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

Link

https://clinicaltrials.gov/show/NCT00814372

Keywords

Versions (1)
  1. 11/16/18 11/16/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 16, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Type 2 Diabetes Mellitus NCT00814372

English

Eligibility Type 2 Diabetes Mellitus NCT00814372

1 forms  
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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

boolean

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

Hemoglobin A1c measurement

Data type

boolean

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

Plasma fasting glucose measurement

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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
Back to the top of the page

Similar models

Eligibility Type 2 Diabetes Mellitus NCT00814372

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial