ID

35789

Description

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

Link

https://clinicaltrials.gov/show/NCT01917656

Keywords

Versions (2)
  1. 3/23/19 3/23/19 -
  2. 3/23/19 3/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01917656

English

Eligibility Diabetes NCT01917656

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01917656
Inclusion Criteria
Description

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
Description

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

Data type

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)
Description

Hemoglobin A1c measurement

Data type

boolean

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

Body mass index

Data type

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
Description

Intention Fasting Daytime | Counseling Risk Fasting

Data type

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
Description

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)
Description

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

Data type

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
Description

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

Data type

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
Description

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Data type

boolean

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

Calcitonin measurement

Data type

boolean

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

Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type

Data type

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)
Description

Liver Dysfunction | Alanine aminotransferase increased

Data type

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)
Description

Renal Insufficiency | Renal function GFR estimation by MDRD

Data type

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
Description

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

Data type

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)
Description

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

Data type

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
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Similar models

Eligibility Diabetes NCT01917656

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01917656
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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