Information:
Fel:
ID
38655
Beskrivning
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone; ODM derived from: https://clinicaltrials.gov/show/NCT01434186
Länk
https://clinicaltrials.gov/show/NCT01434186
Nyckelord
Versioner (1)
- 2019-10-29 2019-10-29 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
29 oktober 2019
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01434186
Eligibility Diabetes Mellitus, Type 2 NCT01434186
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus, Type 2 NCT01434186
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Age
Item
male and female patients eligible if 10 years of age, up to 17 years and 30 weeks of age at the time of screening
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
previously diagnosed as having type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c ≥7.0% and ≤10.5%
boolean
C0474680 (UMLS CUI [1])
Body Weight
Item
body weight ≥ 30 kg
boolean
C0005910 (UMLS CUI [1])
Metformin Dose Stable
Item
stable dose of metformin (≥ 1000mg - ≤ 2000mg) for a minimum of 2 months
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Gender Serum pregnancy test negative | Gender Urine pregnancy test negative
Item
women must have a negative serum or urine pregnancy test
boolean
C0079399 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C0430061 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Gender Breast Feeding Absent
Item
women must not be breastfeeding
boolean
C0079399 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0006147 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Antidiabetics | Exception Metformin
Item
current use of anti-diabetic medications or use within the specified timeframe prior to screening (exception: metformin)
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Plasma fasting glucose measurement
Item
fasting plasma glucose (fpg) > 255 mg/dl
boolean
C0583513 (UMLS CUI [1])
Diabetic Ketoacidosis
Item
diabetic ketoacidosis (dka) within 6 months of study entry
boolean
C0011880 (UMLS CUI [1])
Abnormal renal function
Item
abnormal renal function
boolean
C0151746 (UMLS CUI [1])
Liver disease
Item
active liver disease
boolean
C0023895 (UMLS CUI [1])
Anemia
Item
anemia
boolean
C0002871 (UMLS CUI [1])
Serum thyroid stimulating hormone abnormal
Item
an abnormal thyroid stimulating hormone (tsh)
boolean
C0857987 (UMLS CUI [1])
Elevated creatinine kinase
Item
creatinine kinase (ck) ≥ 3x uln
boolean
C1657311 (UMLS CUI [1])