ID

38885

Beschrijving

Comparison of Two Insulin Degludec Formulations in Subjects With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01364428

Link

https://clinicaltrials.gov/show/NCT01364428

Trefwoorden

Versies (1)
  1. 12-11-19 12-11-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

12 november 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes NCT01364428

Engels

Eligibility Diabetes NCT01364428

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01364428
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes (diagnosed clinically) for minimum 24 weeks prior to randomisation (visit 2)
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
current treatment with basal-only insulin (no prandial insulin) consisting of either insulin detemir once daily (od), insulin glargine od or neutral protamine hagedorn (nph) insulin od/twice daily (bid) for at least 12 weeks prior to randomisation (visit 2), in combination with stable doses of oad(s) (metformin, insulin secretagogue (sulfonylurea or glinide), alpha-glucosidase inhibitor, pioglitazone or dipeptidyl peptidase iv (dpp-iv) inhibitor in any approved (according to label) dose or combination. stable oad doses are defined as unchanged doses for at least 12 weeks prior to randomisation (visit 2)
Beschrijving

Basal insulin | Exception Mealtime Insulin | insulin detemir times per day | Insulin Glargine times per day | NPH insulin times per day | Combined Modality Therapy | Antidiabetics Oral Dose Stable | Metformin | Pills Releasing Insulin | Sulfonylurea | Glinide | alpha-Glucosidase Inhibitors | pioglitazone | Dipeptidyl Peptidase 4 Inhibitors

Datatype

boolean

Alias
UMLS CUI [1]
C0650607
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0587119
UMLS CUI [2,3]
C0021641
UMLS CUI [3,1]
C0537270
UMLS CUI [3,2]
C0439511
UMLS CUI [4,1]
C0907402
UMLS CUI [4,2]
C0439511
UMLS CUI [5,1]
C0021658
UMLS CUI [5,2]
C0439511
UMLS CUI [6]
C0009429
UMLS CUI [7,1]
C0935929
UMLS CUI [7,2]
C1527415
UMLS CUI [7,3]
C0178602
UMLS CUI [7,4]
C0205360
UMLS CUI [8]
C0025598
UMLS CUI [9,1]
C0994475
UMLS CUI [9,2]
C1283071
UMLS CUI [9,3]
C0021641
UMLS CUI [10]
C0038766
UMLS CUI [11]
C2266929
UMLS CUI [12]
C1299007
UMLS CUI [13]
C0071097
UMLS CUI [14]
C2917254
hba1c (glycosylated haemoglobin) between 7.0-10.0% (both inclusive) by central laboratory analysis
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) below or equal to 45 kg/m^2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
ability and willingness to adhere to the protocol including self-measured plasma glucose (smpg) according to the protocol
Beschrijving

Protocol Compliance | Plasma Glucose Measurement Self

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0202042
UMLS CUI [2,2]
C0036588
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with rosiglitazone within the last 12 weeks prior to randomisation (visit 2)
Beschrijving

rosiglitazone

Datatype

boolean

Alias
UMLS CUI [1]
C0289313
treatment with glucagon like peptide-1 (glp-1) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
Beschrijving

GLP-1 Receptor Agonist

Datatype

boolean

Alias
UMLS CUI [1]
C2917359
recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator (trial physician)
Beschrijving

Recurrent severe hypoglycemia | Hypoglycaemic episode Quantity | Loss of hypoglycemic warning

Datatype

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2,1]
C0745153
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0342317
previous participation in this trial. participation is defined as randomised. re-screening is allowed once during the recruitment period
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
known or suspected hypersensitivity to trial products or related products
Beschrijving

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013227
UMLS CUI [4,4]
C0439849
the receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Diabetes NCT01364428

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01364428
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 minimum 24 weeks prior to randomisation (visit 2)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin | Exception Mealtime Insulin | insulin detemir times per day | Insulin Glargine times per day | NPH insulin times per day | Combined Modality Therapy | Antidiabetics Oral Dose Stable | Metformin | Pills Releasing Insulin | Sulfonylurea | Glinide | alpha-Glucosidase Inhibitors | pioglitazone | Dipeptidyl Peptidase 4 Inhibitors
Item
current treatment with basal-only insulin (no prandial insulin) consisting of either insulin detemir once daily (od), insulin glargine od or neutral protamine hagedorn (nph) insulin od/twice daily (bid) for at least 12 weeks prior to randomisation (visit 2), in combination with stable doses of oad(s) (metformin, insulin secretagogue (sulfonylurea or glinide), alpha-glucosidase inhibitor, pioglitazone or dipeptidyl peptidase iv (dpp-iv) inhibitor in any approved (according to label) dose or combination. stable oad doses are defined as unchanged doses for at least 12 weeks prior to randomisation (visit 2)
boolean
C0650607 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0587119 (UMLS CUI [2,2])
C0021641 (UMLS CUI [2,3])
C0537270 (UMLS CUI [3,1])
C0439511 (UMLS CUI [3,2])
C0907402 (UMLS CUI [4,1])
C0439511 (UMLS CUI [4,2])
C0021658 (UMLS CUI [5,1])
C0439511 (UMLS CUI [5,2])
C0009429 (UMLS CUI [6])
C0935929 (UMLS CUI [7,1])
C1527415 (UMLS CUI [7,2])
C0178602 (UMLS CUI [7,3])
C0205360 (UMLS CUI [7,4])
C0025598 (UMLS CUI [8])
C0994475 (UMLS CUI [9,1])
C1283071 (UMLS CUI [9,2])
C0021641 (UMLS CUI [9,3])
C0038766 (UMLS CUI [10])
C2266929 (UMLS CUI [11])
C1299007 (UMLS CUI [12])
C0071097 (UMLS CUI [13])
C2917254 (UMLS CUI [14])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) between 7.0-10.0% (both inclusive) by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below or equal to 45 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Protocol Compliance | Plasma Glucose Measurement Self
Item
ability and willingness to adhere to the protocol including self-measured plasma glucose (smpg) according to the protocol
boolean
C0525058 (UMLS CUI [1])
C0202042 (UMLS CUI [2,1])
C0036588 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
rosiglitazone
Item
treatment with rosiglitazone within the last 12 weeks prior to randomisation (visit 2)
boolean
C0289313 (UMLS CUI [1])
GLP-1 Receptor Agonist
Item
treatment with glucagon like peptide-1 (glp-1) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
boolean
C2917359 (UMLS CUI [1])
Recurrent severe hypoglycemia | Hypoglycaemic episode Quantity | Loss of hypoglycemic warning
Item
recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator (trial physician)
boolean
C0342316 (UMLS CUI [1])
C0745153 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0342317 (UMLS CUI [3])
Study Subject Participation Status
Item
previous participation in this trial. participation is defined as randomised. re-screening is allowed once during the recruitment period
boolean
C2348568 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected hypersensitivity to trial products or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Investigational New Drugs
Item
the receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)
boolean
C0013230 (UMLS CUI [1])
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