ID

32857

Description

Evaluate Safety and Effectiveness of MBX-102 in Type 2 Diabetes Patients With Poor Glycemic Control on Metformin; ODM derived from: https://clinicaltrials.gov/show/NCT00814372

Lien

https://clinicaltrials.gov/show/NCT00814372

Mots-clés

Versions (1)
  1. 16/11/2018 16/11/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

16 novembre 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00814372

Anglais

Eligibility Type 2 Diabetes Mellitus NCT00814372

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with type 2 diabetes who have been on metformin for the last 6 months and are taking a stable dose of metformin (≥ 1500 mg/d) as monotherapy for at least the last 3 months
Description

Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable

Type de données

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
male or female, 18-70 years of age
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
all female patients must be surgically sterile or post-menopausal (at least 40 years of age with no history of menses for at least 2 years; or any age with no history of menses for at least 6 months and serum fsh ≥ 40 miu/ml) or must agree to use two medically accepted methods of contraception including a barrier method. depo contraceptives are excluded.
Description

Female Sterilization | Postmenopausal state | Gender | Age | Amenorrhea Duration | Serum FSH measurement | Contraceptive methods Quantity | Contraception, Barrier | Depot contraceptive Excluded

Type de données

boolean

Alias
UMLS CUI [1]
C0015787
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0079399
UMLS CUI [4]
C0001779
UMLS CUI [5,1]
C0002453
UMLS CUI [5,2]
C0449238
UMLS CUI [6]
C0455276
UMLS CUI [7,1]
C0700589
UMLS CUI [7,2]
C1265611
UMLS CUI [8]
C0004764
UMLS CUI [9,1]
C0419530
UMLS CUI [9,2]
C0332196
female patients must not be pregnant or lactating
Description

Gender | Pregnancy Absent | Breast Feeding Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
bmi ≥ 26 (patients of asian indian origin ≥ 22) kg/m2
Description

Body mass index | Asian Indian

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C1524069
hba1c ≥ 7.5%, ≤ 10.5%
Description

Hemoglobin A1c measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0474680
fpg ≥ 120 mg/dl, ≤ 240 mg/dl
Description

Plasma fasting glucose measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0583513
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of diabetes secondary to pancreatitis or pancreatectomy
Description

Diabetes Mellitus Secondary to Pancreatitis | Diabetes Mellitus Secondary to Pancreatectomy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0030305
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C0030279
any history of ketoacidosis
Description

Ketoacidosis

Type de données

boolean

Alias
UMLS CUI [1]
C0220982
history of insulin use within last one year (insulin use while hospitalized is acceptable)
Description

Insulin use | Hospitalized patients Insulin use allowed

Type de données

boolean

Alias
UMLS CUI [1]
C0240016
UMLS CUI [2,1]
C0870668
UMLS CUI [2,2]
C0240016
UMLS CUI [2,3]
C0683607
weight loss > 10 pounds in the three months prior to screening visit
Description

Weight decreased Amount Timespan

Type de données

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0872291
history of tzd use (actos® or avandia®) within 6 months of screening visit
Description

Thiazolidinediones | Actos | Avandia

Type de données

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C0875954
UMLS CUI [3]
C0875967
history of tzd discontinuation due to side effect or lack of efficacy
Description

Thiazolidinediones Discontinuation Due to Side effect | Thiazolidinediones Discontinuation Due to Lack of Efficacy

Type de données

boolean

Alias
UMLS CUI [1,1]
C1257987
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0879626
UMLS CUI [2,1]
C1257987
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0235828
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00814372

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable
Item
patients with type 2 diabetes who have been on metformin for the last 6 months and are taking a stable dose of metformin (≥ 1500 mg/d) as monotherapy for at least the last 3 months
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Age
Item
male or female, 18-70 years of age
boolean
C0001779 (UMLS CUI [1])
Female Sterilization | Postmenopausal state | Gender | Age | Amenorrhea Duration | Serum FSH measurement | Contraceptive methods Quantity | Contraception, Barrier | Depot contraceptive Excluded
Item
all female patients must be surgically sterile or post-menopausal (at least 40 years of age with no history of menses for at least 2 years; or any age with no history of menses for at least 6 months and serum fsh ≥ 40 miu/ml) or must agree to use two medically accepted methods of contraception including a barrier method. depo contraceptives are excluded.
boolean
C0015787 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C0002453 (UMLS CUI [5,1])
C0449238 (UMLS CUI [5,2])
C0455276 (UMLS CUI [6])
C0700589 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C0004764 (UMLS CUI [8])
C0419530 (UMLS CUI [9,1])
C0332196 (UMLS CUI [9,2])
Gender | Pregnancy Absent | Breast Feeding Absent
Item
female patients must not be pregnant or lactating
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Body mass index | Asian Indian
Item
bmi ≥ 26 (patients of asian indian origin ≥ 22) kg/m2
boolean
C1305855 (UMLS CUI [1])
C1524069 (UMLS CUI [2])
Hemoglobin A1c measurement
Item
hba1c ≥ 7.5%, ≤ 10.5%
boolean
C0474680 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fpg ≥ 120 mg/dl, ≤ 240 mg/dl
boolean
C0583513 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus Secondary to Pancreatitis | Diabetes Mellitus Secondary to Pancreatectomy
Item
history of diabetes secondary to pancreatitis or pancreatectomy
boolean
C0011849 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0030305 (UMLS CUI [1,3])
C0011849 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0030279 (UMLS CUI [2,3])
Ketoacidosis
Item
any history of ketoacidosis
boolean
C0220982 (UMLS CUI [1])
Insulin use | Hospitalized patients Insulin use allowed
Item
history of insulin use within last one year (insulin use while hospitalized is acceptable)
boolean
C0240016 (UMLS CUI [1])
C0870668 (UMLS CUI [2,1])
C0240016 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Weight decreased Amount Timespan
Item
weight loss > 10 pounds in the three months prior to screening visit
boolean
C1262477 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Thiazolidinediones | Actos | Avandia
Item
history of tzd use (actos® or avandia®) within 6 months of screening visit
boolean
C1257987 (UMLS CUI [1])
C0875954 (UMLS CUI [2])
C0875967 (UMLS CUI [3])
Thiazolidinediones Discontinuation Due to Side effect | Thiazolidinediones Discontinuation Due to Lack of Efficacy
Item
history of tzd discontinuation due to side effect or lack of efficacy
boolean
C1257987 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0879626 (UMLS CUI [1,4])
C1257987 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0235828 (UMLS CUI [2,4])
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