ID

16115

Description

Triple Combination Therapy in Type 2 Diabetic Patients Who Had Inadequate Glycemic Control With Combination Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02338921

Link

https://clinicaltrials.gov/show/NCT02338921

Keywords

  1. 6/30/16 6/30/16 -
  2. 7/1/16 7/1/16 - Julian Varghese
Uploaded on

June 30, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Type 2 Diabetes NCT02338921

Eligibility Type 2 Diabetes NCT02338921

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
20 ≤ age < 80 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
hba1c ≥ 7 %
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
combination therapy with glimepiride and metformin over 2 months.
Description

Combination Therapy glimepiride Metformin

Data type

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C0061323
UMLS CUI [1,3]
C0025598
dosage of glimepiride : 1-8mg/day
Description

glimepiride Dosage mg/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0061323
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439422
dosage of metformin : 500-2550mg/day
Description

Metformin Dosage mg/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439422
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes, gestational diabetes, or secondary forms of diabetes
Description

Diabetes Mellitus, Insulin-Dependent | Gestational Diabetes | Secondary diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0085207
UMLS CUI [3]
C0271640
contraindication to sitagliptin or dapagliflozin or lobeglitazone
Description

Medical contraindication sitagliptin | Medical contraindication dapagliflozin | Medical contraindication lobeglitazone

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1565750
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C2353951
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C2744790
pregnant or breast feeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
medication which affect glycemic control (ex. steroid)
Description

Pharmaceutical Preparations Affecting Glycaemia control | Steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C3267174
UMLS CUI [2]
C0038317
disease which affect efficacy and safety of drugs
Description

Disease Affecting drug efficacy | Disease Affecting drug safety

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0598333
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0678800
any major illness (liver disease, renal failure, heart disease, cancer, etc)
Description

Illness Major | Liver diseases | Kidney Failure | Heart Diseases | Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0035078
UMLS CUI [4]
C0018799
UMLS CUI [5]
C0006826
not appropriate for oral antidiabetic agent
Description

contraindication Antidiabetics Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0935929
UMLS CUI [1,3]
C1527415

Similar models

Eligibility Type 2 Diabetes NCT02338921

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
20 ≤ age < 80 years
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c ≥ 7 %
boolean
C0474680 (UMLS CUI [1])
Combination Therapy glimepiride Metformin
Item
combination therapy with glimepiride and metformin over 2 months.
boolean
C0009429 (UMLS CUI [1,1])
C0061323 (UMLS CUI [1,2])
C0025598 (UMLS CUI [1,3])
glimepiride Dosage mg/day
Item
dosage of glimepiride : 1-8mg/day
boolean
C0061323 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439422 (UMLS CUI [1,3])
Metformin Dosage mg/day
Item
dosage of metformin : 500-2550mg/day
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439422 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Gestational Diabetes | Secondary diabetes mellitus
Item
type 1 diabetes, gestational diabetes, or secondary forms of diabetes
boolean
C0011854 (UMLS CUI [1])
C0085207 (UMLS CUI [2])
C0271640 (UMLS CUI [3])
Medical contraindication sitagliptin | Medical contraindication dapagliflozin | Medical contraindication lobeglitazone
Item
contraindication to sitagliptin or dapagliflozin or lobeglitazone
boolean
C1301624 (UMLS CUI [1,1])
C1565750 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C2353951 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C2744790 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pharmaceutical Preparations Affecting Glycaemia control | Steroids
Item
medication which affect glycemic control (ex. steroid)
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C3267174 (UMLS CUI [1,3])
C0038317 (UMLS CUI [2])
Disease Affecting drug efficacy | Disease Affecting drug safety
Item
disease which affect efficacy and safety of drugs
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0598333 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0678800 (UMLS CUI [2,3])
Illness Major | Liver diseases | Kidney Failure | Heart Diseases | Malignant Neoplasms
Item
any major illness (liver disease, renal failure, heart disease, cancer, etc)
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2])
C0035078 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
C0006826 (UMLS CUI [5])
contraindication Antidiabetics Oral
Item
not appropriate for oral antidiabetic agent
boolean
C1301624 (UMLS CUI [1,1])
C0935929 (UMLS CUI [1,2])
C1527415 (UMLS CUI [1,3])

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