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ID

35789

Beskrivning

Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01917656

Länk

https://clinicaltrials.gov/show/NCT01917656

Nyckelord

Versioner (2)
  1. 2019-03-23 2019-03-23 -
  2. 2019-03-23 2019-03-23 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 mars 2019

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Diabetes NCT01917656

    Engelsk

    Eligibility Diabetes NCT01917656

    1 Formulär  
    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT01917656
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    subjects diagnosed with t2dm and treated with metformin equal to or above 1000 mg/day and su (gliclazide, glipizide or glyburide/glibenclamide at maximum tolerated dose (at least half maximum approved dose) or glimepiride at maximum tolerated dose (at least 2 mg/day)), both at a stable dose for at least 90 days prior to screening. stable is defined as unchanged medication and dose
    Beskrivning

    Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable U/day | Sulfonylurea Dose Stable | Gliclazide Maximum Tolerated Dose | Glipizide Maximum Tolerated Dose | Glyburide Maximum Tolerated Dose | Glimepiride 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]
    C0038766
    UMLS CUI [3,2]
    C0178602
    UMLS CUI [3,3]
    C0205360
    UMLS CUI [4,1]
    C0017631
    UMLS CUI [4,2]
    C0752079
    UMLS CUI [5,1]
    C0017642
    UMLS CUI [5,2]
    C0752079
    UMLS CUI [6,1]
    C0017628
    UMLS CUI [6,2]
    C0752079
    UMLS CUI [7,1]
    C0061323
    UMLS CUI [7,2]
    C0752079
    hba1c 7.0-10.0% (53- 86 mmol/mol) (both inclusive)
    Beskrivning

    Hemoglobin A1c measurement

    Datatyp

    boolean

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

    Body mass index

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    subjects who have expressed their intention to fast (daytime, i.e. between sunrise and sunset) during ramadan after receiving medical counselling regarding the risk of fasting
    Beskrivning

    Intention Fasting Daytime | Counseling Risk Fasting

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0162425
    UMLS CUI [1,2]
    C0015663
    UMLS CUI [1,3]
    C0332169
    UMLS CUI [2,1]
    C0010210
    UMLS CUI [2,2]
    C0035647
    UMLS CUI [2,3]
    C0015663
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    any contraindication for successful and sustained fasting from a medical perspective at the discretion of the investigator (such as acute illness, severe hypoglycaemia within 90 days prior to screening, a history of recurrent hypoglycaemia, hypoglycaemia unawareness, ketoacidosis within 90 days prior to screening, hyperosmolar hyperglycaemic coma within 90 days prior to screening, subjects performing intense physical labour)
    Beskrivning

    Medical contraindication Fasting | Acute illness | Hypoglycemia Severe | Recurrent hypoglycemia | Loss of hypoglycemic warning | Ketoacidosis | Hyperglycemic Hyperosmolar Coma | Exercise With intensity

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0015663
    UMLS CUI [2]
    C4061114
    UMLS CUI [3,1]
    C0020615
    UMLS CUI [3,2]
    C0205082
    UMLS CUI [4]
    C1846288
    UMLS CUI [5]
    C0342317
    UMLS CUI [6]
    C0220982
    UMLS CUI [7]
    C0020457
    UMLS CUI [8,1]
    C0015259
    UMLS CUI [8,2]
    C0522510
    any chronic disorder or severe disease which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
    Beskrivning

    Chronic disease compromises Patient safety | Disease Severe compromises Patient safety | Chronic disease compromises Protocol Compliance | Disease Severe compromises Protocol Compliance

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0008679
    UMLS CUI [1,2]
    C2945640
    UMLS CUI [1,3]
    C1113679
    UMLS CUI [2,1]
    C0012634
    UMLS CUI [2,2]
    C0205082
    UMLS CUI [2,3]
    C2945640
    UMLS CUI [2,4]
    C1113679
    UMLS CUI [3,1]
    C0008679
    UMLS CUI [3,2]
    C2945640
    UMLS CUI [3,3]
    C0525058
    UMLS CUI [4,1]
    C0012634
    UMLS CUI [4,2]
    C0205082
    UMLS CUI [4,3]
    C2945640
    UMLS CUI [4,4]
    C0525058
    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
    screening calcitonin value equal to or above 50 ng/l
    Beskrivning

    Calcitonin measurement

    Datatyp

    boolean

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

    Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | 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
    impaired liver function, defined as alanine aminotransferase (alat) equal to or above 2.5 times upper normal limit (unl)
    Beskrivning

    Liver Dysfunction | Alanine aminotransferase increased

    Datatyp

    boolean

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

    Renal Insufficiency | Renal function GFR estimation by MDRD

    Datatyp

    boolean

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

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

    Datatyp

    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
    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
    Tillbaka till toppen

    Similar models

    Eligibility Diabetes NCT01917656

    1 Formulär
    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT01917656
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable U/day | Sulfonylurea Dose Stable | Gliclazide Maximum Tolerated Dose | Glipizide Maximum Tolerated Dose | Glyburide Maximum Tolerated Dose | Glimepiride Maximum Tolerated Dose
    Item
    subjects diagnosed with t2dm and treated with metformin equal to or above 1000 mg/day and su (gliclazide, glipizide or glyburide/glibenclamide at maximum tolerated dose (at least half maximum approved dose) or glimepiride at maximum tolerated dose (at least 2 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])
    C0205360 (UMLS CUI [2,3])
    C0456683 (UMLS CUI [2,4])
    C0038766 (UMLS CUI [3,1])
    C0178602 (UMLS CUI [3,2])
    C0205360 (UMLS CUI [3,3])
    C0017631 (UMLS CUI [4,1])
    C0752079 (UMLS CUI [4,2])
    C0017642 (UMLS CUI [5,1])
    C0752079 (UMLS CUI [5,2])
    C0017628 (UMLS CUI [6,1])
    C0752079 (UMLS CUI [6,2])
    C0061323 (UMLS CUI [7,1])
    C0752079 (UMLS CUI [7,2])
    Hemoglobin A1c measurement
    Item
    hba1c 7.0-10.0% (53- 86 mmol/mol) (both inclusive)
    boolean
    C0474680 (UMLS CUI [1])
    Body mass index
    Item
    body mass index (bmi) equal to or above 20 kg/m^2
    boolean
    C1305855 (UMLS CUI [1])
    Intention Fasting Daytime | Counseling Risk Fasting
    Item
    subjects who have expressed their intention to fast (daytime, i.e. between sunrise and sunset) during ramadan after receiving medical counselling regarding the risk of fasting
    boolean
    C0162425 (UMLS CUI [1,1])
    C0015663 (UMLS CUI [1,2])
    C0332169 (UMLS CUI [1,3])
    C0010210 (UMLS CUI [2,1])
    C0035647 (UMLS CUI [2,2])
    C0015663 (UMLS CUI [2,3])
    Item Group
    C0680251 (UMLS CUI)
    Medical contraindication Fasting | Acute illness | Hypoglycemia Severe | Recurrent hypoglycemia | Loss of hypoglycemic warning | Ketoacidosis | Hyperglycemic Hyperosmolar Coma | Exercise With intensity
    Item
    any contraindication for successful and sustained fasting from a medical perspective at the discretion of the investigator (such as acute illness, severe hypoglycaemia within 90 days prior to screening, a history of recurrent hypoglycaemia, hypoglycaemia unawareness, ketoacidosis within 90 days prior to screening, hyperosmolar hyperglycaemic coma within 90 days prior to screening, subjects performing intense physical labour)
    boolean
    C1301624 (UMLS CUI [1,1])
    C0015663 (UMLS CUI [1,2])
    C4061114 (UMLS CUI [2])
    C0020615 (UMLS CUI [3,1])
    C0205082 (UMLS CUI [3,2])
    C1846288 (UMLS CUI [4])
    C0342317 (UMLS CUI [5])
    C0220982 (UMLS CUI [6])
    C0020457 (UMLS CUI [7])
    C0015259 (UMLS CUI [8,1])
    C0522510 (UMLS CUI [8,2])
    Chronic disease compromises Patient safety | Disease Severe compromises Patient safety | Chronic disease compromises Protocol Compliance | Disease Severe compromises Protocol Compliance
    Item
    any chronic disorder or severe disease which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
    boolean
    C0008679 (UMLS CUI [1,1])
    C2945640 (UMLS CUI [1,2])
    C1113679 (UMLS CUI [1,3])
    C0012634 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    C2945640 (UMLS CUI [2,3])
    C1113679 (UMLS CUI [2,4])
    C0008679 (UMLS CUI [3,1])
    C2945640 (UMLS CUI [3,2])
    C0525058 (UMLS CUI [3,3])
    C0012634 (UMLS CUI [4,1])
    C0205082 (UMLS CUI [4,2])
    C2945640 (UMLS CUI [4,3])
    C0525058 (UMLS CUI [4,4])
    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
    Item
    personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2)
    boolean
    C0238462 (UMLS CUI [1])
    C1833921 (UMLS CUI [2])
    C0027662 (UMLS CUI [3,1])
    C0332307 (UMLS CUI [3,2])
    Liver Dysfunction | Alanine aminotransferase increased
    Item
    impaired liver function, defined as alanine aminotransferase (alat) equal to or above 2.5 times upper normal limit (unl)
    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 (egfr) below 60 ml/min/1.73 m^2 per modification of diet in renal disease (mdrd) 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 (tia) 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])
    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])
    Tillbaka till toppen 

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