ID

38877

Description

Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01336023

Link

https://clinicaltrials.gov/show/NCT01336023

Keywords

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

See clinicaltrials.gov

Uploaded on

November 11, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01336023

English

Eligibility Diabetes NCT01336023

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01336023
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
hba1c 7.0-10.0 % (both inclusive) with the aim of a median hba1c of 8.3%. accordingly, when approximately 50% of the randomised subjects have a hba1c above 8.3%, the remaining subjects randomised must have a hba1c of below or equal to 8.3%, or when approximately 50% of the randomised subjects have a hba1c of below or equal to 8.3%, the remaining subjects randomised must have a hba1c above 8.3%
Description

Hemoglobin A1c measurement | Treatment goal Hemoglobin A1c level Median

Data type

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0679840
UMLS CUI [2,2]
C0474680
UMLS CUI [2,3]
C0876920
male or female, age 18 years or above (taiwan: 20 years or above for a site 653 in taiwan: taichung veterans general hospital)
Description

Age | Taiwan

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0039260
subjects on stable dose of 1-2 oads (metformin [at least 1500 mg or max tolerated dose] or metformin [at least 1500 mg or max tolerated dose] + pioglitazone [at least 30 mg]) for at least 90 days prior to screening
Description

Antidiabetics Oral Dose Stable | Metformin Dose | Metformin Maximum Tolerated Dose | Pioglitazone Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0752079
UMLS CUI [4,1]
C0071097
UMLS CUI [4,2]
C0178602
body mass index (bmi) maximum 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 insulin (except for short-term treatment due to intercurrent illness at the discretion of the investigator)
Description

Insulin regime | Exception Treatment short-term | Etiology Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0443303
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0009488
treatment with glp-1 (glucagon-like peptide-1) receptor agonists (eg exenatide, liraglutide), sulphonylurea or dipeptidyl peptidase 4 (dpp-4) inhibitors within 90 days prior to trial
Description

GLP-1 Receptor Agonist | exenatide | liraglutide | Sulfonylurea | Dipeptidyl Peptidase 4 Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C2917359
UMLS CUI [2]
C0167117
UMLS CUI [3]
C1456408
UMLS CUI [4]
C0038766
UMLS CUI [5]
C2917254
impaired liver function, defined as alanine aminotransferese (alat) at least 2.5 times upper normal range (unr) (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
Description

Liver Dysfunction | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
impaired renal function defined as serum-creatinine at least 133 mcmol/l (at least 1.5 mg/dl) for males and at least 125 mcmol/l (at least 1.4) for females, or as allowed according to local contraindications for metformin (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
Description

Renal Insufficiency | Creatinine measurement, serum | Gender | Medical contraindication Metformin

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0025598
screening calcitonin at least 50 ng/l
Description

Calcitonin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201924
subjects with personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men 2)
Description

Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type

Data type

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2]
C1833921
UMLS CUI [3,1]
C0027662
UMLS CUI [3,2]
C0332307
cardiac disorder defined as: congestive heart failure (nyha class iii-iv), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months and planned coronary, carotid or peripheral artery revascularisation procedures
Description

Heart Disease | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Cerebrovascular accident | Myocardial Infarction | Coronary revascularisation Planned | Carotid revascularisation Planned | Peripheral revascularisation Planned

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0027051
UMLS CUI [6,1]
C0877341
UMLS CUI [6,2]
C1301732
UMLS CUI [7,1]
C3495793
UMLS CUI [7,2]
C1301732
UMLS CUI [8,1]
C1096418
UMLS CUI [8,2]
C1301732
severe uncontrolled treated or untreated hypertension (systolic blood pressure at least 180 mm hg or diastolic blood pressure at least 100 mm hg)
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332155
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
acute treatment required proliferative retinopathy or maculopathy (macular oedema)
Description

Treatment required for Proliferative retinopathy | Treatment required for Disorder of macula of retina | Treatment required for Macular retinal edema

Data type

boolean

Alias
UMLS CUI [1,1]
C0332121
UMLS CUI [1,2]
C0339467
UMLS CUI [2,1]
C0332121
UMLS CUI [2,2]
C0730362
UMLS CUI [3,1]
C0332121
UMLS CUI [3,2]
C0271051
history of chronic pancreatitis or idiopathic acute pancreatitis
Description

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0149521
UMLS CUI [2]
C0341461
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Similar models

Eligibility Diabetes NCT01336023

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01336023
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
subjects with type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement | Treatment goal Hemoglobin A1c level Median
Item
hba1c 7.0-10.0 % (both inclusive) with the aim of a median hba1c of 8.3%. accordingly, when approximately 50% of the randomised subjects have a hba1c above 8.3%, the remaining subjects randomised must have a hba1c of below or equal to 8.3%, or when approximately 50% of the randomised subjects have a hba1c of below or equal to 8.3%, the remaining subjects randomised must have a hba1c above 8.3%
boolean
C0474680 (UMLS CUI [1])
C0679840 (UMLS CUI [2,1])
C0474680 (UMLS CUI [2,2])
C0876920 (UMLS CUI [2,3])
Age | Taiwan
Item
male or female, age 18 years or above (taiwan: 20 years or above for a site 653 in taiwan: taichung veterans general hospital)
boolean
C0001779 (UMLS CUI [1])
C0039260 (UMLS CUI [2])
Antidiabetics Oral Dose Stable | Metformin Dose | Metformin Maximum Tolerated Dose | Pioglitazone Dose
Item
subjects on stable dose of 1-2 oads (metformin [at least 1500 mg or max tolerated dose] or metformin [at least 1500 mg or max tolerated dose] + pioglitazone [at least 30 mg]) for at least 90 days prior to screening
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C0071097 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
Body mass index
Item
body mass index (bmi) maximum 40 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Insulin regime | Exception Treatment short-term | Etiology Comorbidity
Item
treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the investigator)
boolean
C0557978 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0443303 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0009488 (UMLS CUI [3,2])
GLP-1 Receptor Agonist | exenatide | liraglutide | Sulfonylurea | Dipeptidyl Peptidase 4 Inhibitors
Item
treatment with glp-1 (glucagon-like peptide-1) receptor agonists (eg exenatide, liraglutide), sulphonylurea or dipeptidyl peptidase 4 (dpp-4) inhibitors within 90 days prior to trial
boolean
C2917359 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C1456408 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C2917254 (UMLS CUI [5])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired liver function, defined as alanine aminotransferese (alat) at least 2.5 times upper normal range (unr) (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Renal Insufficiency | Creatinine measurement, serum | Gender | Medical contraindication Metformin
Item
impaired renal function defined as serum-creatinine at least 133 mcmol/l (at least 1.5 mg/dl) for males and at least 125 mcmol/l (at least 1.4) for females, or as allowed according to local contraindications for metformin (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0025598 (UMLS CUI [4,2])
Calcitonin measurement
Item
screening calcitonin at least 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type
Item
subjects with personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men 2)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
Heart Disease | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Cerebrovascular accident | Myocardial Infarction | Coronary revascularisation Planned | Carotid revascularisation Planned | Peripheral revascularisation Planned
Item
cardiac disorder defined as: congestive heart failure (nyha class iii-iv), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months and planned coronary, carotid or peripheral artery revascularisation procedures
boolean
C0018799 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0877341 (UMLS CUI [6,1])
C1301732 (UMLS CUI [6,2])
C3495793 (UMLS CUI [7,1])
C1301732 (UMLS CUI [7,2])
C1096418 (UMLS CUI [8,1])
C1301732 (UMLS CUI [8,2])
Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe Untreated | Systolic Pressure | Diastolic blood pressure
Item
severe uncontrolled treated or untreated hypertension (systolic blood pressure at least 180 mm hg or diastolic blood pressure at least 100 mm hg)
boolean
C1868885 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C1868885 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Treatment required for Proliferative retinopathy | Treatment required for Disorder of macula of retina | Treatment required for Macular retinal edema
Item
acute treatment required proliferative retinopathy or maculopathy (macular oedema)
boolean
C0332121 (UMLS CUI [1,1])
C0339467 (UMLS CUI [1,2])
C0332121 (UMLS CUI [2,1])
C0730362 (UMLS CUI [2,2])
C0332121 (UMLS CUI [3,1])
C0271051 (UMLS CUI [3,2])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic pancreatitis or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
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