ID

16037

Description

Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine; ODM derived from: https://clinicaltrials.gov/show/NCT02294474

Link

https://clinicaltrials.gov/show/NCT02294474

Keywords

Versions (1)
  1. 6/27/16 6/27/16 -
Uploaded on

June 27, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02294474

English

Eligibility Type 2 Diabetes Mellitus NCT02294474

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with t2dm diagnosed for at least 12 months and treated with insulin glargine and humalog or novolog®/novorapid® (at least 3 times daily, before each meal) in the 6 months prior to the screening visit
Description

Diabetes Mellitus, Non-Insulin-Dependent | Therapeutic procedure Insulin Glargine Humalog | Therapeutic procedure NovoLog

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0907402
UMLS CUI [2,3]
C0528249
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0939412
written informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
at screening visit, age under legal age of adulthood
Description

Age Adulthood

Data type

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0700597
hba1c <6.5% or >10.0% at screening
Description

Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0019018
diabetes other than t2dm
Description

Diabetes | Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011847
UMLS CUI [2]
C0011860
pregnancy and lactation
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing potential not protected by highly effective contraceptive method of birth control
Description

Childbearing Potential Contraceptive methods Not used

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0445107
use of insulin pump in the 6 months before screening visit
Description

Insulin pump Use

Data type

boolean

Alias
UMLS CUI [1,1]
C1140609
UMLS CUI [1,2]
C1524063
use of insulin other than insulin glargine and humalog or novolog/novorapid in the 6 months prior to screening visit. liprolog® is an eu approved insulin lispro and is allowed in those countries where it is marketed
Description

Insulin | Insulin Glargine | Humalog | NovoLog | Insulin Lispro

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0907402
UMLS CUI [3]
C0528249
UMLS CUI [4]
C0939412
UMLS CUI [5]
C0293359
use of humalog or novolog/novorapid less than 3 times daily, before each meal
Description

Humalog ante cibus Use | NovoLog ante cibus Use

Data type

boolean

Alias
UMLS CUI [1,1]
C0528249
UMLS CUI [1,2]
C1550738
UMLS CUI [1,3]
C1524063
UMLS CUI [2,1]
C0939412
UMLS CUI [2,2]
C1550738
UMLS CUI [2,3]
C1524063
use of non-injectable peptides (eg, glp-1-receptor-agonists or other peptides) in the 6 months prior to screening visit
Description

Peptides Injectable | GLP-1 Receptor Agonist | Peptides

Data type

boolean

Alias
UMLS CUI [1,1]
C0030956
UMLS CUI [1,2]
C0086466
UMLS CUI [2]
C2917359
UMLS CUI [3]
C0030956
body mass index (bmi) ≥40kg/m² at screening visit
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
hospitalization for diabetic ketoacidosis in the last 6 months before screening visit
Description

Hospitalization Diabetic Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0011880
unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment, or injectable drugs) during the study period
Description

Proliferative diabetic retinopathy Unstable | Diabetic Retinopathy Progressive Rapid | Macular retinal edema Requirement Therapeutic procedure | Therapeutic Lasers | Operative Surgical Procedures | Injectables

Data type

boolean

Alias
UMLS CUI [1,1]
C0154830
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0011884
UMLS CUI [2,2]
C0205329
UMLS CUI [2,3]
C0456962
UMLS CUI [3,1]
C0271051
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0087111
UMLS CUI [4]
C0181567
UMLS CUI [5]
C0543467
UMLS CUI [6]
C0086466
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

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02294474

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Therapeutic procedure Insulin Glargine Humalog | Therapeutic procedure NovoLog
Item
patients with t2dm diagnosed for at least 12 months and treated with insulin glargine and humalog or novolog®/novorapid® (at least 3 times daily, before each meal) in the 6 months prior to the screening visit
boolean
C0011860 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0907402 (UMLS CUI [2,2])
C0528249 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0939412 (UMLS CUI [3,2])
Informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age Adulthood
Item
at screening visit, age under legal age of adulthood
boolean
C0001779 (UMLS CUI [1,1])
C0700597 (UMLS CUI [1,2])
Glycosylated hemoglobin A
Item
hba1c <6.5% or >10.0% at screening
boolean
C0019018 (UMLS CUI [1])
Diabetes | Diabetes Mellitus, Non-Insulin-Dependent
Item
diabetes other than t2dm
boolean
C0011847 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy and lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Not used
Item
women of childbearing potential not protected by highly effective contraceptive method of birth control
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0445107 (UMLS CUI [1,3])
Insulin pump Use
Item
use of insulin pump in the 6 months before screening visit
boolean
C1140609 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Insulin | Insulin Glargine | Humalog | NovoLog | Insulin Lispro
Item
use of insulin other than insulin glargine and humalog or novolog/novorapid in the 6 months prior to screening visit. liprolog® is an eu approved insulin lispro and is allowed in those countries where it is marketed
boolean
C0021641 (UMLS CUI [1])
C0907402 (UMLS CUI [2])
C0528249 (UMLS CUI [3])
C0939412 (UMLS CUI [4])
C0293359 (UMLS CUI [5])
Humalog ante cibus Use | NovoLog ante cibus Use
Item
use of humalog or novolog/novorapid less than 3 times daily, before each meal
boolean
C0528249 (UMLS CUI [1,1])
C1550738 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C0939412 (UMLS CUI [2,1])
C1550738 (UMLS CUI [2,2])
C1524063 (UMLS CUI [2,3])
Peptides Injectable | GLP-1 Receptor Agonist | Peptides
Item
use of non-injectable peptides (eg, glp-1-receptor-agonists or other peptides) in the 6 months prior to screening visit
boolean
C0030956 (UMLS CUI [1,1])
C0086466 (UMLS CUI [1,2])
C2917359 (UMLS CUI [2])
C0030956 (UMLS CUI [3])
Body mass index
Item
body mass index (bmi) ≥40kg/m² at screening visit
boolean
C1305855 (UMLS CUI [1])
Hospitalization Diabetic Ketoacidosis
Item
hospitalization for diabetic ketoacidosis in the last 6 months before screening visit
boolean
C0019993 (UMLS CUI [1,1])
C0011880 (UMLS CUI [1,2])
Proliferative diabetic retinopathy Unstable | Diabetic Retinopathy Progressive Rapid | Macular retinal edema Requirement Therapeutic procedure | Therapeutic Lasers | Operative Surgical Procedures | Injectables
Item
unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment, or injectable drugs) during the study period
boolean
C0154830 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0011884 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C0456962 (UMLS CUI [2,3])
C0271051 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0181567 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
C0086466 (UMLS CUI [6])
Study Subject Participation Status
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])
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