ID

16068

Description

Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00034255

Link

https://clinicaltrials.gov/show/NCT00034255

Keywords

Versions (1)
  1. 6/27/16 6/27/16 -
Uploaded on

June 27, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT00034255

English

Eligibility Diabetes Mellitus, Type 1 NCT00034255

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients meeting all of the following inclusion criteria at screening can be considered for admission to the study.
Description

inclusion criteria

Data type

boolean

stage 1 and stage 2:
Description

stage 1 and stage 2:

Data type

boolean

1. male and female patients with, type 1 diabetes mellitus that are 18 through 70 years of age, or type 2 diabetes mellitus that are 30 through 70 years of age.
Description

age and diabetes type

Data type

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0011854
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C0011860
2. patients who are insulin deficient and are diagnosed with type 1 or type 2 diabetes mellitus, and are currently well managed with insulin, with or without metformin.
Description

insulin deficient patients currently well managed

Data type

boolean

Alias
UMLS CUI [1,1]
C1850546
UMLS CUI [1,2]
C2732401
UMLS CUI [2]
C2733147
3. patients who have been on stable doses of insulin treatment for 90 days prior to study randomization.
Description

stable insulin dose

Data type

boolean

Alias
UMLS CUI [1,1]
C1990777
UMLS CUI [1,2]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients meeting any of the following exclusion criteria at screening will not be enrolled in the study:
Description

ID.6

Data type

boolean

1. patients with a history of any clinically significant retinopathy, symptomatic autonomic neuropathy, unstable angina, or kidney problems.
Description

comorbidities

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0035309
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0442874
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0002965
UMLS CUI [4,1]
C0262926
UMLS CUI [4,2]
C0022658
2. patients with an uncontrolled or untreated significant pulmonary, neurological condition, or cardiovascular disease, including hypertension, congestive heart failure, angina, or peripheral vascular disease.
Description

pulmonary, neurological or cardiovascular disease

Data type

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0027765
UMLS CUI [3]
C0007222
3. patients who have received any investigational product within 30 days of admission into the study.
Description

received any investigational product

Data type

boolean

Alias
UMLS CUI [1]
C2348568
4. patients with a history or clinical evidence of multiple organ autoimmune disorders.
Description

medical history of autoimmune disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0004364
5. patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
Description

medical condition decreasing study compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
6. patients who are lactating and breastfeeding.
Description

breastfeeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00034255

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
inclusion criteria
Item
patients meeting all of the following inclusion criteria at screening can be considered for admission to the study.
boolean
stage 1 and stage 2:
Item
stage 1 and stage 2:
boolean
age and diabetes type
Item
1. male and female patients with, type 1 diabetes mellitus that are 18 through 70 years of age, or type 2 diabetes mellitus that are 30 through 70 years of age.
boolean
C0001779 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
insulin deficient patients currently well managed
Item
2. patients who are insulin deficient and are diagnosed with type 1 or type 2 diabetes mellitus, and are currently well managed with insulin, with or without metformin.
boolean
C1850546 (UMLS CUI [1,1])
C2732401 (UMLS CUI [1,2])
C2733147 (UMLS CUI [2])
stable insulin dose
Item
3. patients who have been on stable doses of insulin treatment for 90 days prior to study randomization.
boolean
C1990777 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
ID.6
Item
patients meeting any of the following exclusion criteria at screening will not be enrolled in the study:
boolean
comorbidities
Item
1. patients with a history of any clinically significant retinopathy, symptomatic autonomic neuropathy, unstable angina, or kidney problems.
boolean
C0262926 (UMLS CUI [1,1])
C0035309 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0442874 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0002965 (UMLS CUI [3,2])
C0262926 (UMLS CUI [4,1])
C0022658 (UMLS CUI [4,2])
pulmonary, neurological or cardiovascular disease
Item
2. patients with an uncontrolled or untreated significant pulmonary, neurological condition, or cardiovascular disease, including hypertension, congestive heart failure, angina, or peripheral vascular disease.
boolean
C0024115 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
received any investigational product
Item
3. patients who have received any investigational product within 30 days of admission into the study.
boolean
C2348568 (UMLS CUI [1])
medical history of autoimmune disorders
Item
4. patients with a history or clinical evidence of multiple organ autoimmune disorders.
boolean
C0262926 (UMLS CUI [1,1])
C0004364 (UMLS CUI [1,2])
medical condition decreasing study compliance
Item
5. patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
breastfeeding
Item
6. patients who are lactating and breastfeeding.
boolean
C0006147 (UMLS CUI [1])
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