ID

32762

Descripción

Safety Study to Evaluate BMS-767778 in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus (T2DM); ODM derived from: https://clinicaltrials.gov/show/NCT00707590

Link

https://clinicaltrials.gov/show/NCT00707590

Palabras clave

Versiones (1)
  1. 14/11/18 14/11/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

14 de noviembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00707590

Inglés

Eligibility Type 2 Diabetes Mellitus NCT00707590

1 formularios  
Criteria
Descripción

Criteria

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy male and female subjects as determined by medical history, physical examination, 12-lead electrocardiogram (ecg), and clinical laboratory evaluations will be eligible to participate in the study.
Descripción

Healthy Volunteers Medical History | Healthy Volunteers Physical Examination | Healthy Volunteers 12 lead ECG | Healthy Volunteers Clinical Evaluation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1708335
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C1708335
UMLS CUI [3,2]
C0430456
UMLS CUI [4,1]
C1708335
UMLS CUI [4,2]
C1261322
men and women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile)
Descripción

Infertility | Postmenopausal state | Female Sterilization | Male sterilization

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021359
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0024559
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg or clinical laboratory determinations
Descripción

Single organ dysfunction | Physical examination abnormal | Abnormal vital signs | Electrocardiogram abnormal | Laboratory test result abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0349410
UMLS CUI [2]
C0747585
UMLS CUI [3]
C0277804
UMLS CUI [4]
C0522055
UMLS CUI [5]
C0438215
part c of the study (maximum age 65 years):
Descripción

Clinical Trial Part | Age

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0449719
UMLS CUI [2]
C0001779
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
drug naive patients with t2dm or patients who are on metformin-monotherapy (at current dose for ≥ 8 weeks) with inadequately controlled blood glucose levels (hba1c >7 %and <10 %) men and women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile)
Descripción

Pharmacotherapy Absent | Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable | Blood glucose level Poorly controlled | Hemoglobin A1c measurement | Infertility | Postmenopausal state | Female Sterilization | Male sterilization

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0011860
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C0428554
UMLS CUI [4,2]
C3853134
UMLS CUI [5]
C0474680
UMLS CUI [6]
C0021359
UMLS CUI [7]
C0232970
UMLS CUI [8]
C0015787
UMLS CUI [9]
C0024559
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
poorly controlled diabetes with either new onset or worsening of symptoms of polyuria and polydipsia, weight loss, fatigue, abdominal pain, or other significant signs and symptoms
Descripción

Poorly controlled diabetes mellitus | New or Worsening Symptom Polyuria | New or Worsening Symptom Polydipsia | Weight decreased | Fatigue | Abdominal Pain | Signs and Symptoms Significant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0554876
UMLS CUI [2,1]
C3898139
UMLS CUI [2,2]
C0032617
UMLS CUI [3,1]
C3898139
UMLS CUI [3,2]
C0085602
UMLS CUI [4]
C1262477
UMLS CUI [5]
C0015672
UMLS CUI [6]
C0000737
UMLS CUI [7,1]
C0037088
UMLS CUI [7,2]
C0750502
any of the following medical conditions: uncontrolled hypertension, unstable angina pectora, cushing's syndrome, addison's disease, uncontrolled hyperthyroidism or hypothyroidism, significant liver disease or renal failure, malignant diseases, or immunodeficiency (e.g., hiv/aids or organ-transplant), or history of myocardial infarction, congestive heart failure defined as new york heart association (nyha) stage ii and above, significant valvular disease, cardiac arrhythmia, or transient ischemic attack or cerebrovascular accidents (occurred within 6 months prior to entry into the study), or family history of long qt syndrome
Descripción

Other medical condition | Uncontrolled hypertension | Angina, Unstable | Cushing Syndrome | Addison Disease | Hyperthyroidism Uncontrolled | Hypothyroidism Uncontrolled | Liver disease | Kidney Failure | Malignant disease | Immunodeficiency | HIV Infection | AIDS | Organ Transplantation | Myocardial Infarction | Congestive heart failure New York Heart Association Classification | Valvular disease | Cardiac Arrhythmia | Transient Ischemic Attack | Cerebrovascular accident | Family history of long QT syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3843040
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0010481
UMLS CUI [5]
C0001403
UMLS CUI [6,1]
C0020550
UMLS CUI [6,2]
C0205318
UMLS CUI [7,1]
C0020676
UMLS CUI [7,2]
C0205318
UMLS CUI [8]
C0023895
UMLS CUI [9]
C0035078
UMLS CUI [10]
C0442867
UMLS CUI [11]
C0021051
UMLS CUI [12]
C0019693
UMLS CUI [13]
C0001175
UMLS CUI [14]
C0029216
UMLS CUI [15]
C0027051
UMLS CUI [16,1]
C0018802
UMLS CUI [16,2]
C1275491
UMLS CUI [17]
C3258293
UMLS CUI [18]
C0003811
UMLS CUI [19]
C0007787
UMLS CUI [20]
C0038454
UMLS CUI [21]
C3839836
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00707590

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers Medical History | Healthy Volunteers Physical Examination | Healthy Volunteers 12 lead ECG | Healthy Volunteers Clinical Evaluation
Item
healthy male and female subjects as determined by medical history, physical examination, 12-lead electrocardiogram (ecg), and clinical laboratory evaluations will be eligible to participate in the study.
boolean
C1708335 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1708335 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C1708335 (UMLS CUI [3,1])
C0430456 (UMLS CUI [3,2])
C1708335 (UMLS CUI [4,1])
C1261322 (UMLS CUI [4,2])
Infertility | Postmenopausal state | Female Sterilization | Male sterilization
Item
men and women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile)
boolean
C0021359 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0024559 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Single organ dysfunction | Physical examination abnormal | Abnormal vital signs | Electrocardiogram abnormal | Laboratory test result abnormal
Item
evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg or clinical laboratory determinations
boolean
C0349410 (UMLS CUI [1])
C0747585 (UMLS CUI [2])
C0277804 (UMLS CUI [3])
C0522055 (UMLS CUI [4])
C0438215 (UMLS CUI [5])
Clinical Trial Part | Age
Item
part c of the study (maximum age 65 years):
boolean
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Item Group
C1512693 (UMLS CUI)
Pharmacotherapy Absent | Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable | Blood glucose level Poorly controlled | Hemoglobin A1c measurement | Infertility | Postmenopausal state | Female Sterilization | Male sterilization
Item
drug naive patients with t2dm or patients who are on metformin-monotherapy (at current dose for ≥ 8 weeks) with inadequately controlled blood glucose levels (hba1c >7 %and <10 %) men and women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile)
boolean
C0013216 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0428554 (UMLS CUI [4,1])
C3853134 (UMLS CUI [4,2])
C0474680 (UMLS CUI [5])
C0021359 (UMLS CUI [6])
C0232970 (UMLS CUI [7])
C0015787 (UMLS CUI [8])
C0024559 (UMLS CUI [9])
Item Group
C0680251 (UMLS CUI)
Poorly controlled diabetes mellitus | New or Worsening Symptom Polyuria | New or Worsening Symptom Polydipsia | Weight decreased | Fatigue | Abdominal Pain | Signs and Symptoms Significant
Item
poorly controlled diabetes with either new onset or worsening of symptoms of polyuria and polydipsia, weight loss, fatigue, abdominal pain, or other significant signs and symptoms
boolean
C0554876 (UMLS CUI [1])
C3898139 (UMLS CUI [2,1])
C0032617 (UMLS CUI [2,2])
C3898139 (UMLS CUI [3,1])
C0085602 (UMLS CUI [3,2])
C1262477 (UMLS CUI [4])
C0015672 (UMLS CUI [5])
C0000737 (UMLS CUI [6])
C0037088 (UMLS CUI [7,1])
C0750502 (UMLS CUI [7,2])
Other medical condition | Uncontrolled hypertension | Angina, Unstable | Cushing Syndrome | Addison Disease | Hyperthyroidism Uncontrolled | Hypothyroidism Uncontrolled | Liver disease | Kidney Failure | Malignant disease | Immunodeficiency | HIV Infection | AIDS | Organ Transplantation | Myocardial Infarction | Congestive heart failure New York Heart Association Classification | Valvular disease | Cardiac Arrhythmia | Transient Ischemic Attack | Cerebrovascular accident | Family history of long QT syndrome
Item
any of the following medical conditions: uncontrolled hypertension, unstable angina pectora, cushing's syndrome, addison's disease, uncontrolled hyperthyroidism or hypothyroidism, significant liver disease or renal failure, malignant diseases, or immunodeficiency (e.g., hiv/aids or organ-transplant), or history of myocardial infarction, congestive heart failure defined as new york heart association (nyha) stage ii and above, significant valvular disease, cardiac arrhythmia, or transient ischemic attack or cerebrovascular accidents (occurred within 6 months prior to entry into the study), or family history of long qt syndrome
boolean
C3843040 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0010481 (UMLS CUI [4])
C0001403 (UMLS CUI [5])
C0020550 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0020676 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
C0023895 (UMLS CUI [8])
C0035078 (UMLS CUI [9])
C0442867 (UMLS CUI [10])
C0021051 (UMLS CUI [11])
C0019693 (UMLS CUI [12])
C0001175 (UMLS CUI [13])
C0029216 (UMLS CUI [14])
C0027051 (UMLS CUI [15])
C0018802 (UMLS CUI [16,1])
C1275491 (UMLS CUI [16,2])
C3258293 (UMLS CUI [17])
C0003811 (UMLS CUI [18])
C0007787 (UMLS CUI [19])
C0038454 (UMLS CUI [20])
C3839836 (UMLS CUI [21])
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