ID

38655

Description

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

Link

https://clinicaltrials.gov/show/NCT01434186

Keywords

Versions (1)
  1. 10/29/19 10/29/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 29, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01434186

English

Eligibility Diabetes Mellitus, Type 2 NCT01434186

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female patients eligible if 10 years of age, up to 17 years and 30 weeks of age at the time of screening
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
previously diagnosed as having type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
hba1c ≥7.0% and ≤10.5%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
body weight ≥ 30 kg
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
stable dose of metformin (≥ 1000mg - ≤ 2000mg) for a minimum of 2 months
Description

Metformin Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
women must have a negative serum or urine pregnancy test
Description

Gender Serum pregnancy test negative | Gender Urine pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0430057
women must not be breastfeeding
Description

Gender Breast Feeding Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0006147
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
current use of anti-diabetic medications or use within the specified timeframe prior to screening (exception: metformin)
Description

Antidiabetics | Exception Metformin

Data type

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
fasting plasma glucose (fpg) > 255 mg/dl
Description

Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
diabetic ketoacidosis (dka) within 6 months of study entry
Description

Diabetic Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C0011880
abnormal renal function
Description

Abnormal renal function

Data type

boolean

Alias
UMLS CUI [1]
C0151746
active liver disease
Description

Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
anemia
Description

Anemia

Data type

boolean

Alias
UMLS CUI [1]
C0002871
an abnormal thyroid stimulating hormone (tsh)
Description

Serum thyroid stimulating hormone abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0857987
creatinine kinase (ck) ≥ 3x uln
Description

Elevated creatinine kinase

Data type

boolean

Alias
UMLS CUI [1]
C1657311
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01434186

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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