ID

32908

Description

Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00885378

Link

https://clinicaltrials.gov/show/NCT00885378

Keywords

Versions (1)
  1. 11/19/18 11/19/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 19, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00885378

English

Eligibility Type 2 Diabetes Mellitus NCT00885378

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
18-78 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
taking stable twice daily (bid) dosing of metformin ir (at least 1500 mg) for at least 8 weeks
Description

Metformin Immediate Release | Dose Stable U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C1708470
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C0456683
a1c: 7-10%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
c-peptide: ≥ 0.8 ng/ml
Description

C-peptide measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202100
body mass index (bmi): ≤45 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women of childbearing potential unable or unwilling to use acceptable birth control
Description

Childbearing Potential Contraceptive methods Unable | Childbearing Potential Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
women who are pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
fasting plasma glucose (fpg) >270 mg/dl
Description

Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
significant cardiovascular history
Description

Cardiovascular History

Data type

boolean

Alias
UMLS CUI [1]
C1880008
symptoms of poorly controlled diabetes
Description

Symptoms Poorly controlled diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0554876
history of diabetic ketoacidosis or hyperosmolar nonketotic coma
Description

Diabetic Ketoacidosis | Hyperosmolar Nonketotic Coma

Data type

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C0020457
insulin therapy within one year of screening
Description

Insulin regime

Data type

boolean

Alias
UMLS CUI [1]
C0557978
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00885378

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Age
Item
18-78 years of age
boolean
C0001779 (UMLS CUI [1])
Metformin Immediate Release | Dose Stable U/day
Item
taking stable twice daily (bid) dosing of metformin ir (at least 1500 mg) for at least 8 weeks
boolean
C0025598 (UMLS CUI [1,1])
C1708470 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
Hemoglobin A1c measurement
Item
a1c: 7-10%
boolean
C0474680 (UMLS CUI [1])
C-peptide measurement
Item
c-peptide: ≥ 0.8 ng/ml
boolean
C0202100 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi): ≤45 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential Contraceptive methods Unable | Childbearing Potential Contraceptive methods Unwilling
Item
women of childbearing potential unable or unwilling to use acceptable birth control
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Plasma fasting glucose measurement
Item
fasting plasma glucose (fpg) >270 mg/dl
boolean
C0583513 (UMLS CUI [1])
Cardiovascular History
Item
significant cardiovascular history
boolean
C1880008 (UMLS CUI [1])
Symptoms Poorly controlled diabetes mellitus
Item
symptoms of poorly controlled diabetes
boolean
C1457887 (UMLS CUI [1,1])
C0554876 (UMLS CUI [1,2])
Diabetic Ketoacidosis | Hyperosmolar Nonketotic Coma
Item
history of diabetic ketoacidosis or hyperosmolar nonketotic coma
boolean
C0011880 (UMLS CUI [1])
C0020457 (UMLS CUI [2])
Insulin regime
Item
insulin therapy within one year of screening
boolean
C0557978 (UMLS CUI [1])
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