ID

33741

Description

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

Link

https://clinicaltrials.gov/show/NCT02147431

Keywords

Versions (1)
  1. 12/21/18 12/21/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 21, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT02147431

English

Eligibility Diabetes NCT02147431

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02147431
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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
Description

Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
male or female, age between18-64 years (both inclusive) at the time of signing informed consent
Description

Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
body mass index (bmi) between 20.0-35.0 kg/m^2 (both inclusive)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
hba1c (glycosylated haemoglobin) between 6.5-10.0% (both inclusive)
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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
Description

Hypoglycemic Agents | Exception Metformin | Exception Insulin Comorbidity Related

Data type

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0021641
UMLS CUI [3,3]
C0009488
UMLS CUI [3,4]
C0439849
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
Description

Recurrent severe hypoglycemia | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2]
C0342317
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
C0011880
blood or plasma donation within the past month or more than 500 ml within the last 3 months prior to first semaglutide dosing
Description

Blood Donation | Plasma Donation | Blood Donation Amount | Plasma Donation Amount | Status pre- Semaglutide Dose

Data type

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C0005794
UMLS CUI [3,1]
C0005794
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0032105
UMLS CUI [4,2]
C0005794
UMLS CUI [4,3]
C1265611
UMLS CUI [5,1]
C0332152
UMLS CUI [5,2]
C3885068
UMLS CUI [5,3]
C0178602
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Similar models

Eligibility Diabetes NCT02147431

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02147431
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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