ID

38848

Description

Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01045707

Link

https://clinicaltrials.gov/show/NCT01045707

Keywords

Versions (1)
  1. 11/9/19 11/9/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 9, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01045707

English

Eligibility Diabetes NCT01045707

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01045707
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
for main period (nn5401-3590):
Description

Clinical Trial Period Main

Data type

boolean

Alias
UMLS CUI [1,1]
C2347804
UMLS CUI [1,2]
C1542147
diagnosis of type 2 diabetes mellitus for at least 6 months
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
insulin naïve subjects
Description

Insulin Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332197
treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start
Description

Metformin | Antidiabetics Oral Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C1265611
glycosylated haemoglobin (hba1c) between 7.5 - 11.0% (both inclusive)
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) no higher than 40.0 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
for extension period (nn5401-3726):
Description

Extension Period

Data type

boolean

Alias
UMLS CUI [1,1]
C2347804
UMLS CUI [1,2]
C0231448
informed consent obtained before any trial-related activities
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
must have completed the 26-week treatment period (visit 28) in trial nn5401-3590
Description

Treatment completed Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0580352
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
for main period (nn5401-3590):
Description

Clinical Trial Period Main

Data type

boolean

Alias
UMLS CUI [1,1]
C2347804
UMLS CUI [1,2]
C1542147
treatment with glucagon like peptide-1 (glp-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start
Description

GLP-1 Receptor Agonist | Thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1]
C2917359
UMLS CUI [2]
C1257987
cardiovascular disease diagnosed within 6 months before trial start
Description

Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
for extension period (nn5401-3726):
Description

Extension Period

Data type

boolean

Alias
UMLS CUI [1,1]
C2347804
UMLS CUI [1,2]
C0231448
anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, monoamine oxidase (mao) inhibitors
Description

Change of medication Anticipated | Pharmaceutical Preparations Interfere with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE | Adrenergic beta-1 Receptor Antagonists | Monoamine Oxidase Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C0580105
UMLS CUI [1,2]
C3840775
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0596620
UMLS CUI [3]
C3653708
UMLS CUI [4]
C0304516
UMLS CUI [5]
C0026457
anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician)
Description

Lifestyle changes Anticipated | Shift work | Night shift worker Permanent | Evening shift worker Permanent | Eating habits Variation

Data type

boolean

Alias
UMLS CUI [1,1]
C0870811
UMLS CUI [1,2]
C3840775
UMLS CUI [2]
C1658633
UMLS CUI [3,1]
C0555008
UMLS CUI [3,2]
C0205355
UMLS CUI [4,1]
C4316563
UMLS CUI [4,2]
C0205355
UMLS CUI [5,1]
C1266864
UMLS CUI [5,2]
C0205419
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Description

Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
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Similar models

Eligibility Diabetes NCT01045707

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01045707
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Clinical Trial Period Main
Item
for main period (nn5401-3590):
boolean
C2347804 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosis of type 2 diabetes mellitus for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin Absent
Item
insulin naïve subjects
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Metformin | Antidiabetics Oral Quantity
Item
treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start
boolean
C0025598 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Hemoglobin A1c measurement
Item
glycosylated haemoglobin (hba1c) between 7.5 - 11.0% (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) no higher than 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Extension Period
Item
for extension period (nn5401-3726):
boolean
C2347804 (UMLS CUI [1,1])
C0231448 (UMLS CUI [1,2])
Informed Consent
Item
informed consent obtained before any trial-related activities
boolean
C0021430 (UMLS CUI [1])
Treatment completed Clinical Trial Specified
Item
must have completed the 26-week treatment period (visit 28) in trial nn5401-3590
boolean
C0580352 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Clinical Trial Period Main
Item
for main period (nn5401-3590):
boolean
C2347804 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
GLP-1 Receptor Agonist | Thiazolidinediones
Item
treatment with glucagon like peptide-1 (glp-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start
boolean
C2917359 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
Cardiovascular Disease
Item
cardiovascular disease diagnosed within 6 months before trial start
boolean
C0007222 (UMLS CUI [1])
Extension Period
Item
for extension period (nn5401-3726):
boolean
C2347804 (UMLS CUI [1,1])
C0231448 (UMLS CUI [1,2])
Change of medication Anticipated | Pharmaceutical Preparations Interfere with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE | Adrenergic beta-1 Receptor Antagonists | Monoamine Oxidase Inhibitors
Item
anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, monoamine oxidase (mao) inhibitors
boolean
C0580105 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
C3653708 (UMLS CUI [3])
C0304516 (UMLS CUI [4])
C0026457 (UMLS CUI [5])
Lifestyle changes Anticipated | Shift work | Night shift worker Permanent | Evening shift worker Permanent | Eating habits Variation
Item
anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician)
boolean
C0870811 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C1658633 (UMLS CUI [2])
C0555008 (UMLS CUI [3,1])
C0205355 (UMLS CUI [3,2])
C4316563 (UMLS CUI [4,1])
C0205355 (UMLS CUI [4,2])
C1266864 (UMLS CUI [5,1])
C0205419 (UMLS CUI [5,2])
Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent
Item
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
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