Racial group | Gender | Age
Item
1. subjects of any race and gender within the age range of 30 to 70 years.
boolean
C0034510 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Gender Childbearing Potential Absent | Amenorrhea Duration | Bilateral oophorectomy Postoperative Period | Hysterectomy | Tubal Ligation | Menopausal state | Follicle stimulating hormone measurement | Estradiol measurement
Item
2. all female subjects must be of non-child-bearing potential. for the purposes of this study, this is defined as the subject being amenorrheic for at least 12 consecutive months, or at least 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, or women who underwent tubal ligation. menopausal status will be confirmed by demonstrating levels of follicle stimulating hormone (fsh) 40 - 138 miu/ml and oestradiol < 20 pg/ml at entry, unless this information is available in the subject's medical record. in the event a subject's menopause status has been clearly established (for example, the subject indicates she has been amenorrheic for 10 years), but fsh and/or oestradiol levels are not consistent with a post-menopausal condition, determination of subject eligibility will be at the discretion of the principal investigator following consultation with the sponsor and medical monitor
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0278321 (UMLS CUI [3,1])
C0032790 (UMLS CUI [3,2])
C0020699 (UMLS CUI [4])
C0520483 (UMLS CUI [5])
C0025320 (UMLS CUI [6])
C0202022 (UMLS CUI [7])
C0337434 (UMLS CUI [8])
Gender | Partner | Barrier Contraception Double | Sexual Abstinence
Item
3. all male subjects must agree with their partners to use double-barrier birth control or abstinence while participating in the study and for 12 weeks following the last dose of study drug.
boolean
C0079399 (UMLS CUI [1])
C0682323 (UMLS CUI [2])
C0004764 (UMLS CUI [3,1])
C0205173 (UMLS CUI [3,2])
C0036899 (UMLS CUI [4])
Informed Consent
Item
4. willingness to provide written informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Glucohemoglobin measurement
Item
5. hba1c ≥ 7.5 and ≤ 10.5
boolean
C0202054 (UMLS CUI [1])
Glucose measurement, fasting
Item
6. fasting glucose ≥ 160 and ≤ 240 mg/dl
boolean
C0202045 (UMLS CUI [1])
Body mass index
Item
7. body mass index (bmi) ≥ 25.0 kg/m^2 and ≤ 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Metformin Dose Stable U/day
Item
8. on stable metformin medication for at least 3 months (≥ 1.0 g/day) prior to screening
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
HIV-1 Absent | HIV-2 Absent
Item
9. no prior history of hiv 1 or 2
boolean
C0019704 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0019707 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Hepatitis B Absent | Hepatitis C Absent
Item
10. absence of disease markers for hepatitis b & c virus
boolean
C0019163 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Disease Significant Absent | Laboratory test result abnormal Absent | Laboratory Procedures | Medical History | Physical Examination | End Organ function
Item
11. absence of significant disease or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or physical examination during the screening; normal end organ function
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0022885 (UMLS CUI [3])
C0262926 (UMLS CUI [4])
C0031809 (UMLS CUI [5])
C0444930 (UMLS CUI [6,1])
C0178784 (UMLS CUI [6,2])
C0031843 (UMLS CUI [6,3])
12 lead ECG Normal | Electrocardiogram abnormal Without Clinical Significance
Item
12. have a normal 12-lead ecg or one with abnormality considered to be clinically insignificant
boolean
C0430456 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0522055 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C2826293 (UMLS CUI [2,3])
Chest X-ray normal | Chest X-ray abnormal Without Clinical Significance
Item
13. have a normal chest x-ray (p. a. view) or one with abnormality considered to be clinically insignificant
boolean
C0239026 (UMLS CUI [1])
C0436503 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C2826293 (UMLS CUI [2,3])
Comprehension Study Protocol | Protocol Compliance
Item
14. comprehension of the nature and purpose of the study and compliance with the requirement of the entire protocol
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Illness Major | Chronic disease Independent of Diabetes
Item
1. any major illness in the past three months or any significant ongoing chronic medical illness not related to diabetes
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0332291 (UMLS CUI [2,2])
C0011847 (UMLS CUI [2,3])
Renal Insufficiency | Hepatic impairment | Creatinine measurement, serum | Gender | Elevated liver enzymes
Item
2. renal or liver impairment, defined as serum creatinine level of ≥ 1.4 mg/dl for females and ≥ 1.5 mg/dl for males, and greater than two times the upper limit of normal for liver enzymes, respectively.
boolean
C1565489 (UMLS CUI [1])
C0948807 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
C0235996 (UMLS CUI [5])
Gastrointestinal Diseases Influence Drug absorption | Exception Appendectomy
Item
3. history of or current gastro-intestinal diseases influencing drug absorption, except for appendectomy
boolean
C0017178 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0003611 (UMLS CUI [2,2])
Drug abuse | Benzodiazepines | Opioids | Amphetamines | Cocaine | Tetrahydrocannabinol
Item
4. history, within 3 years, of drug abuse (including benzodiazepines, opioids, amphetamine, cocaine, and thc)
boolean
C0013146 (UMLS CUI [1])
C0005064 (UMLS CUI [2])
C0242402 (UMLS CUI [3])
C0002667 (UMLS CUI [4])
C0009170 (UMLS CUI [5])
C0039663 (UMLS CUI [6])
Chronic Alcoholic Intoxication Duration | Moderate drinker | Alcohol consumption Recent
Item
5. history of alcoholism (more than two years), moderate drinkers (more than three drinks per day) or having consumed alcohol within 48 hrs prior to dosing [one drink is equal to one unit of alcohol (one glass wine, half pint beer, one measure of spirit)]
boolean
C0001973 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0337677 (UMLS CUI [2])
C0001948 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
Study Subject Participation Status
Item
6. participation in any clinical trial within the past three months
boolean
C2348568 (UMLS CUI [1])
Blood Donation Difficult | Access Via arm vein Difficult
Item
7. history of difficulty in donating blood or accessibility of veins in left or right arm
boolean
C0005794 (UMLS CUI [1,1])
C0332218 (UMLS CUI [1,2])
C0444454 (UMLS CUI [2,1])
C0442444 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
Blood Donation Unit Quantity
Item
8. donation of blood (one unit or 350 ml) within three months prior to receiving the first dose of test material
boolean
C0005794 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Pharmacotherapy | Exception Pharmaceutical Preparations Dose Stable Discontinued | Absence Medical contraindication Metformin
Item
9. use of any prescription drug therapy, with exception of any prescription medication administered at a stable dose for at least 6 weeks prior to screening, provided the medication is not contraindicated by the metformin label
boolean
C0013216 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
C1444662 (UMLS CUI [2,5])
C0332197 (UMLS CUI [3,1])
C1301624 (UMLS CUI [3,2])
C0025598 (UMLS CUI [3,3])
Antidiabetics Alternate | Exception Metformin
Item
10. use of any alternate anti-diabetic therapy, except metformin, within three months of enrollment
boolean
C0935929 (UMLS CUI [1,1])
C0332270 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])