Eligibility Diabetes Mellitus, Type 2 NCT01438814

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StudyEvent: Eligibility
1. Eligibility Diabetes Mellitus, Type 2 NCT01438814

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Diabetes Mellitus, Non-Insulin-Dependent

Item

1. diagnosis of type 2 diabetes mellitus (t2dm) prior to informed consent;

boolean

C0011860 (UMLS CUI [1])

Item

2. male and female patients on diet and exercise regimen who are drug naive, defined as absence of any oral antidiabetic therapy or insulin for 12 weeks prior to randomization

boolean

C0079399 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0935929 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0021641 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])

Hemoglobin A1c measurement

Item

3. glycosylated haemoglobin a1c (hba1c) >/= 7.0% (53 mmol/mol) to </= 10.0% (86 mmol/mol) at visit 1 (screening);

boolean

C0474680 (UMLS CUI [1])

Age

Item

4. age>/=18 and </=80 years at visit 1(screening);

boolean

C0001779 (UMLS CUI [1])

Body mass index

Item

5. body mass index (bmi)</= 45kg/m2 at visit 1 (screening);

boolean

C1305855 (UMLS CUI [1])

Informed Consent

Item

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

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Hyperglycemia Uncontrolled | Glucose level | Status post Overnight Fasting

Item

1. uncontrolled hyperglycaemia with a glucose level >240 mg/dl (13.3mmol/l) after an overnight fast during screening/placebo run-in and confirmed by a second measurement (not on the same day);

boolean

C0020456 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0428548 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0439583 (UMLS CUI [3,2])
C0015663 (UMLS CUI [3,3])

Antidiabetics Oral | Insulin

Item

2. treatment with any oral antidiabetic drug or insulin within 12 weeks prior to randomization

boolean

C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2])

Item

3. acute coronary syndrome (non-stemi, stemi and unstable angina pectoris),stroke or transient ischemia attack (tia) within 3 months prior to informed consent;

boolean

C0948089 (UMLS CUI [1])
C1561921 (UMLS CUI [2])
C1536220 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])

Indication Liver disease | Indication Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised

Item

4. indication of liver disease/impaired hepatic function, defined by serum levels of either aspartate aminotransferase (alt or sgpt), alanine aminotransferase (ast or sgot), or alkaline phosphatase above 3 x upper limit of normal (uln) as determined at visit 1 and/or run-in phase,

boolean

C3146298 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0086565 (UMLS CUI [2,2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0151849 (UMLS CUI [5])

Renal Insufficiency | Estimated Glomerular Filtration Rate | Renal Insufficiency Moderate MDRD | Renal Insufficiency Severe MDRD

Item

5. impaired renal function, defined as egfr< 60ml/min (moderate or severe renal impairment, modification of diet in renal disease (mdrd) formula) as determined during screening or at run-in phase

boolean

C1565489 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
C1565489 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C3839656 (UMLS CUI [3,3])
C1565489 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C3839656 (UMLS CUI [4,3])

Bariatric Surgery | Gastrointestinal Surgical Procedure Inducing Malabsorption chronic

Item

6. bariatric surgery within the past two years and other gastrointestinal surgeries that induced chronic malabsorption

boolean

C1456587 (UMLS CUI [1])
C0524722 (UMLS CUI [2,1])
C0205263 (UMLS CUI [2,2])
C3714745 (UMLS CUI [2,3])
C0205191 (UMLS CUI [2,4])

History of malignant neoplasm | Exception Basal cell carcinoma | Cancer treatment

Item

7. medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years

boolean

C0455471 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0920425 (UMLS CUI [3])

Item

8. blood dyscrasia or any other disorders causing haemolysis or unstable red blood cell (eg. malaria, babesiosis, haemolytic anemia)

boolean

C0018939 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0019054 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C0014792 (UMLS CUI [3,3])
C0443343 (UMLS CUI [3,4])
C0024530 (UMLS CUI [4])
C0004576 (UMLS CUI [5])
C0002878 (UMLS CUI [6])

Pancreatitis | Pancreatitis, Chronic

Item

9. known history of pancreatitis and chronic pancreatitis

boolean

C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])

Medical contraindication Metformin

Item

10. contraindications to metformin according to the local label

boolean

C1301624 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])

Anti-Obesity Agents | Treatment Inducing Body Weight Unstable | Operative Surgical Procedures | Diet therapy Aggressive

Item

11. treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen etc) leading to unstable body weight

boolean

C0376607 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205263 (UMLS CUI [2,2])
C0005910 (UMLS CUI [2,3])
C0443343 (UMLS CUI [2,4])
C0543467 (UMLS CUI [3])
C0012159 (UMLS CUI [4,1])
C0580822 (UMLS CUI [4,2])

Systemic steroids | Thyroid Hormones Dosage Change | Endocrine System Disease Uncontrolled | Exception Non-Insulin-Dependent Diabetes Mellitus

Item

12. current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except t2dm

boolean

C2825233 (UMLS CUI [1])
C0040135 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0014130 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0011860 (UMLS CUI [4,2])

Premenopausal state

Item

13. pre-menopausal women (last menstruation less than 1 year prior to informed consent) who:

boolean

C0232969 (UMLS CUI [1])

Breast Feeding | Pregnancy

Item

1. are nursing or pregnant or

boolean

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

Item

2. 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 or who do not agree to continue contraception for at least 30 days after the last dose of study drug. acceptable methods of birth control include tubal ligation, transdermal patch, intra-uterine devices/systems(iuds/iuss), oral, implantable, or injectable contraceptives, complete sexual abstinence (if acceptable by local authorities), double barrier method and vasectomized partner.

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])
C0558080 (UMLS CUI [2,3])
C0520483 (UMLS CUI [3])
C2135981 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0009905 (UMLS CUI [6])
C3837145 (UMLS CUI [7])
C1262153 (UMLS CUI [8])
C0036899 (UMLS CUI [9])
C0004764 (UMLS CUI [10,1])
C0205173 (UMLS CUI [10,2])
C0420842 (UMLS CUI [11])

Substance Use Disorder Interferes with Study Subject Participation Status | Condition Limiting Protocol Compliance

Item

14. alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake

boolean

C0038586 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])

Study Subject Participation Status | Investigational New Drugs

Item

15. participation in another trial with application of any investigational drug within 30 days prior to informed consent

boolean

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

Study Subject Participation Status | Medical condition At risk Patient safety

Item

16. any other clinical condition that would jeopardize patients safety while participating in this trial

boolean

C2348568 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])

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Eligibility Diabetes Mellitus, Type 2 NCT01438814