ID

35724

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT02227212

Stichworte

Versionen (1)
  1. 18.03.19 18.03.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

18. März 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Diabetes Mellitus Type 2 NCT02227212

Englisch

Eligibility Diabetes Mellitus Type 2 NCT02227212

1 Formulare  
Inclusion Criteria
Beschreibung

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Hemoglobin A1c measurement

Datentyp

boolean

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

Age

Datentyp

boolean

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

Body mass index

Datentyp

boolean

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

Diabetes Mellitus | Exception Non-Insulin-Dependent Diabetes Mellitus

Datentyp

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.
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datentyp

boolean

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

Hypoglycemic Agents

Datentyp

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.
Beschreibung

Hypoglycemic Agents New | Weight-Loss Agents

Datentyp

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.
Beschreibung

GLP-1 Receptor Agonist

Datentyp

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.
Beschreibung

Hypoglycemic Agents | Exception Insulin | Exception Sulfonylurea | Exception Glinide

Datentyp

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.
Beschreibung

Insulin use | Exception Acute illness | Exception Operative Surgical Procedures

Datentyp

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.
Beschreibung

Medical contraindication Insulin Glargine | Medical contraindication Lantus

Datentyp

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.
Beschreibung

Medical contraindication Hypoglycemic Agents | Exception Insulin

Datentyp

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.
Beschreibung

Timepoint Eye examination Last

Datentyp

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.
Beschreibung

Episode Quantity Hypoglycemia Severe | Seizure | Coma | Requires Assistance

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Study Subject Participation Status | Considerations Incomplete

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C0205257
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Diabetes Mellitus Type 2 NCT02227212

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video