ID

14610

Description

A Study of the Efficacy and Safety of Topiramate in the Treatment fo Obese, Type 2 Diabetic Patients Treated With Metformin; ODM derived from: https://clinicaltrials.gov/show/NCT00231660

Link

https://clinicaltrials.gov/show/NCT00231660

Keywords

Versions (1)
  1. 4/24/16 4/24/16 -
Uploaded on

April 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Obesity NCT00231660

English

Eligibility Obesity NCT00231660

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00231660
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of type 2 diabetes and receiving metformin monotherapy for at least the previous 4 months and on a stable daily dose for at least 2 months prior to enrollment
Description

Type 2 diabetes and metformin monotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0025598
metformin total daily dose not to exceed 2.1 grams/day
Description

Metformin total daily dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C2348070
body mass index >= 27 and < 50
Description

BMI

Data type

boolean

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

HbA1C

Data type

boolean

Alias
UMLS CUI [1]
C0019018
fasting plasma glucose >= 126 and < 240
Description

Fasting plasma glucose

Data type

boolean

Alias
UMLS CUI [1]
C0583513
stable weight
Description

Stable weight

Data type

boolean

Alias
UMLS CUI [1]
C0517386
female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, or practicing an acceptable method of contraception (requires negative pregnancy test)
Description

Gynaecological status

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0700589
UMLS CUI [4]
C0032976
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known contraindication, or hypersensitivity to topiramate
Description

Contraindication or hypersensitivity to topiramate

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0076829
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0076829
use of other antidiabetic medications within the last 4 months
Description

Antidiabetic medications

Data type

boolean

Alias
UMLS CUI [1]
C0935929
excessive weight loss
Description

Weight loss

Data type

boolean

Alias
UMLS CUI [1]
C1262477
diagnosis of type 1 diabetes
Description

Type 1 diabetes

Data type

boolean

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

Hypoglycemia

Data type

boolean

Alias
UMLS CUI [1]
C0020615
severe pulmonary disease
Description

Pulmonary disease

Data type

boolean

Alias
UMLS CUI [1]
C0024115
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Similar models

Eligibility Obesity NCT00231660

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00231660
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Type 2 diabetes and metformin monotherapy
Item
diagnosis of type 2 diabetes and receiving metformin monotherapy for at least the previous 4 months and on a stable daily dose for at least 2 months prior to enrollment
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
Metformin total daily dose
Item
metformin total daily dose not to exceed 2.1 grams/day
boolean
C0025598 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
BMI
Item
body mass index >= 27 and < 50
boolean
C1305855 (UMLS CUI [1])
HbA1C
Item
hba1c < 11%
boolean
C0019018 (UMLS CUI [1])
Fasting plasma glucose
Item
fasting plasma glucose >= 126 and < 240
boolean
C0583513 (UMLS CUI [1])
Stable weight
Item
stable weight
boolean
C0517386 (UMLS CUI [1])
Gynaecological status
Item
female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, or practicing an acceptable method of contraception (requires negative pregnancy test)
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0032976 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Contraindication or hypersensitivity to topiramate
Item
known contraindication, or hypersensitivity to topiramate
boolean
C1301624 (UMLS CUI [1,1])
C0076829 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0076829 (UMLS CUI [2,2])
Antidiabetic medications
Item
use of other antidiabetic medications within the last 4 months
boolean
C0935929 (UMLS CUI [1])
Weight loss
Item
excessive weight loss
boolean
C1262477 (UMLS CUI [1])
Type 1 diabetes
Item
diagnosis of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Hypoglycemia
Item
history of severe or recurrent hypoglycemic episodes
boolean
C0020615 (UMLS CUI [1])
Pulmonary disease
Item
severe pulmonary disease
boolean
C0024115 (UMLS CUI [1])
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