Information:
Fel:
ID
37301
Beskrivning
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
Länk
https://clinicaltrials.gov/show/NCT02421510
Nyckelord
Versioner (1)
- 2019-07-15 2019-07-15 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
15 juli 2019
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Type 1 Diabetes Mellitus NCT02421510
Eligibility Type 1 Diabetes Mellitus NCT02421510
- StudyEvent: Eligibility
Similar models
Eligibility Type 1 Diabetes Mellitus NCT02421510
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
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])
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])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
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])
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])
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])
C0743113 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])