ID

38849

Descrição

Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin; ODM derived from: https://clinicaltrials.gov/show/NCT01046110

Link

https://clinicaltrials.gov/show/NCT01046110

Palavras-chave

Versões (1)
  1. 09/11/2019 09/11/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

9 de novembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes NCT01046110

Inglês

Eligibility Diabetes NCT01046110

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01046110
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes (diagnosed clinically) for at least 6 months
Descrição

Non-Insulin-Dependent Diabetes Mellitus Disease length

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
ongoing treatment with 1 or 2 of the following oads (metformin, insulin secretagogue (sulphonylurea or glinides) or pioglitazone) in any combination with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated: -metformin: alone or in combination (including fixed combination)1500 mg or maximum tolerated dose (at least 1000 mg daily) -insulin secretagogue (sulfonylurea or glinide): minimum half of the maximal daily dose according to local labelling -pioglitazone: minimum half of the maximal daily dose according to local labelling or maximum tolerated dose
Descrição

Antidiabetics Oral Quantity | Metformin | Pills Releasing Insulin | Sulfonylurea | Glinides | pioglitazone | Combined Modality Therapy | Dose unchanged | Metformin Dose | Metformin Maximum Tolerated Dose

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0025598
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]
C0071097
UMLS CUI [7]
C0009429
UMLS CUI [8,1]
C0178602
UMLS CUI [8,2]
C0442739
UMLS CUI [9,1]
C0025598
UMLS CUI [9,2]
C0178602
UMLS CUI [10,1]
C0025598
UMLS CUI [10,2]
C0752079
body mass index (bmi) below or equal to 40.0 kg/m^2
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
hba1c 7.5-11.0 % (both inclusive) by central laboratory analysis
Descrição

Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
use within the last 3 months prior to visit 1 of: exenatide, liraglutide, rosiglitazone or acarbose
Descrição

exenatide | liraglutide | rosiglitazone | Acarbose

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0167117
UMLS CUI [2]
C1456408
UMLS CUI [3]
C0289313
UMLS CUI [4]
C0050393
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
Descrição

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

Tipo de dados

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)
Descrição

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

Tipo de dados

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
recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Descrição

Recurrent severe hypoglycemia | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2]
C0342317
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
C0011880
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
Descrição

Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent

Tipo de dados

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
cancer and medical history hereof (except basal cell skin cancer or squamous cell skin cancer)
Descrição

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

Tipo de dados

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 NCT01046110

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01046110
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes (diagnosed clinically) for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Antidiabetics Oral Quantity | Metformin | Pills Releasing Insulin | Sulfonylurea | Glinides | pioglitazone | Combined Modality Therapy | Dose unchanged | Metformin Dose | Metformin Maximum Tolerated Dose
Item
ongoing treatment with 1 or 2 of the following oads (metformin, insulin secretagogue (sulphonylurea or glinides) or pioglitazone) in any combination with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated: -metformin: alone or in combination (including fixed combination)1500 mg or maximum tolerated dose (at least 1000 mg daily) -insulin secretagogue (sulfonylurea or glinide): minimum half of the maximal daily dose according to local labelling -pioglitazone: minimum half of the maximal daily dose according to local labelling or maximum tolerated dose
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0025598 (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])
C0071097 (UMLS CUI [6])
C0009429 (UMLS CUI [7])
C0178602 (UMLS CUI [8,1])
C0442739 (UMLS CUI [8,2])
C0025598 (UMLS CUI [9,1])
C0178602 (UMLS CUI [9,2])
C0025598 (UMLS CUI [10,1])
C0752079 (UMLS CUI [10,2])
Body mass index
Item
body mass index (bmi) below or equal to 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c 7.5-11.0 % (both inclusive) by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
exenatide | liraglutide | rosiglitazone | Acarbose
Item
use within the last 3 months prior to visit 1 of: exenatide, liraglutide, rosiglitazone or acarbose
boolean
C0167117 (UMLS CUI [1])
C1456408 (UMLS CUI [2])
C0289313 (UMLS CUI [3])
C0050393 (UMLS CUI [4])
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])
Recurrent severe hypoglycemia | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis
Item
recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
C0019993 (UMLS CUI [3,1])
C0011880 (UMLS CUI [3,2])
Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent
Item
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
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])
Malignant Neoplasms | History of cancer | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
cancer and medical history 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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