ID

33722

Description

Comparing the Efficacy and Safety of NN1250 Once Daily When Titrated Using 2 Different Algorithms in Insulin naïve Subjects With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01326026

Link

https://clinicaltrials.gov/show/NCT01326026

Keywords

Versions (1)
  1. 12/20/18 12/20/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 20, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01326026

English

Eligibility Diabetes NCT01326026

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01326026
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to randomisation (visit 2)
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other oads including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase iv (dpp-iv) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones (tzds) all with unchanged dosing for at least 12 weeks prior to randomisation (visit 2)-metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily
Description

Metformin | Combined Modality Therapy | Antidiabetics Oral Quantity | Pills Insulin Release | Sulfonylurea | Glinide | DPP-4 Inhibitor | alpha-Glucosidase Inhibitors | Thiazolidinediones | Pharmaceutical Preparations Dose unchanged

Data type

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0009429
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0994475
UMLS CUI [4,2]
C0021641
UMLS CUI [4,3]
C1283071
UMLS CUI [5]
C0038766
UMLS CUI [6]
C2266929
UMLS CUI [7]
C3537225
UMLS CUI [8]
C1299007
UMLS CUI [9]
C1257987
UMLS CUI [10,1]
C0013227
UMLS CUI [10,2]
C0178602
UMLS CUI [10,3]
C0442739
hba1c 7.0-10.0% (both inclusive) by central laboratory analysis
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
bmi (body mass index) no higher than 45.0 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with glucagon-like peptide 1 (glp-1) receptor agonist within the last 12 weeks prior to visit 2
Description

GLP-1 Receptor Agonist

Data type

boolean

Alias
UMLS CUI [1]
C2917359
suffer from a life threatening disease (e.g. cancer)
Description

Life threatening illness | Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C3846017
UMLS CUI [2]
C0006826
females of childbearing potential who are pregnant (as determined by central laboratory beta-human chorionic gonadotropin (beta-hcg), breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods as required by law or practise [for germany, adequate contraceptive methods are: implants, injectables, combined oral contraceptives, hormonal iud, sexual abstinence or vasectomised partner])
Description

Pregnancy Serum pregnancy test (B-HCG) | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Contraceptive implant | Injectable contraception | Combined Oral Contraceptives | Intrauterine Devices, Medicated | Sexual Abstinence | Partner had vasectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0430060
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
UMLS CUI [5]
C1657106
UMLS CUI [6]
C1262153
UMLS CUI [7]
C0009906
UMLS CUI [8]
C0021902
UMLS CUI [9]
C0036899
UMLS CUI [10]
C0420842
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Similar models

Eligibility Diabetes NCT01326026

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01326026
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to randomisation (visit 2)
boolean
C0011860 (UMLS CUI [1])
Metformin | Combined Modality Therapy | Antidiabetics Oral Quantity | Pills Insulin Release | Sulfonylurea | Glinide | DPP-4 Inhibitor | alpha-Glucosidase Inhibitors | Thiazolidinediones | Pharmaceutical Preparations Dose unchanged
Item
current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other oads including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase iv (dpp-iv) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones (tzds) all with unchanged dosing for at least 12 weeks prior to randomisation (visit 2)-metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily
boolean
C0025598 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0994475 (UMLS CUI [4,1])
C0021641 (UMLS CUI [4,2])
C1283071 (UMLS CUI [4,3])
C0038766 (UMLS CUI [5])
C2266929 (UMLS CUI [6])
C3537225 (UMLS CUI [7])
C1299007 (UMLS CUI [8])
C1257987 (UMLS CUI [9])
C0013227 (UMLS CUI [10,1])
C0178602 (UMLS CUI [10,2])
C0442739 (UMLS CUI [10,3])
Hemoglobin A1c measurement
Item
hba1c 7.0-10.0% (both inclusive) by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) no higher than 45.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
GLP-1 Receptor Agonist
Item
treatment with glucagon-like peptide 1 (glp-1) receptor agonist within the last 12 weeks prior to visit 2
boolean
C2917359 (UMLS CUI [1])
Life threatening illness | Malignant Neoplasms
Item
suffer from a life threatening disease (e.g. cancer)
boolean
C3846017 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
Pregnancy Serum pregnancy test (B-HCG) | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Contraceptive implant | Injectable contraception | Combined Oral Contraceptives | Intrauterine Devices, Medicated | Sexual Abstinence | Partner had vasectomy
Item
females of childbearing potential who are pregnant (as determined by central laboratory beta-human chorionic gonadotropin (beta-hcg), breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods as required by law or practise [for germany, adequate contraceptive methods are: implants, injectables, combined oral contraceptives, hormonal iud, sexual abstinence or vasectomised partner])
boolean
C0032961 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C1657106 (UMLS CUI [5])
C1262153 (UMLS CUI [6])
C0009906 (UMLS CUI [7])
C0021902 (UMLS CUI [8])
C0036899 (UMLS CUI [9])
C0420842 (UMLS CUI [10])
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