ID

28865

Description

A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02501161

Link

https://clinicaltrials.gov/show/NCT02501161

Keywords

  1. 8/31/15 8/31/15 -
  2. 2/8/18 2/8/18 - Julian Varghese
Copyright Holder

ODM derived from: https://clinicaltrials.gov/show/NCT02501161

Uploaded on

February 8, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Diabetes NCT02501161

Eligibility Diabetes NCT02501161

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02501161
Inclusion Criteria
Description

Inclusion Criteria

male or female, age greater than or equal to 18 years at the time of signing informed consent
Description

age greater than or equal to 60 years; informed consent; female; time

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
UMLS CUI [3]
C0682069
subjects diagnosed with type 2 diabetes mellitus
Description

diagnosed with type 2 diabetes mellitus.; patients with type 2 diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011860
hba1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis
Description

laboratory; hba1c; both

Data type

boolean

Alias
UMLS CUI [1]
C0019018
body mass index greater than or equal to 20 kg/m^2
Description

body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
Description

treatment; screening; diabetes; insulin; day

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0919936
stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: a) biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose documented in the subject medical record), b) other oad(s) allowed: sulphonylurea, glinides, pioglitazone, and dpp4-inhibitors (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record)
Description

daily dose; screening; metformin; other; local; drug; day

Data type

boolean

Alias
UMLS CUI [1]
C0935929
Exclusion Criteria
Description

Exclusion Criteria

screening calcitonin greater than or equal to 50 ng/l
Description

calcitonin; screening

Data type

boolean

Alias
UMLS CUI [1]
C0201924
renal impairment estimated glomerular filtration rate (egfr) less than 60 ml/min/1.73 m2 as per ckd-epi value to be defined as listed in the classification ckd-epi using idms for serum creatinine measurement on the day of screening
Description

estimated glomerular filtration rate <45ml/min/1.73m2; serum creatinine measurement; impairment; screening; renal; value; day; per

Data type

boolean

Alias
UMLS CUI [1]
C1565489
impaired liver function, defined as alat or asat greater than or equal to 2.5 times upper limit of normal
Description

normal; liver; upper

Data type

boolean

Alias
UMLS CUI [1]
C0086565
family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
Description

thyroid; family; type

Data type

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2]
C2956727
history of pancreatitis (acute or chronic)
Description

pancreatitis; chronic; acute

Data type

boolean

Alias
UMLS CUI [1]
C0030305
Inclusion Criteria
Description

Inclusion Criteria

anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
Description

concomitant medications; corticosteroids; glucose; thyroid; weight; affect

Data type

boolean

Alias
UMLS CUI [1]
C2347852

Similar models

Eligibility Diabetes NCT02501161

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02501161
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
age greater than or equal to 60 years; informed consent; female; time
Item
male or female, age greater than or equal to 18 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0682069 (UMLS CUI [3])
diagnosed with type 2 diabetes mellitus.; patients with type 2 diabetes
Item
subjects diagnosed with type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
laboratory; hba1c; both
Item
hba1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis
boolean
C0019018 (UMLS CUI [1])
body mass index
Item
body mass index greater than or equal to 20 kg/m^2
boolean
C1305855 (UMLS CUI [1])
treatment; screening; diabetes; insulin; day
Item
insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
boolean
C0021641 (UMLS CUI [1])
C0919936 (UMLS CUI [2])
daily dose; screening; metformin; other; local; drug; day
Item
stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: a) biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose documented in the subject medical record), b) other oad(s) allowed: sulphonylurea, glinides, pioglitazone, and dpp4-inhibitors (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record)
boolean
C0935929 (UMLS CUI [1])
calcitonin; screening
Item
screening calcitonin greater than or equal to 50 ng/l
boolean
C0201924 (UMLS CUI [1])
estimated glomerular filtration rate <45ml/min/1.73m2; serum creatinine measurement; impairment; screening; renal; value; day; per
Item
renal impairment estimated glomerular filtration rate (egfr) less than 60 ml/min/1.73 m2 as per ckd-epi value to be defined as listed in the classification ckd-epi using idms for serum creatinine measurement on the day of screening
boolean
C1565489 (UMLS CUI [1])
normal; liver; upper
Item
impaired liver function, defined as alat or asat greater than or equal to 2.5 times upper limit of normal
boolean
C0086565 (UMLS CUI [1])
thyroid; family; type
Item
family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
boolean
C0238462 (UMLS CUI [1])
C2956727 (UMLS CUI [2])
pancreatitis; chronic; acute
Item
history of pancreatitis (acute or chronic)
boolean
C0030305 (UMLS CUI [1])
concomitant medications; corticosteroids; glucose; thyroid; weight; affect
Item
anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
boolean
C2347852 (UMLS CUI [1])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial