ID

16041

Description

Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications; ODM derived from: https://clinicaltrials.gov/show/NCT02320721

Link

https://clinicaltrials.gov/show/NCT02320721

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 NCT02320721

English

Eligibility Type 2 Diabetes Mellitus NCT02320721

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients ≥65 years old with type 2 diabetes mellitus, inadequately controlled on antidiabetic regimens either including no insulin, or with basal insulin as their only insulin.
Description

Age | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Therapy Controlled Inadequate | Insulin Absent | Basal insulin

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011860
UMLS CUI [3,1]
C3274787
UMLS CUI [3,2]
C2587213
UMLS CUI [3,3]
C0205412
UMLS CUI [4,1]
C0021641
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C0650607
signed informed consent.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hba1c at screening visit:
Description

Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0019018
<7.0% or >10.0% for patients taking basal insulin.
Description

Basal insulin

Data type

boolean

Alias
UMLS CUI [1]
C0650607
<7.5% or >11.0% for insulin-naïve patients.
Description

Insulin Therapy naive

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0919936
history of type 2 diabetes mellitus for less than 1 year before screening.
Description

Diabetes Mellitus, Non-Insulin-Dependent disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
patients not on stable basal insulin dose (±10% in the last 8 weeks prior to screening visit).
Description

Basal insulin Dose Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0650607
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0443343
change in dose of antidiabetic treatment or initiation of new glucose-lowering medications in the last 8 weeks prior to screening.
Description

Diabetes Therapy Dose Change | Initiation Pharmaceutical Preparations Glucose Lowering

Data type

boolean

Alias
UMLS CUI [1,1]
C3274787
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0392747
UMLS CUI [2,1]
C1704686
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0017725
UMLS CUI [2,4]
C2003888
chronic (>10 days continuous use in previous 6 months) use of bolus insulin injections, whether given separately or as part of a combination with basal insulin, eg, premix insulin; for insulin-naïve individuals: current or previous insulin use except for a maximum of 10 consecutive days (e.g. acute illness, surgery) during the last year prior to screening.
Description

bolus infusion Insulin chronic | bolus infusion Insulin Combined Basal insulin | Insulin Therapy naive | Acute illness | Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C1511237
UMLS CUI [1,2]
C0021641
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C1511237
UMLS CUI [2,2]
C0021641
UMLS CUI [2,3]
C0205195
UMLS CUI [2,4]
C0650607
UMLS CUI [3,1]
C0021641
UMLS CUI [3,2]
C0919936
UMLS CUI [4]
C4061114
UMLS CUI [5]
C0543467
cognitive disorder and dementia assessed clinically and by mini-mental state examination (mmse) score <24, or any neurologic disorder that will likely affect the patient's ability to follow the study procedure. the patient will be eligible despite an mmse score <24 if the investigator determines that the low score reflects educational or cultural background and not dementia as long as the patient is otherwise able to meet the study requirements.
Description

Cognition Disorders | Dementia | Mini-mental state examination | nervous system disorder Affecting Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C0009241
UMLS CUI [2]
C0497327
UMLS CUI [3]
C0451306
UMLS CUI [4,1]
C0027765
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C1321605
patients who have end-stage renal disease (<15 ml/min/1.73m^2, per estimated glomerular filtration rate [egfr] measurement by modification of diet in renal disease [mdrd]).
Description

Kidney Failure, Chronic | Estimated Glomerular Filtration Rate Modification of diet in renal disease formula

Data type

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2,1]
C3811844
UMLS CUI [2,2]
C3839656
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 NCT02320721

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Therapy Controlled Inadequate | Insulin Absent | Basal insulin
Item
patients ≥65 years old with type 2 diabetes mellitus, inadequately controlled on antidiabetic regimens either including no insulin, or with basal insulin as their only insulin.
boolean
C0001779 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C3274787 (UMLS CUI [3,1])
C2587213 (UMLS CUI [3,2])
C0205412 (UMLS CUI [3,3])
C0021641 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0650607 (UMLS CUI [5])
Informed consent
Item
signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Glycosylated hemoglobin A
Item
hba1c at screening visit:
boolean
C0019018 (UMLS CUI [1])
Basal insulin
Item
<7.0% or >10.0% for patients taking basal insulin.
boolean
C0650607 (UMLS CUI [1])
Insulin Therapy naive
Item
<7.5% or >11.0% for insulin-naïve patients.
boolean
C0021641 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent disease length
Item
history of type 2 diabetes mellitus for less than 1 year before screening.
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin Dose Unstable
Item
patients not on stable basal insulin dose (±10% in the last 8 weeks prior to screening visit).
boolean
C0650607 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
Diabetes Therapy Dose Change | Initiation Pharmaceutical Preparations Glucose Lowering
Item
change in dose of antidiabetic treatment or initiation of new glucose-lowering medications in the last 8 weeks prior to screening.
boolean
C3274787 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C1704686 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0017725 (UMLS CUI [2,3])
C2003888 (UMLS CUI [2,4])
bolus infusion Insulin chronic | bolus infusion Insulin Combined Basal insulin | Insulin Therapy naive | Acute illness | Operative Surgical Procedures
Item
chronic (>10 days continuous use in previous 6 months) use of bolus insulin injections, whether given separately or as part of a combination with basal insulin, eg, premix insulin; for insulin-naïve individuals: current or previous insulin use except for a maximum of 10 consecutive days (e.g. acute illness, surgery) during the last year prior to screening.
boolean
C1511237 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C1511237 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C0205195 (UMLS CUI [2,3])
C0650607 (UMLS CUI [2,4])
C0021641 (UMLS CUI [3,1])
C0919936 (UMLS CUI [3,2])
C4061114 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
Cognition Disorders | Dementia | Mini-mental state examination | nervous system disorder Affecting Compliance behavior
Item
cognitive disorder and dementia assessed clinically and by mini-mental state examination (mmse) score <24, or any neurologic disorder that will likely affect the patient's ability to follow the study procedure. the patient will be eligible despite an mmse score <24 if the investigator determines that the low score reflects educational or cultural background and not dementia as long as the patient is otherwise able to meet the study requirements.
boolean
C0009241 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
C0451306 (UMLS CUI [3])
C0027765 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C1321605 (UMLS CUI [4,3])
Kidney Failure, Chronic | Estimated Glomerular Filtration Rate Modification of diet in renal disease formula
Item
patients who have end-stage renal disease (<15 ml/min/1.73m^2, per estimated glomerular filtration rate [egfr] measurement by modification of diet in renal disease [mdrd]).
boolean
C0022661 (UMLS CUI [1])
C3811844 (UMLS CUI [2,1])
C3839656 (UMLS CUI [2,2])
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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