ID

29108

Beschreibung

Efficacy vs Placebo as Initial Combination Therapy With Pioglitazone; ODM derived from: https://clinicaltrials.gov/show/NCT00641043

Link

https://clinicaltrials.gov/show/NCT00641043

Stichworte

Versionen (1)
  1. 25.02.18 25.02.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

25. Februar 2018

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00641043

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT00641043

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. signed and dated written informed consent (ic) by date of visit 1a in accordance with good clinical practice (gcp) and local legislation
Beschreibung

Informed Consent Date of visit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1320303
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.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0919936
UMLS CUI [3]
C0359086
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C0442739
3. glycosylated haemoglobin a1 (hba1c) 7.5-11% at visit 2 (start of run-in).
Beschreibung

Glucohemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202054
4. male and female patients aged > or = 18 and < or = to 80 years at visit 1a (screening).
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
5. body mass index (bmi) < or = 40 kg/m2 at visit 1a (screening)
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
6. signed and dated written informed consent prior to admission to the study in accordance with gcp and local legislation.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. myocardial infarction, stroke or transient isquemic atack (tia) within 6 months prior to inform consent (ic)
Beschreibung

Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
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.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0750857
3. known hypersensitivity or allergy to the investigational product or its excipients and/or to hydrochloride of pioglitazone or its excipients
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0015237
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0872972
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0872972
UMLS CUI [4,3]
C0015237
4. treatment with glucagon-like peptide-1 (glp-1) analogue / agonist within 3 months prior to ic.
Beschreibung

GLP-1 Analogue | GLP-1 Receptor Agonist

Datentyp

boolean

Alias
UMLS CUI [1]
C3273809
UMLS CUI [2]
C2917359
5. treatment with insulin within 3 months prior to ic
Beschreibung

Insulin

Datentyp

boolean

Alias
UMLS CUI [1]
C0021641
6. treatment with anti-obesity drugs 3 months prior to ic.
Beschreibung

Anti-Obesity Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0376607
7. alcohol abuse within the 3 months prior to ic that would interfere with trial participation or drug abuse.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0085762
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0013146
8. participation in another trial with an investigational drug within 2 months prior to ic.
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
9. fasting blood glucose > 240 mg/dl (=13.3 mmol/l) at screening (visit 1).
Beschreibung

Fasting blood glucose measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0428568
10. pre-menopausal women (last menstruation < or =1 year prior to signing ic) who:
Beschreibung

Premenopausal state | Timepoint Menstruation Last

Datentyp

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2,1]
C2348792
UMLS CUI [2,2]
C0025344
UMLS CUI [2,3]
C1517741
are nursing or pregnant,
Beschreibung

Breast Feeding | Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
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.
Beschreibung

Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Tests Periodic Refused | Transdermal contraception | Intrauterine Devices | Contraceptives, Oral | Contraceptive methods Implants | Contraceptive methods Injectables | Sexual Abstinence | Partner had vasectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032976
UMLS CUI [2,3]
C0332182
UMLS CUI [2,4]
C1705116
UMLS CUI [3]
C1168146
UMLS CUI [4]
C0021900
UMLS CUI [5]
C0009905
UMLS CUI [6,1]
C0700589
UMLS CUI [6,2]
C0021102
UMLS CUI [7,1]
C0700589
UMLS CUI [7,2]
C0086466
UMLS CUI [8]
C0036899
UMLS CUI [9]
C2035056
11. treatment with systemic steroids or change in the dosage of thyroid hormone within six weeks prior to ic
Beschreibung

Systemic steroids | Thyroid Hormones Medication dose changed

Datentyp

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2,1]
C0040135
UMLS CUI [2,2]
C1608430
12. heart failure new york heart asociation (nyha) class i-iv, or history of heart failure.
Beschreibung

Heart failure New York Heart Association Classification | Heart failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0018801
13. diabetic ketoacidosis within 6 months prior to ic.
Beschreibung

Diabetic Ketoacidosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0011880
14. hemodialyzed patients due to limited experience with thiazolidinediones (tzds)
Beschreibung

Hemodialysis | Thiazolidinediones Experience Limited

Datentyp

boolean

Alias
UMLS CUI [1]
C0019004
UMLS CUI [2,1]
C1257987
UMLS CUI [2,2]
C0596545
UMLS CUI [2,3]
C0439801
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.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C1533734
UMLS CUI [2,4]
C2352547
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C1533734
UMLS CUI [3,4]
C0071097
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT00641043

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
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])
Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Tests Periodic Refused | Transdermal contraception | Intrauterine Devices | Contraceptives, Oral | Contraceptive methods Implants | Contraceptive methods Injectables | Sexual Abstinence | Partner had vasectomy
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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