ID

37303

Description

Postprandial Blood Glucose Control With BioChaperone® Combo and Insulin Lispro (Humalog®) Mix 25 in People With Type 1 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02514954

Link

https://clinicaltrials.gov/show/NCT02514954

Keywords

Versions (1)
  1. 7/15/19 7/15/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 15, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 1 Diabetes Mellitus NCT02514954

English

Eligibility Type 1 Diabetes Mellitus NCT02514954

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes mellitus (as diagnosed clinically) >= 12 months.
Description

Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
treated with multiple daily insulin injections or csii >= 12 months.
Description

Insulin injection multiple daily | Continuous subcutaneous infusion of insulin

Data type

boolean

Alias
UMLS CUI [1,1]
C0199782
UMLS CUI [1,2]
C0439064
UMLS CUI [1,3]
C0332173
UMLS CUI [2]
C0393124
current total daily insulin treatment < 1.2 (i)u/kg/day.
Description

Insulin Total Daily Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C2348070
current total daily bolus insulin treatment < 0.7 (i)u/kg/day.
Description

Bolus Insulin Daily

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C1705509
UMLS CUI [1,3]
C0332173
usual insulin bolus dose between 0.8 and 2 (i)u per 10 g ch (both inclusive). expecting prandial insulin dose range for standardised meal test between 5 and 12 (i)u.
Description

Bolus Insulin | Insulin Dose During meal

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C1705509
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0587120
bmi 18.5-28.0 kg/m^2 (both inclusive).
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
hba1c <= 9.0% by local laboratory analysis
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
fasting c-peptide <= 0.3 nmol/l.
Description

Fasting C-peptide level

Data type

boolean

Alias
UMLS CUI [1]
C2208720
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected hypersensitivity to trial products or related products.
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations 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
type 2 diabetes mellitus.
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
previous participation in this trial. participation is defined as randomised.
Description

Study Subject Participation Status | Subject is Randomized

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3815594
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 | Abnormal biochemistry finding | Lipids abnormal | Urine screening abnormal

Data type

boolean

Alias
UMLS CUI [1]
C1112712
UMLS CUI [2]
C0586680
UMLS CUI [3]
C0549634
UMLS CUI [4]
C0438142
presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the investigator.
Description

Gastrointestinal symptom Clinical Significance | Nausea | Vomiting | Heartburn | Diarrhea

Data type

boolean

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0027497
UMLS CUI [3]
C0042963
UMLS CUI [4]
C0018834
UMLS CUI [5]
C0011991
known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption.
Description

Delayed gastric emptying Changing Gastrointestinal Motility | Delayed gastric emptying Changing Food absorption | Gastrointestinal Surgical Procedure Changing Gastrointestinal Motility | Gastrointestinal Surgical Procedure Changing Food absorption

Data type

boolean

Alias
UMLS CUI [1,1]
C0740411
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0017184
UMLS CUI [2,1]
C0740411
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0699842
UMLS CUI [3,1]
C0524722
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0017184
UMLS CUI [4,1]
C0524722
UMLS CUI [4,2]
C0392747
UMLS CUI [4,3]
C0699842
unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial.
Description

Eating habit Unusual | Special diet Requirement | Clinical Trial Food Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C1266864
UMLS CUI [1,2]
C2700116
UMLS CUI [2,1]
C0184626
UMLS CUI [2,2]
C1514873
UMLS CUI [3,1]
C0008976
UMLS CUI [3,2]
C0016452
UMLS CUI [3,3]
C0558080
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
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Similar models

Eligibility Type 1 Diabetes Mellitus NCT02514954

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Disease length
Item
type 1 diabetes mellitus (as diagnosed clinically) >= 12 months.
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin injection multiple daily | Continuous subcutaneous infusion of insulin
Item
treated with multiple daily insulin injections or csii >= 12 months.
boolean
C0199782 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0393124 (UMLS CUI [2])
Insulin Total Daily Dose
Item
current total daily insulin treatment < 1.2 (i)u/kg/day.
boolean
C0021641 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
Bolus Insulin Daily
Item
current total daily bolus insulin treatment < 0.7 (i)u/kg/day.
boolean
C0021641 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
Bolus Insulin | Insulin Dose During meal
Item
usual insulin bolus dose between 0.8 and 2 (i)u per 10 g ch (both inclusive). expecting prandial insulin dose range for standardised meal test between 5 and 12 (i)u.
boolean
C0021641 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0587120 (UMLS CUI [2,3])
Body mass index
Item
bmi 18.5-28.0 kg/m^2 (both inclusive).
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c <= 9.0% by local laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Fasting C-peptide level
Item
fasting c-peptide <= 0.3 nmol/l.
boolean
C2208720 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected hypersensitivity to 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])
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes mellitus.
boolean
C0011860 (UMLS CUI [1])
Study Subject Participation Status | Subject is Randomized
Item
previous participation in this trial. participation is defined as randomised.
boolean
C2348568 (UMLS CUI [1])
C3815594 (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 | Abnormal biochemistry finding | Lipids abnormal | Urine screening abnormal
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])
C0586680 (UMLS CUI [2])
C0549634 (UMLS CUI [3])
C0438142 (UMLS CUI [4])
Gastrointestinal symptom Clinical Significance | Nausea | Vomiting | Heartburn | Diarrhea
Item
presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the investigator.
boolean
C0426576 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0027497 (UMLS CUI [2])
C0042963 (UMLS CUI [3])
C0018834 (UMLS CUI [4])
C0011991 (UMLS CUI [5])
Delayed gastric emptying Changing Gastrointestinal Motility | Delayed gastric emptying Changing Food absorption | Gastrointestinal Surgical Procedure Changing Gastrointestinal Motility | Gastrointestinal Surgical Procedure Changing Food absorption
Item
known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption.
boolean
C0740411 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0017184 (UMLS CUI [1,3])
C0740411 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0699842 (UMLS CUI [2,3])
C0524722 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0017184 (UMLS CUI [3,3])
C0524722 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C0699842 (UMLS CUI [4,3])
Eating habit Unusual | Special diet Requirement | Clinical Trial Food Unwilling
Item
unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial.
boolean
C1266864 (UMLS CUI [1,1])
C2700116 (UMLS CUI [1,2])
C0184626 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0008976 (UMLS CUI [3,1])
C0016452 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
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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