ID

35781

Description

A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM); ODM derived from: https://clinicaltrials.gov/show/NCT02451137

Link

https://clinicaltrials.gov/show/NCT02451137

Keywords

Versions (1)
  1. 3/22/19 3/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 22, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02451137

English

Eligibility Diabetes Mellitus, Type 2 NCT02451137

1 forms  
Criteria
Description

Criteria

patients with t2dm, as defined by the american diabetes association/world health organization, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled after at least 1 year of treatment with 2 or more of the following: oral agents (metformin, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 [dpp-4] inhibitors, or sodium-glucose cotransporter 2 [sglt-2] inhibitors) or glucagon-like peptide-1 (glp-1) receptor agonists approved for use with insulin.
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length Poorly controlled | Oral medication Quantity | Metformin | Sulfonylurea | Thiazolidinediones | Dipeptidyl Peptidase-4 Inhibitor | SGLT2 Inhibitor | GLP-1 Receptor Agonist | Use Associated with Insulin

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
UMLS CUI [1,3]
C3853134
UMLS CUI [2,1]
C0175795
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0025598
UMLS CUI [4]
C0038766
UMLS CUI [5]
C1257987
UMLS CUI [6]
C3537225
UMLS CUI [7]
C3273807
UMLS CUI [8]
C2917359
UMLS CUI [9,1]
C0457083
UMLS CUI [9,2]
C0332281
UMLS CUI [9,3]
C0021641
adult patients who have signed an informed consent form and health insurance portability and accountability act (hipaa) authorization form.
Description

Adult | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hba1c <8.0% or >11.0%.
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
males or females <18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
type 1 diabetes mellitus.
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the investigator would restrict or limit the patient's successful participation for the duration of the study.
Description

Abnormality Clinical Significance Physical Examination | Abnormality Clinical Significance Laboratory Procedures | Abnormality Clinical Significance Vital signs | Systemic disease Major | Life Expectancy Short | Study Subject Participation Status Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0031809
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C2826293
UMLS CUI [2,3]
C0022885
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C2826293
UMLS CUI [3,3]
C0150404
UMLS CUI [4,1]
C0442893
UMLS CUI [4,2]
C0205164
UMLS CUI [5,1]
C0023671
UMLS CUI [5,2]
C1806781
UMLS CUI [6,1]
C2348568
UMLS CUI [6,2]
C0439801
use of any product containing insulin (lantus, levemir, humulin, novolin, humalog, novolog, apidra, or afrezza) since the time of diagnosis with t2dm other than temporary use during pregnancy or hospitalization.
Description

Product Containing Insulin | Lantus | Levemir | Humulin | Novolin | Humalog | NovoLog | Apidra | Afrezza | Exception Use Temporary

Data type

boolean

Alias
UMLS CUI [1,1]
C1514468
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0021641
UMLS CUI [2]
C0876064
UMLS CUI [3]
C1314782
UMLS CUI [4]
C3538423
UMLS CUI [5]
C0028467
UMLS CUI [6]
C0528249
UMLS CUI [7]
C0939412
UMLS CUI [8]
C1654827
UMLS CUI [9]
C3834216
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0457083
UMLS CUI [10,3]
C0205374
use of any product containing insulin (lantus, levemir, humulin, novolin, humalog, novolog, apidra, or afrezza) occurring within 3 months prior to the time of screening.
Description

Product Containing Insulin | Lantus | Levemir | Humulin | Novolin | Humalog | NovoLog | Apidra | Afrezza

Data type

boolean

Alias
UMLS CUI [1,1]
C1514468
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0021641
UMLS CUI [2]
C0876064
UMLS CUI [3]
C1314782
UMLS CUI [4]
C3538423
UMLS CUI [5]
C0028467
UMLS CUI [6]
C0528249
UMLS CUI [7]
C0939412
UMLS CUI [8]
C1654827
UMLS CUI [9]
C3834216
use of oral hypoglycemic agents other than those noted in the inclusion criteria, glp-1 receptor agonists not approved for use with insulin, or any investigational agent (drug, biologic, or device) within 3 months prior to the time of screening.
Description

Oral hypoglycemics | Exception Inclusion criteria | Investigational New Drugs | Biological agents | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C0359086
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
UMLS CUI [3]
C0013230
UMLS CUI [4]
C0005515
UMLS CUI [5]
C2346570
all contraindications to commercially available insulin therapy or warnings/precautions of use as displayed in the respective national product labeling for these products.
Description

Medical contraindication Insulin regime

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0557978
pregnancy or lactation.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing potential with no effective contraceptive method.
Description

Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
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 | Considerations Incomplete

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C0205257
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02451137

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Non-Insulin-Dependent Diabetes Mellitus Disease length Poorly controlled | Oral medication Quantity | Metformin | Sulfonylurea | Thiazolidinediones | Dipeptidyl Peptidase-4 Inhibitor | SGLT2 Inhibitor | GLP-1 Receptor Agonist | Use Associated with Insulin
Item
patients with t2dm, as defined by the american diabetes association/world health organization, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled after at least 1 year of treatment with 2 or more of the following: oral agents (metformin, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 [dpp-4] inhibitors, or sodium-glucose cotransporter 2 [sglt-2] inhibitors) or glucagon-like peptide-1 (glp-1) receptor agonists approved for use with insulin.
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C3853134 (UMLS CUI [1,3])
C0175795 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C1257987 (UMLS CUI [5])
C3537225 (UMLS CUI [6])
C3273807 (UMLS CUI [7])
C2917359 (UMLS CUI [8])
C0457083 (UMLS CUI [9,1])
C0332281 (UMLS CUI [9,2])
C0021641 (UMLS CUI [9,3])
Adult | Informed Consent
Item
adult patients who have signed an informed consent form and health insurance portability and accountability act (hipaa) authorization form.
boolean
C0001675 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hemoglobin A1c measurement
Item
hba1c <8.0% or >11.0%.
boolean
C0474680 (UMLS CUI [1])
Age
Item
males or females <18 years of age.
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus.
boolean
C0011854 (UMLS CUI [1])
Abnormality Clinical Significance Physical Examination | Abnormality Clinical Significance Laboratory Procedures | Abnormality Clinical Significance Vital signs | Systemic disease Major | Life Expectancy Short | Study Subject Participation Status Limited
Item
any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the investigator would restrict or limit the patient's successful participation for the duration of the study.
boolean
C1704258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0022885 (UMLS CUI [2,3])
C1704258 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0150404 (UMLS CUI [3,3])
C0442893 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C0023671 (UMLS CUI [5,1])
C1806781 (UMLS CUI [5,2])
C2348568 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
Product Containing Insulin | Lantus | Levemir | Humulin | Novolin | Humalog | NovoLog | Apidra | Afrezza | Exception Use Temporary
Item
use of any product containing insulin (lantus, levemir, humulin, novolin, humalog, novolog, apidra, or afrezza) since the time of diagnosis with t2dm other than temporary use during pregnancy or hospitalization.
boolean
C1514468 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0021641 (UMLS CUI [1,3])
C0876064 (UMLS CUI [2])
C1314782 (UMLS CUI [3])
C3538423 (UMLS CUI [4])
C0028467 (UMLS CUI [5])
C0528249 (UMLS CUI [6])
C0939412 (UMLS CUI [7])
C1654827 (UMLS CUI [8])
C3834216 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0457083 (UMLS CUI [10,2])
C0205374 (UMLS CUI [10,3])
Product Containing Insulin | Lantus | Levemir | Humulin | Novolin | Humalog | NovoLog | Apidra | Afrezza
Item
use of any product containing insulin (lantus, levemir, humulin, novolin, humalog, novolog, apidra, or afrezza) occurring within 3 months prior to the time of screening.
boolean
C1514468 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0021641 (UMLS CUI [1,3])
C0876064 (UMLS CUI [2])
C1314782 (UMLS CUI [3])
C3538423 (UMLS CUI [4])
C0028467 (UMLS CUI [5])
C0528249 (UMLS CUI [6])
C0939412 (UMLS CUI [7])
C1654827 (UMLS CUI [8])
C3834216 (UMLS CUI [9])
Oral hypoglycemics | Exception Inclusion criteria | Investigational New Drugs | Biological agents | Investigational Medical Device
Item
use of oral hypoglycemic agents other than those noted in the inclusion criteria, glp-1 receptor agonists not approved for use with insulin, or any investigational agent (drug, biologic, or device) within 3 months prior to the time of screening.
boolean
C0359086 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3])
C0005515 (UMLS CUI [4])
C2346570 (UMLS CUI [5])
Medical contraindication Insulin regime
Item
all contraindications to commercially available insulin therapy or warnings/precautions of use as displayed in the respective national product labeling for these products.
boolean
C1301624 (UMLS CUI [1,1])
C0557978 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent
Item
women of childbearing potential with no effective contraceptive method.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Study Subject Participation Status | Considerations Incomplete
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])
C0518609 (UMLS CUI [2,1])
C0205257 (UMLS CUI [2,2])
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