ID

38941

Description

Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01618214

Link

https://clinicaltrials.gov/show/NCT01618214

Keywords

Versions (1)
  1. 11/14/19 11/14/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 14, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01618214

English

Eligibility Diabetes NCT01618214

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01618214
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
type 2 diabetes mellitus (diagnosed clinically) for at least 12 months
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
currently treated with premixed/self-mixed human insulin (proportion of short-acting insulin is equal to or lower than 30%) bid (twice daily) combined with metformin with or without alpha-glucosidase inhibitor for at least 3 months prior to screening visit (visit 1) with the minimum dose stated: metformin: at least 1500 mg/day or maximum tolerated dose at least 1000 mg/day (with unchanged dosing within 3 months prior to visit 1) or alpha-glucosidase inhibitors: acarbose or miglitol at least 150 mg/day, or voglibose at least 0.6 mg/day
Description

Premixed insulin times per day | Human Insulin Mixed Self times per day | Short-Acting Insulin Percentage | Combined Modality Therapy | Metformin | alpha-Glucosidase Inhibitors | alpha-Glucosidase Inhibitors Absent | Metformin Dose U/day | Metformin Maximum Tolerated Dose | Acarbose U/day | Miglitol U/day | Voglibose U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C2069057
UMLS CUI [1,2]
C0439511
UMLS CUI [2,1]
C0795635
UMLS CUI [2,2]
C0205430
UMLS CUI [2,3]
C0036588
UMLS CUI [2,4]
C0439511
UMLS CUI [3,1]
C0356365
UMLS CUI [3,2]
C0439165
UMLS CUI [4]
C0009429
UMLS CUI [5]
C0025598
UMLS CUI [6]
C1299007
UMLS CUI [7,1]
C1299007
UMLS CUI [7,2]
C0332197
UMLS CUI [8,1]
C0025598
UMLS CUI [8,2]
C0178602
UMLS CUI [8,3]
C0456683
UMLS CUI [9,1]
C0025598
UMLS CUI [9,2]
C0752079
UMLS CUI [10,1]
C0050393
UMLS CUI [10,2]
C0456683
UMLS CUI [11,1]
C0066535
UMLS CUI [11,2]
C0456683
UMLS CUI [12,1]
C0532578
UMLS CUI [12,2]
C0456683
total daily insulin dose below 1.4 iu/kg
Description

Insulin Cumulative Dose U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C2986497
UMLS CUI [1,3]
C0456683
hba1c above or equal to 7.0% and below or equal to 9.5% (central laboratory)
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) below or equal to 35.0 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 any insulin secretagogue, thiazolidinedione (tzd), dipeptidyl peptidase-4 (dpp-4) inhibitors and glucagon-like peptide-1 (glp-1) receptor agonists within the last 3 months prior to visit 1
Description

Pills Releasing Insulin | Thiazolidinediones | Dipeptidyl Peptidase 4 Inhibitors | GLP-1 Receptor Agonist

Data type

boolean

Alias
UMLS CUI [1,1]
C0994475
UMLS CUI [1,2]
C1283071
UMLS CUI [1,3]
C0021641
UMLS CUI [2]
C1257987
UMLS CUI [3]
C2917254
UMLS CUI [4]
C2917359
previous use of insulin intensification treatment (premixed insulin thrice daily, basal bolus regimen, and continuous subcutaneous insulin infusion (csii)) for more than 14 days
Description

Insulin Intensification therapy | Premixed insulin times per day | Basal insulin Bolus | Continuous subcutaneous infusion of insulin

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C1511484
UMLS CUI [2,1]
C2069057
UMLS CUI [2,2]
C0439511
UMLS CUI [3,1]
C0650607
UMLS CUI [3,2]
C1705509
UMLS CUI [4]
C0393124
previous use of any insulin other than premixed/self-mixed human insulin (proportion of short acting insulin equal to or lower than 30%) bid within 3 month prior to visit 1
Description

Insulin use times per day Previous | Exception Premixed insulin | Exception Human Insulin Self Mixed | Exception Short-Acting Insulin Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0240016
UMLS CUI [1,2]
C0439511
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2069057
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0795635
UMLS CUI [3,3]
C0205430
UMLS CUI [3,4]
C0036588
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0356365
UMLS CUI [4,3]
C0439165
recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Description

Recurrent severe hypoglycemia | Hypoglycaemic episode Severe Quantity | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2,1]
C0745153
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0342317
UMLS CUI [4,1]
C0019993
UMLS CUI [4,2]
C0011880
known proliferative retinopathy or maculopathy requiring treatment
Description

Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0332121
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Similar models

Eligibility Diabetes NCT01618214

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01618214
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
boolean
C0021430 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus (diagnosed clinically) for at least 12 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Premixed insulin times per day | Human Insulin Mixed Self times per day | Short-Acting Insulin Percentage | Combined Modality Therapy | Metformin | alpha-Glucosidase Inhibitors | alpha-Glucosidase Inhibitors Absent | Metformin Dose U/day | Metformin Maximum Tolerated Dose | Acarbose U/day | Miglitol U/day | Voglibose U/day
Item
currently treated with premixed/self-mixed human insulin (proportion of short-acting insulin is equal to or lower than 30%) bid (twice daily) combined with metformin with or without alpha-glucosidase inhibitor for at least 3 months prior to screening visit (visit 1) with the minimum dose stated: metformin: at least 1500 mg/day or maximum tolerated dose at least 1000 mg/day (with unchanged dosing within 3 months prior to visit 1) or alpha-glucosidase inhibitors: acarbose or miglitol at least 150 mg/day, or voglibose at least 0.6 mg/day
boolean
C2069057 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
C0795635 (UMLS CUI [2,1])
C0205430 (UMLS CUI [2,2])
C0036588 (UMLS CUI [2,3])
C0439511 (UMLS CUI [2,4])
C0356365 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0009429 (UMLS CUI [4])
C0025598 (UMLS CUI [5])
C1299007 (UMLS CUI [6])
C1299007 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0025598 (UMLS CUI [8,1])
C0178602 (UMLS CUI [8,2])
C0456683 (UMLS CUI [8,3])
C0025598 (UMLS CUI [9,1])
C0752079 (UMLS CUI [9,2])
C0050393 (UMLS CUI [10,1])
C0456683 (UMLS CUI [10,2])
C0066535 (UMLS CUI [11,1])
C0456683 (UMLS CUI [11,2])
C0532578 (UMLS CUI [12,1])
C0456683 (UMLS CUI [12,2])
Insulin Cumulative Dose U/day
Item
total daily insulin dose below 1.4 iu/kg
boolean
C0021641 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Hemoglobin A1c measurement
Item
hba1c above or equal to 7.0% and below or equal to 9.5% (central laboratory)
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)
Pills Releasing Insulin | Thiazolidinediones | Dipeptidyl Peptidase 4 Inhibitors | GLP-1 Receptor Agonist
Item
treatment with any insulin secretagogue, thiazolidinedione (tzd), dipeptidyl peptidase-4 (dpp-4) inhibitors and glucagon-like peptide-1 (glp-1) receptor agonists within the last 3 months prior to visit 1
boolean
C0994475 (UMLS CUI [1,1])
C1283071 (UMLS CUI [1,2])
C0021641 (UMLS CUI [1,3])
C1257987 (UMLS CUI [2])
C2917254 (UMLS CUI [3])
C2917359 (UMLS CUI [4])
Insulin Intensification therapy | Premixed insulin times per day | Basal insulin Bolus | Continuous subcutaneous infusion of insulin
Item
previous use of insulin intensification treatment (premixed insulin thrice daily, basal bolus regimen, and continuous subcutaneous insulin infusion (csii)) for more than 14 days
boolean
C0021641 (UMLS CUI [1,1])
C1511484 (UMLS CUI [1,2])
C2069057 (UMLS CUI [2,1])
C0439511 (UMLS CUI [2,2])
C0650607 (UMLS CUI [3,1])
C1705509 (UMLS CUI [3,2])
C0393124 (UMLS CUI [4])
Insulin use times per day Previous | Exception Premixed insulin | Exception Human Insulin Self Mixed | Exception Short-Acting Insulin Percentage
Item
previous use of any insulin other than premixed/self-mixed human insulin (proportion of short acting insulin equal to or lower than 30%) bid within 3 month prior to visit 1
boolean
C0240016 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C2069057 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0795635 (UMLS CUI [3,2])
C0205430 (UMLS CUI [3,3])
C0036588 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0356365 (UMLS CUI [4,2])
C0439165 (UMLS CUI [4,3])
Recurrent severe hypoglycemia | Hypoglycaemic episode Severe Quantity | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis
Item
recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, 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])
C0745153 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0342317 (UMLS CUI [3])
C0019993 (UMLS CUI [4,1])
C0011880 (UMLS CUI [4,2])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for
Item
known proliferative retinopathy or maculopathy requiring treatment
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
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