ID

38860

Description

Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01068678

Link

https://clinicaltrials.gov/show/NCT01068678

Keywords

Versions (1)
  1. 11/10/19 11/10/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 10, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01068678

English

Eligibility Diabetes NCT01068678

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01068678
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
insulin naïve subject (allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
Description

Insulin Absent | Insulin short-term allowed | Hospitalization Treatment allowed | Treatment Gestational Diabetes allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0443303
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0683607
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0085207
UMLS CUI [4,3]
C0683607
current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (su) or glinide), dpp-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least three months prior to visit 1 with the minimum doses stated: -metformin: alone or in combination (including fixed combination) 1500 mg daily or maximum tolerated dose (at least 1000 mg daily) -insulin secretaguogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling -dpp-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
Description

Metformin | Combined Modality Therapy | Pills Releasing Insulin | Sulfonylurea | Glinides | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors | Acarbose | Dose unchanged | Dose Minimum U/day | Maximum Tolerated Dose U/day

Data type

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0009429
UMLS CUI [3,1]
C0994475
UMLS CUI [3,2]
C1283071
UMLS CUI [3,3]
C0021641
UMLS CUI [4]
C0038766
UMLS CUI [5]
C3537178
UMLS CUI [6]
C2917254
UMLS CUI [7]
C1299007
UMLS CUI [8]
C0050393
UMLS CUI [9,1]
C0178602
UMLS CUI [9,2]
C0442739
UMLS CUI [10,1]
C0178602
UMLS CUI [10,2]
C1524031
UMLS CUI [10,3]
C0456683
UMLS CUI [11,1]
C0752079
UMLS CUI [11,2]
C0456683
hba1c 7.0-10.0 % (both inclusive) by central laboratory analysis
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) below or equal to 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
use within the last 3 months prior to visit 1 of: thiazoledinediones, exenatide or liraglutide
Description

Thiazolidinediones | exenatide | liraglutide

Data type

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C0167117
UMLS CUI [3]
C1456408
cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Description

Cardiovascular Disease | Cerebrovascular accident | Decompensated cardiac failure New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Angioplasty

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0038454
UMLS CUI [3,1]
C0581377
UMLS CUI [3,2]
C1275491
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0002965
UMLS CUI [6]
C0010055
UMLS CUI [7]
C0162577
uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (hg) and/or diastolic blood pressure at least 100 mmhg)
Description

Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe Untreated | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332155
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for uk: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods)
Description

Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent | Contraceptives, Oral, Hormonal | Injectable contraception | Contraceptive implant | Female Sterilization | Intrauterine Devices | Intrauterine System | Contraception, Barrier

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
UMLS CUI [5]
C0009907
UMLS CUI [6]
C1262153
UMLS CUI [7]
C1657106
UMLS CUI [8]
C0015787
UMLS CUI [9]
C0021900
UMLS CUI [10]
C4293370
UMLS CUI [11]
C0004764
cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)
Description

Malignant Neoplasms | History of cancer | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0455471
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
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Similar models

Eligibility Diabetes NCT01068678

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01068678
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Insulin Absent | Insulin short-term allowed | Hospitalization Treatment allowed | Treatment Gestational Diabetes allowed
Item
insulin naïve subject (allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0019993 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0085207 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Metformin | Combined Modality Therapy | Pills Releasing Insulin | Sulfonylurea | Glinides | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors | Acarbose | Dose unchanged | Dose Minimum U/day | Maximum Tolerated Dose U/day
Item
current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (su) or glinide), dpp-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least three months prior to visit 1 with the minimum doses stated: -metformin: alone or in combination (including fixed combination) 1500 mg daily or maximum tolerated dose (at least 1000 mg daily) -insulin secretaguogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling -dpp-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
boolean
C0025598 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0994475 (UMLS CUI [3,1])
C1283071 (UMLS CUI [3,2])
C0021641 (UMLS CUI [3,3])
C0038766 (UMLS CUI [4])
C3537178 (UMLS CUI [5])
C2917254 (UMLS CUI [6])
C1299007 (UMLS CUI [7])
C0050393 (UMLS CUI [8])
C0178602 (UMLS CUI [9,1])
C0442739 (UMLS CUI [9,2])
C0178602 (UMLS CUI [10,1])
C1524031 (UMLS CUI [10,2])
C0456683 (UMLS CUI [10,3])
C0752079 (UMLS CUI [11,1])
C0456683 (UMLS CUI [11,2])
Hemoglobin A1c measurement
Item
hba1c 7.0-10.0 % (both inclusive) by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below or equal to 45.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Thiazolidinediones | exenatide | liraglutide
Item
use within the last 3 months prior to visit 1 of: thiazoledinediones, exenatide or liraglutide
boolean
C1257987 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C1456408 (UMLS CUI [3])
Cardiovascular Disease | Cerebrovascular accident | Decompensated cardiac failure New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Angioplasty
Item
cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
boolean
C0007222 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0581377 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0010055 (UMLS CUI [6])
C0162577 (UMLS CUI [7])
Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe Untreated | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (hg) and/or diastolic blood pressure at least 100 mmhg)
boolean
C1868885 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C1868885 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent | Contraceptives, Oral, Hormonal | Injectable contraception | Contraceptive implant | Female Sterilization | Intrauterine Devices | Intrauterine System | Contraception, Barrier
Item
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for uk: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods)
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])
C0009907 (UMLS CUI [5])
C1262153 (UMLS CUI [6])
C1657106 (UMLS CUI [7])
C0015787 (UMLS CUI [8])
C0021900 (UMLS CUI [9])
C4293370 (UMLS CUI [10])
C0004764 (UMLS CUI [11])
Malignant Neoplasms | History of cancer | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)
boolean
C0006826 (UMLS CUI [1])
C0455471 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
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