ID

35793

Description

A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02034513

Link

https://clinicaltrials.gov/show/NCT02034513

Keywords

Versions (1)
  1. 3/23/19 3/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT02034513

English

Eligibility Diabetes NCT02034513

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02034513
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects fulfilling at least one of the below criteria: a) experienced at least one severe hypo episode within the last year (according to the ada (american diabetes association) definition, april 2013) b) moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 ml/min/1.73 m^2 per ckd-epi (chronic kidney disease epidemiology collaboration) c) hypoglycaemic symptom unawareness d) diabetes mellitus duration for more than 15 years e) recent episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70 mg/dl [below or equal to 3.9 mmol/l])) within the last 12 weeks prior to visit 1 (screening)
Description

Hypoglycaemic episode Severe Quantity | Chronic Kidney Failure Moderate | Glomerular Filtration Rate | Loss of hypoglycemic warning | Diabetes Mellitus Duration | Episode of Hypoglycemia | Symptoms Hypoglycemia | Episode Glucose low

Data type

boolean

Alias
UMLS CUI [1,1]
C0745153
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0022661
UMLS CUI [2,2]
C0205081
UMLS CUI [3]
C0017654
UMLS CUI [4]
C0342317
UMLS CUI [5,1]
C0011849
UMLS CUI [5,2]
C0449238
UMLS CUI [6,1]
C0332189
UMLS CUI [6,2]
C0020615
UMLS CUI [7,1]
C1457887
UMLS CUI [7,2]
C0020615
UMLS CUI [8,1]
C0332189
UMLS CUI [8,2]
C0860801
male or female, age at least 18 years at the time of signing informed consent
Description

Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
type 1 diabetes mellitus (diagnosed clinically) for at least 52 weeks prior to visit 1
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
current treatment with a basal-bolus regimen consisting of neutral protamine hagedorn (nph) insulin od (once daily) / bid (twice daily) or insulin detemir (idet) od / bid plus 2-4 daily injections of any rapid acting meal time insulin or csii (with rapid acting insulin) for at least 26 weeks prior to visit 1
Description

Basal insulin Bolus | Insulin, isophane | Insulin detemir | Short-Acting Insulin Mealtime | Continuous subcutaneous infusion of insulin | Insulin, Short-Acting

Data type

boolean

Alias
UMLS CUI [1,1]
C0650607
UMLS CUI [1,2]
C1705509
UMLS CUI [2]
C0021658
UMLS CUI [3]
C0537270
UMLS CUI [4,1]
C0356365
UMLS CUI [4,2]
C0587119
UMLS CUI [5]
C0393124
UMLS CUI [6]
C0356365
hba1c (glycosylated haemoglobin) below or equal to 10% by central laboratory analysis
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
bmi (body mass index) below or equal to 45 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with iglar or ideg within the last 26 weeks prior to visit 1 (short term use [less than or equal to 2 weeks] is allowed, but not within 4 weeks prior to screening)
Description

Insulin Glargine | Insulin degludec

Data type

boolean

Alias
UMLS CUI [1]
C0907402
UMLS CUI [2]
C3491971
use of any other anti-diabetic agent than those stated in the inclusion criteria within the last 26 weeks prior to visit 1
Description

Antidiabetics | Exception Inclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
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Similar models

Eligibility Diabetes NCT02034513

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02034513
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hypoglycaemic episode Severe Quantity | Chronic Kidney Failure Moderate | Glomerular Filtration Rate | Loss of hypoglycemic warning | Diabetes Mellitus Duration | Episode of Hypoglycemia | Symptoms Hypoglycemia | Episode Glucose low
Item
subjects fulfilling at least one of the below criteria: a) experienced at least one severe hypo episode within the last year (according to the ada (american diabetes association) definition, april 2013) b) moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 ml/min/1.73 m^2 per ckd-epi (chronic kidney disease epidemiology collaboration) c) hypoglycaemic symptom unawareness d) diabetes mellitus duration for more than 15 years e) recent episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70 mg/dl [below or equal to 3.9 mmol/l])) within the last 12 weeks prior to visit 1 (screening)
boolean
C0745153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0022661 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0017654 (UMLS CUI [3])
C0342317 (UMLS CUI [4])
C0011849 (UMLS CUI [5,1])
C0449238 (UMLS CUI [5,2])
C0332189 (UMLS CUI [6,1])
C0020615 (UMLS CUI [6,2])
C1457887 (UMLS CUI [7,1])
C0020615 (UMLS CUI [7,2])
C0332189 (UMLS CUI [8,1])
C0860801 (UMLS CUI [8,2])
Age | Informed Consent
Item
male or female, age at least 18 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus (diagnosed clinically) for at least 52 weeks prior to visit 1
boolean
C0011854 (UMLS CUI [1])
Basal insulin Bolus | Insulin, isophane | Insulin detemir | Short-Acting Insulin Mealtime | Continuous subcutaneous infusion of insulin | Insulin, Short-Acting
Item
current treatment with a basal-bolus regimen consisting of neutral protamine hagedorn (nph) insulin od (once daily) / bid (twice daily) or insulin detemir (idet) od / bid plus 2-4 daily injections of any rapid acting meal time insulin or csii (with rapid acting insulin) for at least 26 weeks prior to visit 1
boolean
C0650607 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
C0021658 (UMLS CUI [2])
C0537270 (UMLS CUI [3])
C0356365 (UMLS CUI [4,1])
C0587119 (UMLS CUI [4,2])
C0393124 (UMLS CUI [5])
C0356365 (UMLS CUI [6])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) below or equal to 10% by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) below or equal to 45 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Insulin Glargine | Insulin degludec
Item
treatment with iglar or ideg within the last 26 weeks prior to visit 1 (short term use [less than or equal to 2 weeks] is allowed, but not within 4 weeks prior to screening)
boolean
C0907402 (UMLS CUI [1])
C3491971 (UMLS CUI [2])
Antidiabetics | Exception Inclusion criteria
Item
use of any other anti-diabetic agent than those stated in the inclusion criteria within the last 26 weeks prior to visit 1
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
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