ID

34700

Description

Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin in Patients in Type 2 Diabetes Mellitus (T2DM); ODM derived from: https://clinicaltrials.gov/show/NCT01196546

Link

https://clinicaltrials.gov/show/NCT01196546

Keywords

Versions (1)
  1. 1/23/19 1/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 23, 2019

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 NCT01196546

English

Eligibility Type 2 Diabetes Mellitus NCT01196546

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus patients who are treated with metformin monotherapy 1,000 mg daily for at least 3 months
Description

Diabetes Mellitus, Non-Insulin-Dependent | Metformin U/day

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0456683
the patient is required to have hba1c 6.5-11.0%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
bmi in the range of 22-48 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe or uncontrolled type 2 diabetes mellitus (hba1c> 11.0%)
Description

Non-Insulin-Dependent Diabetes Mellitus Severe | Non-Insulin-Dependent Diabetes Mellitus Uncontrolled | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0474680
acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
Description

Complications of Diabetes Mellitus Metabolic | Ketoacidosis | Hyperosmolar state | Coma

Data type

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0311400
UMLS CUI [2]
C0220982
UMLS CUI [3]
C0236013
UMLS CUI [4]
C0009421
congestive heart failure requiring pharmacologic treatment
Description

Congestive heart failure Requirement Pharmacotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013216
any of following within past 6 months: (1) myocardial infarction; (2) unstable angina (3) coronary artery bypass surgery or percutaneous coronary intervention
Description

Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0010055
UMLS CUI [4]
C1532338
liver disease such as cirrhosis or chronic active hepatitis
Description

Liver disease | Liver Cirrhosis | Hepatitis, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0023890
UMLS CUI [3]
C0019189
Back to the top of the page

Similar models

Eligibility Type 2 Diabetes Mellitus NCT01196546

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Metformin U/day
Item
type 2 diabetes mellitus patients who are treated with metformin monotherapy 1,000 mg daily for at least 3 months
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Hemoglobin A1c measurement
Item
the patient is required to have hba1c 6.5-11.0%
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi in the range of 22-48 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Severe | Non-Insulin-Dependent Diabetes Mellitus Uncontrolled | Hemoglobin A1c measurement
Item
severe or uncontrolled type 2 diabetes mellitus (hba1c> 11.0%)
boolean
C0011860 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0474680 (UMLS CUI [3])
Complications of Diabetes Mellitus Metabolic | Ketoacidosis | Hyperosmolar state | Coma
Item
acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
boolean
C0342257 (UMLS CUI [1,1])
C0311400 (UMLS CUI [1,2])
C0220982 (UMLS CUI [2])
C0236013 (UMLS CUI [3])
C0009421 (UMLS CUI [4])
Congestive heart failure Requirement Pharmacotherapy
Item
congestive heart failure requiring pharmacologic treatment
boolean
C0018802 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
any of following within past 6 months: (1) myocardial infarction; (2) unstable angina (3) coronary artery bypass surgery or percutaneous coronary intervention
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C1532338 (UMLS CUI [4])
Liver disease | Liver Cirrhosis | Hepatitis, Chronic
Item
liver disease such as cirrhosis or chronic active hepatitis
boolean
C0023895 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C0019189 (UMLS CUI [3])
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