ID

28976

Description

Active Comparator Study of Generex Oral-lyn™ Spray and Injected Human Insulin; ODM derived from: https://clinicaltrials.gov/show/NCT00668850

Link

https://clinicaltrials.gov/show/NCT00668850

Keywords

Versions (1)
  1. 2/18/18 2/18/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 18, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT00668850

English

Eligibility Diabetes Mellitus NCT00668850

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
be male or female between the ages 18 to 75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
type 1 diabetes mellitus patients (according to ada and/or who classification) who have >1 year history of type 1 dm and are currently managed with daily insulin injections totalling 0.3 to 0.8 iu/kg of body weight;
Description

Insulin-Dependent Diabetes Mellitus ADA Classification | Insulin-Dependent Diabetes Mellitus WHO classification | Insulin-Dependent Diabetes Mellitus Disease length | Insulin injection Dosage Daily

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C1705019
UMLS CUI [1,3]
C0008902
UMLS CUI [2,1]
C0011854
UMLS CUI [2,2]
C4267671
UMLS CUI [3,1]
C0011854
UMLS CUI [3,2]
C0872146
UMLS CUI [4,1]
C0199782
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0332173
current physical examination, vital signs and ecg at screening that reveals no clinically significant abnormalities;
Description

Abnormality Absent Physical Examination | Abnormality Absent Vital signs | Abnormality Absent Electrocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0031809
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0518766
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C1623258
have a body mass index (bmi) <27;
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
8.5% (inclusively)<have a glycosylated haemoglobulin hba1c
Description

ID.5

Data type

boolean

willing and able to follow the american diabetes association diet guidelines for type 1 diabetes; be able to commit to perform home blood glucose monitoring and record values as well as hypoglycemic events
Description

Protocol Compliance Insulin-Dependent Diabetes Mellitus | Blood Glucose Self-Monitoring | Recording Value | Recording Hypoglycemic event

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0011854
UMLS CUI [2]
C0005803
UMLS CUI [3,1]
C0557070
UMLS CUI [3,2]
C1522609
UMLS CUI [4,1]
C0557070
UMLS CUI [4,2]
C0342312
willing to give written informed consent prior to admission into the study.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have a significant active asthma or suspected abnormalities of buccal mucosa; cardiovascular, cerebrovascular, hepatic, renal, gastrointestinal, hematological, or auto-immune disease (other than auto-immune thyroid disease); history of athopy or drugs allergy
Description

Asthma | Buccal mucosa Abnormality Suspected | Cardiovascular Diseases | Cerebrovascular Disorders | Liver diseases | Kidney Diseases | Gastrointestinal Diseases | Hematological Disease | Autoimmune Diseases | Exception Autoimmune thyroid disease | Atopy | Drug Allergy

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C1578559
UMLS CUI [2,2]
C1704258
UMLS CUI [2,3]
C0750491
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0007820
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0017178
UMLS CUI [8]
C0018939
UMLS CUI [9]
C0004364
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0178468
UMLS CUI [11]
C0392707
UMLS CUI [12]
C0013182
have evidence of unstable retinopathy (defined as pre-proliferative or proliferative retinopathy currently requiring photocoagulation therapy), nephropathy or neuropathy (gastroparesis or orthostatic hypotension);
Description

Retinal Disease Unstable | Preproliferative retinopathy Requirement Light Coagulation | Proliferative retinopathy Requirement Light Coagulation | Kidney Diseases | Neuropathy | Gastroparesis | Hypotension, Orthostatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0035309
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0339473
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0023694
UMLS CUI [3,1]
C0339467
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0023694
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0442874
UMLS CUI [6]
C0152020
UMLS CUI [7]
C0020651
have hypoglycemia unawareness;
Description

Loss of hypoglycemic warning

Data type

boolean

Alias
UMLS CUI [1]
C0342317
have had more than one episode of severe hypoglycemia with seizure or coma or ketoacidosis within the past 12 months;
Description

Hypoglycemia Severe Episode Quantity | Seizure | Hypoglycemic coma | Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332189
UMLS CUI [1,4]
C1265611
UMLS CUI [2]
C0036572
UMLS CUI [3]
C0020617
UMLS CUI [4]
C0220982
have a blood pressure in excess of 160/100 mmhg at the screening visit;
Description

Blood Pressure Excess

Data type

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C1979886
have had any acute illness within the 2 weeks prior to screening;
Description

Acute illness

Data type

boolean

Alias
UMLS CUI [1]
C4061114
have a history of drug or alcohol abuse that in the opinion of the investigator would interfere with participation in the protocol
Description

Substance Use Disorder Interferes with Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
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Similar models

Eligibility Diabetes Mellitus NCT00668850

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
be male or female between the ages 18 to 75 years
boolean
C0001779 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus ADA Classification | Insulin-Dependent Diabetes Mellitus WHO classification | Insulin-Dependent Diabetes Mellitus Disease length | Insulin injection Dosage Daily
Item
type 1 diabetes mellitus patients (according to ada and/or who classification) who have >1 year history of type 1 dm and are currently managed with daily insulin injections totalling 0.3 to 0.8 iu/kg of body weight;
boolean
C0011854 (UMLS CUI [1,1])
C1705019 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,3])
C0011854 (UMLS CUI [2,1])
C4267671 (UMLS CUI [2,2])
C0011854 (UMLS CUI [3,1])
C0872146 (UMLS CUI [3,2])
C0199782 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0332173 (UMLS CUI [4,3])
Abnormality Absent Physical Examination | Abnormality Absent Vital signs | Abnormality Absent Electrocardiography
Item
current physical examination, vital signs and ecg at screening that reveals no clinically significant abnormalities;
boolean
C1704258 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0518766 (UMLS CUI [2,3])
C1704258 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1623258 (UMLS CUI [3,3])
Body mass index
Item
have a body mass index (bmi) <27;
boolean
C1305855 (UMLS CUI [1])
ID.5
Item
8.5% (inclusively)<have a glycosylated haemoglobulin hba1c
boolean
Protocol Compliance Insulin-Dependent Diabetes Mellitus | Blood Glucose Self-Monitoring | Recording Value | Recording Hypoglycemic event
Item
willing and able to follow the american diabetes association diet guidelines for type 1 diabetes; be able to commit to perform home blood glucose monitoring and record values as well as hypoglycemic events
boolean
C0525058 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
C0005803 (UMLS CUI [2])
C0557070 (UMLS CUI [3,1])
C1522609 (UMLS CUI [3,2])
C0557070 (UMLS CUI [4,1])
C0342312 (UMLS CUI [4,2])
Informed Consent
Item
willing to give written informed consent prior to admission into the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Asthma | Buccal mucosa Abnormality Suspected | Cardiovascular Diseases | Cerebrovascular Disorders | Liver diseases | Kidney Diseases | Gastrointestinal Diseases | Hematological Disease | Autoimmune Diseases | Exception Autoimmune thyroid disease | Atopy | Drug Allergy
Item
have a significant active asthma or suspected abnormalities of buccal mucosa; cardiovascular, cerebrovascular, hepatic, renal, gastrointestinal, hematological, or auto-immune disease (other than auto-immune thyroid disease); history of athopy or drugs allergy
boolean
C0004096 (UMLS CUI [1])
C1578559 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
C0007222 (UMLS CUI [3])
C0007820 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0017178 (UMLS CUI [7])
C0018939 (UMLS CUI [8])
C0004364 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0178468 (UMLS CUI [10,2])
C0392707 (UMLS CUI [11])
C0013182 (UMLS CUI [12])
Retinal Disease Unstable | Preproliferative retinopathy Requirement Light Coagulation | Proliferative retinopathy Requirement Light Coagulation | Kidney Diseases | Neuropathy | Gastroparesis | Hypotension, Orthostatic
Item
have evidence of unstable retinopathy (defined as pre-proliferative or proliferative retinopathy currently requiring photocoagulation therapy), nephropathy or neuropathy (gastroparesis or orthostatic hypotension);
boolean
C0035309 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0339473 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0023694 (UMLS CUI [2,3])
C0339467 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0023694 (UMLS CUI [3,3])
C0022658 (UMLS CUI [4])
C0442874 (UMLS CUI [5])
C0152020 (UMLS CUI [6])
C0020651 (UMLS CUI [7])
Loss of hypoglycemic warning
Item
have hypoglycemia unawareness;
boolean
C0342317 (UMLS CUI [1])
Hypoglycemia Severe Episode Quantity | Seizure | Hypoglycemic coma | Ketoacidosis
Item
have had more than one episode of severe hypoglycemia with seizure or coma or ketoacidosis within the past 12 months;
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0036572 (UMLS CUI [2])
C0020617 (UMLS CUI [3])
C0220982 (UMLS CUI [4])
Blood Pressure Excess
Item
have a blood pressure in excess of 160/100 mmhg at the screening visit;
boolean
C0005823 (UMLS CUI [1,1])
C1979886 (UMLS CUI [1,2])
Acute illness
Item
have had any acute illness within the 2 weeks prior to screening;
boolean
C4061114 (UMLS CUI [1])
Substance Use Disorder Interferes with Study Subject Participation Status
Item
have a history of drug or alcohol abuse that in the opinion of the investigator would interfere with participation in the protocol
boolean
C0038586 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
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