ID

37352

Beschrijving

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

Trefwoorden

Versies (1)
  1. 20-07-19 20-07-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

20 juli 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02514850

Engels

Eligibility Type 2 Diabetes Mellitus NCT02514850

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatype

boolean

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

Hemoglobin A1c measurement

Datatype

boolean

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

Insulin Total Daily Dose

Datatype

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)
Beschrijving

Body mass index

Datatype

boolean

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

Body Weight

Datatype

boolean

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

Fasting C-peptide level

Datatype

boolean

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

Insulin regime Stable

Datatype

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes mellitus
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

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

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

Datatype

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
Beschrijving

Study Subject Participation Status | Randomization

Datatype

boolean

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

Study Subject Participation Status

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Childbearing Potential Contraceptive methods Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02514850

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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