Eligibility Diabetes Mellitus, Type 2 NCT01708902

1 Formulários

StudyEvent: Eligibility
1. Eligibility Diabetes Mellitus, Type 2 NCT01708902

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])

Gender | Diet therapy | Exercise | Pharmaceutical Preparations Absent

Item

2. male and female patients on diet and exercise regimen who are drug-naïve

boolean

C0079399 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])

Hemoglobin A1c measurement | Group Main | Group Additional

Item

3. glycosylated haemoglobin a1c (hba1c) at v1a >/=7.5 %<11% for main group and hba1c >/= 11.0 % for the additional parallel group

boolean

C0474680 (UMLS CUI [1])
C0441833 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C0441833 (UMLS CUI [3,1])
C1524062 (UMLS CUI [3,2])

Age

Item

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

boolean

C0001779 (UMLS CUI [1])

Body mass index

Item

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

boolean

C1305855 (UMLS CUI [1])

Informed Consent

Item

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

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Hyperglycemia Uncontrolled | Pharmaceutical Preparations Required

Item

1. uncontrolled hyperglycaemia required for rescue medication during placebo run-in phase

boolean

C0020456 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])

Compliance Percentage Investigational New Drugs

Item

2. in main group, the patients with investigational medicinal product(imp) compliance < 80 % or >120 % during 2 weeks placebo run in period

boolean

C1321605 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])

Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack

Item

3. acute coronary syndrome stroke or transient ischaemic attack (tia) within 3 months prior to randomisation

boolean

C0948089 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])

Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised | Serum total bilirubin measurement

Item

4. impaired hepatic function, defined by serum levels of either alanine aminotransferase(alt) ,aspartate aminotransferase(ast), or alkaline phosphatase (ap) above 3 x upper limit of normal (uln) ,or total bilirubin above 1.5 x uln as determined at visit 1a

boolean

C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151849 (UMLS CUI [4])
C1278039 (UMLS CUI [5])

Hypersensitivity Linagliptin | Hypersensitivity Linagliptin Excipient | Metformin allergy | Hypersensitivity Placebo

Item

5. known hypersensitivity or allergy to linagliptin or its excipients or metformin or placebo

boolean

C0020517 (UMLS CUI [1,1])
C2746078 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2746078 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0571648 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0032042 (UMLS CUI [4,2])

Anti-Obesity Agents | Therapeutic procedure Any

Item

6. treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening

boolean

C0376607 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])

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

Item

7. alcohol or drug abuse within the 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 in the opinion of the investigator.

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 | Therapies, Investigational

Item

8. concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form or during the trial.

boolean

C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])

Premenopausal state | Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Absent

Item

9. pre-menopausal women (last menstruation </= 1 year prior to informed consent) who are nursing or pregnant 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

boolean

C0232969 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])

Systemic steroids | Thyroid Hormones Dose Change

Item

10. current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.

boolean

C2825233 (UMLS CUI [1])
C0040135 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])

Kidney Failure | Renal Insufficiency | Estimated Glomerular Filtration Rate

Item

11. renal failure or renal impairment at visit 1a (screening) with an estimated glomerular filtration rate(egfr) < 60 ml/min

boolean

C0035078 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C3811844 (UMLS CUI [3])

Bariatric Surgery | Gastrointestinal Surgical Procedure Inducing Malabsorption chronic

Item

12. bariatric surgery within the past two years and other gastrointestinal surgeries that induce 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])

Dehydration

Item

13. dehydration by clinical judgement of the investigator

boolean

C0011175 (UMLS CUI [1])

Congestive heart failure Unstable | Congestive heart failure

Item

14. clinical detected unstable or acute congestive heart failure

boolean

C0018802 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])

Metabolic acidosis | Chronic metabolic acidosis

Item

15. acute or chronic metabolic acidosis (present in patient history)

boolean

C0220981 (UMLS CUI [1])
C0740749 (UMLS CUI [2])

Galactosemia Hereditary

Item

16. hereditary galactose intolerance

boolean

C0016952 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])

History of pancreatitis | Pancreatitis, Chronic

Item

17. known history of pancreatitis and chronic pancreatitis

boolean

C3887021 (UMLS CUI [1])
C0149521 (UMLS CUI [2])

Cancer History | Exception Basal cell carcinoma | Cancer treatment

Item

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

boolean

C1512706 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0920425 (UMLS CUI [3])

Study Subject Participation Status | Other medical condition At risk Patient safety

Item

19. any other clinical condition that would jeopardize patients safety while participating in this clinical trial at the discretion of investigator

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 NCT01708902