ID

38935

Description

The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01617434

Link

https://clinicaltrials.gov/show/NCT01617434

Keywords

Versions (1)
  1. 11/14/19 11/14/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 14, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01617434

English

Eligibility Diabetes NCT01617434

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01617434
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 2 diabetes for at least 180 days prior to screening and treated with stable basal insulin analogue dose of minimum 20 u/day with or without stable metformin equal to or above 1500 mg/day for at least 8 weeks prior to screening (defined as insulin adjustments less than 10% during the past 8 weeks as assessed by the investigator)
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length | Basal insulin Analogue Dose U/day | Metformin Dose Stable U/day | Metformin Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0650607
UMLS CUI [2,2]
C0243071
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0456683
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [3,4]
C0456683
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C0332197
hba1c (glycosylated haemoglobin a1c) 7.0-10.0% (both inclusive)
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) 20-45 kg/m^2 (both inclusive)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant
Description

Pregnancy | Breast Feeding | Pregnancy intended

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness
Description

Hypoglycaemic episode Severe Recurrent | Loss of hypoglycemic warning

Data type

boolean

Alias
UMLS CUI [1,1]
C0745153
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2945760
UMLS CUI [2]
C0342317
treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to screening
Description

Hypoglycemic Agents | Exception Inclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
impaired liver or renal function
Description

Liver Dysfunction | Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C1565489
uncontrolled treated or untreated hypertension (systolic blood pressure (sbp) equal to or above 180 mmhg and/or diastolic blood pressure (dbp) equal to or above 100 mmhg)
Description

Uncontrolled hypertension Treated | Uncontrolled hypertension Untreated | Systolic Pressure | Diastolic blood pressure

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]
C0871470
UMLS CUI [4]
C0428883
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
known or suspected abuse of alcohol or narcotics
Description

Alcohol abuse | Alcohol abuse Suspected | Narcotic Abuse | Narcotic Abuse Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2,1]
C0085762
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 NCT01617434

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01617434
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length | Basal insulin Analogue Dose U/day | Metformin Dose Stable U/day | Metformin Absent
Item
diagnosed with type 2 diabetes for at least 180 days prior to screening and treated with stable basal insulin analogue dose of minimum 20 u/day with or without stable metformin equal to or above 1500 mg/day for at least 8 weeks prior to screening (defined as insulin adjustments less than 10% during the past 8 weeks as assessed by the investigator)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0650607 (UMLS CUI [2,1])
C0243071 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0456683 (UMLS CUI [3,4])
C0025598 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin a1c) 7.0-10.0% (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) 20-45 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy intended
Item
female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
Hypoglycaemic episode Severe Recurrent | Loss of hypoglycemic warning
Item
recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness
boolean
C0745153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945760 (UMLS CUI [1,3])
C0342317 (UMLS CUI [2])
Hypoglycemic Agents | Exception Inclusion criteria
Item
treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to screening
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
Liver Dysfunction | Renal Insufficiency
Item
impaired liver or renal function
boolean
C0086565 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Uncontrolled hypertension Treated | Uncontrolled hypertension Untreated | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled treated or untreated hypertension (systolic blood pressure (sbp) equal to or above 180 mmhg and/or diastolic blood pressure (dbp) equal to or above 100 mmhg)
boolean
C1868885 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
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])
Alcohol abuse | Alcohol abuse Suspected | Narcotic Abuse | Narcotic Abuse Suspected
Item
known or suspected abuse of alcohol or narcotics
boolean
C0085762 (UMLS CUI [1])
C0085762 (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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