ID

38969

Beschreibung

Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin; ODM derived from: https://clinicaltrials.gov/show/NCT01907854

Link

https://clinicaltrials.gov/show/NCT01907854

Stichworte

Versionen (1)
  1. 16.11.19 16.11.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

16. November 2019

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes NCT01907854

Englisch

Eligibility Diabetes NCT01907854

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01907854
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
subjects diagnosed with type 2 diabetes and treated with metformin equal to or above 1500 mg/day (or maximum tolerated dose equal to or above 1000 mg/day) and sitagliptin 100 mg/day, both at a stable dose for at least 90 days prior to screening. stable is defined as unchanged medication and dose
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose U/day | Metformin Maximum Tolerated Dose | Sitagliptin Dose U/day

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0752079
UMLS CUI [4,1]
C1565750
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0456683
hba1c 7.5% - 9.5% (58 mmol/mol - 80 mmol/mol) (both inclusive)
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
body mass index equal to or above 20 kg/m^2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any chronic disorder or severe disease which at the discretion of the investigator might jeopardise subject's safety or compliance with the protocol
Beschreibung

Chronic disease At risk Patient safety | Disease Severe At risk Patient safety | Chronic disease Protocol Compliance At risk | Disease Severe Protocol Compliance At risk

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1444641
UMLS CUI [2,4]
C1113679
UMLS CUI [3,1]
C0008679
UMLS CUI [3,2]
C0525058
UMLS CUI [3,3]
C1444641
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0525058
UMLS CUI [4,4]
C1444641
treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. an exception is short-term treatment (equal to or less than 7 days in total) with insulin in connection with intercurrent illness
Beschreibung

Hypoglycemic Agents | Exception Inclusion criteria | Exception Insulin regime short-term | Relationship Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0557978
UMLS CUI [3,3]
C0443303
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
C0009488
female who is pregnant, breast-feeding, intends to become pregnant or of child-bearing potential not using adequate contraceptive methods (adequate contraceptive measures as required by local regulations or practice)
Beschreibung

Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
history of chronic pancreatitis or idiopathic acute pancreatitis
Beschreibung

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0149521
UMLS CUI [2]
C0341461
screening calcitonin value equal to or above 50 ng/l
Beschreibung

Calcitonin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201924
personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
Beschreibung

Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type

Datentyp

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2]
C1833921
UMLS CUI [3,1]
C0027662
UMLS CUI [3,2]
C0332307
UMLS CUI [4,1]
C4039247
UMLS CUI [4,2]
C0332307
diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
Beschreibung

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
impaired liver function, defined as alanine aminotransferase equal to or above 2.5 times upper normal limit
Beschreibung

Liver Dysfunction | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
impaired renal function defined as estimated glomerular filtration rate 60 ml/min/1.73 m^2 per modification of diet in renal disease formula
Beschreibung

Renal Insufficiency | Renal function GFR estimation by MDRD

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C2170215
any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack or other significant cardiovascular event as judged by the investigator within 90 days prior to screening
Beschreibung

Episode of Unstable Angina | Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack | Cardiovascular event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0002965
UMLS CUI [2]
C0948089
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0007787
UMLS CUI [5]
C1320716
heart failure, new york heart association class iv
Beschreibung

Heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mmhg and/or diastolic blood pressure equal to or above 100 mmhg)
Beschreibung

Uncontrolled hypertension Treated | Uncontrolled hypertension Untreated | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
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Ähnliche Modelle

Eligibility Diabetes NCT01907854

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01907854
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose U/day | Metformin Maximum Tolerated Dose | Sitagliptin Dose U/day
Item
subjects diagnosed with type 2 diabetes and treated with metformin equal to or above 1500 mg/day (or maximum tolerated dose equal to or above 1000 mg/day) and sitagliptin 100 mg/day, both at a stable dose for at least 90 days prior to screening. stable is defined as unchanged medication and dose
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0025598 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C1565750 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0456683 (UMLS CUI [4,3])
Hemoglobin A1c measurement
Item
hba1c 7.5% - 9.5% (58 mmol/mol - 80 mmol/mol) (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index equal to or above 20 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chronic disease At risk Patient safety | Disease Severe At risk Patient safety | Chronic disease Protocol Compliance At risk | Disease Severe Protocol Compliance At risk
Item
any chronic disorder or severe disease which at the discretion of the investigator might jeopardise subject's safety or compliance with the protocol
boolean
C0008679 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C1113679 (UMLS CUI [2,4])
C0008679 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C1444641 (UMLS CUI [4,4])
Hypoglycemic Agents | Exception Inclusion criteria | Exception Insulin regime short-term | Relationship Comorbidity
Item
treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. an exception is short-term treatment (equal to or less than 7 days in total) with insulin in connection with intercurrent illness
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0557978 (UMLS CUI [3,2])
C0443303 (UMLS CUI [3,3])
C0439849 (UMLS CUI [4,1])
C0009488 (UMLS CUI [4,2])
Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential Contraceptive methods Absent
Item
female who is pregnant, breast-feeding, intends to become pregnant or of child-bearing potential not using adequate contraceptive methods (adequate contraceptive measures as required by local regulations or practice)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic pancreatitis or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
Calcitonin measurement
Item
screening calcitonin value equal to or above 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type
Item
personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C4039247 (UMLS CUI [4,1])
C0332307 (UMLS CUI [4,2])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired liver function, defined as alanine aminotransferase equal to or above 2.5 times upper normal limit
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Renal Insufficiency | Renal function GFR estimation by MDRD
Item
impaired renal function defined as estimated glomerular filtration rate 60 ml/min/1.73 m^2 per modification of diet in renal disease formula
boolean
C1565489 (UMLS CUI [1])
C2170215 (UMLS CUI [2])
Episode of Unstable Angina | Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack | Cardiovascular event
Item
any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack or other significant cardiovascular event as judged by the investigator within 90 days prior to screening
boolean
C0332189 (UMLS CUI [1,1])
C0002965 (UMLS CUI [1,2])
C0948089 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
C1320716 (UMLS CUI [5])
Heart failure New York Heart Association Classification
Item
heart failure, new york heart association class iv
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Uncontrolled hypertension Treated | Uncontrolled hypertension Untreated | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mmhg and/or diastolic blood pressure equal to or above 100 mmhg)
boolean
C1868885 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
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