ID

37301

Description

Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02421510

Link

https://clinicaltrials.gov/show/NCT02421510

Keywords

  1. 7/15/19 7/15/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 15, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Type 1 Diabetes Mellitus NCT02421510

Eligibility Type 1 Diabetes Mellitus NCT02421510

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient has given written informed consent to participate in the study in accordance with local regulations
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
adult patients 18 years and older with a diagnosis of t1d made at least 1 year prior to informed consent
Description

Adult | Age | Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0011854
patients are being treated with insulin or insulin analog 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
willing and able to perform smbg and complete the study diary as required per protocol
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
at the screening visit, a1c must be between 7.0% to 11.0%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
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
use of antidiabetic agent other than insulin or insulin analog at the time of screening
Description

Antidiabetics | Exception Insulin | Exception Insulin Analog

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 sodium-glucose cotransporter (sglt) inhibitors within 8 weeks prior to screening
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 mellitus (t2dm), or severely uncontrolled t1d as determined by the investigator
Description

Diabetes Mellitus, Non-Insulin-Dependent | Diabetes mellitus Insulin dependent Uncontrolled Severe

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0743113
UMLS CUI [2,2]
C0205082

Similar models

Eligibility Type 1 Diabetes Mellitus NCT02421510

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
patient has given written informed consent to participate in the study in accordance with local regulations
boolean
C0021430 (UMLS CUI [1])
Adult | Age | Diabetes Mellitus, Insulin-Dependent
Item
adult patients 18 years and older with a diagnosis of t1d made at least 1 year prior to informed consent
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0011854 (UMLS CUI [3])
Insulin | Insulin Analog | Continuous subcutaneous infusion of insulin | Insulin injection multiple daily
Item
patients are being treated with insulin or insulin analog 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])
Blood Glucose Self-Monitoring | Subject Diary Completion
Item
willing and able to perform smbg and complete the study diary as required per protocol
boolean
C0005803 (UMLS CUI [1])
C3890583 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Hemoglobin A1c measurement
Item
at the screening visit, a1c must be between 7.0% to 11.0%
boolean
C0474680 (UMLS CUI [1])
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)
Antidiabetics | Exception Insulin | Exception Insulin Analog
Item
use of antidiabetic agent other than insulin or insulin analog 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 sodium-glucose cotransporter (sglt) inhibitors within 8 weeks prior to screening
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 Insulin dependent Uncontrolled Severe
Item
type 2 diabetes mellitus (t2dm), or severely uncontrolled t1d as determined by the investigator
boolean
C0011860 (UMLS CUI [1])
C0743113 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])

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