ID

42160

Beschrijving

Liraglutide and Insulin Therapy in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01392898

Link

https://clinicaltrials.gov/show/NCT01392898

Trefwoorden

Versies (2)
  1. 13-03-16 13-03-16 -
  2. 13-04-21 13-04-21 - Dr. rer. medic Philipp Neuhaus
Geüploaded op

13 april 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT01392898

Engels

Eligibility Type 2 Diabetes Mellitus NCT01392898

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with type 2 diabetes mellitus on short-term insulin therapy (≤ 12 months); all types of insulin allowed
Beschrijving

diabetes mellitus type 2; insulin therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0441730
UMLS CUI [2]
C0557978
documented insulin-associated weight gain ≥ 3.0 kg from the start of insulin therapy until inclusion
Beschrijving

weight gain; insulin therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0043094
UMLS CUI [2]
C0557978
age 18-75 years
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
bmi ≥ 25 kg/m2
Beschrijving

bmi

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
stable glycaemic control mirrored by hba1c ≥ 6.5 and ≤ 8.5 %
Beschrijving

hba1c

Datatype

boolean

Alias
UMLS CUI [1]
C0019018
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability to provide informed consent
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
type 1 diabetes mellitus, mody diabetes, or lada diabetes (presence of anti-gad)
Beschrijving

Diabetes type 1; mody diabetes; lada diabetes

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0441729
UMLS CUI [2]
C0342276
UMLS CUI [3]
C1960272
presence of any medical condition that might interfere with the current study protocol.
Beschrijving

Compliance behavior Limited Comorbidity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
inflammatory bowel disease (e.g. m. crohn, ulcerative colitis)
Beschrijving

inflammatory bowel disease; Crohn Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C0010346
recurrent hypoglycaemic events
Beschrijving

hypoglycaemic event recurrent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C2945760
diabetic gastroparesis
Beschrijving

diabetic gastroparesis

Datatype

boolean

Alias
UMLS CUI [1]
C0267176
heart failure (lvef ≤ 30%)
Beschrijving

lvef ; heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0018801
use of tzds (glitazones), ddp-iv (dipeptidylpeptidase-inhibitor)
Beschrijving

Thiazolidinediones

Datatype

boolean

Alias
UMLS CUI [1]
C1257987
use of medication associated with impaired glucose metabolism including corticosteroids
Beschrijving

Adverse reaction to drug; glucose metabolism; corticosteroids

Datatype

boolean

Alias
UMLS CUI [1]
C0041755
UMLS CUI [2]
C0596620
UMLS CUI [3]
C0001617
pregnancy or breast-feeding (contraception of at least 3 months before inclusion is required for fertile women)
Beschrijving

pregnancy; lactating

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
pre-existing thyroid disease
Beschrijving

thyroid disease

Datatype

boolean

Alias
UMLS CUI [1]
C0040128
liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range)
Beschrijving

liver disease; aspartate aminotransferase level; alanine aminotransferase level

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0428339
UMLS CUI [2,2]
C1272112
renal disease (creatinine > 130 µmol/l or mdrd-gfr <30 ml/min/1.73m2)
Beschrijving

renal disease; creatinine

Datatype

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0201975
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT01392898

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
diabetes mellitus type 2; insulin therapy
Item
patients with type 2 diabetes mellitus on short-term insulin therapy (≤ 12 months); all types of insulin allowed
boolean
C0011849 (UMLS CUI [1,1])
C0441730 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2])
weight gain; insulin therapy
Item
documented insulin-associated weight gain ≥ 3.0 kg from the start of insulin therapy until inclusion
boolean
C0043094 (UMLS CUI [1])
C0557978 (UMLS CUI [2])
age
Item
age 18-75 years
boolean
C0001779 (UMLS CUI [1])
bmi
Item
bmi ≥ 25 kg/m2
boolean
C1305855 (UMLS CUI [1])
hba1c
Item
stable glycaemic control mirrored by hba1c ≥ 6.5 and ≤ 8.5 %
boolean
C0019018 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
informed consent
Item
inability to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Diabetes type 1; mody diabetes; lada diabetes
Item
type 1 diabetes mellitus, mody diabetes, or lada diabetes (presence of anti-gad)
boolean
C0011849 (UMLS CUI [1,1])
C0441729 (UMLS CUI [1,2])
C0342276 (UMLS CUI [2])
C1960272 (UMLS CUI [3])
Compliance behavior Limited Comorbidity
Item
presence of any medical condition that might interfere with the current study protocol.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
inflammatory bowel disease; Crohn Disease
Item
inflammatory bowel disease (e.g. m. crohn, ulcerative colitis)
boolean
C0021390 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
hypoglycaemic event recurrent
Item
recurrent hypoglycaemic events
boolean
C0342312 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
diabetic gastroparesis
Item
diabetic gastroparesis
boolean
C0267176 (UMLS CUI [1])
lvef ; heart failure
Item
heart failure (lvef ≤ 30%)
boolean
C0428772 (UMLS CUI [1])
C0018801 (UMLS CUI [2])
Thiazolidinediones
Item
use of tzds (glitazones), ddp-iv (dipeptidylpeptidase-inhibitor)
boolean
C1257987 (UMLS CUI [1])
Adverse reaction to drug; glucose metabolism; corticosteroids
Item
use of medication associated with impaired glucose metabolism including corticosteroids
boolean
C0041755 (UMLS CUI [1])
C0596620 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
pregnancy; lactating
Item
pregnancy or breast-feeding (contraception of at least 3 months before inclusion is required for fertile women)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
thyroid disease
Item
pre-existing thyroid disease
boolean
C0040128 (UMLS CUI [1])
liver disease; aspartate aminotransferase level; alanine aminotransferase level
Item
liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range)
boolean
C0023895 (UMLS CUI [1])
C0428339 (UMLS CUI [2,1])
C1272112 (UMLS CUI [2,2])
renal disease; creatinine
Item
renal disease (creatinine > 130 µmol/l or mdrd-gfr <30 ml/min/1.73m2)
boolean
C0022658 (UMLS CUI [1])
C0201975 (UMLS CUI [2])
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