ID

37352

Description

A Trial to Compare the Pharmacodynamic and Pharmacokinetic Properties of Biochaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02514850

Link

https://clinicaltrials.gov/show/NCT02514850

Keywords

Versions (1)
  1. 7/20/19 7/20/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 20, 2019

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.

Back to model comments
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 Type 2 Diabetes Mellitus NCT02514850

English

Eligibility Type 2 Diabetes Mellitus NCT02514850

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
hba1c levels ≤ 9.0%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
total insulin dose of < 1.2 u/kg/day
Description

Insulin Total Daily Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C2348070
body mass index between 20.0 and 35.0 kg/m2 (both inclusive)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
body weight ≤ 125.0 kg
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
fasting serum c-peptide ≤ 1 nmol/l
Description

Fasting C-peptide level

Data type

boolean

Alias
UMLS CUI [1]
C2208720
treated with a stable insulin regimen for ≥ 3 months prior to screening
Description

Insulin regime Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
known or suspected allergy to the trial products or related products
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Products Related | Hypersensitivity Suspected Pharmaceutical Products Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013227
UMLS CUI [4,4]
C0439849
previous participation in this trial. participation is defined as randomised
Description

Study Subject Participation Status | Randomization

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0034656
participation in any clinical trial within 3 months prior to this trial
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
clinically significant abnormal haematology, biochemistry, lipids, or urinalysis screening tests, as judged by the investigator considering the underlying disease
Description

Haematology test abnormal considering Primary disorder | Abnormal biochemistry finding considering Primary disorder | Lipids abnormal considering Primary disorder | Urine screening abnormal considering Primary disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C1112712
UMLS CUI [1,2]
C0750591
UMLS CUI [1,3]
C0277554
UMLS CUI [2,1]
C0586680
UMLS CUI [2,2]
C0750591
UMLS CUI [2,3]
C0277554
UMLS CUI [3,1]
C0549634
UMLS CUI [3,2]
C0750591
UMLS CUI [3,3]
C0277554
UMLS CUI [4,1]
C0438142
UMLS CUI [4,2]
C0750591
UMLS CUI [4,3]
C0277554
supine blood pressure at screening outside the range of 90-160 mmhg for systolic or 50-95 mmhg for diastolic and/or resting supine heart rate outside the range 50 -90 beats per minute. this exclusion criterion also pertains to subjects being on antihypertensives
Description

Lying systolic blood pressure | Lying diastolic blood pressure | Heart rate supine resting | Antihypertensive Agents

Data type

boolean

Alias
UMLS CUI [1]
C1319895
UMLS CUI [2]
C1319896
UMLS CUI [3,1]
C3262833
UMLS CUI [3,2]
C0035253
UMLS CUI [4]
C0003364
use of glp-1 receptor agonists or oral antidiabetic drugs (oads) other than stable intake of metformin within 4 weeks prior to screening
Description

GLP-1 Receptor Agonist | Antidiabetics Oral | Exception Metformin Intake Stable

Data type

boolean

Alias
UMLS CUI [1]
C2917359
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0025598
UMLS CUI [3,3]
C1512806
UMLS CUI [3,4]
C0205360
women of child bearing potential, not willing to use contraceptive methods
Description

Childbearing Potential Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
Back to the top of the page

Similar models

Eligibility Type 2 Diabetes Mellitus NCT02514850

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c levels ≤ 9.0%
boolean
C0474680 (UMLS CUI [1])
Insulin Total Daily Dose
Item
total insulin dose of < 1.2 u/kg/day
boolean
C0021641 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
Body mass index
Item
body mass index between 20.0 and 35.0 kg/m2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Body Weight
Item
body weight ≤ 125.0 kg
boolean
C0005910 (UMLS CUI [1])
Fasting C-peptide level
Item
fasting serum c-peptide ≤ 1 nmol/l
boolean
C2208720 (UMLS CUI [1])
Insulin regime Stable
Item
treated with a stable insulin regimen for ≥ 3 months prior to screening
boolean
C0557978 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Products Related | Hypersensitivity Suspected Pharmaceutical Products Related
Item
known or suspected allergy to the trial products or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Study Subject Participation Status | Randomization
Item
previous participation in this trial. participation is defined as randomised
boolean
C2348568 (UMLS CUI [1])
C0034656 (UMLS CUI [2])
Study Subject Participation Status
Item
participation in any clinical trial within 3 months prior to this trial
boolean
C2348568 (UMLS CUI [1])
Haematology test abnormal considering Primary disorder | Abnormal biochemistry finding considering Primary disorder | Lipids abnormal considering Primary disorder | Urine screening abnormal considering Primary disorder
Item
clinically significant abnormal haematology, biochemistry, lipids, or urinalysis screening tests, as judged by the investigator considering the underlying disease
boolean
C1112712 (UMLS CUI [1,1])
C0750591 (UMLS CUI [1,2])
C0277554 (UMLS CUI [1,3])
C0586680 (UMLS CUI [2,1])
C0750591 (UMLS CUI [2,2])
C0277554 (UMLS CUI [2,3])
C0549634 (UMLS CUI [3,1])
C0750591 (UMLS CUI [3,2])
C0277554 (UMLS CUI [3,3])
C0438142 (UMLS CUI [4,1])
C0750591 (UMLS CUI [4,2])
C0277554 (UMLS CUI [4,3])
Lying systolic blood pressure | Lying diastolic blood pressure | Heart rate supine resting | Antihypertensive Agents
Item
supine blood pressure at screening outside the range of 90-160 mmhg for systolic or 50-95 mmhg for diastolic and/or resting supine heart rate outside the range 50 -90 beats per minute. this exclusion criterion also pertains to subjects being on antihypertensives
boolean
C1319895 (UMLS CUI [1])
C1319896 (UMLS CUI [2])
C3262833 (UMLS CUI [3,1])
C0035253 (UMLS CUI [3,2])
C0003364 (UMLS CUI [4])
GLP-1 Receptor Agonist | Antidiabetics Oral | Exception Metformin Intake Stable
Item
use of glp-1 receptor agonists or oral antidiabetic drugs (oads) other than stable intake of metformin within 4 weeks prior to screening
boolean
C2917359 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])
C1512806 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
Childbearing Potential Contraceptive methods Unwilling
Item
women of child bearing potential, not willing to use contraceptive methods
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Back to the top of the page 

Contact

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

Fields marked with * are required.

Help

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