ID

38960

Description

The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01836523

Link

https://clinicaltrials.gov/show/NCT01836523

Keywords

Versions (1)
  1. 11/15/19 11/15/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 15, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01836523

English

Eligibility Diabetes NCT01836523

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01836523
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
type 1 diabetes mellitus for 12 months or longer
Description

Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
basal bolus or csii (continuous subcutaneous insulin infusion, insulin pump) treatment for 6 months or longer
Description

Basal Bolus | Continuous subcutaneous infusion of insulin | Insulin pump

Data type

boolean

Alias
UMLS CUI [1,1]
C0650607
UMLS CUI [1,2]
C1705509
UMLS CUI [2]
C0393124
UMLS CUI [3]
C1140609
stable insulin treatment for the last 3 months prior to screening, as judged and documented by the investigator
Description

Insulin regime Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0205360
hba1c 7.0-10% (diabetes control and complications trial (dcct)), both inclusive, (corresponding to 53-86 mmol/mol (international federation of clinical chemistry (ifcc))
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, complete trial related questionnaires, diaries, self-monitoring of plasma glucose, self titration of insulin and attend all scheduled visits
Description

Protocol Compliance | Questionnaire Completion | Subject Diary | Plasma Glucose Measurement Self Monitoring | Insulin Titration Self

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0205197
UMLS CUI [3]
C3890583
UMLS CUI [4,1]
C0202042
UMLS CUI [4,2]
C0588436
UMLS CUI [5,1]
C0021641
UMLS CUI [5,2]
C0162621
UMLS CUI [5,3]
C0036588
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior use of glucagon-like peptide-1 (glp-1) receptor agonist or dipeptidyl peptidase iv (dpp-4) inhibitors
Description

GLP-1 Receptor Agonist | Dipeptidyl Peptidase 4 Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C2917359
UMLS CUI [2]
C2917254
use of any medication, which in the investigator's opinion could interfere with the glycaemic control or affect the subject's safety.premix insulin is not allowed
Description

Pharmaceutical Preparation Interferes with Glycaemia control | Pharmaceutical Preparations Affecting Patient safety | Premixed insulin

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C3267174
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C1113679
UMLS CUI [3]
C2069057
known proliferative retinopathy or maculopathy requiring acute treatment
Description

Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0332121
severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator
Description

Neuropathy Severe | Autonomic neuropathy | Gastroparesis

Data type

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0259749
UMLS CUI [3]
C0152020
uncontrolled/ untreated blood pressure at screening above 160 mmhg for systolic or above 100 mmhg for diastolic
Description

Blood Pressure Uncontrolled | Blood Pressure Untreated | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0005823
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
history of acute or chronic pancreatitis
Description

Pancreatitis | Pancreatitis, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
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 or multiple endocrine neoplasia type 2 (men2)
Description

Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of 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
UMLS CUI [4,1]
C4039247
UMLS CUI [4,2]
C0332307
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 NCT01836523

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01836523
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent obtained
boolean
C0021430 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Disease length
Item
type 1 diabetes mellitus for 12 months or longer
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal Bolus | Continuous subcutaneous infusion of insulin | Insulin pump
Item
basal bolus or csii (continuous subcutaneous insulin infusion, insulin pump) treatment for 6 months or longer
boolean
C0650607 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
C0393124 (UMLS CUI [2])
C1140609 (UMLS CUI [3])
Insulin regime Stable
Item
stable insulin treatment for the last 3 months prior to screening, as judged and documented by the investigator
boolean
C0557978 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c 7.0-10% (diabetes control and complications trial (dcct)), both inclusive, (corresponding to 53-86 mmol/mol (international federation of clinical chemistry (ifcc))
boolean
C0474680 (UMLS CUI [1])
Protocol Compliance | Questionnaire Completion | Subject Diary | Plasma Glucose Measurement Self Monitoring | Insulin Titration Self
Item
ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, complete trial related questionnaires, diaries, self-monitoring of plasma glucose, self titration of insulin and attend all scheduled visits
boolean
C0525058 (UMLS CUI [1])
C0034394 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C3890583 (UMLS CUI [3])
C0202042 (UMLS CUI [4,1])
C0588436 (UMLS CUI [4,2])
C0021641 (UMLS CUI [5,1])
C0162621 (UMLS CUI [5,2])
C0036588 (UMLS CUI [5,3])
Item Group
C0680251 (UMLS CUI)
GLP-1 Receptor Agonist | Dipeptidyl Peptidase 4 Inhibitors
Item
prior use of glucagon-like peptide-1 (glp-1) receptor agonist or dipeptidyl peptidase iv (dpp-4) inhibitors
boolean
C2917359 (UMLS CUI [1])
C2917254 (UMLS CUI [2])
Pharmaceutical Preparation Interferes with Glycaemia control | Pharmaceutical Preparations Affecting Patient safety | Premixed insulin
Item
use of any medication, which in the investigator's opinion could interfere with the glycaemic control or affect the subject's safety.premix insulin is not allowed
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C3267174 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C2069057 (UMLS CUI [3])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for
Item
known proliferative retinopathy or maculopathy requiring acute treatment
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Neuropathy Severe | Autonomic neuropathy | Gastroparesis
Item
severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator
boolean
C0442874 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0259749 (UMLS CUI [2])
C0152020 (UMLS CUI [3])
Blood Pressure Uncontrolled | Blood Pressure Untreated | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled/ untreated blood pressure at screening above 160 mmhg for systolic or above 100 mmhg for diastolic
boolean
C0005823 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0005823 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Pancreatitis | Pancreatitis, Chronic
Item
history of acute or chronic pancreatitis
boolean
C0030305 (UMLS CUI [1])
C0149521 (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 | Family history of multiple endocrine neoplasia Type
Item
personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (men2)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C4039247 (UMLS CUI [4,1])
C0332307 (UMLS CUI [4,2])
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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