ID

38978

Beskrivning

The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02008682

Länk

https://clinicaltrials.gov/show/NCT02008682

Nyckelord

Versioner (1)
  1. 2019-11-17 2019-11-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 november 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes NCT02008682

Engelsk

Eligibility Diabetes NCT02008682

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02008682
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, age at least 18 years and below 80 years at the time of signing informed consent
Beskrivning

Age | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
subjects diagnosed type 2 diabetes mellitus and treated with metformin monotherapy at a stable dose of at least 1500 mg daily or maximum tolerated dose above or equal to 1000 mg daily for at least 60 days prior to screening
Beskrivning

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

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
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0752079
hba1c 7.0-10.0% (both inclusive)
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
body mass index below or equal to 45.0 kg/m^2
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 60 days prior to screening. an exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with intercurrent illness
Beskrivning

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

Datatyp

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
history of chronic pancreatitis or idiopathic acute pancreatitis
Beskrivning

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0149521
UMLS CUI [2]
C0341461
any chronic disorder or severe disease which at the discretion of the investigator might jeopardise subject's safety or compliance with the protocol
Beskrivning

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

Datatyp

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
screening calcitonin value above or equal to 50 ng/l
Beskrivning

Calcitonin measurement

Datatyp

boolean

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

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

Datatyp

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)
Beskrivning

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

Datatyp

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
any contraindications to liraglutide, sitagliptin or metformin according to local labelling
Beskrivning

Medical contraindication Liraglutide | Medical contraindication Sitagliptin | Medical contraindication Metformin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1456408
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1565750
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0025598
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Similar models

Eligibility Diabetes NCT02008682

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02008682
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
male or female, age at least 18 years and below 80 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable U/day | Metformin Maximum Tolerated Dose
Item
subjects diagnosed type 2 diabetes mellitus and treated with metformin monotherapy at a stable dose of at least 1500 mg daily or maximum tolerated dose above or equal to 1000 mg daily for at least 60 days prior to screening
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])
C0025598 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
Hemoglobin A1c measurement
Item
hba1c 7.0-10.0% (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index below or equal to 45.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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 60 days prior to screening. an exception is short-term treatment (below or equal to 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])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic pancreatitis or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
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])
Calcitonin measurement
Item
screening calcitonin value above or equal to 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])
Medical contraindication Liraglutide | Medical contraindication Sitagliptin | Medical contraindication Metformin
Item
any contraindications to liraglutide, sitagliptin or metformin according to local labelling
boolean
C1301624 (UMLS CUI [1,1])
C1456408 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C1565750 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])
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