ID

44575

Beschrijving

Effects of Dapagliflozin on the Incretin Sensitivity of the Pancreatic Beta Cell; ODM derived from: https://clinicaltrials.gov/show/NCT02420392

Link

https://clinicaltrials.gov/show/NCT02420392

Trefwoorden

Versies (2)
  1. 21-03-19 21-03-19 -
  2. 27-09-21 27-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

27 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02420392

Engels

Eligibility Diabetes Mellitus, Type 2 NCT02420392

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes for dapagliflozin arm
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | Dapagliflozin Protocol Treatment Arm

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C2353951
UMLS CUI [2,2]
C1522541
normal glucose tolerance (fasting plasma glucose <100 mgd/l, hba1c <6.0%) for normal glucose tolerance arm
Beschrijving

Glucose tolerance test normal | Plasma fasting glucose measurement | Hemoglobin A1c measurement | Glucose tolerance normal Protocol Treatment Arm

Datatype

boolean

Alias
UMLS CUI [1]
C0438251
UMLS CUI [2]
C0583513
UMLS CUI [3]
C0474680
UMLS CUI [4,1]
C0438251
UMLS CUI [4,2]
C1522541
age 18 to 75 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
bmi <35 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
for type 2 diabetes patients, at least 3 months of treatment period and hba1c 7.5 to 11.0% and treatment with lifestyle modification and/or metformin or sulfonylurea
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement | Lifestyle change therapy | Metformin | Sulfonylurea

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0474680
UMLS CUI [3]
C2960841
UMLS CUI [4]
C0025598
UMLS CUI [5]
C0038766
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
who is allergic to dapagliflozin
Beschrijving

Hypersensitivity Dapagliflozin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2353951
type 1 diabetes
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
patients with history of diabetic ketoacidosis
Beschrijving

Diabetic Ketoacidosis

Datatype

boolean

Alias
UMLS CUI [1]
C0011880
reduced renal function (egfr <60ml/min/1.73m2)
Beschrijving

Renal Insufficiency | Estimated Glomerular Filtration Rate

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C3811844
taking loop diuretics or dehydrated patient
Beschrijving

Loop Diuretics | Patient Dehydrated

Datatype

boolean

Alias
UMLS CUI [1]
C0354100
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0011175
history of hypotension when taking hypertensive medication
Beschrijving

Hypotension | Relationship Antihypertensive Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0003364
diagnosed with heart failure
Beschrijving

Heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0018801
diagnosed with cerebral infarction
Beschrijving

Cerebral Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0007785
taking insulin, dpp-4 inhibitor, glp-1 analogue, pioglitazone, alpha-glucosidase inhibitor
Beschrijving

Insulin | DPP-4 Inhibitor | GLP-1 Analogue | pioglitazone | alpha-Glucosidase Inhibitors

Datatype

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C3537225
UMLS CUI [3]
C3273809
UMLS CUI [4]
C0071097
UMLS CUI [5]
C1299007
above upper limit of normal hematocrit range (male 39-52%, female 36-48%)
Beschrijving

Hematocrit increased | Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0239935
UMLS CUI [2]
C0079399
pregnant or breastfeeding women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of recurrent genitourinary infection
Beschrijving

Genitourinary tract infection Recurrent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1279264
UMLS CUI [1,2]
C2945760
ast/alt more than two fold increased above normal upper limit
Beschrijving

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
hemolytic disorder
Beschrijving

Hemolytic disorder

Datatype

boolean

Alias
UMLS CUI [1]
C1263988
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02420392

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Dapagliflozin Protocol Treatment Arm
Item
type 2 diabetes for dapagliflozin arm
boolean
C0011860 (UMLS CUI [1])
C2353951 (UMLS CUI [2,1])
C1522541 (UMLS CUI [2,2])
Glucose tolerance test normal | Plasma fasting glucose measurement | Hemoglobin A1c measurement | Glucose tolerance normal Protocol Treatment Arm
Item
normal glucose tolerance (fasting plasma glucose <100 mgd/l, hba1c <6.0%) for normal glucose tolerance arm
boolean
C0438251 (UMLS CUI [1])
C0583513 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
C0438251 (UMLS CUI [4,1])
C1522541 (UMLS CUI [4,2])
Age
Item
age 18 to 75 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
bmi <35 kg/m2
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement | Lifestyle change therapy | Metformin | Sulfonylurea
Item
for type 2 diabetes patients, at least 3 months of treatment period and hba1c 7.5 to 11.0% and treatment with lifestyle modification and/or metformin or sulfonylurea
boolean
C0011860 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C2960841 (UMLS CUI [3])
C0025598 (UMLS CUI [4])
C0038766 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Dapagliflozin
Item
who is allergic to dapagliflozin
boolean
C0020517 (UMLS CUI [1,1])
C2353951 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Diabetic Ketoacidosis
Item
patients with history of diabetic ketoacidosis
boolean
C0011880 (UMLS CUI [1])
Renal Insufficiency | Estimated Glomerular Filtration Rate
Item
reduced renal function (egfr <60ml/min/1.73m2)
boolean
C1565489 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Loop Diuretics | Patient Dehydrated
Item
taking loop diuretics or dehydrated patient
boolean
C0354100 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0011175 (UMLS CUI [2,2])
Hypotension | Relationship Antihypertensive Agents
Item
history of hypotension when taking hypertensive medication
boolean
C0020649 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0003364 (UMLS CUI [2,2])
Heart failure
Item
diagnosed with heart failure
boolean
C0018801 (UMLS CUI [1])
Cerebral Infarction
Item
diagnosed with cerebral infarction
boolean
C0007785 (UMLS CUI [1])
Insulin | DPP-4 Inhibitor | GLP-1 Analogue | pioglitazone | alpha-Glucosidase Inhibitors
Item
taking insulin, dpp-4 inhibitor, glp-1 analogue, pioglitazone, alpha-glucosidase inhibitor
boolean
C0021641 (UMLS CUI [1])
C3537225 (UMLS CUI [2])
C3273809 (UMLS CUI [3])
C0071097 (UMLS CUI [4])
C1299007 (UMLS CUI [5])
Hematocrit increased | Gender
Item
above upper limit of normal hematocrit range (male 39-52%, female 36-48%)
boolean
C0239935 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Genitourinary tract infection Recurrent
Item
history of recurrent genitourinary infection
boolean
C1279264 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
ast/alt more than two fold increased above normal upper limit
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Hemolytic disorder
Item
hemolytic disorder
boolean
C1263988 (UMLS CUI [1])
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