ID

17833

Beschreibung

Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult); ODM derived from: https://clinicaltrials.gov/show/NCT00456027

Link

https://clinicaltrials.gov/show/NCT00456027

Stichworte

Versionen (1)
  1. 04.10.16 04.10.16 -
Hochgeladen am

4. Oktober 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Latent Autoimmune Diabetes in Adult (LADA) NCT00456027

Englisch

Eligibility Latent Autoimmune Diabetes in Adult (LADA) NCT00456027

1 Formulare  
Criteria
Beschreibung

Criteria

male and female patients between 30-70 years of age diagnosed with type 2 diabetes within 5 years
Beschreibung

Age | Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011860
presence of gad65 antibodies
Beschreibung

Serum Gad65 Auto Antibodies Test Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1255118
UMLS CUI [1,2]
C1514241
detectable c-peptide level
Beschreibung

C-peptide level Detectable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0202100
UMLS CUI [1,2]
C3830527
patients requiring treatment with diet and/or oral hypoglycaemic agents (oha)
Beschreibung

Diet therapy Patient need for | Oral hypoglycemic Patient need for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012159
UMLS CUI [1,2]
C0686904
UMLS CUI [2,1]
C0359086
UMLS CUI [2,2]
C0686904
written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
key exclusion criteria:
Beschreibung

Exclusion Criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
treatment with insulin
Beschreibung

Insulin regime

Datentyp

boolean

Alias
UMLS CUI [1]
C0557978
intolerance to oha
Beschreibung

intolerance to Oral hypoglycemic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0359086
secondary diabetes mellitus
Beschreibung

Secondary diabetes mellitus

Datentyp

boolean

Alias
UMLS CUI [1]
C0271640
history of certain diseases or conditions (e.g. anaemia, epilepsy, head trauma, neurological disease, alcohol or drug abuse, hiv, hepatitis)
Beschreibung

Disease Any | medical condition Any | Anemia | Epilepsy | Craniocerebral Trauma | nervous system disorder | Substance Use Disorders | HIV | Hepatitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1552551
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1552551
UMLS CUI [3]
C0002871
UMLS CUI [4]
C0014544
UMLS CUI [5]
C0018674
UMLS CUI [6]
C0027765
UMLS CUI [7]
C0038586
UMLS CUI [8]
C0019682
UMLS CUI [9]
C0019158
treatment with any vaccine within one month prior to first diamyd® dose or planned treatment with vaccine up to 2 months after the second diamyd® dose
Beschreibung

Vaccine Any | Glutamate decarboxylase 65 Dose Ordinal number

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1552551
UMLS CUI [2,1]
C1291583
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0439080
participation in other clinical trials with a new chemical entity within the previous 3 months
Beschreibung

Study Subject Participation Status | Chemicals Investigational

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0220806
UMLS CUI [2,2]
C1517586
pregnancy (or planned pregnancy within one year after 2nd administration)
Beschreibung

Pregnancy | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
Beschreibung

Comorbidity Serious Study Subject Participation Status Ineligible | medical condition Serious Study Subject Participation Status Ineligible

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C1512714
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C1512714
significant illness other than diabetes within 2 weeks prior to first dosing
Beschreibung

Illness Significant | Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0011849
unwillingness to comply with the provisions of the protocol
Beschreibung

Protocol Compliance Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
clinically significant history of acute reaction to drugs in the past
Beschreibung

Acute allergic reaction Clinical Significant Pharmaceutical Preparations

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0413234
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0013227
treatment with immunosuppressants
Beschreibung

Immunosuppressive Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0021081
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Ähnliche Modelle

Eligibility Latent Autoimmune Diabetes in Adult (LADA) NCT00456027

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Age | Diabetes Mellitus, Non-Insulin-Dependent
Item
male and female patients between 30-70 years of age diagnosed with type 2 diabetes within 5 years
boolean
C0001779 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Serum Gad65 Auto Antibodies Test Positive
Item
presence of gad65 antibodies
boolean
C1255118 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C-peptide level Detectable
Item
detectable c-peptide level
boolean
C0202100 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
Diet therapy Patient need for | Oral hypoglycemic Patient need for
Item
patients requiring treatment with diet and/or oral hypoglycaemic agents (oha)
boolean
C0012159 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0359086 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Insulin regime
Item
treatment with insulin
boolean
C0557978 (UMLS CUI [1])
intolerance to Oral hypoglycemic
Item
intolerance to oha
boolean
C1744706 (UMLS CUI [1,1])
C0359086 (UMLS CUI [1,2])
Secondary diabetes mellitus
Item
secondary diabetes mellitus
boolean
C0271640 (UMLS CUI [1])
Disease Any | medical condition Any | Anemia | Epilepsy | Craniocerebral Trauma | nervous system disorder | Substance Use Disorders | HIV | Hepatitis
Item
history of certain diseases or conditions (e.g. anaemia, epilepsy, head trauma, neurological disease, alcohol or drug abuse, hiv, hepatitis)
boolean
C0012634 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
C0002871 (UMLS CUI [3])
C0014544 (UMLS CUI [4])
C0018674 (UMLS CUI [5])
C0027765 (UMLS CUI [6])
C0038586 (UMLS CUI [7])
C0019682 (UMLS CUI [8])
C0019158 (UMLS CUI [9])
Vaccine Any | Glutamate decarboxylase 65 Dose Ordinal number
Item
treatment with any vaccine within one month prior to first diamyd® dose or planned treatment with vaccine up to 2 months after the second diamyd® dose
boolean
C0042210 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1291583 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0439080 (UMLS CUI [2,3])
Study Subject Participation Status | Chemicals Investigational
Item
participation in other clinical trials with a new chemical entity within the previous 3 months
boolean
C2348568 (UMLS CUI [1])
C0220806 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Pregnancy | Pregnancy, Planned
Item
pregnancy (or planned pregnancy within one year after 2nd administration)
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Comorbidity Serious Study Subject Participation Status Ineligible | medical condition Serious Study Subject Participation Status Ineligible
Item
presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1512714 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1512714 (UMLS CUI [2,4])
Illness Significant | Diabetes Mellitus
Item
significant illness other than diabetes within 2 weeks prior to first dosing
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
Protocol Compliance Unwilling
Item
unwillingness to comply with the provisions of the protocol
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Acute allergic reaction Clinical Significant Pharmaceutical Preparations
Item
clinically significant history of acute reaction to drugs in the past
boolean
C0413234 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Immunosuppressive Agents
Item
treatment with immunosuppressants
boolean
C0021081 (UMLS CUI [1])
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