ID

38961

Descrição

A Trial Comparing the Glycaemic Control of Levemir® Administered Once Daily According to Two Insulin Detemir Titration Algorithms After 20 Weeks in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Treatment With or Without Other Anti-diabetic Drugs (OADs); ODM derived from: https://clinicaltrials.gov/show/NCT01868542

Link

https://clinicaltrials.gov/show/NCT01868542

Palavras-chave

Versões (1)
  1. 15/11/2019 15/11/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

15 de novembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes NCT01868542

Inglês

Eligibility Diabetes NCT01868542

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01868542
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 2 diabetes mellitus at least 3 months prior to visit 1 (week -2)
Descrição

Non-Insulin-Dependent Diabetes Mellitus Disease length

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
treatment with at least 1000 mg metformin per day with/without other oads at a stable dose (at either the maximal tolerated dose or at least half of the maximum recommended dose according to the package insert) for at least 3 months prior to visit 1
Descrição

Metformin U/day | Antidiabetics Oral Dose Stable | Antidiabetics Oral Maximum Tolerated Dose | Antidiabetics Oral Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0456683
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205360
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C0752079
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C1527415
UMLS CUI [4,3]
C0332197
insulin-naïve subjects
Descrição

Insulin Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332197
hba1c above or equal to 7.5% by central laboratory analysis
Descrição

Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) below or equal to 35.0 kg/m^2
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
Descrição

Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential 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]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
the receipt of any investigational product within 4 weeks prior to visit 1
Descrição

Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
any contraindication to insulin detemir according to the domestic labelling
Descrição

Medical contraindication Insulin detemir

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0537270
anticipated change of dose of any systemic treatment with products, which in the investigator's opinion could interfere with glucose metabolism (such as systemic corticosteroids, beta-blockers, monoamine oxidase [mao] inhibitors)
Descrição

Systemic therapy Dose Change | Pharmaceutical Preparations Interfere with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE | Adrenergic beta-1 Receptor Antagonists | Monoamine Oxidase Inhibitors

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0392747
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
clinically significant diseases which, in the investigator's opinion, may confound the results of the trial or pose additional risk in administering trial product
Descrição

Disease Interferes with Research results | Disease Investigational New Drugs At risk

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1444641
any conditions that the investigator judges would interfere with trial participation or evaluation of the results
Descrição

Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
UMLS CUI [2,4]
C0683954
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Similar models

Eligibility Diabetes NCT01868542

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01868542
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosed with type 2 diabetes mellitus at least 3 months prior to visit 1 (week -2)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Metformin U/day | Antidiabetics Oral Dose Stable | Antidiabetics Oral Maximum Tolerated Dose | Antidiabetics Oral Absent
Item
treatment with at least 1000 mg metformin per day with/without other oads at a stable dose (at either the maximal tolerated dose or at least half of the maximum recommended dose according to the package insert) for at least 3 months prior to visit 1
boolean
C0025598 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0752079 (UMLS CUI [3,3])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Insulin Absent
Item
insulin-naïve subjects
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c above or equal to 7.5% by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below or equal to 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential Contraceptive methods Absent
Item
female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Investigational New Drugs
Item
the receipt of any investigational product within 4 weeks prior to visit 1
boolean
C0013230 (UMLS CUI [1])
Medical contraindication Insulin detemir
Item
any contraindication to insulin detemir according to the domestic labelling
boolean
C1301624 (UMLS CUI [1,1])
C0537270 (UMLS CUI [1,2])
Systemic therapy Dose Change | Pharmaceutical Preparations Interfere with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE | Adrenergic beta-1 Receptor Antagonists | Monoamine Oxidase Inhibitors
Item
anticipated change of dose of any systemic treatment with products, which in the investigator's opinion could interfere with glucose metabolism (such as systemic corticosteroids, beta-blockers, monoamine oxidase [mao] inhibitors)
boolean
C1515119 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
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])
Disease Interferes with Research results | Disease Investigational New Drugs At risk
Item
clinically significant diseases which, in the investigator's opinion, may confound the results of the trial or pose additional risk in administering trial product
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results
Item
any conditions that the investigator judges would interfere with trial participation or evaluation of the results
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
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