ID

29137

Description

Study to Optimize Insulin Treatment by Basal Regimen With Insulin Glargine in Type-2-Diabetic Patients Previously Uncontrolled on Premixed Insulin; ODM derived from: https://clinicaltrials.gov/show/NCT00693771

Link

https://clinicaltrials.gov/show/NCT00693771

Keywords

Versions (1)
  1. 2/28/18 2/28/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 28, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00693771

English

Eligibility Diabetes Mellitus, Type 2 NCT00693771

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with type 2 diabetes mellitus inadequately controlled at least 3 months on premixed insulin with 1 or 2 oads
Description

Non-Insulin-Dependent Diabetes Mellitus Control Inadequate | Premixed insulin | Antidiabetics Oral Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0243148
UMLS CUI [1,3]
C0205412
UMLS CUI [2]
C2069057
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C1265611
7.5 ≤ hba1c ≤ 9.5%
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
fpg ≥6.7 mmol/l
Description

Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
history of diabetes mellitus ≤10 years
Description

Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0872146
premix insulin daily dosage ≤ 50 iu/day
Description

Premixed insulin Dosage IU/day

Data type

boolean

Alias
UMLS CUI [1,1]
C2069057
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439465
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
former treated on tzd
Description

Thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1]
C1257987
pregnancy / lactation
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
creatine ≥1.5 mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
hepatic disease, jaundice,or alt/ast≥ 2.5 times of normal range
Description

Liver disease | Icterus | Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022346
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151904
hormone therapy,
Description

Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279025
acute status of diabetes complications
Description

Status Complications of Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0342257
severe concomitant disease or complications with high risk of unexpected fatal events, like myocardial infarct, stroke, heart failure.
Description

Comorbidity Severe | Complication Severe | High risk Event Fatal Unexpected | Myocardial Infarction | Cerebrovascular accident | Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0009566
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0332167
UMLS CUI [3,2]
C0441471
UMLS CUI [3,3]
C1302234
UMLS CUI [3,4]
C4055646
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0018801
allergic to insulin glargine or any ingredient
Description

Hypersensitivity Insulin Glargine | Hypersensitivity Insulin Glargine Ingredient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0907402
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0907402
UMLS CUI [2,3]
C1550600
participation in another clinical trial within 3 months
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Description

Study Subject Participation Status Aspect Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1879746
UMLS CUI [1,3]
C1524062
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00693771

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Control Inadequate | Premixed insulin | Antidiabetics Oral Quantity
Item
patients with type 2 diabetes mellitus inadequately controlled at least 3 months on premixed insulin with 1 or 2 oads
boolean
C0011860 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C2069057 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Glucohemoglobin measurement
Item
7.5 ≤ hba1c ≤ 9.5%
boolean
C0202054 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fpg ≥6.7 mmol/l
boolean
C0583513 (UMLS CUI [1])
Diabetes Mellitus Disease length
Item
history of diabetes mellitus ≤10 years
boolean
C0011849 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Premixed insulin Dosage IU/day
Item
premix insulin daily dosage ≤ 50 iu/day
boolean
C2069057 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439465 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Thiazolidinediones
Item
former treated on tzd
boolean
C1257987 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy / lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Creatinine measurement, serum
Item
creatine ≥1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Liver disease | Icterus | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
hepatic disease, jaundice,or alt/ast≥ 2.5 times of normal range
boolean
C0023895 (UMLS CUI [1])
C0022346 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
Hormone Therapy
Item
hormone therapy,
boolean
C0279025 (UMLS CUI [1])
Status Complications of Diabetes Mellitus
Item
acute status of diabetes complications
boolean
C0449438 (UMLS CUI [1,1])
C0342257 (UMLS CUI [1,2])
Comorbidity Severe | Complication Severe | High risk Event Fatal Unexpected | Myocardial Infarction | Cerebrovascular accident | Heart failure
Item
severe concomitant disease or complications with high risk of unexpected fatal events, like myocardial infarct, stroke, heart failure.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009566 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332167 (UMLS CUI [3,1])
C0441471 (UMLS CUI [3,2])
C1302234 (UMLS CUI [3,3])
C4055646 (UMLS CUI [3,4])
C0027051 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0018801 (UMLS CUI [6])
Hypersensitivity Insulin Glargine | Hypersensitivity Insulin Glargine Ingredient
Item
allergic to insulin glargine or any ingredient
boolean
C0020517 (UMLS CUI [1,1])
C0907402 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0907402 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
Study Subject Participation Status
Item
participation in another clinical trial within 3 months
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status Aspect Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1,1])
C1879746 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
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