ID

35815

Description

A Study to Compare Insulin Intensification of Biphasic Insulin Aspart 30 and Insulin Analogues (Insulin Glargine and Insulin Aspart) in Insulin naïve Type 2 Diabetic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02453685

Link

https://clinicaltrials.gov/show/NCT02453685

Keywords

Versions (1)
  1. 3/25/19 3/25/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 25, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT02453685

English

Eligibility Diabetes NCT02453685

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02453685
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
male or female, age at least 18 years at the time of signing informed consent
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes subjects clinically diagnosed at least 6 months prior to screening
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
treatment with stable daily dose (for at least 90 days prior to screening) of: -
Description

Therapy Daily Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0205360
metformin (equal or above 1000 mg or maximum tolerated dose documented in the patient medical record) and - sulfonylurea - and willing to discontinue any other oral antidiabetic drugs containing insulin secretagogues, dpp4i (dipeptidyl peptidase-4 inhibitor), sglt2 (sodium glucose co-transporter 2), colesevelam, bromocriptin and/or combination products at randomisation
Description

Metformin Dosage | Metformin Maximum Tolerated Dose | Sulfonylurea | Antidiabetics Oral To be stopped | Pills Insulin Releasing To be stopped | Dipeptidyl Peptidase-4 Inhibitor To be stopped | Sodium-Glucose Cotransporter 2 Inhibitor To be stopped | Colesevelam To be stopped | Bromocriptine To be stopped | Combination Product To be stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0752079
UMLS CUI [3]
C0038766
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C1527415
UMLS CUI [4,3]
C1272691
UMLS CUI [5,1]
C0994475
UMLS CUI [5,2]
C0021641
UMLS CUI [5,3]
C1283071
UMLS CUI [5,4]
C1272691
UMLS CUI [6,1]
C3537225
UMLS CUI [6,2]
C1272691
UMLS CUI [7,1]
C3542461
UMLS CUI [7,2]
C1272691
UMLS CUI [8,1]
C0541155
UMLS CUI [8,2]
C1272691
UMLS CUI [9,1]
C0006230
UMLS CUI [9,2]
C1272691
UMLS CUI [10,1]
C1880146
UMLS CUI [10,2]
C1272691
insulin-naïve. short term insulin treatment for acute illnesses for a total of 14 days or less is allowed as is prior insulin treatment for gestational diabetes
Description

Insulin Absent | Insulin regime short-term allowed | Insulin regime short-term Acute illness | Insulin regime Gestational Diabetes

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0443303
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C0557978
UMLS CUI [3,2]
C0443303
UMLS CUI [3,3]
C4061114
UMLS CUI [4,1]
C0557978
UMLS CUI [4,2]
C0085207
hba1c (glycosylated haemoglobin) 7.0-9.5 % (both inclusive) analysed by central laboratory
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
willing to consume 3 main meals daily (morning, mid-day and evening) throughout the entire trial. the definition for 'main meal' will be according to the investigator's discretion
Description

Consumption Meal Main Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0009830
UMLS CUI [1,2]
C1998602
UMLS CUI [1,3]
C1542147
UMLS CUI [1,4]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
anticipated initiation or change in concomitant medications known to affect weight or glucose metabolism, in excess of 14 days (i.e. sibutramine, orlistat, thyroid hormones, systemic corticosteroids and other weight loss/modifying agents)
Description

Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting Glucose metabolism | Change of medication Affecting Body Weight | Change of medication Affecting Glucose metabolism | sibutramine | orlistat | Thyroid Hormones | CORTICOSTEROIDS FOR SYSTEMIC USE | Weight-Loss Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005910
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0596620
UMLS CUI [3,1]
C0580105
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0005910
UMLS CUI [4,1]
C0580105
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0596620
UMLS CUI [5]
C0074493
UMLS CUI [6]
C0076275
UMLS CUI [7]
C0040135
UMLS CUI [8]
C3653708
UMLS CUI [9]
C0376606
impaired liver function, defined as alt (alanine aminotransferase) at least 2.5 times upper limit of normal (central laboratory value measured at screening visit)
Description

Liver Dysfunction | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
inadequately treated high blood pressure defined as class 2 hypertension or higher (i.e. systolic blood pressure equal to or above 160 mm hg or diastolic equal to or above 100 mm hg) in accordance with the national high blood pressure education program, 7th joint national committee1 and esh/esc 2013 guidelines2
Description

Hypertensive disease Treated Inadequate | Hypertensive disease Class | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C0205412
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0456387
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
within the past 180 days prior to randomisation, any of the following: myocardial infarction, stroke or hospitalization for unstable angina and /or transient ischemic attack
Description

Myocardial Infarction | Cerebrovascular accident | Hospitalization Unstable Angina | Hospitalization Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
C0002965
UMLS CUI [4,1]
C0019993
UMLS CUI [4,2]
C0007787
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Similar models

Eligibility Diabetes NCT02453685

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02453685
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
boolean
C0021430 (UMLS CUI [1])
Age
Item
male or female, age at least 18 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes subjects clinically diagnosed at least 6 months prior to screening
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Therapy Daily Dose Stable
Item
treatment with stable daily dose (for at least 90 days prior to screening) of: -
boolean
C0087111 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Metformin Dosage | Metformin Maximum Tolerated Dose | Sulfonylurea | Antidiabetics Oral To be stopped | Pills Insulin Releasing To be stopped | Dipeptidyl Peptidase-4 Inhibitor To be stopped | Sodium-Glucose Cotransporter 2 Inhibitor To be stopped | Colesevelam To be stopped | Bromocriptine To be stopped | Combination Product To be stopped
Item
metformin (equal or above 1000 mg or maximum tolerated dose documented in the patient medical record) and - sulfonylurea - and willing to discontinue any other oral antidiabetic drugs containing insulin secretagogues, dpp4i (dipeptidyl peptidase-4 inhibitor), sglt2 (sodium glucose co-transporter 2), colesevelam, bromocriptin and/or combination products at randomisation
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C0752079 (UMLS CUI [2,2])
C0038766 (UMLS CUI [3])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C1272691 (UMLS CUI [4,3])
C0994475 (UMLS CUI [5,1])
C0021641 (UMLS CUI [5,2])
C1283071 (UMLS CUI [5,3])
C1272691 (UMLS CUI [5,4])
C3537225 (UMLS CUI [6,1])
C1272691 (UMLS CUI [6,2])
C3542461 (UMLS CUI [7,1])
C1272691 (UMLS CUI [7,2])
C0541155 (UMLS CUI [8,1])
C1272691 (UMLS CUI [8,2])
C0006230 (UMLS CUI [9,1])
C1272691 (UMLS CUI [9,2])
C1880146 (UMLS CUI [10,1])
C1272691 (UMLS CUI [10,2])
Insulin Absent | Insulin regime short-term allowed | Insulin regime short-term Acute illness | Insulin regime Gestational Diabetes
Item
insulin-naïve. short term insulin treatment for acute illnesses for a total of 14 days or less is allowed as is prior insulin treatment for gestational diabetes
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0557978 (UMLS CUI [3,1])
C0443303 (UMLS CUI [3,2])
C4061114 (UMLS CUI [3,3])
C0557978 (UMLS CUI [4,1])
C0085207 (UMLS CUI [4,2])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) 7.0-9.5 % (both inclusive) analysed by central laboratory
boolean
C0474680 (UMLS CUI [1])
Consumption Meal Main Quantity
Item
willing to consume 3 main meals daily (morning, mid-day and evening) throughout the entire trial. the definition for 'main meal' will be according to the investigator's discretion
boolean
C0009830 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting Glucose metabolism | Change of medication Affecting Body Weight | Change of medication Affecting Glucose metabolism | sibutramine | orlistat | Thyroid Hormones | CORTICOSTEROIDS FOR SYSTEMIC USE | Weight-Loss Agents
Item
anticipated initiation or change in concomitant medications known to affect weight or glucose metabolism, in excess of 14 days (i.e. sibutramine, orlistat, thyroid hormones, systemic corticosteroids and other weight loss/modifying agents)
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
C0580105 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0005910 (UMLS CUI [3,3])
C0580105 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0596620 (UMLS CUI [4,3])
C0074493 (UMLS CUI [5])
C0076275 (UMLS CUI [6])
C0040135 (UMLS CUI [7])
C3653708 (UMLS CUI [8])
C0376606 (UMLS CUI [9])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired liver function, defined as alt (alanine aminotransferase) at least 2.5 times upper limit of normal (central laboratory value measured at screening visit)
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Hypertensive disease Treated Inadequate | Hypertensive disease Class | Systolic Pressure | Diastolic blood pressure
Item
inadequately treated high blood pressure defined as class 2 hypertension or higher (i.e. systolic blood pressure equal to or above 160 mm hg or diastolic equal to or above 100 mm hg) in accordance with the national high blood pressure education program, 7th joint national committee1 and esh/esc 2013 guidelines2
boolean
C0020538 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0020538 (UMLS CUI [2,1])
C0456387 (UMLS CUI [2,2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Myocardial Infarction | Cerebrovascular accident | Hospitalization Unstable Angina | Hospitalization Transient Ischemic Attack
Item
within the past 180 days prior to randomisation, any of the following: myocardial infarction, stroke or hospitalization for unstable angina and /or transient ischemic attack
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0019993 (UMLS CUI [3,1])
C0002965 (UMLS CUI [3,2])
C0019993 (UMLS CUI [4,1])
C0007787 (UMLS CUI [4,2])
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