulin | Insulin Analog | Continuous subcutaneous infusion of insulin | Insulin injection multiple daily
Item
patients are being treated with insulin or insulin analogue delivered via csii or mdi
boolean
C0021641 (UMLS CUI [1])
C2825028 (UMLS CUI [2])
C0393124 (UMLS CUI [3])
C0199782 (UMLS CUI [4,1])
C0439064 (UMLS CUI [4,2])
C0332173 (UMLS CUI [4,3])
Hemoglobin A1c measurement
Item
at screening, must have a1c ≥9.0%
boolean
C0474680 (UMLS CUI [1])
Blood Glucose Self-Monitoring | Subject Diary Completion
Item
must be willing and able to perform smbg and complete the study diary
boolean
C0005803 (UMLS CUI [1])
C3890583 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative
Item
females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
LX4211 | Sotagliflozin
Item
any prior use of lx4211/sotagliflozin
boolean
C3502472 (UMLS CUI [1])
C3502471 (UMLS CUI [2])
Antidiabetics | Exception Insulin | Exception Insulin Analogue
Item
use of antidiabetic agent other than insulin or insulin analogue at the time of screening
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2825028 (UMLS CUI [3,2])
Sodium-Glucose Transporter Inhibitors
Item
use of sglt inhibitors within 8 weeks prior to start of the placebo run-in period
boolean
C3665045 (UMLS CUI [1])
Corticosteroids for systemic use chronic
Item
chronic systemic corticosteroid use
boolean
C3653708 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent | Diabetes mellitus uncontrolled Severe
Item
type 2 diabetes, or severely uncontrolled diabetes mellitus as determined by the investigator
boolean
C0011860 (UMLS CUI [1])
C0421258 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Diabetic Ketoacidosis | Diabetic hyperosmolar non-ketotic state
Item
history of dka or nonketotic hyperosmolar state within 6 months prior to the screening visit
boolean
C0011880 (UMLS CUI [1])
C0553772 (UMLS CUI [2])
Hypoglycemia Event Severe
Item
history of severe hypoglycemic event within 1 month prior to screening visit
boolean
C0020615 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
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