ID

20692

Beschreibung

Lantus Versus Levemir Treat-To-Target; ODM derived from: https://clinicaltrials.gov/show/NCT00405418

Link

https://clinicaltrials.gov/show/NCT00405418

Stichworte

Versionen (1)
  1. 11.03.17 11.03.17 -
Hochgeladen am

11. März 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00405418

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT00405418

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes for at least 1 year
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
insulin naïve
Beschreibung

Insulin naive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0919936
treated with stable doses of oral antidiabetics for at least 3 months prior to study start, including at least metformin (at least 1g/day)
Beschreibung

Antidiabetics Oral Dose Stable | Metformin U/day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0456683
7% ≤ hba1c ≤ 10.5 %
Beschreibung

Glycosylated hemoglobin A Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0439165
body mass index (bmi) < 40 kg/m²
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
ability and willingness to perform blood glucose monitoring using a blood glucose meter and to use a patient diary
Beschreibung

Blood Glucose Self-Monitoring Blood glucose meter Able | Blood Glucose Self-Monitoring Blood glucose meter Willing | Subject Diary Use Able | Subject Diary Use Willing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005803
UMLS CUI [1,2]
C0472226
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0005803
UMLS CUI [2,2]
C0472226
UMLS CUI [2,3]
C0600109
UMLS CUI [3,1]
C3890583
UMLS CUI [3,2]
C0457083
UMLS CUI [3,3]
C0085732
UMLS CUI [4,1]
C3890583
UMLS CUI [4,2]
C0457083
UMLS CUI [4,3]
C0600109
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes
Beschreibung

Diabetes Mellitus, Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for less than 1 week)
Beschreibung

Insulin | Therapeutic procedure Gestational Diabetes | Insulin Therapeutic procedure Brief

Datentyp

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0085207
UMLS CUI [3,1]
C0021641
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C1879313
treatment with glucagon-like peptide (glp)-1 receptor agonists or with dipeptidyl peptidase (dpp)-iv inhibitors
Beschreibung

Glucagon-Like Peptide-1 Receptor agonists | Dipeptidyl-Peptidase IV Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0378073
UMLS CUI [1,2]
C0243192
UMLS CUI [2]
C1827106
active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)
Beschreibung

Proliferative diabetic retinopathy | Light Coagulation | Operative Surgical Procedures | Retinal Disease Unstable Rapidly progressive | Slit lamp fundus examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0154830
UMLS CUI [2]
C0023694
UMLS CUI [3]
C0543467
UMLS CUI [4,1]
C0035309
UMLS CUI [4,2]
C0443343
UMLS CUI [4,3]
C1838681
UMLS CUI [5]
C1444586
pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method)
Beschreibung

Pregnancy | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0427780
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
breast-feeding
Beschreibung

Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
history of hypersensitivity to the study drugs or to drugs with a similar chemical structure
Beschreibung

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Chemical Structure Similar

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0220807
UMLS CUI [2,4]
C2348205
treatment with systemic corticosteroids in the 3 months prior to study entry
Beschreibung

CORTICOSTEROIDS FOR SYSTEMIC USE

Datentyp

boolean

Alias
UMLS CUI [1]
C3653708
treatment with any investigational product in the 2 months prior to study entry
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
Beschreibung

Probability Illicit drug use Patient need for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033204
UMLS CUI [1,2]
C0281875
UMLS CUI [1,3]
C0686904
clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
Beschreibung

Cardiovascular Disease | Liver disease | nervous system disorder | Endocrine System Disease | Disease Major Protocol Compliance Difficulty | Disease Major Research results Difficulty

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0027765
UMLS CUI [4]
C0014130
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0205164
UMLS CUI [5,3]
C0525058
UMLS CUI [5,4]
C0332218
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0205164
UMLS CUI [6,3]
C0683954
UMLS CUI [6,4]
C0332218
impaired hepatic function as shown by alamine aminotransferase (alt) and/or aspartate aminotransferase (ast) greater than three times the upper limit of normal range at study entry
Beschreibung

Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
impaired renal function as shown by serum creatinine ≥ 1.5 mg/dl (≥ 133 μmol/l) in men and ≥ 1.4 mg/dl (124 μmol/l) in women at study entry
Beschreibung

Renal Insufficiency | Creatinine measurement, serum | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
history of drug or alcohol abuse in the last year
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT00405418

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes for at least 1 year
boolean
C0011860 (UMLS CUI [1])
Insulin naive
Item
insulin naïve
boolean
C0021641 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Antidiabetics Oral Dose Stable | Metformin U/day
Item
treated with stable doses of oral antidiabetics for at least 3 months prior to study start, including at least metformin (at least 1g/day)
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0025598 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Glycosylated hemoglobin A Percentage
Item
7% ≤ hba1c ≤ 10.5 %
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Body mass index
Item
body mass index (bmi) < 40 kg/m²
boolean
C1305855 (UMLS CUI [1])
Blood Glucose Self-Monitoring Blood glucose meter Able | Blood Glucose Self-Monitoring Blood glucose meter Willing | Subject Diary Use Able | Subject Diary Use Willing
Item
ability and willingness to perform blood glucose monitoring using a blood glucose meter and to use a patient diary
boolean
C0005803 (UMLS CUI [1,1])
C0472226 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0005803 (UMLS CUI [2,1])
C0472226 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
C3890583 (UMLS CUI [3,1])
C0457083 (UMLS CUI [3,2])
C0085732 (UMLS CUI [3,3])
C3890583 (UMLS CUI [4,1])
C0457083 (UMLS CUI [4,2])
C0600109 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Insulin | Therapeutic procedure Gestational Diabetes | Insulin Therapeutic procedure Brief
Item
current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for less than 1 week)
boolean
C0021641 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0085207 (UMLS CUI [2,2])
C0021641 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C1879313 (UMLS CUI [3,3])
Glucagon-Like Peptide-1 Receptor agonists | Dipeptidyl-Peptidase IV Inhibitors
Item
treatment with glucagon-like peptide (glp)-1 receptor agonists or with dipeptidyl peptidase (dpp)-iv inhibitors
boolean
C0378073 (UMLS CUI [1,1])
C0243192 (UMLS CUI [1,2])
C1827106 (UMLS CUI [2])
Proliferative diabetic retinopathy | Light Coagulation | Operative Surgical Procedures | Retinal Disease Unstable Rapidly progressive | Slit lamp fundus examination
Item
active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)
boolean
C0154830 (UMLS CUI [1])
C0023694 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C0035309 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C1838681 (UMLS CUI [4,3])
C1444586 (UMLS CUI [5])
Pregnancy | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method)
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Breast Feeding
Item
breast-feeding
boolean
C0006147 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Chemical Structure Similar
Item
history of hypersensitivity to the study drugs or to drugs with a similar chemical structure
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0220807 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
CORTICOSTEROIDS FOR SYSTEMIC USE
Item
treatment with systemic corticosteroids in the 3 months prior to study entry
boolean
C3653708 (UMLS CUI [1])
Investigational New Drugs
Item
treatment with any investigational product in the 2 months prior to study entry
boolean
C0013230 (UMLS CUI [1])
Probability Illicit drug use Patient need for
Item
likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
boolean
C0033204 (UMLS CUI [1,1])
C0281875 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
Cardiovascular Disease | Liver disease | nervous system disorder | Endocrine System Disease | Disease Major Protocol Compliance Difficulty | Disease Major Research results Difficulty
Item
clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
boolean
C0007222 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0014130 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0205164 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0332218 (UMLS CUI [5,4])
C0012634 (UMLS CUI [6,1])
C0205164 (UMLS CUI [6,2])
C0683954 (UMLS CUI [6,3])
C0332218 (UMLS CUI [6,4])
Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
impaired hepatic function as shown by alamine aminotransferase (alt) and/or aspartate aminotransferase (ast) greater than three times the upper limit of normal range at study entry
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Renal Insufficiency | Creatinine measurement, serum | Gender
Item
impaired renal function as shown by serum creatinine ≥ 1.5 mg/dl (≥ 133 μmol/l) in men and ≥ 1.4 mg/dl (124 μmol/l) in women at study entry
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Substance Use Disorders
Item
history of drug or alcohol abuse in the last year
boolean
C0038586 (UMLS CUI [1])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
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