Information:
Fel:
ID
35716
Beskrivning
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02229383
Länk
https://clinicaltrials.gov/show/NCT02229383
Nyckelord
Versioner (1)
- 2019-03-17 2019-03-17 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
17 mars 2019
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT02229383
Eligibility Diabetes Mellitus NCT02229383
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus NCT02229383
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
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])
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])
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])
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])
C0521143 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2,1])
C0521143 (UMLS CUI [2,2])