ID

37384

Beskrivning

Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2); ODM derived from: https://clinicaltrials.gov/show/NCT02227875

Länk

https://clinicaltrials.gov/show/NCT02227875

Nyckelord

Versioner (1)
  1. 2019-07-21 2019-07-21 -
Rättsinnehavare

See clinicaltrials.gov

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21 juli 2019

DOI

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Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT02227875

Engelsk

Eligibility Type 2 Diabetes NCT02227875

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with an established diagnosis of t2dm per ada 2014 criteria who also fulfill the following:
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
diagnosis established 1 year prior to screening
Beskrivning

Disease length

Datatyp

boolean

Alias
UMLS CUI [1]
C0872146
insulin-naïve or
Beskrivning

Insulin Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332197
on lantus® once daily at stable dose (±15% variation in dose) for at least 3 months prior to screening
Beskrivning

Lantus Dose Stable Once daily

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0876064
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0556983
body mass index (bmi) of 18.50 to 40.00 kg/m2 at screening (both values inclusive).
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
stable weight, with no more than 5 kg gain or loss, in the 3 months prior to screening; this information will be collected by patient interview during medical history.
Beskrivning

Stable body weight | Weight Gain Amount Timespan | Weight loss Amount Timespan

Datatyp

boolean

Alias
UMLS CUI [1]
C0517386
UMLS CUI [2,1]
C0043094
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0872291
UMLS CUI [3,1]
C1262477
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0872291
hemoglobin ≥9.0 g/dl at screening
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
glycosylated hemoglobin (hba1c) of <10.5% or between 7.5 to 10.5% for insulin naïve patients at screening.
Beskrivning

Hemoglobin A1c measurement | Hemoglobin A1c measurement Insulin Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0474680
UMLS CUI [2,2]
C0021641
UMLS CUI [2,3]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analog preparations used in the trial, or history of significant allergic drug reactions.
Beskrivning

Hypersensitivity Ingredient Insulin | Hypersensitivity Ingredient Insulin Analog | Drug Allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1550600
UMLS CUI [1,3]
C0021641
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1550600
UMLS CUI [2,3]
C2825028
UMLS CUI [3]
C0013182
history of use of animal insulin within the last 3 years, any insulin other than lantus® within the last 3 months prior to screening, or use of biosimilar insulin glargine at any time prior to screening.
Beskrivning

Animal Insulin | Insulin Any | Exception Lantus | Insulin Glargine biosimilar

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003062
UMLS CUI [1,2]
C0021641
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C1552551
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0876064
UMLS CUI [4,1]
C0907402
UMLS CUI [4,2]
C4045974
patients requiring basal-bolus insulin therapy or who in the opinion of the investigator require mealtime insulin in order to achieve glycemic control.
Beskrivning

Patient need for Basal insulin Bolus | Mealtime Insulin Glycaemia control

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0650607
UMLS CUI [1,3]
C1705509
UMLS CUI [2,1]
C0587119
UMLS CUI [2,2]
C0021641
UMLS CUI [2,3]
C3267174
regular use of immune-modulator therapy in the 1 year prior to screening.
Beskrivning

Immunomodulation Regular

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1963758
UMLS CUI [1,2]
C0205272
history of ≥2 episodes of severe hypoglycemia within the 6 months before screening or history of hypoglycemia unawareness (a sample questionnaire is provided in appendix i) as judged by the investigator.
Beskrivning

Episode Quantity Hypoglycemia Severe | Loss of hypoglycemic warning

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]
C0342317
history of ≥1 episode of hyperglycemic hyperosmolar coma or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months prior to screening.
Beskrivning

Episode Quantity Hyperglycemic Hyperosmolar Coma | Emergency department visit Diabetes mellitus uncontrolled | Hospitalization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0020457
UMLS CUI [2,1]
C0586082
UMLS CUI [2,2]
C0421258
UMLS CUI [3]
C0019993
serological evidence of human immunodeficiency virus (hiv), hepatitis b (hbsag) or hepatitis c (hcvab) antibodies at screening.
Beskrivning

HIV Seropositivity | Hepatitis B antibody positive | Hepatitis B surface antigen positive | Hepatitis C antibody positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0860013
UMLS CUI [3]
C0149709
UMLS CUI [4]
C0281863
history of drug or alcohol dependence or abuse during the 1 year prior to screening.
Beskrivning

Substance Dependence | Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0038586
receipt of another investigational drug in the 3 months prior to screening (or as per local regulations), or if the screening visit is within 5 half-lives of another investigational drug (whichever is longer), or scheduled to receive another investigational drug during the current trial period.
Beskrivning

Investigational New Drugs | Investigational New Drugs Scheduled

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0205539
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Similar models

Eligibility Type 2 Diabetes NCT02227875

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
patients with an established diagnosis of t2dm per ada 2014 criteria who also fulfill the following:
boolean
C0011860 (UMLS CUI [1])
Disease length
Item
diagnosis established 1 year prior to screening
boolean
C0872146 (UMLS CUI [1])
Insulin Absent
Item
insulin-naïve or
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Lantus Dose Stable Once daily
Item
on lantus® once daily at stable dose (±15% variation in dose) for at least 3 months prior to screening
boolean
C0876064 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0556983 (UMLS CUI [1,4])
Body mass index
Item
body mass index (bmi) of 18.50 to 40.00 kg/m2 at screening (both values inclusive).
boolean
C1305855 (UMLS CUI [1])
Stable body weight | Weight Gain Amount Timespan | Weight loss Amount Timespan
Item
stable weight, with no more than 5 kg gain or loss, in the 3 months prior to screening; this information will be collected by patient interview during medical history.
boolean
C0517386 (UMLS CUI [1])
C0043094 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0872291 (UMLS CUI [2,3])
C1262477 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0872291 (UMLS CUI [3,3])
Hemoglobin measurement
Item
hemoglobin ≥9.0 g/dl at screening
boolean
C0518015 (UMLS CUI [1])
Hemoglobin A1c measurement | Hemoglobin A1c measurement Insulin Absent
Item
glycosylated hemoglobin (hba1c) of <10.5% or between 7.5 to 10.5% for insulin naïve patients at screening.
boolean
C0474680 (UMLS CUI [1])
C0474680 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Ingredient Insulin | Hypersensitivity Ingredient Insulin Analog | Drug Allergy
Item
history of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analog preparations used in the trial, or history of significant allergic drug reactions.
boolean
C0020517 (UMLS CUI [1,1])
C1550600 (UMLS CUI [1,2])
C0021641 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1550600 (UMLS CUI [2,2])
C2825028 (UMLS CUI [2,3])
C0013182 (UMLS CUI [3])
Animal Insulin | Insulin Any | Exception Lantus | Insulin Glargine biosimilar
Item
history of use of animal insulin within the last 3 years, any insulin other than lantus® within the last 3 months prior to screening, or use of biosimilar insulin glargine at any time prior to screening.
boolean
C0003062 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0876064 (UMLS CUI [3,2])
C0907402 (UMLS CUI [4,1])
C4045974 (UMLS CUI [4,2])
Patient need for Basal insulin Bolus | Mealtime Insulin Glycaemia control
Item
patients requiring basal-bolus insulin therapy or who in the opinion of the investigator require mealtime insulin in order to achieve glycemic control.
boolean
C0686904 (UMLS CUI [1,1])
C0650607 (UMLS CUI [1,2])
C1705509 (UMLS CUI [1,3])
C0587119 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C3267174 (UMLS CUI [2,3])
Immunomodulation Regular
Item
regular use of immune-modulator therapy in the 1 year prior to screening.
boolean
C1963758 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Episode Quantity Hypoglycemia Severe | Loss of hypoglycemic warning
Item
history of ≥2 episodes of severe hypoglycemia within the 6 months before screening or history of hypoglycemia unawareness (a sample questionnaire is provided in appendix i) as judged by the investigator.
boolean
C0332189 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0020615 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0342317 (UMLS CUI [2])
Episode Quantity Hyperglycemic Hyperosmolar Coma | Emergency department visit Diabetes mellitus uncontrolled | Hospitalization
Item
history of ≥1 episode of hyperglycemic hyperosmolar coma or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months prior to screening.
boolean
C0332189 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0020457 (UMLS CUI [1,3])
C0586082 (UMLS CUI [2,1])
C0421258 (UMLS CUI [2,2])
C0019993 (UMLS CUI [3])
HIV Seropositivity | Hepatitis B antibody positive | Hepatitis B surface antigen positive | Hepatitis C antibody positive
Item
serological evidence of human immunodeficiency virus (hiv), hepatitis b (hbsag) or hepatitis c (hcvab) antibodies at screening.
boolean
C0019699 (UMLS CUI [1])
C0860013 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
C0281863 (UMLS CUI [4])
Substance Dependence | Substance Use Disorders
Item
history of drug or alcohol dependence or abuse during the 1 year prior to screening.
boolean
C0038580 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
Investigational New Drugs | Investigational New Drugs Scheduled
Item
receipt of another investigational drug in the 3 months prior to screening (or as per local regulations), or if the screening visit is within 5 half-lives of another investigational drug (whichever is longer), or scheduled to receive another investigational drug during the current trial period.
boolean
C0013230 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
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