ID

35803

Beschreibung

A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02420262

Link

https://clinicaltrials.gov/show/NCT02420262

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 NCT02420262

Englisch

Eligibility Diabetes NCT02420262

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02420262
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, age at least 18 years at the time of signing informed consent
Beschreibung

Age | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

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

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
current treatment with iglar (insulin glargine) for at least 90 calendar days prior to screening
Beschreibung

Insulin Glargine

Datentyp

boolean

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

Insulin Glargine Daily Dose Stable

Datentyp

boolean

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

Metformin Daily Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0205360
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
treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening
Beschreibung

Antidiabetics | Anti-Obesity Agents | Exception Inclusion criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2]
C0376607
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1512693
anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)
Beschreibung

Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting Glucose metabolism | Weight-Loss Agents | sibutramine | orlistat | Thyroid Hormones | Adrenal Cortex Hormones

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005910
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0596620
UMLS CUI [3]
C0376606
UMLS CUI [4]
C0074493
UMLS CUI [5]
C0076275
UMLS CUI [6]
C0040135
UMLS CUI [7]
C0001617
impaired liver function, defined as alanine aminotransferase (alt) at least 2.5 times upper limit of normal
Beschreibung

Liver Dysfunction | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
renal impairment egfr (electronic case report form) below 60 ml/min/1.73 m^2 as per ckd-epi (chronic kidney disease epidemiology collaboration)
Beschreibung

Renal Insufficiency | Estimated Glomerular Filtration Rate

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C3811844
screening calcitonin at least 50 ng/l
Beschreibung

Calcitonin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201924
history of pancreatitis (acute or chronic)
Beschreibung

Pancreatitis | Pancreatitis, Chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
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
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Ähnliche Modelle

Eligibility Diabetes NCT02420262

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02420262
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
male or female, age at least 18 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) 7.0-10.0% [53mmol/mol-86mmol/mol] (both inclusive) by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Insulin Glargine
Item
current treatment with iglar (insulin glargine) for at least 90 calendar days prior to screening
boolean
C0907402 (UMLS CUI [1])
Insulin Glargine Daily Dose Stable
Item
stable daily dose of iglar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. individual fluctuations of plus/minus 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive
boolean
C0907402 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Metformin Daily Dose Stable
Item
stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least 90 calendar days prior to screening
boolean
C0025598 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
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 | Anti-Obesity Agents | Exception Inclusion criteria
Item
treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening
boolean
C0935929 (UMLS CUI [1])
C0376607 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1512693 (UMLS CUI [3,2])
Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting Glucose metabolism | Weight-Loss Agents | sibutramine | orlistat | Thyroid Hormones | Adrenal Cortex Hormones
Item
anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
C0376606 (UMLS CUI [3])
C0074493 (UMLS CUI [4])
C0076275 (UMLS CUI [5])
C0040135 (UMLS CUI [6])
C0001617 (UMLS CUI [7])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired liver function, defined as alanine aminotransferase (alt) at least 2.5 times upper limit of normal
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Renal Insufficiency | Estimated Glomerular Filtration Rate
Item
renal impairment egfr (electronic case report form) below 60 ml/min/1.73 m^2 as per ckd-epi (chronic kidney disease epidemiology collaboration)
boolean
C1565489 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Calcitonin measurement
Item
screening calcitonin at least 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Pancreatitis | Pancreatitis, Chronic
Item
history of pancreatitis (acute or chronic)
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type
Item
personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
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