ID

38947

Description

Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine; ODM derived from: https://clinicaltrials.gov/show/NCT01680341

Link

https://clinicaltrials.gov/show/NCT01680341

Keywords

Versions (1)
  1. 11/15/19 11/15/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 15, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01680341

English

Eligibility Diabetes NCT01680341

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01680341
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
- - type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to visit 2 (randomisation)
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
- - currently treated with iglar (insulin glargine) and up to 3 oral antidiabetic drugs (oads) (metformin, dpp-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase inhibitor). all antidiabetic treatments should have been ongoing for at least 12 weeks prior to visit 2 (randomisation) and doses should have been stable in this period of time
Description

Insulin Glargine | Antidiabetics Oral Quantity | Metformin | Dipeptidyl Peptidase 4 Inhibitors | Sulfonylurea | Glinide | alpha-Glucosidase Inhibitors | Diabetes Therapy Dose Stable

Data type

boolean

Alias
UMLS CUI [1]
C0907402
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0025598
UMLS CUI [4]
C2917254
UMLS CUI [5]
C0038766
UMLS CUI [6]
C2266929
UMLS CUI [7]
C1299007
UMLS CUI [8,1]
C3274787
UMLS CUI [8,2]
C0178602
UMLS CUI [8,3]
C0205360
- - glycosylated haemoglobin (hba1c) 7.0-10.0% (both inclusive) by central laboratory analysis
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
- - body mass index (bmi) below or equal to 40 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

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

GLP-1 Receptor Agonist | Thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1]
C2917359
UMLS CUI [2]
C1257987
- - stroke; heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 24 weeks prior to visit 2 (randomisation)
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0010055
UMLS CUI [6]
C0162577
- - uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 180 mmhg and/or diastolic blood pressure above or equal to 100 mmhg
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C4013784
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
- - recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator
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
- - life-threatening disease (e.g. cancer)
Description

Life threatening illness | Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C3846017
UMLS CUI [2]
C0006826
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Similar models

Eligibility Diabetes NCT01680341

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01680341
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 24 weeks prior to visit 2 (randomisation)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin Glargine | Antidiabetics Oral Quantity | Metformin | Dipeptidyl Peptidase 4 Inhibitors | Sulfonylurea | Glinide | alpha-Glucosidase Inhibitors | Diabetes Therapy Dose Stable
Item
- - currently treated with iglar (insulin glargine) and up to 3 oral antidiabetic drugs (oads) (metformin, dpp-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase inhibitor). all antidiabetic treatments should have been ongoing for at least 12 weeks prior to visit 2 (randomisation) and doses should have been stable in this period of time
boolean
C0907402 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0025598 (UMLS CUI [3])
C2917254 (UMLS CUI [4])
C0038766 (UMLS CUI [5])
C2266929 (UMLS CUI [6])
C1299007 (UMLS CUI [7])
C3274787 (UMLS CUI [8,1])
C0178602 (UMLS CUI [8,2])
C0205360 (UMLS CUI [8,3])
Hemoglobin A1c measurement
Item
- - glycosylated haemoglobin (hba1c) 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 40 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
GLP-1 Receptor Agonist | Thiazolidinediones
Item
- - treatment with glucagon-like peptide 1 (glp-1) receptor agonists or thiazolidinediones (tzds) both within the last 12 weeks prior to visit 2 (randomisation)
boolean
C2917359 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
Cerebrovascular accident | Heart failure New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Angioplasty
Item
- - stroke; heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 24 weeks prior to visit 2 (randomisation)
boolean
C0038454 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C0162577 (UMLS CUI [6])
Uncontrolled hypertension Severe | Severe hypertension Untreated | Systolic Pressure | Diastolic blood pressure
Item
- - uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 180 mmhg and/or diastolic blood pressure above or equal to 100 mmhg
boolean
C1868885 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C4013784 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Recurrent severe hypoglycemia | Hypoglycaemic episode Severe Quantity | Loss of hypoglycemic warning
Item
- - recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator
boolean
C0342316 (UMLS CUI [1])
C0745153 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0342317 (UMLS CUI [3])
Life threatening illness | Malignant Neoplasms
Item
- - life-threatening disease (e.g. cancer)
boolean
C3846017 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
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