ID

38925

Description

Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01541215

Link

https://clinicaltrials.gov/show/NCT01541215

Keywords

Versions (1)
  1. 11/13/19 11/13/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 13, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01541215

English

Eligibility Diabetes NCT01541215

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01541215
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
children and adolescents between the ages of 10-16 years. subjects cannot turn 17 years and 11 months before the end of treatment (52 weeks)
Description

Children | Adolescents | Age

Data type

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2]
C0205653
UMLS CUI [3]
C0001779
diagnosis of type 2 diabetes mellitus and treated for at least 30 days with: diet and exercise alone, diet and exercise in combination with metformin monotherapy, diet and exercise in combination with metformin and a stable (stable is defined as basal insulin adjustments up to 15%) dose of basal insulin, diet and exercise in combination with a stable (stable is defined as basal insulin adjustments up to 15%) dose of basal insulin
Description

Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Combined Modality Therapy | Metformin | Basal insulin Dose Stable

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0205360
hba1c: 7.0-11% (inclusive) if diet and exercise treated or 6.5-11% (inclusive) if treated with metformin as monotherapy, basal insulin as monotherapy or metformin and basal insulin in combination
Description

Hemoglobin A1c measurement | Diet therapy | Exercise | Metformin | Basal insulin | Combined Modality Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0015259
UMLS CUI [4]
C0025598
UMLS CUI [5]
C0650607
UMLS CUI [6]
C0009429
body mass index (bmi) above 85% percentile of the general age and gender matched population
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
type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
maturity onset diabetes of the young (mody)
Description

Maturity onset diabetes mellitus in young

Data type

boolean

Alias
UMLS CUI [1]
C0342276
use of any antidiabetic agent other than metformin and/or basal insulin within 90 days prior to screening
Description

Antidiabetics | Exception Metformin | Exception Basal insulin

Data type

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0650607
recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
Description

Recurrent severe hypoglycemia | Loss of hypoglycemic warning

Data type

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2]
C0342317
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
any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial
Description

Disease Interferes with Research results | Exception Condition Associated with Non-Insulin-Dependent Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0348080
UMLS CUI [2,3]
C0332281
UMLS CUI [2,4]
C0011860
uncontrolled hypertension, treated or untreated above 99th percentile for age and gender in children
Description

Uncontrolled hypertension Treated | Uncontrolled hypertension Untreated | Age Children | Gender Children

Data type

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C0001779
UMLS CUI [3,2]
C0008059
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0008059
known or suspected abuse of alcohol or drugs/narcotics
Description

Substance Use Disorders | Substance Use Disorders Suspected | Narcotic Abuse | Narcotic Abuse Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0038586
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0524661
UMLS CUI [4,1]
C0524661
UMLS CUI [4,2]
C0750491
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Similar models

Eligibility Diabetes NCT01541215

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01541215
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Children | Adolescents | Age
Item
children and adolescents between the ages of 10-16 years. subjects cannot turn 17 years and 11 months before the end of treatment (52 weeks)
boolean
C0008059 (UMLS CUI [1])
C0205653 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Combined Modality Therapy | Metformin | Basal insulin Dose Stable
Item
diagnosis of type 2 diabetes mellitus and treated for at least 30 days with: diet and exercise alone, diet and exercise in combination with metformin monotherapy, diet and exercise in combination with metformin and a stable (stable is defined as basal insulin adjustments up to 15%) dose of basal insulin, diet and exercise in combination with a stable (stable is defined as basal insulin adjustments up to 15%) dose of basal insulin
boolean
C0011860 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Hemoglobin A1c measurement | Diet therapy | Exercise | Metformin | Basal insulin | Combined Modality Therapy
Item
hba1c: 7.0-11% (inclusive) if diet and exercise treated or 6.5-11% (inclusive) if treated with metformin as monotherapy, basal insulin as monotherapy or metformin and basal insulin in combination
boolean
C0474680 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C0025598 (UMLS CUI [4])
C0650607 (UMLS CUI [5])
C0009429 (UMLS CUI [6])
Body mass index | Age | Gender
Item
body mass index (bmi) above 85% percentile of the general age and gender matched population
boolean
C1305855 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Maturity onset diabetes mellitus in young
Item
maturity onset diabetes of the young (mody)
boolean
C0342276 (UMLS CUI [1])
Antidiabetics | Exception Metformin | Exception Basal insulin
Item
use of any antidiabetic agent other than metformin and/or basal insulin within 90 days prior to screening
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0650607 (UMLS CUI [3,2])
Recurrent severe hypoglycemia | Loss of hypoglycemic warning
Item
recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic pancreatitis or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
Disease Interferes with Research results | Exception Condition Associated with Non-Insulin-Dependent Diabetes Mellitus
Item
any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C0332281 (UMLS CUI [2,3])
C0011860 (UMLS CUI [2,4])
Uncontrolled hypertension Treated | Uncontrolled hypertension Untreated | Age Children | Gender Children
Item
uncontrolled hypertension, treated or untreated above 99th percentile for age and gender in children
boolean
C1868885 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3,1])
C0008059 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0008059 (UMLS CUI [4,2])
Substance Use Disorders | Substance Use Disorders Suspected | Narcotic Abuse | Narcotic Abuse Suspected
Item
known or suspected abuse of alcohol or drugs/narcotics
boolean
C0038586 (UMLS CUI [1])
C0038586 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0524661 (UMLS CUI [3])
C0524661 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
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