ID

38975

Beskrivning

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01952145

Länk

https://clinicaltrials.gov/show/NCT01952145

Nyckelord

Versioner (1)
  1. 2019-11-17 2019-11-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 november 2019

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes NCT01952145

Engelsk

Eligibility Diabetes NCT01952145

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01952145
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
hba1c 7.0-10.0% [53-86 mmol/mol] (both inclusive) by central laboratory analysis
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
current treatment with insulin glargine for at least 90 days prior to screening
Beskrivning

Insulin Glargine

Datatyp

boolean

Alias
UMLS CUI [1]
C0907402
stable daily dose of insulin glargine between 20 units and 50 units (both inclusive) for at least 56 days prior to screening. total daily dose should be within the range of 20-50 units, both inclusive, on the day of screening, but individual fluctuations of plus/minus 10 procent within the 56 days prior to screening are acceptable
Beskrivning

Insulin Glargine Dose Stable U/day | Insulin Glargine Total Daily Dose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0907402
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0456683
UMLS CUI [2,1]
C0907402
UMLS CUI [2,2]
C2348070
stable daily dose of metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening
Beskrivning

Metformin Daily Dose Stable | Metformin Maximum Tolerated Dose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0752079
body mass index (bmi) below or equal to 40 kg/m^2
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any use of oral antidiabetic agents (oads) (except for metformin) within 90 days prior to visit 1 (screening)
Beskrivning

Antidiabetics Oral | Exception Metformin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
current use of any drug (except metformin and insulin glargine) or anticipated change inconcomitant medication, which in the investigator's opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids)
Beskrivning

Pharmaceutical Preparation Interferes with Glucose metabolism | Exception Metformin | Exception Insulin Glargine | Change of medication Interferes with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0596620
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0907402
UMLS CUI [4,1]
C0580105
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0596620
UMLS CUI [5]
C3653708
previous and/or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness includinggestational diabetes is allowed at the discretion of the investigator)
Beskrivning

Insulin regime | Exception Basal insulin | Insulin Mealtime | Premixed insulin | Insulin regime short-term allowed | Etiology Comorbidity | Etiology Gestational Diabetes

Datatyp

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0650607
UMLS CUI [3,1]
C0021641
UMLS CUI [3,2]
C0587119
UMLS CUI [4]
C2069057
UMLS CUI [5,1]
C0557978
UMLS CUI [5,2]
C0443303
UMLS CUI [5,3]
C0683607
UMLS CUI [6,1]
C0015127
UMLS CUI [6,2]
C0009488
UMLS CUI [7,1]
C0015127
UMLS CUI [7,2]
C0085207
previous and/or current treatment with glucagon-like peptide-1 (glp-1) receptor agonists (e.g. exenatide, liraglutide)
Beskrivning

GLP-1 Receptor Agonist | exenatide | liraglutide

Datatyp

boolean

Alias
UMLS CUI [1]
C2917359
UMLS CUI [2]
C0167117
UMLS CUI [3]
C1456408
impaired liver function, defined as alat (alanine aminotransferase) above or equal to 2.5 times upper normal range (unr)
Beskrivning

Liver Dysfunction | Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
impaired renal function defined as serum-creatinine above or equal to 133 micromol/l (above or equal to 1.5 mg/dl) for males and above or equal to 125 micromol/l (1.4 mg/dl) for females, or as allowed according to local contraindications for metformin
Beskrivning

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

Datatyp

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 above or equal to 50 ng/l
Beskrivning

Calcitonin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201924
personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2)
Beskrivning

Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type

Datatyp

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2]
C1833921
UMLS CUI [3,1]
C0027662
UMLS CUI [3,2]
C0332307
UMLS CUI [4,1]
C4039247
UMLS CUI [4,2]
C0332307
history of chronic pancreatitis or idiopathic acute pancreatitis
Beskrivning

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Datatyp

boolean

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

Eligibility Diabetes NCT01952145

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01952145
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c 7.0-10.0% [53-86 mmol/mol] (both inclusive) by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Insulin Glargine
Item
current treatment with insulin glargine for at least 90 days prior to screening
boolean
C0907402 (UMLS CUI [1])
Insulin Glargine Dose Stable U/day | Insulin Glargine Total Daily Dose
Item
stable daily dose of insulin glargine between 20 units and 50 units (both inclusive) for at least 56 days prior to screening. total daily dose should be within the range of 20-50 units, both inclusive, on the day of screening, but individual fluctuations of plus/minus 10 procent within the 56 days prior to screening are acceptable
boolean
C0907402 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
C0907402 (UMLS CUI [2,1])
C2348070 (UMLS CUI [2,2])
Metformin Daily Dose Stable | Metformin Maximum Tolerated Dose
Item
stable daily dose of metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening
boolean
C0025598 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2,1])
C0752079 (UMLS CUI [2,2])
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)
Antidiabetics Oral | Exception Metformin
Item
any use of oral antidiabetic agents (oads) (except for metformin) within 90 days prior to visit 1 (screening)
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Pharmaceutical Preparation Interferes with Glucose metabolism | Exception Metformin | Exception Insulin Glargine | Change of medication Interferes with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
current use of any drug (except metformin and insulin glargine) or anticipated change inconcomitant medication, which in the investigator's opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids)
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0907402 (UMLS CUI [3,2])
C0580105 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0596620 (UMLS CUI [4,3])
C3653708 (UMLS CUI [5])
Insulin regime | Exception Basal insulin | Insulin Mealtime | Premixed insulin | Insulin regime short-term allowed | Etiology Comorbidity | Etiology Gestational Diabetes
Item
previous and/or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness includinggestational diabetes is allowed at the discretion of the investigator)
boolean
C0557978 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0650607 (UMLS CUI [2,2])
C0021641 (UMLS CUI [3,1])
C0587119 (UMLS CUI [3,2])
C2069057 (UMLS CUI [4])
C0557978 (UMLS CUI [5,1])
C0443303 (UMLS CUI [5,2])
C0683607 (UMLS CUI [5,3])
C0015127 (UMLS CUI [6,1])
C0009488 (UMLS CUI [6,2])
C0015127 (UMLS CUI [7,1])
C0085207 (UMLS CUI [7,2])
GLP-1 Receptor Agonist | exenatide | liraglutide
Item
previous and/or current treatment with glucagon-like peptide-1 (glp-1) receptor agonists (e.g. exenatide, liraglutide)
boolean
C2917359 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C1456408 (UMLS CUI [3])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired liver function, defined as alat (alanine aminotransferase) above or equal to 2.5 times upper normal range (unr)
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 above or equal to 133 micromol/l (above or equal to 1.5 mg/dl) for males and above or equal to 125 micromol/l (1.4 mg/dl) for females, or as allowed according to local contraindications for metformin
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 above or equal to 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type
Item
personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C4039247 (UMLS CUI [4,1])
C0332307 (UMLS CUI [4,2])
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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