ID

38889

Description

Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens; ODM derived from: https://clinicaltrials.gov/show/NCT01365507

Link

https://clinicaltrials.gov/show/NCT01365507

Keywords

Versions (1)
  1. 11/12/19 11/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 12, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01365507

English

Eligibility Diabetes NCT01365507

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01365507
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes (diagnosed clinically) for 24 weeks or longer prior to randomisation (visit 2)
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
insulin naïve subjects (allowed are: previous short term insulin treatment no longer than or equal to 14 days in total; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days in total)
Description

Insulin Absent | Insulin regime short-term allowed | Treatment Hospitalization allowed | Treatment Gestational Diabetes allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0443303
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0019993
UMLS CUI [3,3]
C0683607
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0085207
UMLS CUI [4,3]
C0683607
current treatment: metformin alone or metformin in any combination of 1 or 2 additional oads (oral anti-diabetic drug) including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase iv (dpp-iv) inhibitors, alpha-glucosidase inhibitors or thiazolidinediones (tzds) - all with unchanged dosing for at least 12 weeks prior to randomisation (visit 2). metformin dose, alone or in combination (including fixed combination), must be at least 1000 mg daily
Description

Metformin | Combined Modality Therapy | Antidiabetics Oral | Pills Releasing Insulin | Sulfonylurea | Glinide | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors | Thiazolidinediones | Pharmaceutical Preparations Dose unchanged

Data type

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0009429
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [4,1]
C0994475
UMLS CUI [4,2]
C1283071
UMLS CUI [4,3]
C0021641
UMLS CUI [5]
C0038766
UMLS CUI [6]
C2266929
UMLS CUI [7]
C2917254
UMLS CUI [8]
C1299007
UMLS CUI [9]
C1257987
UMLS CUI [10,1]
C0013227
UMLS CUI [10,2]
C0178602
UMLS CUI [10,3]
C0442739
hba1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive)
Description

Hemoglobin A1c measurement

Data type

boolean

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

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
ability and willingness to adhere to the protocol including self measurement of plasma glucose
Description

Protocol Compliance | Plasma Glucose Measurement Self

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with glp-1 (glucagon like peptide) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
Description

GLP-1 Receptor Agonist

Data type

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)
Description

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

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
previous participation in this trial. participation is defined as randomised. re-screening is allowed once during the recruitment period
Description

Study Subject Participation Status

Data type

boolean

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

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

Data type

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)
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
anticipated significant lifestyle changes during the study, e.g. shift work (including permanent night/evening shift workers) as well as highly variable eating habits
Description

Lifestyle changes Anticipated | Shift work | Night shift worker Permanent | Evening shift worker Permanent | Eating habit Variation

Data type

boolean

Alias
UMLS CUI [1,1]
C0870811
UMLS CUI [1,2]
C3840775
UMLS CUI [2]
C1658633
UMLS CUI [3,1]
C0555008
UMLS CUI [3,2]
C0205355
UMLS CUI [4,1]
C4316563
UMLS CUI [4,2]
C0205355
UMLS CUI [5,1]
C1266864
UMLS CUI [5,2]
C0205419
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Similar models

Eligibility Diabetes NCT01365507

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01365507
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 24 weeks or longer prior to randomisation (visit 2)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin Absent | Insulin regime short-term allowed | Treatment Hospitalization allowed | Treatment Gestational Diabetes allowed
Item
insulin naïve subjects (allowed are: previous short term insulin treatment no longer than or equal to 14 days in total; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days in total)
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0019993 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0085207 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Metformin | Combined Modality Therapy | Antidiabetics Oral | Pills Releasing Insulin | Sulfonylurea | Glinide | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors | Thiazolidinediones | Pharmaceutical Preparations Dose unchanged
Item
current treatment: metformin alone or metformin in any combination of 1 or 2 additional oads (oral anti-diabetic drug) including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase iv (dpp-iv) inhibitors, alpha-glucosidase inhibitors or thiazolidinediones (tzds) - all with unchanged dosing for at least 12 weeks prior to randomisation (visit 2). metformin dose, alone or in combination (including fixed combination), must be at least 1000 mg daily
boolean
C0025598 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0994475 (UMLS CUI [4,1])
C1283071 (UMLS CUI [4,2])
C0021641 (UMLS CUI [4,3])
C0038766 (UMLS CUI [5])
C2266929 (UMLS CUI [6])
C2917254 (UMLS CUI [7])
C1299007 (UMLS CUI [8])
C1257987 (UMLS CUI [9])
C0013227 (UMLS CUI [10,1])
C0178602 (UMLS CUI [10,2])
C0442739 (UMLS CUI [10,3])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) 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 measurement of plasma glucose
boolean
C0525058 (UMLS CUI [1])
C0202042 (UMLS CUI [2,1])
C0036588 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
GLP-1 Receptor Agonist
Item
treatment with glp-1 (glucagon like peptide) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
boolean
C2917359 (UMLS CUI [1])
Recurrent severe hypoglycemia | Hypoglycaemic episode Severe 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])
C0205082 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
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])
Lifestyle changes Anticipated | Shift work | Night shift worker Permanent | Evening shift worker Permanent | Eating habit Variation
Item
anticipated significant lifestyle changes during the study, e.g. shift work (including permanent night/evening shift workers) as well as highly variable eating habits
boolean
C0870811 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C1658633 (UMLS CUI [2])
C0555008 (UMLS CUI [3,1])
C0205355 (UMLS CUI [3,2])
C4316563 (UMLS CUI [4,1])
C0205355 (UMLS CUI [4,2])
C1266864 (UMLS CUI [5,1])
C0205419 (UMLS CUI [5,2])
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