ID

38924

Description

Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin; ODM derived from: https://clinicaltrials.gov/show/NCT01519674

Link

https://clinicaltrials.gov/show/NCT01519674

Keywords

Versions (1)
  1. 11/13/19 11/13/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 13, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01519674

English

Eligibility Diabetes NCT01519674

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01519674
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 2 diabetes for a minimum of 6 months prior to screening (visit 1)
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
stable treatment with a total daily dose of at least 1000 mg of metformin (with or without additional oral anti-diabetic drugs (oads) treatment). the metformin dose must have been unchanged for at least 3 months prior to screening (visit 1)
Description

Treatment Stable | Metformin Cumulative Dose U/day | Antidiabetics Oral | Antidiabetics Oral Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C2986497
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C1527415
UMLS CUI [4,3]
C0332197
stable treatment with a total daily dose of at least 100 mg sitagliptin. the sitagliptin dose must have been unchanged for at least 3 months prior to screening (visit 1)
Description

Treatment Stable | Sitagliptin Cumulative Dose U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C1565750
UMLS CUI [2,2]
C2986497
UMLS CUI [2,3]
C0456683
subject is insulin-naïve (never previously treated with insulin). (however, short term insulin use due to intermittent illness of up to 14 days or insulin treatment for gestational diabetes is allowed)
Description

Insulin Absent | Insulin use short-term allowed | Etiology Comorbidity Duration | Etiology Insulin regime Gestational Diabetes

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0240016
UMLS CUI [2,2]
C0443303
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0009488
UMLS CUI [3,3]
C0449238
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0557978
UMLS CUI [4,3]
C0085207
hba1c (glycosylated haemoglobin) between 7.0 to 10.0 % (53-86 mmol/mol) (both inclusive) by central laboratory analysis demonstrating inadequate control on sitagliptin and metformin (with or without other oads)
Description

Hemoglobin A1c measurement | Control Inadequate | sitagliptin | Metformin | Antidiabetics Oral | Antidiabetics Oral Absent

Data type

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C2587213
UMLS CUI [2,2]
C0205412
UMLS CUI [3]
C1565750
UMLS CUI [4]
C0025598
UMLS CUI [5,1]
C0935929
UMLS CUI [5,2]
C1527415
UMLS CUI [6,1]
C0935929
UMLS CUI [6,2]
C1527415
UMLS CUI [6,3]
C0332197
body mass index (bmi) below or equal to 40.0 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
able and willing to eat at least 2 meals (breakfast and dinner) every day during the trial
Description

Meal Quantity Daily | Breakfast | Dinner

Data type

boolean

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0332173
UMLS CUI [2]
C2698559
UMLS CUI [3]
C4048877
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with thiazolidinedione (tzd) or glucagon-like-peptide-1 (glp-1) receptor agonist within the last 3 months prior to screening (visit 1)
Description

Thiazolidinediones | GLP-1 Receptor Agonist

Data type

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C2917359
cardiac disease within the last 6 months prior to screening (visit 1), defined as: decompensated heart failure new york heart association (nyha) class iii or iv; unstable angina pectoris; or myocardial infarction
Description

Heart Disease | Decompensated cardiac failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C0581377
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0027051
severe hypertension, systolic blood pressure equal to or above 180 mm hg or diastolic blood pressure equal to or above 100 mm hg, after 5 minutes rest in the sitting position using mean value of 3 measurements at screening (visit 1)
Description

Hypertension, severe | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Status post Rest Number of minutes

Data type

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0444504
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0035253
UMLS CUI [4,3]
C1562039
anticipated change of dose of any systemic treatment with products, which in the trial physician's opinion could interfere with glucose metabolism (e.g., systemic corticosteroids)
Description

Systemic therapy Medication dose changed | Pharmaceutical Preparations Interfere with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C1608430
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0596620
UMLS CUI [3]
C3653708
clinically significant diseases (except for conditions associated with type 2 diabetes) which, in the trial physician's opinion may confound the results of the trial or pose additional risk in administering trial product(s)
Description

Disease Interferes with Research results | Exception Condition Associated with Non-Insulin-Dependent Diabetes Mellitus | Disease Investigational New Drugs At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0348080
UMLS CUI [2,3]
C0332281
UMLS CUI [2,4]
C0011860
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0013230
UMLS CUI [3,3]
C1444641
impaired hepatic function as indicated by aspartate aminotransferase (asat) or alanine aminotransferase (alat) above 2.5 times the upper normal range, according to central laboratory reference ranges
Description

Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
impaired renal function as indicated by serum creatinine levels equal to or above 133 micromol/l (1.5 mg/dl) for males and equal to or above 124 micromol/l (1.4 mg/dl) for females or estimated creatinine clearance below 60 ml/min, based on the cockroft &
Description

Renal Insufficiency | Creatinine measurement, serum | Gender | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
UMLS CUI [4]
C2711451
gault formula and according to local practise for metformin use
Description

ID.15

Data type

boolean

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Similar models

Eligibility Diabetes NCT01519674

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01519674
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosed with type 2 diabetes for a minimum of 6 months prior to screening (visit 1)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Treatment Stable | Metformin Cumulative Dose U/day | Antidiabetics Oral | Antidiabetics Oral Absent
Item
stable treatment with a total daily dose of at least 1000 mg of metformin (with or without additional oral anti-diabetic drugs (oads) treatment). the metformin dose must have been unchanged for at least 3 months prior to screening (visit 1)
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Treatment Stable | Sitagliptin Cumulative Dose U/day
Item
stable treatment with a total daily dose of at least 100 mg sitagliptin. the sitagliptin dose must have been unchanged for at least 3 months prior to screening (visit 1)
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1565750 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
Insulin Absent | Insulin use short-term allowed | Etiology Comorbidity Duration | Etiology Insulin regime Gestational Diabetes
Item
subject is insulin-naïve (never previously treated with insulin). (however, short term insulin use due to intermittent illness of up to 14 days or insulin treatment for gestational diabetes is allowed)
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0240016 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0009488 (UMLS CUI [3,2])
C0449238 (UMLS CUI [3,3])
C0015127 (UMLS CUI [4,1])
C0557978 (UMLS CUI [4,2])
C0085207 (UMLS CUI [4,3])
Hemoglobin A1c measurement | Control Inadequate | sitagliptin | Metformin | Antidiabetics Oral | Antidiabetics Oral Absent
Item
hba1c (glycosylated haemoglobin) between 7.0 to 10.0 % (53-86 mmol/mol) (both inclusive) by central laboratory analysis demonstrating inadequate control on sitagliptin and metformin (with or without other oads)
boolean
C0474680 (UMLS CUI [1])
C2587213 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C1565750 (UMLS CUI [3])
C0025598 (UMLS CUI [4])
C0935929 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
C0935929 (UMLS CUI [6,1])
C1527415 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
Body mass index
Item
body mass index (bmi) below or equal to 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Meal Quantity Daily | Breakfast | Dinner
Item
able and willing to eat at least 2 meals (breakfast and dinner) every day during the trial
boolean
C1998602 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C2698559 (UMLS CUI [2])
C4048877 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Thiazolidinediones | GLP-1 Receptor Agonist
Item
treatment with thiazolidinedione (tzd) or glucagon-like-peptide-1 (glp-1) receptor agonist within the last 3 months prior to screening (visit 1)
boolean
C1257987 (UMLS CUI [1])
C2917359 (UMLS CUI [2])
Heart Disease | Decompensated cardiac failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction
Item
cardiac disease within the last 6 months prior to screening (visit 1), defined as: decompensated heart failure new york heart association (nyha) class iii or iv; unstable angina pectoris; or myocardial infarction
boolean
C0018799 (UMLS CUI [1])
C0581377 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Hypertension, severe | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Status post Rest Number of minutes
Item
severe hypertension, systolic blood pressure equal to or above 180 mm hg or diastolic blood pressure equal to or above 100 mm hg, after 5 minutes rest in the sitting position using mean value of 3 measurements at screening (visit 1)
boolean
C4013784 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0035253 (UMLS CUI [4,2])
C1562039 (UMLS CUI [4,3])
Systemic therapy Medication dose changed | Pharmaceutical Preparations Interfere with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
anticipated change of dose of any systemic treatment with products, which in the trial physician's opinion could interfere with glucose metabolism (e.g., systemic corticosteroids)
boolean
C1515119 (UMLS CUI [1,1])
C1608430 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
C3653708 (UMLS CUI [3])
Disease Interferes with Research results | Exception Condition Associated with Non-Insulin-Dependent Diabetes Mellitus | Disease Investigational New Drugs At risk
Item
clinically significant diseases (except for conditions associated with type 2 diabetes) which, in the trial physician's opinion may confound the results of the trial or pose additional risk in administering trial product(s)
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C0332281 (UMLS CUI [2,3])
C0011860 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
impaired hepatic function as indicated by aspartate aminotransferase (asat) or alanine aminotransferase (alat) above 2.5 times the upper normal range, according to central laboratory reference ranges
boolean
C0086565 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Renal Insufficiency | Creatinine measurement, serum | Gender | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
impaired renal function as indicated by serum creatinine levels equal to or above 133 micromol/l (1.5 mg/dl) for males and equal to or above 124 micromol/l (1.4 mg/dl) for females or estimated creatinine clearance below 60 ml/min, based on the cockroft &
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C2711451 (UMLS CUI [4])
ID.15
Item
gault formula and according to local practise for metformin use
boolean
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