Eligibility Type 2 Diabetes Mellitus NCT00361153

1 moduli

StudyEvent: Eligibility
1. Eligibility Type 2 Diabetes Mellitus NCT00361153

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

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antidiabetic treatment may include oral agents; all antidiabetic agents must be withdrawn before randomization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])

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])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

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])

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Eligibility Type 2 Diabetes Mellitus NCT00361153