diabetes mellitus
Item
diagnosis of type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
pain due to diabetic peripheral polyneuropathy
Item
pain for at least 6 months prior to randomization that the investigator attributes to diabetic peripheral polyneuropathy
boolean
C2673754 (UMLS CUI [1,1])
C2673754 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
nerve conduction studies and quantitative sensory testing
Item
two sets of baseline nerve conduction studies and quantitative sensory testing
boolean
C0200125 (UMLS CUI [1])
C0430838 (UMLS CUI [2])
HbA1c
Item
hba1c =< 9%
boolean
C0019018 (UMLS CUI [1])
diabetes controlled
Item
diabetes controlled on stable regimen
boolean
C3274787 (UMLS CUI [1])
postmenopausal or contraceptive use
Item
female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)
boolean
C0232970 (UMLS CUI [1])
C1999124 (UMLS CUI [2])
diabetes mellitus type I
Item
diagnosis of type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
polyneuropathy
Item
polyneuropathy due to other underlying causes
boolean
C0152025 (UMLS CUI [1])
hospitalization due to episodes of hyper/hypoglycemia
Item
hospitalization within the past 3 months due to episodes of hyper/hypoglycemia
boolean
C0019993 (UMLS CUI [1,1])
C0020456 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0020615 (UMLS CUI [2,2])
other unstable medical conditions
Item
other unstable medical conditions
boolean
C3843040 (UMLS CUI [1])
history of suicidal attempts
Item
history of suicidal attempts
boolean
C0038663 (UMLS CUI [1])
exposure to any other experimental drugs
Item
exposure to any other experimental drugs or device within the past 30 days
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])