ID

29099

Beskrivning

A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00449605

Länk

https://clinicaltrials.gov/show/NCT00449605

Nyckelord

Versioner (1)
  1. 2018-02-24 2018-02-24 -
Rättsinnehavare

See clinicaltrials.gov

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24 februari 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00449605

Engelsk

Eligibility Diabetes Mellitus, Type 2 NCT00449605

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with legal age
Beskrivning

Age Legal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1301860
body mass index >27kg/m2
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
type 2 diabetes as defined by who criteria, treated with metformin for at least 6 months and with a stable dose of metformin >=1500 mg/day for at least three months
Beskrivning

Non-Insulin-Dependent Diabetes Mellitus WHO classification | Metformin | Metformin Dose Stable U/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C4267671
UMLS CUI [2]
C0025598
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [3,4]
C0456683
hba1c >=7% and <=9% at screening visit
Beskrivning

Glucohemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202054
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
weight loss > 5 kg within three months prior to screening
Beskrivning

Weight decreased Quantity Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0449238
presence of any clinically significant endocrine disease according to the investigator
Beskrivning

Endocrine System Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0014130
presence of type 1 diabetes
Beskrivning

Diabetes Mellitus, Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
presence or history of cancer within the past 5 years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer
Beskrivning

Malignant Neoplasms | Exception Basal cell carcinoma Localized Treated | Exception Carcinoma in situ of uterine cervix Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C0392752
UMLS CUI [2,4]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1522326
previous participation in a clinical study with rimonabant
Beskrivning

Study Subject Participation Status | rimonabant

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1142933
absence of effective medical contraceptive method for females of childbearing potential
Beskrivning

Childbearing Potential Contraceptive methods Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
within 3 months prior to screening visit: use of oral antidiabetic drugs (other than metformin) and/or insulin, of anti-obesity drugs or other drugs for weight reduction
Beskrivning

Antidiabetics Oral | Exception Metformin | Insulin | Anti-Obesity Agents | Weight-Loss Agents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
UMLS CUI [3]
C0021641
UMLS CUI [4]
C0376607
UMLS CUI [5]
C0376606
within 2 months prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment
Beskrivning

CORTICOSTEROIDS FOR SYSTEMIC USE Active Long-term | CORTICOSTEROIDS SYSTEMIC Use Prolonged | Lipid-lowering therapy Change

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3653708
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0443252
UMLS CUI [2,1]
C3653708
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C0439590
UMLS CUI [3,1]
C0585943
UMLS CUI [3,2]
C0392747
presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the investigator would compromise the patient's safety or successful participation in the study, including uncontrolled serious psychiatric illness
Beskrivning

Medical condition Severe compromises Patient safety | Medical condition Severe compromises Study Subject Participation Status | Severe Mental Disorders compromise Patient safety | Severe Mental Disorders compromise Study Subject Participation Status | Chronic disease compromises Patient safety | Chronic disease compromises Study Subject Participation Status | Chronic infectious disease compromises Patient safety | Chronic infectious disease compromises Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C1113679
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C2348568
UMLS CUI [3,1]
C4046029
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C1113679
UMLS CUI [4,1]
C4046029
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C2348568
UMLS CUI [5,1]
C0008679
UMLS CUI [5,2]
C2945640
UMLS CUI [5,3]
C1113679
UMLS CUI [6,1]
C0008679
UMLS CUI [6,2]
C2945640
UMLS CUI [6,3]
C2348568
UMLS CUI [7,1]
C0151317
UMLS CUI [7,2]
C2945640
UMLS CUI [7,3]
C1113679
UMLS CUI [8,1]
C0151317
UMLS CUI [8,2]
C2945640
UMLS CUI [8,3]
C2348568
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beskrivning

Study Subject Participation Status Aspect Additional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1879746
UMLS CUI [1,3]
C1524062
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00449605

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age Legal
Item
patients with legal age
boolean
C0001779 (UMLS CUI [1,1])
C1301860 (UMLS CUI [1,2])
Body mass index
Item
body mass index >27kg/m2
boolean
C1305855 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus WHO classification | Metformin | Metformin Dose Stable U/day
Item
type 2 diabetes as defined by who criteria, treated with metformin for at least 6 months and with a stable dose of metformin >=1500 mg/day for at least three months
boolean
C0011860 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0456683 (UMLS CUI [3,4])
Glucohemoglobin measurement
Item
hba1c >=7% and <=9% at screening visit
boolean
C0202054 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Weight decreased Quantity Duration
Item
weight loss > 5 kg within three months prior to screening
boolean
C1262477 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Endocrine System Diseases
Item
presence of any clinically significant endocrine disease according to the investigator
boolean
C0014130 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
presence of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Malignant Neoplasms | Exception Basal cell carcinoma Localized Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
presence or history of cancer within the past 5 years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0392752 (UMLS CUI [2,3])
C1522326 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Study Subject Participation Status | rimonabant
Item
previous participation in a clinical study with rimonabant
boolean
C2348568 (UMLS CUI [1])
C1142933 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent
Item
absence of effective medical contraceptive method for females of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Antidiabetics Oral | Exception Metformin | Insulin | Anti-Obesity Agents | Weight-Loss Agents
Item
within 3 months prior to screening visit: use of oral antidiabetic drugs (other than metformin) and/or insulin, of anti-obesity drugs or other drugs for weight reduction
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C0021641 (UMLS CUI [3])
C0376607 (UMLS CUI [4])
C0376606 (UMLS CUI [5])
CORTICOSTEROIDS FOR SYSTEMIC USE Active Long-term | CORTICOSTEROIDS SYSTEMIC Use Prolonged | Lipid-lowering therapy Change
Item
within 2 months prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment
boolean
C3653708 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
C3653708 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0439590 (UMLS CUI [2,3])
C0585943 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
Medical condition Severe compromises Patient safety | Medical condition Severe compromises Study Subject Participation Status | Severe Mental Disorders compromise Patient safety | Severe Mental Disorders compromise Study Subject Participation Status | Chronic disease compromises Patient safety | Chronic disease compromises Study Subject Participation Status | Chronic infectious disease compromises Patient safety | Chronic infectious disease compromises Study Subject Participation Status
Item
presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the investigator would compromise the patient's safety or successful participation in the study, including uncontrolled serious psychiatric illness
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C4046029 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C4046029 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C0008679 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
C0008679 (UMLS CUI [6,1])
C2945640 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
C0151317 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C1113679 (UMLS CUI [7,3])
C0151317 (UMLS CUI [8,1])
C2945640 (UMLS CUI [8,2])
C2348568 (UMLS CUI [8,3])
Study Subject Participation Status Aspect Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1,1])
C1879746 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
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