ID

15255

Description

A Study of the Efficacy and Safety of Topiramate in Obese, Type 2 Diabetic Patients Inadequately Controlled on Sulfonylurea Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00231634

Link

https://clinicaltrials.gov/show/NCT00231634

Keywords

Versions (1)
  1. 5/23/16 5/23/16 -
Uploaded on

May 23, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Obesity NCT00231634

English

Eligibility Obesity NCT00231634

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00231634
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of type 2 diabetes, receiving only second generation sulfonylurea therapy (may include: glipizide, gliclazide, glimepiride, glibenclamide/glyburide, and gliquadone) for at least 4 months and on stable dose for at least 2 months
Description

type 2 diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011860
body mass index >= 27 and < 50
Description

BMI

Data type

boolean

Alias
UMLS CUI [1]
C1305855
hba1c < 11% at enrollment
Description

Hba1c

Data type

boolean

Alias
UMLS CUI [1]
C0019018
diagnosed hypertension or hyperlipidemia must be controlled
Description

hypertension or hyperlipidemia

Data type

boolean

Alias
UMLS CUI [1]
C0745117
UMLS CUI [2,1]
C0020473
UMLS CUI [2,2]
C0742801
female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception (requires negative pregnancy test)
Description

postmenopausal or contraceptive use

Data type

boolean

Alias
UMLS CUI [1,1]
C0232970
UMLS CUI [1,2]
C1999124
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known contraindication or hypersensitivity to topiramate or sulfonylurea therapy
Description

hypersensitivity to topiramate

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0076829
UMLS CUI [1,3]
C0020517
UMLS CUI [2,1]
C0038766
UMLS CUI [2,2]
C1301624
UMLS CUI [2,3]
C0020517
pregnancy or women who are nursing or plan to become pregnant during the study
Description

pregnancy or nursing

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
diagnosed with type 1 diabetes
Description

type 1 diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011854
history of severe or recurrent hypoglycemic episodes
Description

severe recurrent hypoglycemic episodes

Data type

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2945760
treatment with any antidiabetic agent other than sulfonylurea
Description

antidiabetic agent

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0205394
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Similar models

Eligibility Obesity NCT00231634

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00231634
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
type 2 diabetes
Item
diagnosis of type 2 diabetes, receiving only second generation sulfonylurea therapy (may include: glipizide, gliclazide, glimepiride, glibenclamide/glyburide, and gliquadone) for at least 4 months and on stable dose for at least 2 months
boolean
C0011860 (UMLS CUI [1])
BMI
Item
body mass index >= 27 and < 50
boolean
C1305855 (UMLS CUI [1])
Hba1c
Item
hba1c < 11% at enrollment
boolean
C0019018 (UMLS CUI [1])
hypertension or hyperlipidemia
Item
diagnosed hypertension or hyperlipidemia must be controlled
boolean
C0745117 (UMLS CUI [1])
C0020473 (UMLS CUI [2,1])
C0742801 (UMLS CUI [2,2])
postmenopausal or contraceptive use
Item
female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception (requires negative pregnancy test)
boolean
C0232970 (UMLS CUI [1,1])
C1999124 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
hypersensitivity to topiramate
Item
known contraindication or hypersensitivity to topiramate or sulfonylurea therapy
boolean
C1301624 (UMLS CUI [1,1])
C0076829 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
C0020517 (UMLS CUI [2,3])
pregnancy or nursing
Item
pregnancy or women who are nursing or plan to become pregnant during the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
type 1 diabetes
Item
diagnosed with type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
severe recurrent hypoglycemic episodes
Item
history of severe or recurrent hypoglycemic episodes
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945760 (UMLS CUI [1,3])
antidiabetic agent
Item
treatment with any antidiabetic agent other than sulfonylurea
boolean
C0935929 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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