ID

35768

Beschrijving

Linagliptin as Add on to Basal Insulin in the Elderly; ODM derived from: https://clinicaltrials.gov/show/NCT02240680

Link

https://clinicaltrials.gov/show/NCT02240680

Trefwoorden

Versies (1)
  1. 21-03-19 21-03-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

21 maart 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02240680

Engels

Eligibility Diabetes Mellitus, Type 2 NCT02240680

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must sign and date an informed consent consistent with international conference on harmonisation and good clinical practice guidelines and local regulations prior to any evaluation and participation in the trial.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
male and female patients with a clinical diagnosis of type 2 diabetes mellitus, at the time of informed consent, who are:
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
70 years of age or older at informed consent or screen visit,
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
taking stable doses of basal insulin [strictly inclusive of: insulin neutral protamine hagedorn and isophane insulin; insulin degludec; insulin detemir; and insulin glargine] for at least 4 weeks prior to randomisation (visit 3) with dose adjustments up to a maximum of plus or minus 20% of baseline being allowed,
Beschrijving

Basal insulin Dose Stable | Neutral Protamine Hagedorn Insulin | insulin degludec | insulin detemir | Insulin Glargine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0650607
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0021658
UMLS CUI [3]
C3491971
UMLS CUI [4]
C0537270
UMLS CUI [5]
C0907402
may or may not be taking metformin immediate release or extended release [if the patient is taking metformin, stable dose must be maintained for at least twelve weeks without dose adjustments prior to randomisation (visit 3)], and
Beschrijving

Metformin Immediate Release | Metformin Extended Release | Metformin Immediate Release Absent | Metformin Extended Release Absent | Metformin Dose Stable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C1708470
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C1707968
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C1708470
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C1707968
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C0025598
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0205360
may or may not be taking alpha-glucosidase inhibitors [acarbose, miglitol, and voglibose; if the patient is taking alpha-glucosidase inhibitors, stable dose must be maintained for at least twelve weeks without dose adjustments prior to randomisation (visit 3)].
Beschrijving

alpha-Glucosidase Inhibitors Dose Stable | alpha-Glucosidase Inhibitors Absent | Acarbose | miglitol | voglibose

Datatype

boolean

Alias
UMLS CUI [1,1]
C1299007
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C1299007
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0050393
UMLS CUI [4]
C0066535
UMLS CUI [5]
C0532578
patients must have an glycosylated haemoglobin of 7.5% (58 millimoles per mole) to 10.0% (86 millimoles per mole) at the first visit (screen).
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
patients must have a body mass index of 45 kilogram/meter squared or less at the screen visit.
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
in the investigator's opinion, patients must be reliable, compliant, and agree to cooperate with all planned future trial evaluations as explained in detail during the informed consent process and to be able to perform them.
Beschrijving

Protocol Compliance | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
impaired cognitive ability as supported by the saint louis university mental status examination, additional assessment if necessary, and verified by the investigator at the screen visit.
Beschrijving

Impaired cognition Mental status Examination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0338656
UMLS CUI [1,2]
C0278060
UMLS CUI [1,3]
C4321457
depressed mood as supported by a score of 10 or more on the patient health questionnaire at the screen visit.
Beschrijving

Depressed mood Patient Health Questionnaire

Datatype

boolean

Alias
UMLS CUI [1,1]
C0344315
UMLS CUI [1,2]
C1879301
type 1 diabetes mellitus as determined by past medical records and history.
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
acute coronary syndrome (non-st elevation myocardial infarction, stroke or transient ischemic attack within 3 months prior to screen visit.
Beschrijving

Acute Coronary Syndrome | Non-ST elevation (NSTEMI) myocardial infarction | Cerebrovascular accident | Transient Ischemic Attack

Datatype

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C1561921
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0007787
indication of liver disease determined during screen and/or run-in period, defined by a serum level above 3 times the upper limit of normal in any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase.
Beschrijving

Indication Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0023895
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151849
bariatric, gastric bypass, and other gastrointestinal procedures or surgeries (including all types of gastric banding, restriction, and/or lapband) with the objective of promoting weight loss within the past two years at screen visit.
Beschrijving

Bariatric Surgery | Gastric Bypass | Gastrointestinal Surgical Procedure | Gastric banding | Other Coding | Objective (goal) Weight loss

Datatype

boolean

Alias
UMLS CUI [1]
C1456587
UMLS CUI [2]
C0017125
UMLS CUI [3]
C0524722
UMLS CUI [4]
C1960832
UMLS CUI [5]
C3846158
UMLS CUI [6,1]
C0018017
UMLS CUI [6,2]
C1262477
medical history of cancer (except for resected non-invasive basal or squamous cell carcinoma) and/or treatment for cancer within the last 5 years.
Beschrijving

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma | Cancer treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007137
UMLS CUI [4]
C0920425
blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (malaria, babesiosis, haemolytic anaemia).
Beschrijving

Hematological Disease | Disease Causing Hemolysis | Disease Causing Erythrocytes Unstable | Malaria | Babesiosis | Anemia, Hemolytic

Datatype

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0019054
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0678227
UMLS CUI [3,3]
C0014792
UMLS CUI [3,4]
C0443343
UMLS CUI [4]
C0024530
UMLS CUI [5]
C0004576
UMLS CUI [6]
C0002878
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02240680

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
patients must sign and date an informed consent consistent with international conference on harmonisation and good clinical practice guidelines and local regulations prior to any evaluation and participation in the trial.
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
male and female patients with a clinical diagnosis of type 2 diabetes mellitus, at the time of informed consent, who are:
boolean
C0011860 (UMLS CUI [1])
Age
Item
70 years of age or older at informed consent or screen visit,
boolean
C0001779 (UMLS CUI [1])
Basal insulin Dose Stable | Neutral Protamine Hagedorn Insulin | insulin degludec | insulin detemir | Insulin Glargine
Item
taking stable doses of basal insulin [strictly inclusive of: insulin neutral protamine hagedorn and isophane insulin; insulin degludec; insulin detemir; and insulin glargine] for at least 4 weeks prior to randomisation (visit 3) with dose adjustments up to a maximum of plus or minus 20% of baseline being allowed,
boolean
C0650607 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0021658 (UMLS CUI [2])
C3491971 (UMLS CUI [3])
C0537270 (UMLS CUI [4])
C0907402 (UMLS CUI [5])
Metformin Immediate Release | Metformin Extended Release | Metformin Immediate Release Absent | Metformin Extended Release Absent | Metformin Dose Stable
Item
may or may not be taking metformin immediate release or extended release [if the patient is taking metformin, stable dose must be maintained for at least twelve weeks without dose adjustments prior to randomisation (visit 3)], and
boolean
C0025598 (UMLS CUI [1,1])
C1708470 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C1707968 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3,1])
C1708470 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0025598 (UMLS CUI [4,1])
C1707968 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0025598 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
alpha-Glucosidase Inhibitors Dose Stable | alpha-Glucosidase Inhibitors Absent | Acarbose | miglitol | voglibose
Item
may or may not be taking alpha-glucosidase inhibitors [acarbose, miglitol, and voglibose; if the patient is taking alpha-glucosidase inhibitors, stable dose must be maintained for at least twelve weeks without dose adjustments prior to randomisation (visit 3)].
boolean
C1299007 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1299007 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0050393 (UMLS CUI [3])
C0066535 (UMLS CUI [4])
C0532578 (UMLS CUI [5])
Hemoglobin A1c measurement
Item
patients must have an glycosylated haemoglobin of 7.5% (58 millimoles per mole) to 10.0% (86 millimoles per mole) at the first visit (screen).
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
patients must have a body mass index of 45 kilogram/meter squared or less at the screen visit.
boolean
C1305855 (UMLS CUI [1])
Protocol Compliance | Informed Consent
Item
in the investigator's opinion, patients must be reliable, compliant, and agree to cooperate with all planned future trial evaluations as explained in detail during the informed consent process and to be able to perform them.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Impaired cognition Mental status Examination
Item
impaired cognitive ability as supported by the saint louis university mental status examination, additional assessment if necessary, and verified by the investigator at the screen visit.
boolean
C0338656 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
C4321457 (UMLS CUI [1,3])
Depressed mood Patient Health Questionnaire
Item
depressed mood as supported by a score of 10 or more on the patient health questionnaire at the screen visit.
boolean
C0344315 (UMLS CUI [1,1])
C1879301 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus as determined by past medical records and history.
boolean
C0011854 (UMLS CUI [1])
Acute Coronary Syndrome | Non-ST elevation (NSTEMI) myocardial infarction | Cerebrovascular accident | Transient Ischemic Attack
Item
acute coronary syndrome (non-st elevation myocardial infarction, stroke or transient ischemic attack within 3 months prior to screen visit.
boolean
C0948089 (UMLS CUI [1])
C1561921 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
Indication Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised
Item
indication of liver disease determined during screen and/or run-in period, defined by a serum level above 3 times the upper limit of normal in any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase.
boolean
C3146298 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151849 (UMLS CUI [4])
Bariatric Surgery | Gastric Bypass | Gastrointestinal Surgical Procedure | Gastric banding | Other Coding | Objective (goal) Weight loss
Item
bariatric, gastric bypass, and other gastrointestinal procedures or surgeries (including all types of gastric banding, restriction, and/or lapband) with the objective of promoting weight loss within the past two years at screen visit.
boolean
C1456587 (UMLS CUI [1])
C0017125 (UMLS CUI [2])
C0524722 (UMLS CUI [3])
C1960832 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
C0018017 (UMLS CUI [6,1])
C1262477 (UMLS CUI [6,2])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma | Cancer treatment
Item
medical history of cancer (except for resected non-invasive basal or squamous cell carcinoma) and/or treatment for cancer within the last 5 years.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007137 (UMLS CUI [3,2])
C0920425 (UMLS CUI [4])
Hematological Disease | Disease Causing Hemolysis | Disease Causing Erythrocytes Unstable | Malaria | Babesiosis | Anemia, Hemolytic
Item
blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (malaria, babesiosis, haemolytic anaemia).
boolean
C0018939 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0019054 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C0014792 (UMLS CUI [3,3])
C0443343 (UMLS CUI [3,4])
C0024530 (UMLS CUI [4])
C0004576 (UMLS CUI [5])
C0002878 (UMLS CUI [6])
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