ID

35724

Beskrivning

Ease of Use and Safety of the New U300 Pen Injector in Insulin-Naïve Patients With T2DM; ODM derived from: https://clinicaltrials.gov/show/NCT02227212

Länk

https://clinicaltrials.gov/show/NCT02227212

Nyckelord

Versioner (1)
  1. 2019-03-18 2019-03-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 mars 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus Type 2 NCT02227212

Engelsk

Eligibility Diabetes Mellitus Type 2 NCT02227212

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with t2dm inadequately controlled with non-insulin, non-injectable anti-hyperglycemic drug(s) and for whom the investigator/treating physicians has decided that basal insulin is appropriate.
Beskrivning

Non-Insulin-Dependent Diabetes Mellitus Poorly controlled | Hypoglycemic Agents | Exception Insulin | Exception Injectables | Basal insulin Appropriate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C3853134
UMLS CUI [2]
C0020616
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0021641
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0086466
UMLS CUI [5,1]
C0650607
UMLS CUI [5,2]
C1548787
signed written informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
glycated hemoglobin a1c (hba1c) <7.0% (<53 mmol/mol) or >11% (97 mmol/mol) at screening.
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
age <18 years at the time of screening.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
body mass index (bmi) >40 kg/m2.
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
diabetes other than t2dm.
Beskrivning

Diabetes Mellitus | Exception Non-Insulin-Dependent Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011860
history of t2dm for less than 1 year before screening.
Beskrivning

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
less than 6 months anti-hyperglycemic treatment before screening.
Beskrivning

Hypoglycemic Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0020616
initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit.
Beskrivning

Hypoglycemic Agents New | Weight-Loss Agents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C0205314
UMLS CUI [2]
C0376606
previous treatment with glucagon like peptide-1 (glp-1) agonist.
Beskrivning

GLP-1 Receptor Agonist

Datatyp

boolean

Alias
UMLS CUI [1]
C2917359
patients receiving only non-insulin anti-hyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinides.
Beskrivning

Hypoglycemic Agents | Exception Insulin | Exception Sulfonylurea | Exception Glinide

Datatyp

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021641
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0038766
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C2266929
current or previous insulin use except for a maximum of 8 consecutive days and a total of 14 days (eg, acute illness, surgery) during the last year prior to screening.
Beskrivning

Insulin use | Exception Acute illness | Exception Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1]
C0240016
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C4061114
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0543467
any contraindication to insulin glargine (lantus) according to the national product labeling or any excipients.
Beskrivning

Medical contraindication Insulin Glargine | Medical contraindication Lantus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0907402
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0876064
any contraindication to the mandatory background non-insulin anti-hyperglycemic medication according to the respective national product labeling.
Beskrivning

Medical contraindication Hypoglycemic Agents | Exception Insulin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021641
latest eye examination by an ophthalmologist >12 months prior to inclusion.
Beskrivning

Timepoint Eye examination Last

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C0200149
UMLS CUI [1,3]
C1517741
more than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months.
Beskrivning

Episode Quantity Hypoglycemia Severe | Seizure | Coma | Requires Assistance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0020615
UMLS CUI [1,4]
C0205082
UMLS CUI [2]
C0036572
UMLS CUI [3]
C0009421
UMLS CUI [4]
C1269765
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.
Beskrivning

Proliferative diabetic retinopathy Unstable | Diabetic Retinopathy Progressive Rapid | Macular edema Treatment required for | Laser Surgery | Operative Surgical Procedures | Injectables

Datatyp

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]
C0332121
UMLS CUI [4]
C0023087
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.
Beskrivning

Study Subject Participation Status | Considerations Incomplete

Datatyp

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 NCT02227212

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Poorly controlled | Hypoglycemic Agents | Exception Insulin | Exception Injectables | Basal insulin Appropriate
Item
patients with t2dm inadequately controlled with non-insulin, non-injectable anti-hyperglycemic drug(s) and for whom the investigator/treating physicians has decided that basal insulin is appropriate.
boolean
C0011860 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0020616 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0021641 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0086466 (UMLS CUI [4,2])
C0650607 (UMLS CUI [5,1])
C1548787 (UMLS CUI [5,2])
Informed Consent
Item
signed written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hemoglobin A1c measurement
Item
glycated hemoglobin a1c (hba1c) <7.0% (<53 mmol/mol) or >11% (97 mmol/mol) at screening.
boolean
C0474680 (UMLS CUI [1])
Age
Item
age <18 years at the time of screening.
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) >40 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus | Exception Non-Insulin-Dependent Diabetes Mellitus
Item
diabetes other than t2dm.
boolean
C0011849 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
history of t2dm for less than 1 year before screening.
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hypoglycemic Agents
Item
less than 6 months anti-hyperglycemic treatment before screening.
boolean
C0020616 (UMLS CUI [1])
Hypoglycemic Agents New | Weight-Loss Agents
Item
initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit.
boolean
C0020616 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0376606 (UMLS CUI [2])
GLP-1 Receptor Agonist
Item
previous treatment with glucagon like peptide-1 (glp-1) agonist.
boolean
C2917359 (UMLS CUI [1])
Hypoglycemic Agents | Exception Insulin | Exception Sulfonylurea | Exception Glinide
Item
patients receiving only non-insulin anti-hyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinides.
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0038766 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C2266929 (UMLS CUI [4,2])
Insulin use | Exception Acute illness | Exception Operative Surgical Procedures
Item
current or previous insulin use except for a maximum of 8 consecutive days and a total of 14 days (eg, acute illness, surgery) during the last year prior to screening.
boolean
C0240016 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C4061114 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
Medical contraindication Insulin Glargine | Medical contraindication Lantus
Item
any contraindication to insulin glargine (lantus) according to the national product labeling or any excipients.
boolean
C1301624 (UMLS CUI [1,1])
C0907402 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0876064 (UMLS CUI [2,2])
Medical contraindication Hypoglycemic Agents | Exception Insulin
Item
any contraindication to the mandatory background non-insulin anti-hyperglycemic medication according to the respective national product labeling.
boolean
C1301624 (UMLS CUI [1,1])
C0020616 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
Timepoint Eye examination Last
Item
latest eye examination by an ophthalmologist >12 months prior to inclusion.
boolean
C2348792 (UMLS CUI [1,1])
C0200149 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
Episode Quantity Hypoglycemia Severe | Seizure | Coma | Requires Assistance
Item
more than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months.
boolean
C0332189 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0020615 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0036572 (UMLS CUI [2])
C0009421 (UMLS CUI [3])
C1269765 (UMLS CUI [4])
Proliferative diabetic retinopathy Unstable | Diabetic Retinopathy Progressive Rapid | Macular edema Treatment required for | Laser Surgery | 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])
C0332121 (UMLS CUI [3,2])
C0023087 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
C0086466 (UMLS CUI [6])
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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