ID

29219

Description

Comparison of Two NN5401 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00614055

Link

https://clinicaltrials.gov/show/NCT00614055

Keywords

Versions (1)
  1. 3/8/18 3/8/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 8, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT00614055

English

Eligibility Diabetes NCT00614055

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00614055
Inclusion Criteria
Description

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.)
Description

Informed Consent

Data type

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)
Description

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

Data type

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 month at a stable maximum tolerated dose or at least half maximum allowed dose according to locally approved summary of product characteristics (spc)
Description

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

Data type

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)
Description

Glucohemoglobin measurement

Data type

boolean

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

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
metformin contraindication according to local practice
Description

Medical contraindication Metformin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0025598
thiazolidinedione (tzd) treatments within the previous three months prior to visit 1
Description

Thiazolidinediones

Data type

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
Description

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

Data type

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 that, in the opinion of the investigator, may confound the results of the trial or pose additional risk in administering trial product
Description

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

Data type

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
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Similar models

Eligibility Diabetes NCT00614055

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00614055
Name
Type
Description | Question | Decode (Coded Value)
Data type
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 month at a stable maximum tolerated dose or at least half maximum 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) treatments within the previous three 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
Item
subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system 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])
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