ID

37402

Beschreibung

Vildagliptin Versus Dapagliflozin on Glucagon; ODM derived from: https://clinicaltrials.gov/show/NCT02475070

Link

https://clinicaltrials.gov/show/NCT02475070

Stichworte

Versionen (1)
  1. 23.07.19 23.07.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

23. Juli 2019

DOI

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Eligibility Type 2 Diabetes NCT02475070

Englisch

Eligibility Type 2 Diabetes NCT02475070

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. patients with type 2 diabetes treated with a stable dose of metformin during the last three months
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
3. age 20-70 years.
Beschreibung

Age

Datentyp

boolean

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

Hemoglobin A1c measurement

Datentyp

boolean

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

Completion of clinical trial Able

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. use of other glucose-lowering therapy than metformin within three months prior to visit 1.
Beschreibung

Hypoglycemic Agents | Exception Metformin

Datentyp

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
2. a history of any secondary forms of diabetes, e.g., cushing's syndrome and acromegaly.
Beschreibung

Secondary diabetes mellitus | Cushing Syndrome | Acromegaly

Datentyp

boolean

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C1167896
4. estimated glomerular filtration rate <60 ml/min
Beschreibung

Estimated Glomerular Filtration Rate

Datentyp

boolean

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

Communicable Diseases Affecting Blood Glucose Control

Datentyp

boolean

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

Hypoglycaemic episode Recurrent | Hypoglycaemic episode Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0745153
UMLS CUI [1,2]
C2945760
UMLS CUI [2,1]
C0745153
UMLS CUI [2,2]
C0205082
7. any history of acute pancreatitis
Beschreibung

Pancreatitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0030305
8. any history of anaphylaxis, angioedema, and exfoliative skin conditions including stevens-johnson syndrome.
Beschreibung

Anaphylaxis | Angioedema | Skin condition Exfoliative | Stevens-Johnson Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0002792
UMLS CUI [2]
C0002994
UMLS CUI [3,1]
C1719933
UMLS CUI [3,2]
C0205226
UMLS CUI [4]
C0038325
9. liver disease such as cirrhosis or chronic active hepatitis
Beschreibung

Liver disease | Liver Cirrhosis | Hepatitis, Chronic

Datentyp

boolean

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

Coronary heart disease | Heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C0010068
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
11. 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.
Beschreibung

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

Datentyp

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
12. treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
Beschreibung

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

Datentyp

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
13. use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study
Beschreibung

Investigational New Drugs Inappropriate Clinical Trial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0008976
14. hypersensitivity to vildagliptin or dapagliflozin or any compound in the tablet core
Beschreibung

Hypersensitivity Vildagliptin | Hypersensitivity Dapagliflozin | Hypersensitivity Compound Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1570906
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2353951
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1706082
UMLS CUI [3,3]
C0013230
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Ähnliche Modelle

Eligibility Type 2 Diabetes NCT02475070

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
Item
2. patients with type 2 diabetes treated with a stable dose of metformin during the last three months
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Age
Item
3. age 20-70 years.
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
4. hba1c 6.5-8.5% (48-67 mmol/mol) 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)
Hypoglycemic Agents | Exception Metformin
Item
1. use of other glucose-lowering therapy than metformin within three months prior to visit 1.
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Secondary diabetes mellitus | Cushing Syndrome | Acromegaly
Item
2. 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, Insulin-Dependent | Anti-GAD antibody positive
Item
3. type 1 diabetes, positive gad antibodies
boolean
C0011854 (UMLS CUI [1])
C1167896 (UMLS CUI [2])
Estimated Glomerular Filtration Rate
Item
4. estimated glomerular filtration rate <60 ml/min
boolean
C3811844 (UMLS CUI [1])
Communicable Diseases Affecting Blood Glucose Control
Item
5. 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
6. 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])
Pancreatitis
Item
7. any history of acute pancreatitis
boolean
C0030305 (UMLS CUI [1])
Anaphylaxis | Angioedema | Skin condition Exfoliative | Stevens-Johnson Syndrome
Item
8. any history of anaphylaxis, angioedema, and exfoliative skin conditions including stevens-johnson syndrome.
boolean
C0002792 (UMLS CUI [1])
C0002994 (UMLS CUI [2])
C1719933 (UMLS CUI [3,1])
C0205226 (UMLS CUI [3,2])
C0038325 (UMLS CUI [4])
Liver disease | Liver Cirrhosis | Hepatitis, Chronic
Item
9. 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
10. 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
11. 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 | Steroid therapy oral chronic | Steroid therapy parenteral chronic
Item
12. 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
13. 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])
Hypersensitivity Vildagliptin | Hypersensitivity Dapagliflozin | Hypersensitivity Compound Investigational New Drugs
Item
14. hypersensitivity to vildagliptin or dapagliflozin or any compound in the tablet core
boolean
C0020517 (UMLS CUI [1,1])
C1570906 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2353951 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1706082 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
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