Criteria Fulfill
Item
subjects meeting the following criteria at the screening visit will be eligible to participate in the trial:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Informed Consent
Item
have given written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
ages 18 to 75 years, inclusive
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus disease length
Item
diagnosis of type 2 diabetes mellitus of at least 3 months duration
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Glycosylated hemoglobin A
Item
hba1c 7.0- 10.0%, inclusive
boolean
C0019018 (UMLS CUI [1])
Antidiabetics | Antidiabetics Oral | Antidiabetics To be stopped
Item
antidiabetic treatment may include oral agents; all antidiabetic agents must be withdrawn before randomization
boolean
C0935929 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0935929 (UMLS CUI [3,1])
C1272691 (UMLS CUI [3,2])
Gender Serum pregnancy test (B-HCG) Negative | Breast Feeding Absent | Planned Pregnancy Absent | Hysterectomy | Tubal Ligation | Postmenopausal state | Gender Contraceptive methods | Oral contraception | Injectable contraception | Hormonal contraception Implantable | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Sexual Abstinence Unacceptable | Partner Condom Unacceptable | Partner had vasectomy Unacceptable
Item
women may be enrolled if they are not pregnant (negative serum βhcg at the screening visit), are not breast-feeding, and do not plan to become pregnant during the trial. in addition, they must either have had a hysterectomy or tubal ligation at least 6 months before signing informed consent, be post-menopausal for 1 year, or practicing an acceptable method of birth control. an acceptable method of birth control may be oral, injectable or implantable hormonal contraceptives, intrauterine device, diaphragm plus spermicide, or female condom plus spermicide. abstinence, partner's use of condoms, and partner's vasectomy are not acceptable methods of contraception
boolean
C0079399 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0032992 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0020699 (UMLS CUI [4])
C0520483 (UMLS CUI [5])
C0232970 (UMLS CUI [6])
C0079399 (UMLS CUI [7,1])
C0700589 (UMLS CUI [7,2])
C0029151 (UMLS CUI [8])
C1262153 (UMLS CUI [9])
C2985296 (UMLS CUI [10,1])
C0021102 (UMLS CUI [10,2])
C0021900 (UMLS CUI [11])
C0042241 (UMLS CUI [12])
C0087145 (UMLS CUI [13])
C0221829 (UMLS CUI [14])
C0036899 (UMLS CUI [15,1])
C1883420 (UMLS CUI [15,2])
C0682323 (UMLS CUI [16,1])
C0677582 (UMLS CUI [16,2])
C1883420 (UMLS CUI [16,3])
C0420842 (UMLS CUI [17,1])
C1883420 (UMLS CUI [17,2])
Body mass index
Item
bmi 25 - 45 kg/m sq, inclusive
boolean
C1305855 (UMLS CUI [1])
Criteria None
Item
subjects are excluded from participation in the study if any of the following criteria apply:
boolean
C0243161 (UMLS CUI [1,1])
C0549184 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent | Diabetic Ketoacidosis
Item
type 1 diabetes mellitus or history of diabetic ketoacidosis
boolean
C0011854 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
Antilipemic agent Unstable | Antihypertensive Agents Unstable
Item
treatment with lipid or blood pressure lowering therapy that has not been stable for three months before randomization
boolean
C0086440 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Welchol | Cholestyramine | Colestipol | Therapeutic procedure Hyperlipidemia
Item
treatment with welchol, cholestyramine or colestipol for hyperlipidemia within the last 3 months
boolean
C0939530 (UMLS CUI [1])
C0008402 (UMLS CUI [2])
C0009279 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0020473 (UMLS CUI [4,2])
Thiazolidinediones
Item
treatment with thiazolidinediones
boolean
C1257987 (UMLS CUI [1])
Deglutition Disorders | Swallowing problem | Motility disorder of intestine
Item
history of dysphagia, swallowing disorders, or intestinal motility disorder
boolean
C0011168 (UMLS CUI [1])
C0392678 (UMLS CUI [2])
C0400865 (UMLS CUI [3])
Serum Triglyceride Measurement
Item
serum triglyceride >500 mg/dl at visit 1
boolean
C0542495 (UMLS CUI [1])
Low density lipoprotein cholesterol measurement
Item
serum ldl-c <60 mg/dl at visit 1
boolean
C0202117 (UMLS CUI [1])
Condition At risk Study Subject | Therapeutic procedure At risk Study Subject | Condition Study Subject Participation Status Unfavorable | Therapeutic procedure Study Subject Participation Status Unfavorable
Item
any condition or therapy which, in the opinion of the investigator, poses a risk to the subject or makes participation not in the subject's best interest
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0681850 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C3640815 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C3640815 (UMLS CUI [4,3])
Investigational New Drugs
Item
use of any investigational drug within 30 days before randomization
boolean
C0013230 (UMLS CUI [1])
Adrenal Cortex Hormones Oral chronic
Item
chronic treatment with oral corticosteroids
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
Hyperthyroidism | Thyroid Hormones | Thyroxine
Item
history of hyperthyroidism and/or treatment with thyroid hormone/ levothyroxine
boolean
C0020550 (UMLS CUI [1])
C0040135 (UMLS CUI [2])
C0040165 (UMLS CUI [3])