ID

33700

Description

Pharmacokinetic Single Dose Trial of Empagliflozin in Children and Adolescents With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02121483

Link

https://clinicaltrials.gov/show/NCT02121483

Keywords

Versions (1)
  1. 12/20/18 12/20/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 20, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02121483

English

Eligibility Diabetes Mellitus, Type 2 NCT02121483

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
children and adolescents with type 2 diabetes mellitus
Description

Children | Adolescents | Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2]
C0205653
UMLS CUI [3]
C0011860
insufficient glycaemic control (hba1c =10.5%) despite diet and exercise and/or stable metformin and/or stable basal insulin
Description

Poor glycemic control | Hemoglobin A1c measurement | Diet therapy | Exercise | Metformin Stable | Insulin Basal Stable

Data type

boolean

Alias
UMLS CUI [1]
C0342299
UMLS CUI [2]
C0474680
UMLS CUI [3]
C0012159
UMLS CUI [4]
C0015259
UMLS CUI [5,1]
C0025598
UMLS CUI [5,2]
C0205360
UMLS CUI [6,1]
C0021641
UMLS CUI [6,2]
C0205112
UMLS CUI [6,3]
C0205360
negative for islet cell antigen and glutamic acid decarboxylase autoantibodies and fasting c-peptide levels >= 0.85 ng/ml
Description

Islet Cell Antigen Negative | Glutamic Acid Decarboxylase Antibody Negative | Fasting C-peptide level

Data type

boolean

Alias
UMLS CUI [1,1]
C1522529
UMLS CUI [1,2]
C0003320
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C0443891
UMLS CUI [2,2]
C1513916
UMLS CUI [3]
C2208720
bmi > 50th percentile for age and sex
Description

Body mass index | Age | Gender

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0079399
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled hyperglycaemia with a glucose level > 240 mg/dl (> 13.3 mmol/l)
Description

Hyperglycemia Uncontrolled | Glucose measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0020456
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0337438
history of acute metabolic decompensation such as diabetic ketoacidosis within 3 months before the screening visit with the exception of acute de-compensation at the time of type 2 diabetes diagnosis
Description

Acute metabolic decompensation | Diabetic Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C2673978
UMLS CUI [2]
C0011880
current short-acting insulin or having received short-acting insulin for more than 3 days within 12 weeks prior to randomisation
Description

Insulin, Short-Acting

Data type

boolean

Alias
UMLS CUI [1]
C0356365
treatment with weight reduction medications within 4 weeks before randomisation
Description

Weight-Loss Agents

Data type

boolean

Alias
UMLS CUI [1]
C0376606
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02121483

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Children | Adolescents | Diabetes Mellitus, Non-Insulin-Dependent
Item
children and adolescents with type 2 diabetes mellitus
boolean
C0008059 (UMLS CUI [1])
C0205653 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
Poor glycemic control | Hemoglobin A1c measurement | Diet therapy | Exercise | Metformin Stable | Insulin Basal Stable
Item
insufficient glycaemic control (hba1c =10.5%) despite diet and exercise and/or stable metformin and/or stable basal insulin
boolean
C0342299 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C0012159 (UMLS CUI [3])
C0015259 (UMLS CUI [4])
C0025598 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
C0021641 (UMLS CUI [6,1])
C0205112 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
Islet Cell Antigen Negative | Glutamic Acid Decarboxylase Antibody Negative | Fasting C-peptide level
Item
negative for islet cell antigen and glutamic acid decarboxylase autoantibodies and fasting c-peptide levels >= 0.85 ng/ml
boolean
C1522529 (UMLS CUI [1,1])
C0003320 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0443891 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C2208720 (UMLS CUI [3])
Body mass index | Age | Gender
Item
bmi > 50th percentile for age and sex
boolean
C1305855 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Hyperglycemia Uncontrolled | Glucose measurement
Item
uncontrolled hyperglycaemia with a glucose level > 240 mg/dl (> 13.3 mmol/l)
boolean
C0020456 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0337438 (UMLS CUI [2])
Acute metabolic decompensation | Diabetic Ketoacidosis
Item
history of acute metabolic decompensation such as diabetic ketoacidosis within 3 months before the screening visit with the exception of acute de-compensation at the time of type 2 diabetes diagnosis
boolean
C2673978 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
Insulin, Short-Acting
Item
current short-acting insulin or having received short-acting insulin for more than 3 days within 12 weeks prior to randomisation
boolean
C0356365 (UMLS CUI [1])
Weight-Loss Agents
Item
treatment with weight reduction medications within 4 weeks before randomisation
boolean
C0376606 (UMLS CUI [1])
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