ID

38957

Beschrijving

Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01819129

Link

https://clinicaltrials.gov/show/NCT01819129

Trefwoorden

Versies (1)
  1. 15-11-19 15-11-19 -
Houder van rechten

See clinicaltrials.gov

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15 november 2019

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes NCT01819129

Engels

Eligibility Diabetes NCT01819129

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01819129
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes (diagnosed clinically) for 6 months or longer at time of screening (visit 1)
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
treated with basal insulin for at least 6 months prior to screening (visit 1)
Beschrijving

Basal insulin

Datatype

boolean

Alias
UMLS CUI [1]
C0650607
current once daily treatment with insulin nph (neutral protamine hagedorn), insulin detemir or glargine for at least 3 months prior to the screening visit (visit 1)
Beschrijving

NPH insulin times/day | insulin detemir times/day | Insulin Glargine times/day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021658
UMLS CUI [1,2]
C0439511
UMLS CUI [2,1]
C0537270
UMLS CUI [2,2]
C0439511
UMLS CUI [3,1]
C0907402
UMLS CUI [3,2]
C0439511
current treatment with: a. metformin with unchanged dosing for at least 3 months prior to screening (visit 1). the metformin dose must be at least 1000 mg or b. metformin in combination with sulfonylurea (su) or glinide or dpp-iv (dipeptidyl peptidase-4) inhibitors and/or alpha-glucosidase inhibitors (agi) with unchanged dosing for at least 3 months prior to screening (visit 1). the metformin dose must be at least 1000 mg
Beschrijving

Metformin Dose unchanged | Combined Modality Therapy | Sulfonylurea | Glinide | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0442739
UMLS CUI [2]
C0009429
UMLS CUI [3]
C0038766
UMLS CUI [4]
C2266929
UMLS CUI [5]
C2917254
UMLS CUI [6]
C1299007
hba1c by central laboratory: a. 7.0 - 9.5% (53 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (visit 1) or b. 7.0 - 9.0% (53 - 75 mmol/mol) (both inclusive) in the metformin + other oad (oral antidiabetic drug) (su, glinide, ddp-iv inhibitors, agi) combination group at the screening visit (visit 1)
Beschrijving

Hemoglobin A1c measurement | Metformin | Antidiabetics Oral | Sulfonylurea | Glinide | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors | Combined Modality Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2]
C0025598
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [4]
C0038766
UMLS CUI [5]
C2266929
UMLS CUI [6]
C2917254
UMLS CUI [7]
C1299007
UMLS CUI [8]
C0009429
body mass index (bmi) equal to or below 40.0 kg/m^2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days consecutive treatment) and not 3 months prior to the screening visit (visit 1)
Beschrijving

Bolus Insulin | Exception Insulin use short-term | Etiology Comorbidity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C1705509
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0240016
UMLS CUI [2,3]
C0443303
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0009488
use of glp-1 (glucagon-like peptide-1) agonists and/or tzds within the last 3 months prior to screening (visit 1)
Beschrijving

GLP-1 Receptor Agonist | Thiazolidinediones

Datatype

boolean

Alias
UMLS CUI [1]
C2917359
UMLS CUI [2]
C1257987
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 prior to screening (visit 1)
Beschrijving

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

Datatype

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
cardiovascular disease, within the last 6 months prior to screening (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
Beschrijving

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

Datatype

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
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Similar models

Eligibility Diabetes NCT01819129

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01819129
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes (diagnosed clinically) for 6 months or longer at time of screening (visit 1)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin
Item
treated with basal insulin for at least 6 months prior to screening (visit 1)
boolean
C0650607 (UMLS CUI [1])
NPH insulin times/day | insulin detemir times/day | Insulin Glargine times/day
Item
current once daily treatment with insulin nph (neutral protamine hagedorn), insulin detemir or glargine for at least 3 months prior to the screening visit (visit 1)
boolean
C0021658 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
C0537270 (UMLS CUI [2,1])
C0439511 (UMLS CUI [2,2])
C0907402 (UMLS CUI [3,1])
C0439511 (UMLS CUI [3,2])
Metformin Dose unchanged | Combined Modality Therapy | Sulfonylurea | Glinide | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors
Item
current treatment with: a. metformin with unchanged dosing for at least 3 months prior to screening (visit 1). the metformin dose must be at least 1000 mg or b. metformin in combination with sulfonylurea (su) or glinide or dpp-iv (dipeptidyl peptidase-4) inhibitors and/or alpha-glucosidase inhibitors (agi) with unchanged dosing for at least 3 months prior to screening (visit 1). the metformin dose must be at least 1000 mg
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
C0009429 (UMLS CUI [2])
C0038766 (UMLS CUI [3])
C2266929 (UMLS CUI [4])
C2917254 (UMLS CUI [5])
C1299007 (UMLS CUI [6])
Hemoglobin A1c measurement | Metformin | Antidiabetics Oral | Sulfonylurea | Glinide | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors | Combined Modality Therapy
Item
hba1c by central laboratory: a. 7.0 - 9.5% (53 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (visit 1) or b. 7.0 - 9.0% (53 - 75 mmol/mol) (both inclusive) in the metformin + other oad (oral antidiabetic drug) (su, glinide, ddp-iv inhibitors, agi) combination group at the screening visit (visit 1)
boolean
C0474680 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0038766 (UMLS CUI [4])
C2266929 (UMLS CUI [5])
C2917254 (UMLS CUI [6])
C1299007 (UMLS CUI [7])
C0009429 (UMLS CUI [8])
Body mass index
Item
body mass index (bmi) equal to or below 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Bolus Insulin | Exception Insulin use short-term | Etiology Comorbidity
Item
any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days consecutive treatment) and not 3 months prior to the screening visit (visit 1)
boolean
C0021641 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0240016 (UMLS CUI [2,2])
C0443303 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0009488 (UMLS CUI [3,2])
GLP-1 Receptor Agonist | Thiazolidinediones
Item
use of glp-1 (glucagon-like peptide-1) agonists and/or tzds within the last 3 months prior to screening (visit 1)
boolean
C2917359 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
Recurrent severe hypoglycemia | Hypoglycaemic episode Severe Quantity | 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 prior to screening (visit 1)
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])
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 screening (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])
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