ID

15305

Description

Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent; ODM derived from: https://clinicaltrials.gov/show/NCT01511198

Link

https://clinicaltrials.gov/show/NCT01511198

Keywords

  1. 5/25/16 5/25/16 -
Uploaded on

May 25, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetes NCT01511198

Eligibility Diabetes NCT01511198

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01511198
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetic
Description

type 2 diabetic

Data type

boolean

Alias
UMLS CUI [1]
C0011860
treated with oha (oral hypoglycaemic agent monotherapy for at least 3 months. prior use of metformin is allowed
Description

oral hypoglycaemic agent

Data type

boolean

Alias
UMLS CUI [1]
C0359086
body mass index (bmi) between 27.0-42.0 kg/m^2 (inclusive)
Description

BMI

Data type

boolean

Alias
UMLS CUI [1]
C1305855
hba1c maximum 10% based on analysis from central laboratory
Description

hba1c

Data type

boolean

Alias
UMLS CUI [1]
C0019018
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
cardiac problems
Description

cardiac problems

Data type

boolean

Alias
UMLS CUI [1]
C0262402
uncontrolled treated/untreated hypertension
Description

untreated hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0020538
proliferative retinopathy or known autonomic neuropathy
Description

proliferative retinopathy or known autonomic neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0339467
UMLS CUI [2]
C0259749
recurrent severe hypoglycemia as judged by the investigator
Description

severe hypoglycemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
known or suspected allergy to trial product or related products
Description

allergy to trial product

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3854006
use of any drug (except for ohas), which in the investigators opinion could interfere with the glucose level or body weight or any contraindication to metformin use or intolerance to metformin 1000 mg (prior to trial entry or during run-in period). stable doses, for 3 months or greater, of thyroid hormone replacement are allowed
Description

use of any drug contraindicated

Data type

boolean

Alias
UMLS CUI [1]
C3845816
known or suspected abuse of alcohol or narcotics
Description

abuse of alcohol or narcotics

Data type

boolean

Alias
UMLS CUI [1]
C0038586
current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness
Description

thiazolidinediones or chronic daily use of insulin

Data type

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C0021641
tsh (thyroid stimulating hormone) below 0.2 or above 15 u/ml
Description

thyroid stimulating hormone

Data type

boolean

Alias
UMLS CUI [1]
C0202230
type 1 or other specific causes of diabetes
Description

type 1 diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011854

Similar models

Eligibility Diabetes NCT01511198

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01511198
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
type 2 diabetic
Item
type 2 diabetic
boolean
C0011860 (UMLS CUI [1])
oral hypoglycaemic agent
Item
treated with oha (oral hypoglycaemic agent monotherapy for at least 3 months. prior use of metformin is allowed
boolean
C0359086 (UMLS CUI [1])
BMI
Item
body mass index (bmi) between 27.0-42.0 kg/m^2 (inclusive)
boolean
C1305855 (UMLS CUI [1])
hba1c
Item
hba1c maximum 10% based on analysis from central laboratory
boolean
C0019018 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
cardiac problems
Item
cardiac problems
boolean
C0262402 (UMLS CUI [1])
untreated hypertension
Item
uncontrolled treated/untreated hypertension
boolean
C0020538 (UMLS CUI [1])
proliferative retinopathy or known autonomic neuropathy
Item
proliferative retinopathy or known autonomic neuropathy
boolean
C0339467 (UMLS CUI [1])
C0259749 (UMLS CUI [2])
severe hypoglycemia
Item
recurrent severe hypoglycemia as judged by the investigator
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
allergy to trial product
Item
known or suspected allergy to trial product or related products
boolean
C0020517 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
use of any drug contraindicated
Item
use of any drug (except for ohas), which in the investigators opinion could interfere with the glucose level or body weight or any contraindication to metformin use or intolerance to metformin 1000 mg (prior to trial entry or during run-in period). stable doses, for 3 months or greater, of thyroid hormone replacement are allowed
boolean
C3845816 (UMLS CUI [1])
abuse of alcohol or narcotics
Item
known or suspected abuse of alcohol or narcotics
boolean
C0038586 (UMLS CUI [1])
thiazolidinediones or chronic daily use of insulin
Item
current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness
boolean
C1257987 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
thyroid stimulating hormone
Item
tsh (thyroid stimulating hormone) below 0.2 or above 15 u/ml
boolean
C0202230 (UMLS CUI [1])
type 1 diabetes
Item
type 1 or other specific causes of diabetes
boolean
C0011854 (UMLS CUI [1])

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