ID

37308

Beskrivning

Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1); ODM derived from: https://clinicaltrials.gov/show/NCT02227862

Länk

https://clinicaltrials.gov/show/NCT02227862

Nyckelord

Versioner (1)
  1. 2019-07-15 2019-07-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 juli 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 1 Diabetes NCT02227862

Engelsk

Eligibility Type 1 Diabetes NCT02227862

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with an established diagnosis of t1dm per ada 2014 criteria
Beskrivning

Diabetes Mellitus, Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
body mass index (bmi) of 18.5 to 35 kg/m2 at screening (both values inclusive).
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
glycosylated hemoglobin (hba1c) ≤9.5% at screening.
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
hemoglobin ≥9.0 g/dl at screening.
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the trial, or history of significant allergic drug reactions.
Beskrivning

Hypersensitivity Insulin Ingredient | Hypersensitivity Insulin Analogue Ingredient | Drug Allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0021641
UMLS CUI [1,3]
C1550600
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2825028
UMLS CUI [2,3]
C1550600
UMLS CUI [3]
C0013182
history of use of animal insulin within the last 3 years or use of biosimilar insulin glargine at any time prior.
Beskrivning

Animal Insulin | Insulin Glargine Biosimilar

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003062
UMLS CUI [1,2]
C0021641
UMLS CUI [2,1]
C0907402
UMLS CUI [2,2]
C4045974
history of use of a regular immunomodulator therapy in the 1 year prior to screening.
Beskrivning

Immunomodulatory therapy Regular

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1963758
UMLS CUI [1,2]
C0205272
history of ≥2 episodes of severe hypoglycemia within the 6 months before screening or history of hypoglycemia unawareness (a sample questionnaire is provided in appendix i), as judged by the investigator.
Beskrivning

Episode Quantity Hypoglycemia Severe | Loss of hypoglycemic warning

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0020615
UMLS CUI [1,4]
C0205082
UMLS CUI [2]
C0342317
history of ≥1 episodes of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months prior to screening.
Beskrivning

Episode of Diabetic Ketoacidosis | Emergency visit Uncontrolled diabetes mellitus | Hospitalization Due to Uncontrolled diabetes mellitus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0011880
UMLS CUI [2,1]
C0553618
UMLS CUI [2,2]
C0421258
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0421258
serological evidence of human immunodeficiency virus (hiv), hepatitis b (hbsag) or hepatitis c (hcvab) antibodies at screening.
Beskrivning

HIV Seropositivity | Hepatitis B antibody positive | Hepatitis B surface antigen positive | Hepatitis C antibody positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0860013
UMLS CUI [3]
C0149709
UMLS CUI [4]
C0281863
history of drug or alcohol dependence or abuse during the 1 year prior to screening.
Beskrivning

Substance Dependence | Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0038586
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Similar models

Eligibility Type 1 Diabetes NCT02227862

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
patients with an established diagnosis of t1dm per ada 2014 criteria
boolean
C0011854 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) of 18.5 to 35 kg/m2 at screening (both values inclusive).
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
glycosylated hemoglobin (hba1c) ≤9.5% at screening.
boolean
C0474680 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin ≥9.0 g/dl at screening.
boolean
C0518015 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Insulin Ingredient | Hypersensitivity Insulin Analogue Ingredient | Drug Allergy
Item
history of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the trial, or history of significant allergic drug reactions.
boolean
C0020517 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C2825028 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
C0013182 (UMLS CUI [3])
Animal Insulin | Insulin Glargine Biosimilar
Item
history of use of animal insulin within the last 3 years or use of biosimilar insulin glargine at any time prior.
boolean
C0003062 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C0907402 (UMLS CUI [2,1])
C4045974 (UMLS CUI [2,2])
Immunomodulatory therapy Regular
Item
history of use of a regular immunomodulator therapy in the 1 year prior to screening.
boolean
C1963758 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Episode Quantity Hypoglycemia Severe | Loss of hypoglycemic warning
Item
history of ≥2 episodes of severe hypoglycemia within the 6 months before screening or history of hypoglycemia unawareness (a sample questionnaire is provided in appendix i), as judged by the investigator.
boolean
C0332189 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0020615 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0342317 (UMLS CUI [2])
Episode of Diabetic Ketoacidosis | Emergency visit Uncontrolled diabetes mellitus | Hospitalization Due to Uncontrolled diabetes mellitus
Item
history of ≥1 episodes of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months prior to screening.
boolean
C0332189 (UMLS CUI [1,1])
C0011880 (UMLS CUI [1,2])
C0553618 (UMLS CUI [2,1])
C0421258 (UMLS CUI [2,2])
C0019993 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0421258 (UMLS CUI [3,3])
HIV Seropositivity | Hepatitis B antibody positive | Hepatitis B surface antigen positive | Hepatitis C antibody positive
Item
serological evidence of human immunodeficiency virus (hiv), hepatitis b (hbsag) or hepatitis c (hcvab) antibodies at screening.
boolean
C0019699 (UMLS CUI [1])
C0860013 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
C0281863 (UMLS CUI [4])
Substance Dependence | Substance Use Disorders
Item
history of drug or alcohol dependence or abuse during the 1 year prior to screening.
boolean
C0038580 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
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