ID

35801

Beschreibung

A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms; ODM derived from: https://clinicaltrials.gov/show/NCT02298192

Link

https://clinicaltrials.gov/show/NCT02298192

Stichworte

Versionen (1)
  1. 24.03.19 24.03.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

24. März 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes NCT02298192

Englisch

Eligibility Diabetes NCT02298192

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02298192
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
male or female equal to or above 18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
hba1c (glycosylated haemoglobin) 7.0 - 10.0% [53 mmol/mol - 86 mmol/mol] (both inclusive), confirmed by the central laboratory
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
stable daily treatment with metformin (above or equal to 1500 mg or max tolerated dose) with or without pioglitazone (above orequal to 30 mg) for at least 90 days prior to screening
Beschreibung

Metformin Stable U/day | Metformin Maximum Tolerated Dose | Pioglitazone Dosage | Pioglitazone Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0456683
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0752079
UMLS CUI [3,1]
C0071097
UMLS CUI [3,2]
C0178602
UMLS CUI [4,1]
C0071097
UMLS CUI [4,2]
C0332197
body mass index (bmi) below or equal to 40 kg/m^2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
current use of any anti-diabetic drugs (except for metformin and pioglitazone) or anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids)
Beschreibung

Antidiabetics | Exception Metformin | Exception Pioglitazone | Change of medication Interferes with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE

Datentyp

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0071097
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 insulin (short term treatment due to intercurrent illness, including gestational diabetes, is allowed at the discretion of the investigator)
Beschreibung

Insulin regime | Exception Therapeutic procedure short-term Comorbidity | Exception Therapeutic procedure short-term Gestational Diabetes

Datentyp

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0443303
UMLS CUI [2,4]
C0009488
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0443303
UMLS CUI [3,4]
C0085207
treatment with glucagon-like peptide-1 (glp-1) receptor agonists, sulpfonylurea, glinides, dipeptidyl peptidase 4 (dpp-4) inhibitors or sodium-glucose co-transporter 2 (sglt2) inhibitors within 90 days prior to the screening visit
Beschreibung

GLP-1 Receptor Agonist | Sulfonylurea | Glinide | Dipeptidyl Peptidase-4 Inhibitor | SGLT2 Inhibitor

Datentyp

boolean

Alias
UMLS CUI [1]
C2917359
UMLS CUI [2]
C0038766
UMLS CUI [3]
C2266929
UMLS CUI [4]
C3537225
UMLS CUI [5]
C3273807
impaired liver function, defined as alanine aminotransferase (alat) above or equal to 2.5 times upper normal range (unr)
Beschreibung

Liver Dysfunction | Alanine aminotransferase increased

Datentyp

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 (above or equal to 1.4 mg/dl) for females, or as defined according to local contraindications for metformin
Beschreibung

Renal Insufficiency | Creatinine measurement, serum | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
screening calcitonin above or equal to 50 ng/l
Beschreibung

Calcitonin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201924
proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment, according to investigator's clinical judgment
Beschreibung

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

Datentyp

boolean

Alias
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]
C0332121
personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2)
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2]
C1833921
UMLS CUI [3,1]
C0027662
UMLS CUI [3,2]
C0332307
history of pancreatitis (acute or chronic)
Beschreibung

Pancreatitis | Pancreatitis, Chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
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Ähnliche Modelle

Eligibility Diabetes NCT02298192

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02298192
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Age
Item
male or female equal to or above 18 years of age
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) 7.0 - 10.0% [53 mmol/mol - 86 mmol/mol] (both inclusive), confirmed by the central laboratory
boolean
C0474680 (UMLS CUI [1])
Metformin Stable U/day | Metformin Maximum Tolerated Dose | Pioglitazone Dosage | Pioglitazone Absent
Item
stable daily treatment with metformin (above or equal to 1500 mg or max tolerated dose) with or without pioglitazone (above orequal to 30 mg) for at least 90 days prior to screening
boolean
C0025598 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2,1])
C0752079 (UMLS CUI [2,2])
C0071097 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0071097 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
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 | Exception Metformin | Exception Pioglitazone | Change of medication Interferes with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
current use of any anti-diabetic drugs (except for metformin and pioglitazone) or anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids)
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0071097 (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 Therapeutic procedure short-term Comorbidity | Exception Therapeutic procedure short-term Gestational Diabetes
Item
previous and / or current treatment with insulin (short term treatment due to intercurrent illness, including gestational diabetes, is allowed 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])
C0009488 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0443303 (UMLS CUI [3,3])
C0085207 (UMLS CUI [3,4])
GLP-1 Receptor Agonist | Sulfonylurea | Glinide | Dipeptidyl Peptidase-4 Inhibitor | SGLT2 Inhibitor
Item
treatment with glucagon-like peptide-1 (glp-1) receptor agonists, sulpfonylurea, glinides, dipeptidyl peptidase 4 (dpp-4) inhibitors or sodium-glucose co-transporter 2 (sglt2) inhibitors within 90 days prior to the screening visit
boolean
C2917359 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
C2266929 (UMLS CUI [3])
C3537225 (UMLS CUI [4])
C3273807 (UMLS CUI [5])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired liver function, defined as alanine aminotransferase (alat) 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
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 (above or equal to 1.4 mg/dl) for females, or as defined according to local contraindications for metformin
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Calcitonin measurement
Item
screening calcitonin above or equal to 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for | Macular retinal edema Treatment required for
Item
proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment, according to investigator's clinical judgment
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C0271051 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | 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])
Pancreatitis | Pancreatitis, Chronic
Item
history of pancreatitis (acute or chronic)
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
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