ID

25528

Description

Safety, Tolerability, and Efficacy Study of MB07803 Administered to Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00458016

Lien

https://clinicaltrials.gov/show/NCT00458016

Mots-clés

Versions (1)
  1. 04/09/2017 04/09/2017 -
Téléchargé le

4 septembre 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00458016

Anglais

Eligibility Type 2 Diabetes Mellitus NCT00458016

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
fasting plasma glucose between 120 - 270 mg/dl at screening
Description

Plasma fasting glucose measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0583513
hba1c measurements between 6.0 - 10% at screening
Description

HbA1c measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0373638
females who are surgically sterile (i.e. women who have had a hysterectomy or tubal ligation). females who are postmenopausal for at least 12 consecutive months and documented by blood follicular stimulating hormone (fsh) greater than or equal to 40 mlu/ml.females of childbearing potential must be willing to use an approved double-barrier method of birth control (e.g. condom plus spermicide ;iud plus spermicide) from the time of signing the informed consent form through 4 weeks following the last dose of study drug.
Description

Female Sterilization | Hysterectomy | Tubal Ligation | Postmenopausal state | Blood Follicle Stimulating Hormone Level | Childbearing Potential Contraceptive methods | Barrier Contraception Double | Female Condoms | Vaginal Spermicides | Intrauterine Devices

Type de données

boolean

Alias
UMLS CUI [1]
C0015787
UMLS CUI [2]
C0020699
UMLS CUI [3]
C0520483
UMLS CUI [4]
C0232970
UMLS CUI [5,1]
C0005767
UMLS CUI [5,2]
C0733758
UMLS CUI [5,3]
C0441889
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0700589
UMLS CUI [7,1]
C0004764
UMLS CUI [7,2]
C0205173
UMLS CUI [8]
C0221829
UMLS CUI [9]
C0087145
UMLS CUI [10]
C0021900
body mass index (bmi) in the range of 18.5 - 37 kg/m2 patients with a bmi in the range of 37.5 - 40 kg/m2 who in the investigator's opinion, are in good health and satisfy the eligibility criteria, will be considered on a case-by case basis
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
written informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Type de données

boolean

Alias
UMLS CUI [1]
C0011854
type 2 diabetes mellitus with a history of diabetic ketoacidosis or ketosis-prone
Description

Diabetes Mellitus, Non-Insulin-Dependent | Diabetic Ketoacidosis | Ketosis-prone diabetes

Type de données

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0011880
UMLS CUI [3]
C3837958
use of thiazolidinediones (tzds)
Description

Thiazolidinediones

Type de données

boolean

Alias
UMLS CUI [1]
C1257987
currently on more than two oral hypoglycemic agent
Description

Oral hypoglycemic Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C1265611
history of outpatient insulin use
Description

Outpatient Insulin use

Type de données

boolean

Alias
UMLS CUI [1,1]
C0029921
UMLS CUI [1,2]
C0240016
clinically significant history of cardiac disease within 6 months of informed consent
Description

Heart Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0018799
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00458016

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Plasma fasting glucose measurement
Item
fasting plasma glucose between 120 - 270 mg/dl at screening
boolean
C0583513 (UMLS CUI [1])
HbA1c measurement
Item
hba1c measurements between 6.0 - 10% at screening
boolean
C0373638 (UMLS CUI [1])
Female Sterilization | Hysterectomy | Tubal Ligation | Postmenopausal state | Blood Follicle Stimulating Hormone Level | Childbearing Potential Contraceptive methods | Barrier Contraception Double | Female Condoms | Vaginal Spermicides | Intrauterine Devices
Item
females who are surgically sterile (i.e. women who have had a hysterectomy or tubal ligation). females who are postmenopausal for at least 12 consecutive months and documented by blood follicular stimulating hormone (fsh) greater than or equal to 40 mlu/ml.females of childbearing potential must be willing to use an approved double-barrier method of birth control (e.g. condom plus spermicide ;iud plus spermicide) from the time of signing the informed consent form through 4 weeks following the last dose of study drug.
boolean
C0015787 (UMLS CUI [1])
C0020699 (UMLS CUI [2])
C0520483 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
C0005767 (UMLS CUI [5,1])
C0733758 (UMLS CUI [5,2])
C0441889 (UMLS CUI [5,3])
C3831118 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C0004764 (UMLS CUI [7,1])
C0205173 (UMLS CUI [7,2])
C0221829 (UMLS CUI [8])
C0087145 (UMLS CUI [9])
C0021900 (UMLS CUI [10])
Body mass index
Item
body mass index (bmi) in the range of 18.5 - 37 kg/m2 patients with a bmi in the range of 37.5 - 40 kg/m2 who in the investigator's opinion, are in good health and satisfy the eligibility criteria, will be considered on a case-by case basis
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Diabetic Ketoacidosis | Ketosis-prone diabetes
Item
type 2 diabetes mellitus with a history of diabetic ketoacidosis or ketosis-prone
boolean
C0011860 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
C3837958 (UMLS CUI [3])
Thiazolidinediones
Item
use of thiazolidinediones (tzds)
boolean
C1257987 (UMLS CUI [1])
Oral hypoglycemic Quantity
Item
currently on more than two oral hypoglycemic agent
boolean
C0359086 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Outpatient Insulin use
Item
history of outpatient insulin use
boolean
C0029921 (UMLS CUI [1,1])
C0240016 (UMLS CUI [1,2])
Heart Disease
Item
clinically significant history of cardiac disease within 6 months of informed consent
boolean
C0018799 (UMLS CUI [1])
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