ID

34741

Description

Effect of Combined Incretin-Based Therapy Plus Canagliflozin on Glycemic Control and the Compensatory Rise in Hepatic Glucose Production in Type 2 Diabetic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02324842

Link

https://clinicaltrials.gov/show/NCT02324842

Keywords

Versions (1)
  1. 1/25/19 1/25/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 25, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02324842

English

Eligibility Type 2 Diabetes Mellitus NCT02324842

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects between the ages of 18-70
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects with type 2 diabetes mellitus (t2dm)
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
drug naïve or on stable dose (more than 3 months) of metformin
Description

Pharmaceutical Preparations Absent | Metformin Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
have an hba1c levels ≥7.0% and <10.0%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
stable weight (± 3 lbs) over the preceding 3 months
Description

Stable body weight Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0517386
UMLS CUI [1,2]
C0449238
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects taking drugs known to affect glucose metabolism (other than metformin) will be excluded.
Description

Pharmaceutical Preparations Affecting Glucose metabolism | Exception Metformin

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0596620
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
individuals with evidence of proliferative diabetic retinopathy or plasma creatinine >1.4 females or >1.5 males or egfr< 60 ml/min.172m2 will be excluded
Description

Proliferative diabetic retinopathy | Plasma creatinine measurement | Gender | Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C0154830
UMLS CUI [2]
C1278055
UMLS CUI [3]
C0079399
UMLS CUI [4]
C3811844
unstable body weight (change of greater than ±3 lbs over the preceding 3 months)
Description

Body Weight Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0443343
participates in excessively heavy exercise program
Description

Participation Exercise Very heavy

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0015259
UMLS CUI [1,3]
C0439540
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02324842

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female subjects between the ages of 18-70
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
subjects with type 2 diabetes mellitus (t2dm)
boolean
C0011860 (UMLS CUI [1])
Pharmaceutical Preparations Absent | Metformin Dose Stable
Item
drug naïve or on stable dose (more than 3 months) of metformin
boolean
C0013227 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Hemoglobin A1c measurement
Item
have an hba1c levels ≥7.0% and <10.0%
boolean
C0474680 (UMLS CUI [1])
Stable body weight Duration
Item
stable weight (± 3 lbs) over the preceding 3 months
boolean
C0517386 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Affecting Glucose metabolism | Exception Metformin
Item
subjects taking drugs known to affect glucose metabolism (other than metformin) will be excluded.
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Proliferative diabetic retinopathy | Plasma creatinine measurement | Gender | Estimated Glomerular Filtration Rate
Item
individuals with evidence of proliferative diabetic retinopathy or plasma creatinine >1.4 females or >1.5 males or egfr< 60 ml/min.172m2 will be excluded
boolean
C0154830 (UMLS CUI [1])
C1278055 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C3811844 (UMLS CUI [4])
Body Weight Unstable
Item
unstable body weight (change of greater than ±3 lbs over the preceding 3 months)
boolean
C0005910 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Participation Exercise Very heavy
Item
participates in excessively heavy exercise program
boolean
C0679823 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C0439540 (UMLS CUI [1,3])
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