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Eligibility Diabetes Mellitus NCT02229383

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
has a diagnosis of type 2 diabetes mellitus (t2dm)
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
has hba1c of 7.5% to 12.0%, inclusive, at visit 1 (screening).
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
has fasting plasma glucose (fpg) concentration <280 mg/dl (15.6 mmol/l) at visit 1 (screening)
Description

Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
treated with basal insulin glargine at a dose of ≥20 units/day once daily for at least 6 weeks prior to screening, in combination with diet and exercise alone or in combination with:
Description

Insulin Glargine Dose U/day | Combined Modality Therapy | Diet therapy | Exercise

Data type

boolean

Alias
UMLS CUI [1,1]
C0907402
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
UMLS CUI [2]
C0009429
UMLS CUI [3]
C0012159
UMLS CUI [4]
C0015259
1. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to visit 1
Description

Metformin Dose Stable U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0456683
2. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to visit 1 (screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the screening visit
Description

Metformin Dose Stable U/day | Sulfonylurea Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0456683
UMLS CUI [2,1]
C0038766
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
serum calcitonin concentration ≥40 pg/ml (≥40 ng/l) at visit 1 (screening)
Description

Serum calcitonin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0863135
history of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dl (≥5.65 mmol/l) at visit 1
Description

Pancreatitis | Pancreatitis, Chronic | Triglycerides measurement

Data type

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
UMLS CUI [3]
C0202236
positive serological test for hepatitis b or hepatitis c
Description

Hepatitis B Seropositive | Hepatitis C Seropositive

Data type

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0521143
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C0521143
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Similar models

Eligibility Diabetes Mellitus NCT02229383

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
has a diagnosis of type 2 diabetes mellitus (t2dm)
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
has hba1c of 7.5% to 12.0%, inclusive, at visit 1 (screening).
boolean
C0474680 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
has fasting plasma glucose (fpg) concentration <280 mg/dl (15.6 mmol/l) at visit 1 (screening)
boolean
C0583513 (UMLS CUI [1])
Insulin Glargine Dose U/day | Combined Modality Therapy | Diet therapy | Exercise
Item
treated with basal insulin glargine at a dose of ≥20 units/day once daily for at least 6 weeks prior to screening, in combination with diet and exercise alone or in combination with:
boolean
C0907402 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0009429 (UMLS CUI [2])
C0012159 (UMLS CUI [3])
C0015259 (UMLS CUI [4])
Metformin Dose Stable U/day
Item
1. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to visit 1
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
Metformin Dose Stable U/day | Sulfonylurea Dose Stable
Item
2. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to visit 1 (screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the screening visit
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
C0038766 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Serum calcitonin measurement
Item
serum calcitonin concentration ≥40 pg/ml (≥40 ng/l) at visit 1 (screening)
boolean
C0863135 (UMLS CUI [1])
Pancreatitis | Pancreatitis, Chronic | Triglycerides measurement
Item
history of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dl (≥5.65 mmol/l) at visit 1
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
C0202236 (UMLS CUI [3])
Hepatitis B Seropositive | Hepatitis C Seropositive
Item
positive serological test for hepatitis b or hepatitis c
boolean
C0019163 (UMLS CUI [1,1])
C0521143 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2,1])
C0521143 (UMLS CUI [2,2])
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