ID

29218

Beskrivning

Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00613951

Länk

https://clinicaltrials.gov/show/NCT00613951

Nyckelord

Versioner (1)
  1. 2018-03-08 2018-03-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 mars 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes NCT00613951

Engelsk

Eligibility Diabetes NCT00613951

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00613951
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject.)
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximum 14 days within the last 3 months)
Beskrivning

Non-Insulin-Dependent Diabetes Mellitus Disease length | Insulin naive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0919936
treatment with one or two oral anti-diabetic drugs (oads): metformin, sulfonylurea, other insulin secretagogue (e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to locally approved summary of product characteristics (spc)
Beskrivning

Antidiabetics Oral Quantity | Metformin | Sulfonylurea | Insulin Releasing Pills | repaglinide | nateglinide | alpha-Glucosidase Inhibitors Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0025598
UMLS CUI [3]
C0038766
UMLS CUI [4,1]
C0021641
UMLS CUI [4,2]
C1283071
UMLS CUI [4,3]
C0994475
UMLS CUI [5]
C0246689
UMLS CUI [6]
C0903898
UMLS CUI [7,1]
C1299007
UMLS CUI [7,2]
C0178602
UMLS CUI [7,3]
C0205360
hba1c, 7.0-11.0 % (both inclusive)
Beskrivning

Glucohemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202054
body mass index (bmi), 25.0-37.0 kg/m^2 (both inclusive)
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
metformin contraindication according to local practice
Beskrivning

Medical contraindication Metformin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0025598
thiazolidinedione (tzd) treatment within previous 3 months prior to visit 1
Beskrivning

Thiazolidinediones

Datatyp

boolean

Alias
UMLS CUI [1]
C1257987
any systemic treatment with products, which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) within 3 months prior to randomisation
Beskrivning

Systemic therapy Interferes with Glucose metabolism | Systemic therapy Interferes with Lipid Metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0596620
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0598783
UMLS CUI [3]
C3653708
subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the investigator, may confound the results of the trial or pose additional risk in administering trial product
Beskrivning

Disease Clinical Significance Interferes with Research results | Disease Clinical Significance At risk Investigational New Drugs | Gastrointestinal Diseases | Lung diseases | Nervous system disorder | Disorder of the genitourinary system | Hematological Disease | Exception Condition Associated with Non-Insulin-Dependent Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0683954
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2826293
UMLS CUI [2,3]
C1444641
UMLS CUI [2,4]
C0013230
UMLS CUI [3]
C0017178
UMLS CUI [4]
C0024115
UMLS CUI [5]
C0027765
UMLS CUI [6]
C0080276
UMLS CUI [7]
C0018939
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0348080
UMLS CUI [8,3]
C0332281
UMLS CUI [8,4]
C0011860
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Similar models

Eligibility Diabetes NCT00613951

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00613951
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject.)
boolean
C0021430 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length | Insulin naive
Item
insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximum 14 days within the last 3 months)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C0919936 (UMLS CUI [2,2])
Antidiabetics Oral Quantity | Metformin | Sulfonylurea | Insulin Releasing Pills | repaglinide | nateglinide | alpha-Glucosidase Inhibitors Dose Stable
Item
treatment with one or two oral anti-diabetic drugs (oads): metformin, sulfonylurea, other insulin secretagogue (e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to locally approved summary of product characteristics (spc)
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2])
C0038766 (UMLS CUI [3])
C0021641 (UMLS CUI [4,1])
C1283071 (UMLS CUI [4,2])
C0994475 (UMLS CUI [4,3])
C0246689 (UMLS CUI [5])
C0903898 (UMLS CUI [6])
C1299007 (UMLS CUI [7,1])
C0178602 (UMLS CUI [7,2])
C0205360 (UMLS CUI [7,3])
Glucohemoglobin measurement
Item
hba1c, 7.0-11.0 % (both inclusive)
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi), 25.0-37.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Metformin
Item
metformin contraindication according to local practice
boolean
C1301624 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
Thiazolidinediones
Item
thiazolidinedione (tzd) treatment within previous 3 months prior to visit 1
boolean
C1257987 (UMLS CUI [1])
Systemic therapy Interferes with Glucose metabolism | Systemic therapy Interferes with Lipid Metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
any systemic treatment with products, which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) within 3 months prior to randomisation
boolean
C1515119 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
C1515119 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0598783 (UMLS CUI [2,3])
C3653708 (UMLS CUI [3])
Disease Clinical Significance Interferes with Research results | Disease Clinical Significance At risk Investigational New Drugs | Gastrointestinal Diseases | Lung diseases | Nervous system disorder | Disorder of the genitourinary system | Hematological Disease | Exception Condition Associated with Non-Insulin-Dependent Diabetes Mellitus
Item
subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the investigator, may confound the results of the trial or pose additional risk in administering trial product
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0683954 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C0017178 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0080276 (UMLS CUI [6])
C0018939 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C0348080 (UMLS CUI [8,2])
C0332281 (UMLS CUI [8,3])
C0011860 (UMLS CUI [8,4])
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