ID

38898

Descrição

Comparison of Biphasic Insulin Aspart 30 Individually Adjusted by the Subject and the Trial Physician, Both Combined With Metformin in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01427920

Link

https://clinicaltrials.gov/show/NCT01427920

Palavras-chave

Versões (1)
  1. 12/11/2019 12/11/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

12 de novembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes NCT01427920

Inglês

Eligibility Diabetes NCT01427920

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01427920
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 2 diabetes for a minimum of 12 months prior to visit 1 (screening)
Descrição

Non-Insulin-Dependent Diabetes Mellitus Disease length

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
currently treated with a basal insulin analogue for at least 3 months prior to visit 1 (screening)
Descrição

Basal insulin Analogue

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0650607
UMLS CUI [1,2]
C0243071
stable treatment (no change in dose or regimen) with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) ± additional oad treatment. the metformin treatment must have been stable for at least 2 months prior to visit 1 (screening)
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C2986497
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0752079
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C1527415
UMLS CUI [5,1]
C0935929
UMLS CUI [5,2]
C1527415
UMLS CUI [5,3]
C0332197
hba1c higher or equal to 7.0% and below or equal to 10.0% (one re-test within one week of screening visit was allowed. the last sample was to be conclusive)
Descrição

Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474680
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
able and willing to eat at least 2 main meals each day during the trial
Descrição

Meal Main Quantity each day

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C1542147
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0332173
able and willing to adhere to the protocol including compliance with performance of self measured plasma glucose (smpg), injection regimen and titrating themselves according to the protocol
Descrição

Protocol Compliance | Plasma Glucose Measurement Self | Injection therapy | Titration Self

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0202042
UMLS CUI [2,2]
C0036588
UMLS CUI [3]
C0444472
UMLS CUI [4,1]
C0162621
UMLS CUI [4,2]
C0036588
experience in performing self measured plasma glucose (smpg)
Descrição

Experience Plasma Glucose Measurement Self

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0596545
UMLS CUI [1,2]
C0202042
UMLS CUI [1,3]
C0036588
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with any thiazolidinedione (tzd) and glucagon-like peptide-1 (glp-1) receptor agonists or pramlintide within the last 3 months prior to visit 1 (screening)
Descrição

Thiazolidinediones | GLP-1 Receptor Agonist | Pramlintide

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C2917359
UMLS CUI [3]
C0537551
impaired hepatic function defined as alanine aminotransferase (alat) above or equal to 2.5 times upper referenced limit (one re-test within one week of screening visit was allowed. the last sample was to be conclusive)
Descrição

Liver Dysfunction | Alanine aminotransferase increased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
impaired kidney function with serum creatinine above or equal to 133 micromol/l (1.5 mg/dl) for males and above or equal to 124 micromol/l (1.4 mg/dl) for females (one re-test within one week of screening visit was allowed. the last sample was to be conclusive)
Descrição

Renal Insufficiency | Creatinine measurement, serum | Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
cardiac problems or uncontrolled treated/untreated severe hypertension (defined as systolic blood pressure higher or equal to 180 mmhg and/or diastolic blood pressure higher or equal to 100 mmhg)
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0262402
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1868885
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0332155
UMLS CUI [4]
C0871470
UMLS CUI [5]
C0428883
previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations) or bolus insulin. previous use of pre-mixed or bolus insulin products was allowed only in case of hospitalisation or a severe condition requiring intermittent use of pre-mixed or bolus insulin products for less than 14 consecutive days, but not during the last 3 months prior to screening visit (visit 1)
Descrição

Premixed insulin | Premixed insulin Analogue | Premixed Human Insulin | Bolus Insulin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2069057
UMLS CUI [2,1]
C2069057
UMLS CUI [2,2]
C0243071
UMLS CUI [3,1]
C2069057
UMLS CUI [3,2]
C0795635
UMLS CUI [4,1]
C0021641
UMLS CUI [4,2]
C1705509
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Similar models

Eligibility Diabetes NCT01427920

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01427920
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 for a minimum of 12 months prior to visit 1 (screening)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin Analogue
Item
currently treated with a basal insulin analogue for at least 3 months prior to visit 1 (screening)
boolean
C0650607 (UMLS CUI [1,1])
C0243071 (UMLS CUI [1,2])
Treatment Stable | Metformin Cumulative Dose U/day | Metformin Maximum Tolerated Dose | Antidiabetics Oral | Antidiabetics Oral Absent
Item
stable treatment (no change in dose or regimen) with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) ± additional oad treatment. the metformin treatment must have been stable for at least 2 months prior to visit 1 (screening)
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0025598 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0935929 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Hemoglobin A1c measurement
Item
hba1c higher or equal to 7.0% and below or equal to 10.0% (one re-test within one week of screening visit was allowed. the last sample was to be conclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below or equal to 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Meal Main Quantity each day
Item
able and willing to eat at least 2 main meals each day during the trial
boolean
C1998602 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332173 (UMLS CUI [1,4])
Protocol Compliance | Plasma Glucose Measurement Self | Injection therapy | Titration Self
Item
able and willing to adhere to the protocol including compliance with performance of self measured plasma glucose (smpg), injection regimen and titrating themselves according to the protocol
boolean
C0525058 (UMLS CUI [1])
C0202042 (UMLS CUI [2,1])
C0036588 (UMLS CUI [2,2])
C0444472 (UMLS CUI [3])
C0162621 (UMLS CUI [4,1])
C0036588 (UMLS CUI [4,2])
Experience Plasma Glucose Measurement Self
Item
experience in performing self measured plasma glucose (smpg)
boolean
C0596545 (UMLS CUI [1,1])
C0202042 (UMLS CUI [1,2])
C0036588 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Thiazolidinediones | GLP-1 Receptor Agonist | Pramlintide
Item
treatment with any thiazolidinedione (tzd) and glucagon-like peptide-1 (glp-1) receptor agonists or pramlintide within the last 3 months prior to visit 1 (screening)
boolean
C1257987 (UMLS CUI [1])
C2917359 (UMLS CUI [2])
C0537551 (UMLS CUI [3])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired hepatic function defined as alanine aminotransferase (alat) above or equal to 2.5 times upper referenced limit (one re-test within one week of screening visit was allowed. the last sample was to be conclusive)
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Renal Insufficiency | Creatinine measurement, serum | Gender
Item
impaired kidney function with serum creatinine above or equal to 133 micromol/l (1.5 mg/dl) for males and above or equal to 124 micromol/l (1.4 mg/dl) for females (one re-test within one week of screening visit was allowed. the last sample was to be conclusive)
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Cardiac problem | Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe Untreated | Systolic Pressure | Diastolic blood pressure
Item
cardiac problems or uncontrolled treated/untreated severe hypertension (defined as systolic blood pressure higher or equal to 180 mmhg and/or diastolic blood pressure higher or equal to 100 mmhg)
boolean
C0262402 (UMLS CUI [1])
C1868885 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1868885 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0332155 (UMLS CUI [3,3])
C0871470 (UMLS CUI [4])
C0428883 (UMLS CUI [5])
Premixed insulin | Premixed insulin Analogue | Premixed Human Insulin | Bolus Insulin
Item
previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations) or bolus insulin. previous use of pre-mixed or bolus insulin products was allowed only in case of hospitalisation or a severe condition requiring intermittent use of pre-mixed or bolus insulin products for less than 14 consecutive days, but not during the last 3 months prior to screening visit (visit 1)
boolean
C2069057 (UMLS CUI [1])
C2069057 (UMLS CUI [2,1])
C0243071 (UMLS CUI [2,2])
C2069057 (UMLS CUI [3,1])
C0795635 (UMLS CUI [3,2])
C0021641 (UMLS CUI [4,1])
C1705509 (UMLS CUI [4,2])
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