ID

38874

Description

Efficacy and Safety of Basal-bolus Therapy, Comparing Stepwise Addition of Insulin Aspart Versus Complete Basal-bolus Regimen; ODM derived from: https://clinicaltrials.gov/show/NCT01165684

Link

https://clinicaltrials.gov/show/NCT01165684

Keywords

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

See clinicaltrials.gov

Uploaded on

November 11, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01165684

English

Eligibility Diabetes NCT01165684

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01165684
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes (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
basal insulin treatment (nph once or twice daily, insulin glargine once daily or insulin detemir once daily) for at least 6 months
Description

Basal insulin | NPH insulin times per day | Insulin Glargine times per day | insulin detemir times per day

Data type

boolean

Alias
UMLS CUI [1]
C0650607
UMLS CUI [2,1]
C0021658
UMLS CUI [2,2]
C0439511
UMLS CUI [3,1]
C0907402
UMLS CUI [3,2]
C0439511
UMLS CUI [4,1]
C0537270
UMLS CUI [4,2]
C0439511
hba1c: 7.0-9.0 % (both inclusive) by central laboratory analysis (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive)
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
bmi (body mass index) less than 40.0 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous use of pre-mix or bolus insulin (allowed is previous use of bolus insulin only in case of a hospitalisation or a severe condition requiring intermittent use of bolus insulin for less than 14 consecutive days, but not during the last 6 months prior to screening visit (visit 1)
Description

Premixed insulin | Bolus Insulin

Data type

boolean

Alias
UMLS CUI [1]
C2069057
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C1705509
use of glp-1 (glucagon-like peptide-1) receptor agonists or pramlintide within the last 6 months prior to prior to screening visit (visit 1)
Description

GLP-1 Receptor Agonist | Pramlintide

Data type

boolean

Alias
UMLS CUI [1]
C2917359
UMLS CUI [2]
C0537551
anticipated change in concomitant medication known to interfere significantly with glucose metabolism (e.g. systemic corticosteroids, beta-blockers, mao (monoamine oxidase) inhibitors, etc.)
Description

Change of medication Interferes with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE | Adrenergic beta-1 Receptor Antagonists | Monoamine Oxidase Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C0580105
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0596620
UMLS CUI [2]
C3653708
UMLS CUI [3]
C0304516
UMLS CUI [4]
C0026457
cardiovascular disease, within the last 12 months prior to screening visit (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 sitting at least 180 millimetre (mm) mercury (hg) and/or diastolic blood pressure at least 100 mmhg). for argentina: systolic blood pressure sitting at least 150 mmhg and/or diastolic blood pressure at least 90 mmhg
Description

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

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
UMLS CUI [5]
C0003761
impaired liver function, defined as alat (alanine aminotransferase) at least 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive)
Description

Liver Dysfunction | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
impaired renal function defined as serum creatinine above 135 micromol/l (above 1.5 mg/dl) for males and above 110 micromol/l (above 1.2 mg/dl) for females; and, if required by the locally applicable metformin label, glomerular filtration rate below 60 ml/min, calculated by the cockroft & gault formula). one retest within a week is permitted with the result of the last sample being conclusive
Description

Renal Insufficiency | Creatinine measurement, serum | Gender | Estimated Glomerular Filtration Rate Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
UMLS CUI [4,1]
C3811844
UMLS CUI [4,2]
C2924627
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
proliferative retinopathy or maculopathy requiring treatment according to the investigator
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
treatment with oads (oral anti-diabetic drug) contraindicated or unapproved for combination treatment with insulin (according to local oad label)
Description

Medical contraindication Antidiabetics Oral | Combined Modality Therapy Unapproved Insulin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0935929
UMLS CUI [1,3]
C1527415
UMLS CUI [2,1]
C0009429
UMLS CUI [2,2]
C1443286
UMLS CUI [2,3]
C0021641
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Similar models

Eligibility Diabetes NCT01165684

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01165684
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes (diagnosed clinically) for at least 12 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin | NPH insulin times per day | Insulin Glargine times per day | insulin detemir times per day
Item
basal insulin treatment (nph once or twice daily, insulin glargine once daily or insulin detemir once daily) for at least 6 months
boolean
C0650607 (UMLS CUI [1])
C0021658 (UMLS CUI [2,1])
C0439511 (UMLS CUI [2,2])
C0907402 (UMLS CUI [3,1])
C0439511 (UMLS CUI [3,2])
C0537270 (UMLS CUI [4,1])
C0439511 (UMLS CUI [4,2])
Hemoglobin A1c measurement
Item
hba1c: 7.0-9.0 % (both inclusive) by central laboratory analysis (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) less than 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Premixed insulin | Bolus Insulin
Item
previous use of pre-mix or bolus insulin (allowed is previous use of bolus insulin only in case of a hospitalisation or a severe condition requiring intermittent use of bolus insulin for less than 14 consecutive days, but not during the last 6 months prior to screening visit (visit 1)
boolean
C2069057 (UMLS CUI [1])
C0021641 (UMLS CUI [2,1])
C1705509 (UMLS CUI [2,2])
GLP-1 Receptor Agonist | Pramlintide
Item
use of glp-1 (glucagon-like peptide-1) receptor agonists or pramlintide within the last 6 months prior to prior to screening visit (visit 1)
boolean
C2917359 (UMLS CUI [1])
C0537551 (UMLS CUI [2])
Change of medication Interferes with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE | Adrenergic beta-1 Receptor Antagonists | Monoamine Oxidase Inhibitors
Item
anticipated change in concomitant medication known to interfere significantly with glucose metabolism (e.g. systemic corticosteroids, beta-blockers, mao (monoamine oxidase) inhibitors, etc.)
boolean
C0580105 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
C3653708 (UMLS CUI [2])
C0304516 (UMLS CUI [3])
C0026457 (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 12 months prior to screening visit (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 | Argentina
Item
uncontrolled treated/untreated severe hypertension (systolic blood pressure sitting at least 180 millimetre (mm) mercury (hg) and/or diastolic blood pressure at least 100 mmhg). for argentina: systolic blood pressure sitting at least 150 mmhg and/or diastolic blood pressure at least 90 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])
C0003761 (UMLS CUI [5])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired liver function, defined as alat (alanine aminotransferase) at least 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive)
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Renal Insufficiency | Creatinine measurement, serum | Gender | Estimated Glomerular Filtration Rate Cockcroft-Gault formula
Item
impaired renal function defined as serum creatinine above 135 micromol/l (above 1.5 mg/dl) for males and above 110 micromol/l (above 1.2 mg/dl) for females; and, if required by the locally applicable metformin label, glomerular filtration rate below 60 ml/min, calculated by the cockroft & gault formula). one retest within a week is permitted with the result of the last sample being conclusive
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C3811844 (UMLS CUI [4,1])
C2924627 (UMLS CUI [4,2])
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
proliferative retinopathy or maculopathy requiring treatment according to the investigator
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Medical contraindication Antidiabetics Oral | Combined Modality Therapy Unapproved Insulin
Item
treatment with oads (oral anti-diabetic drug) contraindicated or unapproved for combination treatment with insulin (according to local oad label)
boolean
C1301624 (UMLS CUI [1,1])
C0935929 (UMLS CUI [1,2])
C1527415 (UMLS CUI [1,3])
C0009429 (UMLS CUI [2,1])
C1443286 (UMLS CUI [2,2])
C0021641 (UMLS CUI [2,3])
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