ID

38964

Descrição

Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01850615

Link

https://clinicaltrials.gov/show/NCT01850615

Palavras-chave

Versões (1)
  1. 16/11/2019 16/11/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

16 de novembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes NCT01850615

Inglês

Eligibility Diabetes NCT01850615

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01850615
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes (diagnosed clinically) for at least 6 months prior to the screening visit (visit 1)
Descrição

Non-Insulin-Dependent Diabetes Mellitus Disease length

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
current treatment with once daily insulin detemir, insulin glargine or human isophane insulin, nph for at least 3 months prior to the screening visit (visit 1)
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0537270
UMLS CUI [1,2]
C0439511
UMLS CUI [2,1]
C0907402
UMLS CUI [2,2]
C0439511
UMLS CUI [3,1]
C0021658
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 dipeptidyl peptidase-iv 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
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0442739
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1524031
UMLS CUI [3]
C0009429
UMLS CUI [4]
C0038766
UMLS CUI [5]
C2266929
UMLS CUI [6]
C2917254
UMLS CUI [7]
C1299007
hba1c by central laboratory a) 7.5-9.5% (58 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (visit 1) or b) 7.5-9.0% (58 - 75 mmol/mol) (both inclusive) in the metformin + other oral antidiabetic drug (oad) (sulphonylurea (su), glinide, dipeptidyl peptidase-iv (ddp-iv) inhibitors, alpha-glucosidase inhibitors (agi) combination group at the screening visit (visit 1)
Descrição

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

Tipo de dados

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
body mass index (bmi) equal or less than 40.0 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
any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days of consecutive treatment) and not within 3 months prior to the screening visit (visit 1)
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0240016
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 glucagon-like peptide-1 (glp-1) agonists and/or thiazolidinediones (tzd) within the last 3 months prior to screening (visit 1)
Descrição

GLP-1 Receptor Agonist | Thiazolidinediones

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2917359
UMLS CUI [2]
C1257987
recurrent severe hypoglycaemia (more than one 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)
Descrição

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

Tipo de dados

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
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Similar models

Eligibility Diabetes NCT01850615

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01850615
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes (diagnosed clinically) for at least 6 months prior to the screening visit (visit 1)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
insulin detemir times/day | Insulin Glargine times/day | NPH insulin times/day
Item
current treatment with once daily insulin detemir, insulin glargine or human isophane insulin, nph for at least 3 months prior to the screening visit (visit 1)
boolean
C0537270 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
C0907402 (UMLS CUI [2,1])
C0439511 (UMLS CUI [2,2])
C0021658 (UMLS CUI [3,1])
C0439511 (UMLS CUI [3,2])
Metformin Dose unchanged | Metformin Dose Minimum | 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 dipeptidyl peptidase-iv 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])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1524031 (UMLS CUI [2,3])
C0009429 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C2266929 (UMLS CUI [5])
C2917254 (UMLS CUI [6])
C1299007 (UMLS CUI [7])
Hemoglobin A1c measurement | Metformin | Antidiabetics Oral | Sulfonylurea | Glinide | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors
Item
hba1c by central laboratory a) 7.5-9.5% (58 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (visit 1) or b) 7.5-9.0% (58 - 75 mmol/mol) (both inclusive) in the metformin + other oral antidiabetic drug (oad) (sulphonylurea (su), glinide, dipeptidyl peptidase-iv (ddp-iv) inhibitors, alpha-glucosidase 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])
Body mass index
Item
body mass index (bmi) equal or less than 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Bolus Insulin use | 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 of consecutive treatment) and not within 3 months prior to the screening visit (visit 1)
boolean
C0240016 (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 glucagon-like peptide-1 (glp-1) agonists and/or thiazolidinediones (tzd) 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 one 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])
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