Information:
Fel:
ID
33741
Beskrivning
A Trial Investigating the Effect of Semaglutide on Hypoglycaemic Counterregulation Compared to Placebo in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02147431
Länk
https://clinicaltrials.gov/show/NCT02147431
Nyckelord
Versioner (1)
- 2018-12-21 2018-12-21 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
21 december 2018
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Diabetes NCT02147431
Eligibility Diabetes NCT02147431
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes NCT02147431
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable
Item
subjects diagnosed with type 2 diabetes and on stable treatment for a period of 90 days prior to screening with metformin as monotherapy. stable is defined as unchanged dose
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Age | Informed Consent
Item
male or female, age between18-64 years (both inclusive) at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0021430 (UMLS CUI [2])
Body mass index
Item
body mass index (bmi) between 20.0-35.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) between 6.5-10.0% (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Hypoglycemic Agents | Exception Metformin | Exception Insulin Comorbidity Related
Item
treatment with any glucose lowering agent(s) other than metformin in a period of 90 days before screening. an exception is short-term treatment (less than or equal to 7 days in total) with insulin in connection with intercurrent illness
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0021641 (UMLS CUI [3,2])
C0009488 (UMLS CUI [3,3])
C0439849 (UMLS CUI [3,4])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0021641 (UMLS CUI [3,2])
C0009488 (UMLS CUI [3,3])
C0439849 (UMLS CUI [3,4])
Recurrent severe hypoglycemia | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis
Item
recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
C0019993 (UMLS CUI [3,1])
C0011880 (UMLS CUI [3,2])
C0342317 (UMLS CUI [2])
C0019993 (UMLS CUI [3,1])
C0011880 (UMLS CUI [3,2])
Blood Donation | Plasma Donation | Blood Donation Amount | Plasma Donation Amount | Status pre- Semaglutide Dose
Item
blood or plasma donation within the past month or more than 500 ml within the last 3 months prior to first semaglutide dosing
boolean
C0005794 (UMLS CUI [1])
C0032105 (UMLS CUI [2,1])
C0005794 (UMLS CUI [2,2])
C0005794 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0032105 (UMLS CUI [4,1])
C0005794 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0332152 (UMLS CUI [5,1])
C3885068 (UMLS CUI [5,2])
C0178602 (UMLS CUI [5,3])
C0032105 (UMLS CUI [2,1])
C0005794 (UMLS CUI [2,2])
C0005794 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0032105 (UMLS CUI [4,1])
C0005794 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0332152 (UMLS CUI [5,1])
C3885068 (UMLS CUI [5,2])
C0178602 (UMLS CUI [5,3])