ID

34770

Description

Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02288273

Link

https://clinicaltrials.gov/show/NCT02288273

Keywords

  1. 1/27/19 1/27/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 27, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes NCT02288273

Eligibility Type 2 Diabetes NCT02288273

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus (t2dm) treated with stable dose of metformin > or = to 1500mg/day as monotherapy for at least 8 weeks
Description

Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable U/day

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [2,4]
C0456683
hemoglobin a1c (hba1c) 7% to 10% at screening
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) < or = to 45 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of taking antihyperglycemic therapy other than metformin or metformin extended release (xr) during the 8 weeks prior to screening
Description

Hypoglycemic Agents | Exception Metformin | Exception Metformin Extended Release

Data type

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0025598
UMLS CUI [3,3]
C1707968
history of taking a dipeptidyl peptidase-4 (dpp-4) inhibitor or pramlintide during 12 weeks prior to screening
Description

Dipeptidyl-Peptidase IV Inhibitors | Pramlintide

Data type

boolean

Alias
UMLS CUI [1]
C1827106
UMLS CUI [2]
C0537551
history of potent, inhaled or intrapulmonary steroids 3 months prior to screening or during the study
Description

Steroids | Inhaled steroids | Steroids Intrapulmonary

Data type

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2]
C2065041
UMLS CUI [3,1]
C0038317
UMLS CUI [3,2]
C1522224
history of prescription or over the counter weight loss medication during 3 months prior to screening
Description

Weight-Loss Agents Prescription | Weight-Loss Agents Over the counter

Data type

boolean

Alias
UMLS CUI [1,1]
C0376606
UMLS CUI [1,2]
C0033080
UMLS CUI [2,1]
C0376606
UMLS CUI [2,2]
C0013231
previous exposure to exenatide or any glucagon-like peptide-1 (glp-1) receptor agonist during 6 months prior to screening
Description

Exposure to Exenatide | Exposure to GLP-1 Receptor Agonist

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0167117
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C2917359

Similar models

Eligibility Type 2 Diabetes NCT02288273

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable U/day
Item
type 2 diabetes mellitus (t2dm) treated with stable dose of metformin > or = to 1500mg/day as monotherapy for at least 8 weeks
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
Hemoglobin A1c measurement
Item
hemoglobin a1c (hba1c) 7% to 10% at screening
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) < or = to 45 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypoglycemic Agents | Exception Metformin | Exception Metformin Extended Release
Item
history of taking antihyperglycemic therapy other than metformin or metformin extended release (xr) during the 8 weeks prior to screening
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])
C1707968 (UMLS CUI [3,3])
Dipeptidyl-Peptidase IV Inhibitors | Pramlintide
Item
history of taking a dipeptidyl peptidase-4 (dpp-4) inhibitor or pramlintide during 12 weeks prior to screening
boolean
C1827106 (UMLS CUI [1])
C0537551 (UMLS CUI [2])
Steroids | Inhaled steroids | Steroids Intrapulmonary
Item
history of potent, inhaled or intrapulmonary steroids 3 months prior to screening or during the study
boolean
C0038317 (UMLS CUI [1])
C2065041 (UMLS CUI [2])
C0038317 (UMLS CUI [3,1])
C1522224 (UMLS CUI [3,2])
Weight-Loss Agents Prescription | Weight-Loss Agents Over the counter
Item
history of prescription or over the counter weight loss medication during 3 months prior to screening
boolean
C0376606 (UMLS CUI [1,1])
C0033080 (UMLS CUI [1,2])
C0376606 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
Exposure to Exenatide | Exposure to GLP-1 Receptor Agonist
Item
previous exposure to exenatide or any glucagon-like peptide-1 (glp-1) receptor agonist during 6 months prior to screening
boolean
C0332157 (UMLS CUI [1,1])
C0167117 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C2917359 (UMLS CUI [2,2])

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