ID

38875

Beschreibung

Comparison of Two Biphasic Insulin Aspart 30 Treatment Regimens in Subjects With Type 2 Diabetes Not Achieving HbA1c Treatment Targets on OADs Alone; ODM derived from: https://clinicaltrials.gov/show/NCT01215435

Link

https://clinicaltrials.gov/show/NCT01215435

Stichworte

Versionen (1)
  1. 11.11.19 11.11.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

11. November 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes NCT01215435

Englisch

Eligibility Diabetes NCT01215435

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01215435
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 2 diabetes for a minimum of 6 months prior to visit 1
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
hba1c at least 7.0 % - maximum 11 % at screening
Beschreibung

Hemoglobin A1c measurement | Hemoglobin A1c measurement Maximum

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0474680
UMLS CUI [2,2]
C0806909
subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed)
Beschreibung

Insulin Absent | Insulin regime short-term allowed

Datentyp

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
an antidiabetic regimen that has been stable for at least 3 months prior to screening
Beschreibung

Diabetes Therapy Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3274787
UMLS CUI [1,2]
C0205360
an antidiabetic regimen that includes a minimum of 2 oads
Beschreibung

Diabetes Therapy | Antidiabetics Oral Quantity Minimum

Datentyp

boolean

Alias
UMLS CUI [1]
C3274787
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C1524031
oads dosed at least 50% of the maximum recommended dose
Beschreibung

Antidiabetics Oral Dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0178602
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected hypersensitivity to trial product(s) or related products
Beschreibung

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013227
UMLS CUI [4,4]
C0439849
females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
Beschreibung

Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
the receipt of any investigational medicinal product within one month prior to this trial
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
suffer from a life threatening disease (cancer)
Beschreibung

Life threatening illness | Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C3846017
UMLS CUI [2]
C0006826
cardiac disease: class iii or iv congestive heart failure (chf), unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to screening
Beschreibung

Heart Disease | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction Treated | Myocardial Infarction Untreated

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0002965
UMLS CUI [4,1]
C0027051
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C0027051
UMLS CUI [5,2]
C0332155
hepatic insufficiency (alanine aminotransferase (alt) or aspartate aminotransferase (ast) above 2 times the central laboratory's upper reference limit)
Beschreibung

Hepatic Insufficiency | Alanine aminotransferase increased | Aspartate aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C1306571
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
renal insufficiency (serum creatinine above 1.6 mg/dl for males; 1.4 mg/dl for females
Beschreibung

Renal Insufficiency | Creatinine measurement, serum | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
recurrent hypoglycaemia or hypoglycaemic unawareness
Beschreibung

Recurrent hypoglycemia | Loss of hypoglycemic warning

Datentyp

boolean

Alias
UMLS CUI [1]
C1846288
UMLS CUI [2]
C0342317
anemia (haemoglobin below 10 mg/dl)
Beschreibung

Anemia | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
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Ähnliche Modelle

Eligibility Diabetes NCT01215435

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01215435
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 6 months prior to visit 1
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hemoglobin A1c measurement | Hemoglobin A1c measurement Maximum
Item
hba1c at least 7.0 % - maximum 11 % at screening
boolean
C0474680 (UMLS CUI [1])
C0474680 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
Insulin Absent | Insulin regime short-term allowed
Item
subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed)
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])
Diabetes Therapy Stable
Item
an antidiabetic regimen that has been stable for at least 3 months prior to screening
boolean
C3274787 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Diabetes Therapy | Antidiabetics Oral Quantity Minimum
Item
an antidiabetic regimen that includes a minimum of 2 oads
boolean
C3274787 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1524031 (UMLS CUI [2,4])
Antidiabetics Oral Dose
Item
oads dosed at least 50% of the maximum recommended dose
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected hypersensitivity to trial product(s) or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential Contraceptive methods Absent
Item
females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Investigational New Drugs
Item
the receipt of any investigational medicinal product within one month prior to this trial
boolean
C0013230 (UMLS CUI [1])
Life threatening illness | Malignant Neoplasms
Item
suffer from a life threatening disease (cancer)
boolean
C3846017 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
Heart Disease | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction Treated | Myocardial Infarction Untreated
Item
cardiac disease: class iii or iv congestive heart failure (chf), unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to screening
boolean
C0018799 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0027051 (UMLS CUI [5,1])
C0332155 (UMLS CUI [5,2])
Hepatic Insufficiency | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
hepatic insufficiency (alanine aminotransferase (alt) or aspartate aminotransferase (ast) above 2 times the central laboratory's upper reference limit)
boolean
C1306571 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Renal Insufficiency | Creatinine measurement, serum | Gender
Item
renal insufficiency (serum creatinine above 1.6 mg/dl for males; 1.4 mg/dl for females
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Recurrent hypoglycemia | Loss of hypoglycemic warning
Item
recurrent hypoglycaemia or hypoglycaemic unawareness
boolean
C1846288 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
Anemia | Hemoglobin measurement
Item
anemia (haemoglobin below 10 mg/dl)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
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