ID

38929

Beschreibung

Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01589653

Link

https://clinicaltrials.gov/show/NCT01589653

Stichworte

Versionen (1)
  1. 13.11.19 13.11.19 -
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See clinicaltrials.gov

Hochgeladen am

13. November 2019

DOI

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Eligibility Diabetes NCT01589653

Englisch

Eligibility Diabetes NCT01589653

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01589653
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 2 diabetes for a minimum of 12 months prior to screening
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
currently treated with a nph insulin for at least 3 months prior to screening
Beschreibung

NPH insulin

Datentyp

boolean

Alias
UMLS CUI [1]
C0021658
stable treatment (no change in dose or regimen) with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) ± additional oad treatment.the metformin treatment must have been stable for at least 2 months prior to screening
Beschreibung

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

Datentyp

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]
C0025598
UMLS CUI [3,2]
C0752079
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C1527415
UMLS CUI [5,1]
C0935929
UMLS CUI [5,2]
C1527415
UMLS CUI [5,3]
C0332197
hba1c between 7.0% and 10.0% (both inclusive). (one re-test within one week of screening visit is allowed. the last sample will be conclusive.)
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) below or equal to 40.0 kg/m^2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
able and willing to eat at least 2 main meals each day during the trial
Beschreibung

Meal Quantity Daily

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0332173
able and willing to adhere to the protocol including compliance with performance of self measured plasma glucose (smpg), injection regimen and titrating themselves according to the protocol
Beschreibung

Protocol Compliance | Plasma Glucose Measurement Self | Injection therapy | Titration Self

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0202042
UMLS CUI [2,2]
C0036588
UMLS CUI [3]
C0444472
UMLS CUI [4,1]
C0162621
UMLS CUI [4,2]
C0036588
experience in performing self measured plasma glucose (smpg)
Beschreibung

Experience Plasma Glucose Measurement Self

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0596545
UMLS CUI [1,2]
C0202042
UMLS CUI [1,3]
C0036588
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with any thiazolidinedione (tzd) and glucagon-like peptide-1 (glp-1) receptor agonists or pramlintide within the last 3 months prior to screening
Beschreibung

Thiazolidinediones | GLP-1 Receptor Agonist | Pramlintide

Datentyp

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C2917359
UMLS CUI [3]
C0537551
impaired hepatic function defined as alanine aminotransferase (alat) above or equal to 2.5 times upper referenced limit. (one re-test within one week of screening visit is allowed. the last sample will be conclusive.)
Beschreibung

Liver Dysfunction | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
impaired kidney function with serum creatinine above or equal to 133 µmol/l (1.5 mg/dl) for males and above or equal to 124 µmol/l (1.4 mg/dl) for females. (one re-test within one week of screening visit is allowed. the last sample will be conclusive.)
Beschreibung

Renal Insufficiency | Creatinine measurement, serum | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
cardiac problems or uncontrolled treated/untreated severe hypertension (defined as systolic blood pressure above or equal to 180 mmhg and/or diastolic blood pressure above or equal to 100 mmhg)
Beschreibung

Cardiac problem | Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe Untreated | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0262402
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1868885
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0332155
UMLS CUI [4]
C0871470
UMLS CUI [5]
C0428883
previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations)
Beschreibung

Premixed insulin | Premixed insulin Analogue | Premixed Human Insulin

Datentyp

boolean

Alias
UMLS CUI [1]
C2069057
UMLS CUI [2,1]
C2069057
UMLS CUI [2,2]
C0243071
UMLS CUI [3,1]
C2069057
UMLS CUI [3,2]
C0795635
recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Beschreibung

Recurrent severe hypoglycemia | Hypoglycaemic episode Severe Quantity | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2,1]
C0745153
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0342317
UMLS CUI [4,1]
C0019993
UMLS CUI [4,2]
C0011880
known proliferative retinopathy or maculopathy requiring treatment
Beschreibung

Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0332121
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Ähnliche Modelle

Eligibility Diabetes NCT01589653

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01589653
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosed with type 2 diabetes for a minimum of 12 months prior to screening
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
NPH insulin
Item
currently treated with a nph insulin for at least 3 months prior to screening
boolean
C0021658 (UMLS CUI [1])
Treatment Stable | Metformin Cumulative Dose U/day | Metformin Maximum Tolerated Dose | Antidiabetics Oral | Antidiabetics Oral Absent
Item
stable treatment (no change in dose or regimen) with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) ± additional oad treatment.the metformin treatment must have been stable for at least 2 months prior to screening
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])
C0025598 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0935929 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Hemoglobin A1c measurement
Item
hba1c between 7.0% and 10.0% (both inclusive). (one re-test within one week of screening visit is allowed. the last sample will be conclusive.)
boolean
C0474680 (UMLS CUI [1])
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
Item
able and willing to eat at least 2 main meals each day during the trial
boolean
C1998602 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
Protocol Compliance | Plasma Glucose Measurement Self | Injection therapy | Titration Self
Item
able and willing to adhere to the protocol including compliance with performance of self measured plasma glucose (smpg), injection regimen and titrating themselves according to the protocol
boolean
C0525058 (UMLS CUI [1])
C0202042 (UMLS CUI [2,1])
C0036588 (UMLS CUI [2,2])
C0444472 (UMLS CUI [3])
C0162621 (UMLS CUI [4,1])
C0036588 (UMLS CUI [4,2])
Experience Plasma Glucose Measurement Self
Item
experience in performing self measured plasma glucose (smpg)
boolean
C0596545 (UMLS CUI [1,1])
C0202042 (UMLS CUI [1,2])
C0036588 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Thiazolidinediones | GLP-1 Receptor Agonist | Pramlintide
Item
treatment with any thiazolidinedione (tzd) and glucagon-like peptide-1 (glp-1) receptor agonists or pramlintide within the last 3 months prior to screening
boolean
C1257987 (UMLS CUI [1])
C2917359 (UMLS CUI [2])
C0537551 (UMLS CUI [3])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired hepatic function defined as alanine aminotransferase (alat) above or equal to 2.5 times upper referenced limit. (one re-test within one week of screening visit is allowed. the last sample will be conclusive.)
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Renal Insufficiency | Creatinine measurement, serum | Gender
Item
impaired kidney function with serum creatinine above or equal to 133 µmol/l (1.5 mg/dl) for males and above or equal to 124 µmol/l (1.4 mg/dl) for females. (one re-test within one week of screening visit is allowed. the last sample will be conclusive.)
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Cardiac problem | Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe Untreated | Systolic Pressure | Diastolic blood pressure
Item
cardiac problems or uncontrolled treated/untreated severe hypertension (defined as systolic blood pressure above or equal to 180 mmhg and/or diastolic blood pressure above or equal to 100 mmhg)
boolean
C0262402 (UMLS CUI [1])
C1868885 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1868885 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0332155 (UMLS CUI [3,3])
C0871470 (UMLS CUI [4])
C0428883 (UMLS CUI [5])
Premixed insulin | Premixed insulin Analogue | Premixed Human Insulin
Item
previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations)
boolean
C2069057 (UMLS CUI [1])
C2069057 (UMLS CUI [2,1])
C0243071 (UMLS CUI [2,2])
C2069057 (UMLS CUI [3,1])
C0795635 (UMLS CUI [3,2])
Recurrent severe hypoglycemia | Hypoglycaemic episode Severe Quantity | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis
Item
recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
boolean
C0342316 (UMLS CUI [1])
C0745153 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0342317 (UMLS CUI [3])
C0019993 (UMLS CUI [4,1])
C0011880 (UMLS CUI [4,2])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for
Item
known proliferative retinopathy or maculopathy requiring treatment
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
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