Diabetes Mellitus, Non-Insulin-Dependent
Item
t2dm more than 12 monthm
boolean
C0011860 (UMLS CUI [1])
Age
Item
age ≥18 and ≤70 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index between 18.0 and 35.0 kg/m2 inclusive.
boolean
C1305855 (UMLS CUI [1])
Healthy | Medical History | Physical Examination | Biochemical finding
Item
considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the investigator.
boolean
C3898900 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0428132 (UMLS CUI [4])
Females | Pregnancy | Breast Feeding | Female Sterilization | Tubal Occlusion | Hysterectomy | bilateral salpingectomy | Bilateral oophorectomy | Postmenopausal state | Males | Male sterilization | Sexual Abstinence | Childbearing Potential | Contraceptive methods
Item
females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for >12 months. males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of study drug.
boolean
C0086287 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
C0041275 (UMLS CUI [5])
C0020699 (UMLS CUI [6])
C2243030 (UMLS CUI [7])
C0278321 (UMLS CUI [8])
C0232970 (UMLS CUI [9])
C0086582 (UMLS CUI [10])
C0024559 (UMLS CUI [11])
C0036899 (UMLS CUI [12])
C3831118 (UMLS CUI [13])
C0700589 (UMLS CUI [14])
Informed Consent | Research Activities
Item
signed and dated informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject).
boolean
C0021430 (UMLS CUI [1])
C0242481 (UMLS CUI [2])
Inclusion | Diabetes Mellitus, Non-Insulin-Dependent
Item
inclusion criteria for t2dm:
boolean
C1512693 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent
Item
t1dm more than 12 monthm
boolean
C0011854 (UMLS CUI [1])
Age
Item
age ≥18 and ≤70 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index between 18.0 and 30.0 kg/m2 inclusive.
boolean
C1305855 (UMLS CUI [1])
Healthy | Medical History | Physical Examination | Biochemical finding
Item
considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the investigator.
boolean
C3898900 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0428132 (UMLS CUI [4])
Females | Pregnancy | Breast Feeding | Female Sterilization | Tubal Occlusion | Hysterectomy | bilateral salpingectomy | Bilateral oophorectomy | Postmenopausal state | Males | Male sterilization | Sexual Abstinence | Childbearing Potential | Contraceptive methods
Item
females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for >12 months. males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of study drug.
boolean
C0086287 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
C0041275 (UMLS CUI [5])
C0020699 (UMLS CUI [6])
C2243030 (UMLS CUI [7])
C0278321 (UMLS CUI [8])
C0232970 (UMLS CUI [9])
C0086582 (UMLS CUI [10])
C0024559 (UMLS CUI [11])
C0036899 (UMLS CUI [12])
C3831118 (UMLS CUI [13])
C0700589 (UMLS CUI [14])
informed consent | Research Activities
Item
signed and dated informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject).
boolean
C0021430 (UMLS CUI [1])
C0242481 (UMLS CUI [2])
Proliferative retinopathy | Disorder of macula of retina Proliferative | Gastroparesis Severe | Neuropathy Severe | Autonomic neuropathy
Item
a subject who has proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator
boolean
C0339467 (UMLS CUI [1])
C0730362 (UMLS CUI [2,1])
C0334094 (UMLS CUI [2,2])
C0152020 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0442874 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0259749 (UMLS CUI [5])
Hypoglycemia Major Recurrent | Hypoglycemia unawareness | Ketoacidosis Recent
Item
recurrent major hypoglycemia or hypoglycemic unawareness or recent ketoacidosis
boolean
C0020615 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C2945760 (UMLS CUI [1,3])
C0342317 (UMLS CUI [2])
C0220982 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status
Item
participation in an investigational study within 30 days prior to dosing
boolean
C2348568 (UMLS CUI [1])
Electrocardiogram abnormal
Item
clinically significant abnormal ecg at screening, as judged by the investigator
boolean
C0522055 (UMLS CUI [1])