ID

19408

Description

WelChol® With Metformin in Treating Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00147719

Link

https://clinicaltrials.gov/show/NCT00147719

Keywords

  1. 12/29/16 12/29/16 -
Uploaded on

December 29, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes NCT00147719

Eligibility Type 2 Diabetes NCT00147719

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-75 years, inclusive
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed with type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
hemoglobin (hba1c) between 7.5% to 9.5%
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
prescribed an ada accepted diet
Description

Diet prescribed

Data type

boolean

Alias
UMLS CUI [1,1]
C0012155
UMLS CUI [1,2]
C0278329
receiving stable dose of metformin alone or in combination with other oral anti-diabetic medications for 90 days before visit 1
Description

Metformin Dose Stable | Metformin Combination Antidiabetics Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0205195
UMLS CUI [2,3]
C0935929
UMLS CUI [2,4]
C1527415
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of type 1 diabetes or ketoacidosis
Description

Diabetes Mellitus, Insulin-Dependent | Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0220982
history of chronic (more than 2 months) insulin therapy or the initiation of insulin for chronic treatment
Description

Insulin regime chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0205191
history of pancreatitis
Description

Pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0030305
uncontrolled hypertension
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
recent severe cardiovascular disease
Description

Cardiovascular Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205082
allergy or toxic response to colesevelam or any of its components
Description

Hypersensitivity Colesevelam | Toxic reaction Colesevelam | Hypersensitivity Colesevelam Component | Toxic reaction Colesevelam Component

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0541155
UMLS CUI [2,1]
C0542243
UMLS CUI [2,2]
C0541155
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0541155
UMLS CUI [3,3]
C1705248
UMLS CUI [4,1]
C0542243
UMLS CUI [4,2]
C0541155
UMLS CUI [4,3]
C1705248
body mass index (bmi) >45 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855

Similar models

Eligibility Type 2 Diabetes NCT00147719

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18-75 years, inclusive
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosed with type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Glucohemoglobin measurement
Item
hemoglobin (hba1c) between 7.5% to 9.5%
boolean
C0202054 (UMLS CUI [1])
Diet prescribed
Item
prescribed an ada accepted diet
boolean
C0012155 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
Metformin Dose Stable | Metformin Combination Antidiabetics Oral
Item
receiving stable dose of metformin alone or in combination with other oral anti-diabetic medications for 90 days before visit 1
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2,1])
C0205195 (UMLS CUI [2,2])
C0935929 (UMLS CUI [2,3])
C1527415 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Ketoacidosis
Item
history of type 1 diabetes or ketoacidosis
boolean
C0011854 (UMLS CUI [1])
C0220982 (UMLS CUI [2])
Insulin regime chronic
Item
history of chronic (more than 2 months) insulin therapy or the initiation of insulin for chronic treatment
boolean
C0557978 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Pancreatitis
Item
history of pancreatitis
boolean
C0030305 (UMLS CUI [1])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Cardiovascular Disease Severe
Item
recent severe cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Hypersensitivity Colesevelam | Toxic reaction Colesevelam | Hypersensitivity Colesevelam Component | Toxic reaction Colesevelam Component
Item
allergy or toxic response to colesevelam or any of its components
boolean
C0020517 (UMLS CUI [1,1])
C0541155 (UMLS CUI [1,2])
C0542243 (UMLS CUI [2,1])
C0541155 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0541155 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
C0542243 (UMLS CUI [4,1])
C0541155 (UMLS CUI [4,2])
C1705248 (UMLS CUI [4,3])
Body mass index
Item
body mass index (bmi) >45 kg/m2
boolean
C1305855 (UMLS CUI [1])

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