Eligibility Diabetes Mellitus, Type 2 NCT00641043

1 Formulários

StudyEvent: Eligibility
1. Eligibility Diabetes Mellitus, Type 2 NCT00641043

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Informed Consent Date of visit

Item

1. signed and dated written informed consent (ic) by date of visit 1a in accordance with good clinical practice (gcp) and local legislation

boolean

C0021430 (UMLS CUI [1,1])
C1320303 (UMLS CUI [1,2])

Diabetes Mellitus, Non-Insulin-Dependent | Therapy naive | Oral hypoglycemic | Antidiabetics unchanged

Item

2. patients with a diagnosis of type 2 diabetes mellitus and treatment naive or previously treated with any oral hypoglycaemic agent; antidiabetic therapy has to be unchanged for ten weeks prior to informed consent.

boolean

C0011860 (UMLS CUI [1])
C0919936 (UMLS CUI [2])
C0359086 (UMLS CUI [3])
C0935929 (UMLS CUI [4,1])
C0442739 (UMLS CUI [4,2])

Glucohemoglobin measurement

Item

3. glycosylated haemoglobin a1 (hba1c) 7.5-11% at visit 2 (start of run-in).

boolean

C0202054 (UMLS CUI [1])

Age

Item

4. male and female patients aged > or = 18 and < or = to 80 years at visit 1a (screening).

boolean

C0001779 (UMLS CUI [1])

Body mass index

Item

5. body mass index (bmi) < or = 40 kg/m2 at visit 1a (screening)

boolean

C1305855 (UMLS CUI [1])

Informed Consent

Item

6. signed and dated written informed consent prior to admission to the study in accordance with gcp and local legislation.

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack

Item

1. myocardial infarction, stroke or transient isquemic atack (tia) within 6 months prior to inform consent (ic)

boolean

C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])

Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase serum increased

Item

2. impaired hepatic function, defined by serum levels of either alanine aminotransferase (alt), aspartate aminotransferase (ast), or alkaline phosphatase above 3 x upper limit of normal (uln) determined at visit 1a.

boolean

C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0750857 (UMLS CUI [4])

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient | Hypersensitivity Pioglitazone hydrochloride | Hypersensitivity Pioglitazone hydrochloride Excipient

Item

3. known hypersensitivity or allergy to the investigational product or its excipients and/or to hydrochloride of pioglitazone or its excipients

boolean

C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0872972 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0872972 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])

GLP-1 Analogue | GLP-1 Receptor Agonist

Item

4. treatment with glucagon-like peptide-1 (glp-1) analogue / agonist within 3 months prior to ic.

boolean

C3273809 (UMLS CUI [1])
C2917359 (UMLS CUI [2])

Insulin

Item

5. treatment with insulin within 3 months prior to ic

boolean

C0021641 (UMLS CUI [1])

Anti-Obesity Agents

Item

6. treatment with anti-obesity drugs 3 months prior to ic.

boolean

C0376607 (UMLS CUI [1])

Alcohol abuse Interferes with Study Subject Participation Status | Alcohol abuse Interferes with Drug abuse

Item

7. alcohol abuse within the 3 months prior to ic that would interfere with trial participation or drug abuse.

boolean

C0085762 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0085762 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0013146 (UMLS CUI [2,3])

Study Subject Participation Status | Investigational New Drugs

Item

8. participation in another trial with an investigational drug within 2 months prior to ic.

boolean

C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])

Fasting blood glucose measurement

Item

9. fasting blood glucose > 240 mg/dl (=13.3 mmol/l) at screening (visit 1).

boolean

C0428568 (UMLS CUI [1])

Premenopausal state | Timepoint Menstruation Last

Item

10. pre-menopausal women (last menstruation < or =1 year prior to signing ic) who:

boolean

C0232969 (UMLS CUI [1])
C2348792 (UMLS CUI [2,1])
C0025344 (UMLS CUI [2,2])
C1517741 (UMLS CUI [2,3])

Breast Feeding | Pregnancy

Item

are nursing or pregnant,

boolean

C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])

Item

or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. acceptable methods of birth control include transdermal patch, intra uterine devices/systems (iuds/iuss), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. no exception will be made.

boolean

C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
C0332182 (UMLS CUI [2,3])
C1705116 (UMLS CUI [2,4])
C1168146 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0009905 (UMLS CUI [5])
C0700589 (UMLS CUI [6,1])
C0021102 (UMLS CUI [6,2])
C0700589 (UMLS CUI [7,1])
C0086466 (UMLS CUI [7,2])
C0036899 (UMLS CUI [8])
C2035056 (UMLS CUI [9])

Systemic steroids | Thyroid Hormones Medication dose changed

Item

11. treatment with systemic steroids or change in the dosage of thyroid hormone within six weeks prior to ic

boolean

C2825233 (UMLS CUI [1])
C0040135 (UMLS CUI [2,1])
C1608430 (UMLS CUI [2,2])

Heart failure New York Heart Association Classification | Heart failure

Item

12. heart failure new york heart asociation (nyha) class i-iv, or history of heart failure.

boolean

C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2])

Diabetic Ketoacidosis

Item

13. diabetic ketoacidosis within 6 months prior to ic.

boolean

C0011880 (UMLS CUI [1])

Hemodialysis | Thiazolidinediones Experience Limited

Item

14. hemodialyzed patients due to limited experience with thiazolidinediones (tzds)

boolean

C0019004 (UMLS CUI [1])
C1257987 (UMLS CUI [2,1])
C0596545 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])

Medical condition Preventing Completion of clinical trial | Medical condition Preventing Administration BI 1356 | Medical condition Preventing Administration Pioglitazone

Item

15. any other clinical condition wich, in the opinion of the investigator, would not alow safe completion of the protocol and safe administration of bi1356 and pioglitazone.

boolean

C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C1533734 (UMLS CUI [2,3])
C2352547 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C1533734 (UMLS CUI [3,3])
C0071097 (UMLS CUI [3,4])

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Eligibility Diabetes Mellitus, Type 2 NCT00641043