ID

37386

Beskrivning

Sitagliptin and Glucagon Counterregulation; ODM derived from: https://clinicaltrials.gov/show/NCT02256189

Länk

https://clinicaltrials.gov/show/NCT02256189

Nyckelord

Versioner (1)
  1. 2019-07-21 2019-07-21 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

21 juli 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT02256189

Engelsk

Eligibility Type 2 Diabetes NCT02256189

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. written consent has been given.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
2. patients with metformin treated t2dm (metformin dose >1.0 g/day and stable during the preceding 3 months)
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable U/day

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [2,4]
C0456683
3. age >65 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
4. hba1c 6.5-8.5% (48-67 mmol/mol; inclusive) at visit 1.
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
5. ability to complete the study
Beskrivning

Completion of clinical trial Able

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2732579
UMLS CUI [1,2]
C0085732
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. a history of any secondary forms of diabetes, e.g., cushing's syndrome and acromegaly.
Beskrivning

Secondary diabetes mellitus | Cushing Syndrome | Acromegaly

Datatyp

boolean

Alias
UMLS CUI [1]
C0271640
UMLS CUI [2]
C0010481
UMLS CUI [3]
C0001206
2. type 2 diabetes, positive gad antibodies
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent | Anti-GAD antibody positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C1167896
3. egfr <60 ml/min
Beskrivning

Estimated Glomerular Filtration Rate

Datatyp

boolean

Alias
UMLS CUI [1]
C3811844
4. acute infections which may affect blood glucose control within 4 weeks prior to visit 1
Beskrivning

Communicable Diseases Affecting Blood Glucose Control

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005802
UMLS CUI [1,4]
C0243148
5. any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes.
Beskrivning

Hypoglycaemic episode Recurrent | Hypoglycaemic episode Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0745153
UMLS CUI [1,2]
C2945760
UMLS CUI [2,1]
C0745153
UMLS CUI [2,2]
C0205082
6. liver disease such as cirrhosis or chronic active hepatitis
Beskrivning

Liver disease | Liver Cirrhosis | Hepatitis, Chronic

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0023890
UMLS CUI [3]
C0019189
7. history of coronary heart disease or heart failure class iii or iv
Beskrivning

Coronary heart disease | Heart failure New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C0010068
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
8. donation of one unit (500 ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
Beskrivning

Blood Donation Unit Quantity | Blood Loss Unit Quantity | Blood Transfusion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0439148
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C3163616
UMLS CUI [2,2]
C0439148
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0005841
9. treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
Beskrivning

Growth hormone treatment | Corticosteroid therapy oral chronic | Corticosteroid therapy parenteral chronic

Datatyp

boolean

Alias
UMLS CUI [1]
C0744483
UMLS CUI [2,1]
C0149783
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0205191
UMLS CUI [3,1]
C0149783
UMLS CUI [3,2]
C1518896
UMLS CUI [3,3]
C0205191
10. use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study
Beskrivning

Investigational New Drugs Inappropriate Clinical Trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0008976
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Similar models

Eligibility Type 2 Diabetes NCT02256189

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. written consent has been given.
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable U/day
Item
2. patients with metformin treated t2dm (metformin dose >1.0 g/day and stable during the preceding 3 months)
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
Age
Item
3. age >65 years.
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
4. hba1c 6.5-8.5% (48-67 mmol/mol; inclusive) at visit 1.
boolean
C0474680 (UMLS CUI [1])
Completion of clinical trial Able
Item
5. ability to complete the study
boolean
C2732579 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Secondary diabetes mellitus | Cushing Syndrome | Acromegaly
Item
1. a history of any secondary forms of diabetes, e.g., cushing's syndrome and acromegaly.
boolean
C0271640 (UMLS CUI [1])
C0010481 (UMLS CUI [2])
C0001206 (UMLS CUI [3])
Diabetes Mellitus, Non-Insulin-Dependent | Anti-GAD antibody positive
Item
2. type 2 diabetes, positive gad antibodies
boolean
C0011860 (UMLS CUI [1])
C1167896 (UMLS CUI [2])
Estimated Glomerular Filtration Rate
Item
3. egfr <60 ml/min
boolean
C3811844 (UMLS CUI [1])
Communicable Diseases Affecting Blood Glucose Control
Item
4. acute infections which may affect blood glucose control within 4 weeks prior to visit 1
boolean
C0009450 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005802 (UMLS CUI [1,3])
C0243148 (UMLS CUI [1,4])
Hypoglycaemic episode Recurrent | Hypoglycaemic episode Severe
Item
5. any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes.
boolean
C0745153 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C0745153 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Liver disease | Liver Cirrhosis | Hepatitis, Chronic
Item
6. liver disease such as cirrhosis or chronic active hepatitis
boolean
C0023895 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C0019189 (UMLS CUI [3])
Coronary heart disease | Heart failure New York Heart Association Classification
Item
7. history of coronary heart disease or heart failure class iii or iv
boolean
C0010068 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Blood Donation Unit Quantity | Blood Loss Unit Quantity | Blood Transfusion
Item
8. donation of one unit (500 ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
boolean
C0005794 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3163616 (UMLS CUI [2,1])
C0439148 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0005841 (UMLS CUI [3])
Growth hormone treatment | Corticosteroid therapy oral chronic | Corticosteroid therapy parenteral chronic
Item
9. treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
boolean
C0744483 (UMLS CUI [1])
C0149783 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C0149783 (UMLS CUI [3,1])
C1518896 (UMLS CUI [3,2])
C0205191 (UMLS CUI [3,3])
Investigational New Drugs Inappropriate Clinical Trial
Item
10. use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study
boolean
C0013230 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
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