ID

17146

Beschrijving

OPAL - Insulin Glulisine, Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00272012

Link

https://clinicaltrials.gov/show/NCT00272012

Trefwoorden

Versies (1)
  1. 28-08-16 28-08-16 -
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28 augustus 2016

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus Type 2 NCT00272012

Engels

Eligibility Diabetes Mellitus Type 2 NCT00272012

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus, previously treated with combination therapy of insulin glargine + oad (maximal tolerated dose / approved in combination with insulin according to local spcs (summary of product characteristics), not including use of a-glucosidase inhibitors) for at least 3 months
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | Combined Modality Therapy | Insulin Glargine Maximum Tolerated Dose | Oral hypoglycemic Maximum Tolerated Dose | Insulin | Glucosidase Inhibitor

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0009429
UMLS CUI [3,1]
C0907402
UMLS CUI [3,2]
C0752079
UMLS CUI [4,1]
C0359086
UMLS CUI [4,2]
C0752079
UMLS CUI [5]
C0021641
UMLS CUI [6]
C1512211
pre-screening hba1c value greater/equal 7% - smaller/equal 9%
Beschrijving

Glycosylated hemoglobin A

Datatype

boolean

Alias
UMLS CUI [1]
C0019018
fbg (fasting blood glucose) smaller/equal 120 mg/dl (6.6 mmol/l)
Beschrijving

Fasting blood glucose measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0428568
women are either not of childbearing potential (surgically sterile, or postmenopausal for more than 2 years) or are not pregnant and agree to use a reliable contraceptive measure for the duration of the study. reliable contraceptive measures include the following: systemic contraceptive (oral, implant, injections), diaphragm with intravaginal spermicide, cervical cap, intrauterine device, or condom with spermicide.
Beschrijving

Childbearing Potential | Female Sterilization | Postmenopausal state | Pregnancy | Contraceptive methods | CONTRACEPTIVES,SYSTEMIC | Contraceptives, Oral | Contraceptive implant | Contraceptive injection | Vaginal contraceptive diaphragm | Vaginal Spermicides | CERVICAL CAP FOR CONTRACEPTIVE USE | Intrauterine Devices | Female Condoms | Spermicides

Datatype

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0032961
UMLS CUI [5]
C0700589
UMLS CUI [6]
C1874923
UMLS CUI [7]
C0009905
UMLS CUI [8]
C1657106
UMLS CUI [9]
C1656586
UMLS CUI [10]
C0042241
UMLS CUI [11]
C0087145
UMLS CUI [12]
C0493327
UMLS CUI [13]
C0021900
UMLS CUI [14]
C0221829
UMLS CUI [15]
C0037862
ability and willingness to perform blood glucose monitoring using the sponsor-provided blood glucose meter and subject diary at home
Beschrijving

Blood glucose monitoring Willing | Blood glucose meter | Subject Diary

Datatype

boolean

Alias
UMLS CUI [1,1]
C1820407
UMLS CUI [1,2]
C0600109
UMLS CUI [2]
C0472226
UMLS CUI [3]
C3890583
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than two fbg greater 120 mg/dl (6.6 mmol/l) as measured on 5 consecutive days before visit ii
Beschrijving

Fasting blood glucose measurement Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0428568
UMLS CUI [1,2]
C1265611
active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation)
Beschrijving

Proliferative diabetic retinopathy | Focal photocoagulation | Panretinal photocoagulation | Vitrectomy | Retinal Diseases Unstable Rapidly progressive | Operative Surgical Procedures Patient need for | Laser photocoagulation

Datatype

boolean

Alias
UMLS CUI [1]
C0154830
UMLS CUI [2]
C1302105
UMLS CUI [3]
C0730064
UMLS CUI [4]
C0042903
UMLS CUI [5,1]
C0035309
UMLS CUI [5,2]
C0443343
UMLS CUI [5,3]
C1838681
UMLS CUI [6,1]
C0543467
UMLS CUI [6,2]
C0686904
UMLS CUI [7]
C0441510
clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
Beschrijving

Cardiovascular Diseases Relevant Clinical | Liver diseases | nervous system disorder | Endocrine System Diseases | Systemic disease Major Interferes with Protocol Compliance | Systemic disease Major Interferes with research results

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0205210
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0027765
UMLS CUI [4]
C0014130
UMLS CUI [5,1]
C0442893
UMLS CUI [5,2]
C0205164
UMLS CUI [5,3]
C0521102
UMLS CUI [5,4]
C0525058
UMLS CUI [6,1]
C0442893
UMLS CUI [6,2]
C0205164
UMLS CUI [6,3]
C0521102
UMLS CUI [6,4]
C0683954
known impaired hepatic and renal function
Beschrijving

Hepatic Insufficiency | Renal Insufficiency

Datatype

boolean

Alias
UMLS CUI [1]
C1306571
UMLS CUI [2]
C1565489
history of drug or alcohol abuse
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
history of hypersensitivity to insulin or insulin analogues or any of the excipients in the insulin glulisine formulation
Beschrijving

Hypersensitivity Insulin | Hypersensitivity Insulin Analogue | Hypersensitivity Insulin Glulisine Excipient

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0021641
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2825028
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1313386
UMLS CUI [3,3]
C0015237
treatment with any investigational drug in the last month before visit i
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
pregnant or breast-feeding women, or women planning to become pregnant during the study
Beschrijving

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
Beschrijving

Illicit Drugs Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0086190
UMLS CUI [1,2]
C2348563
night shift workers if they are unable to comply with the treatment regimen
Beschrijving

Night shift worker Compliance behavior Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0555008
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
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Similar models

Eligibility Diabetes Mellitus Type 2 NCT00272012

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Combined Modality Therapy | Insulin Glargine Maximum Tolerated Dose | Oral hypoglycemic Maximum Tolerated Dose | Insulin | Glucosidase Inhibitor
Item
type 2 diabetes mellitus, previously treated with combination therapy of insulin glargine + oad (maximal tolerated dose / approved in combination with insulin according to local spcs (summary of product characteristics), not including use of a-glucosidase inhibitors) for at least 3 months
boolean
C0011860 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0907402 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C0359086 (UMLS CUI [4,1])
C0752079 (UMLS CUI [4,2])
C0021641 (UMLS CUI [5])
C1512211 (UMLS CUI [6])
Glycosylated hemoglobin A
Item
pre-screening hba1c value greater/equal 7% - smaller/equal 9%
boolean
C0019018 (UMLS CUI [1])
Fasting blood glucose measurement
Item
fbg (fasting blood glucose) smaller/equal 120 mg/dl (6.6 mmol/l)
boolean
C0428568 (UMLS CUI [1])
Childbearing Potential | Female Sterilization | Postmenopausal state | Pregnancy | Contraceptive methods | CONTRACEPTIVES,SYSTEMIC | Contraceptives, Oral | Contraceptive implant | Contraceptive injection | Vaginal contraceptive diaphragm | Vaginal Spermicides | CERVICAL CAP FOR CONTRACEPTIVE USE | Intrauterine Devices | Female Condoms | Spermicides
Item
women are either not of childbearing potential (surgically sterile, or postmenopausal for more than 2 years) or are not pregnant and agree to use a reliable contraceptive measure for the duration of the study. reliable contraceptive measures include the following: systemic contraceptive (oral, implant, injections), diaphragm with intravaginal spermicide, cervical cap, intrauterine device, or condom with spermicide.
boolean
C3831118 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
C0700589 (UMLS CUI [5])
C1874923 (UMLS CUI [6])
C0009905 (UMLS CUI [7])
C1657106 (UMLS CUI [8])
C1656586 (UMLS CUI [9])
C0042241 (UMLS CUI [10])
C0087145 (UMLS CUI [11])
C0493327 (UMLS CUI [12])
C0021900 (UMLS CUI [13])
C0221829 (UMLS CUI [14])
C0037862 (UMLS CUI [15])
Blood glucose monitoring Willing | Blood glucose meter | Subject Diary
Item
ability and willingness to perform blood glucose monitoring using the sponsor-provided blood glucose meter and subject diary at home
boolean
C1820407 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0472226 (UMLS CUI [2])
C3890583 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Fasting blood glucose measurement Quantity
Item
more than two fbg greater 120 mg/dl (6.6 mmol/l) as measured on 5 consecutive days before visit ii
boolean
C0428568 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Proliferative diabetic retinopathy | Focal photocoagulation | Panretinal photocoagulation | Vitrectomy | Retinal Diseases Unstable Rapidly progressive | Operative Surgical Procedures Patient need for | Laser photocoagulation
Item
active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation)
boolean
C0154830 (UMLS CUI [1])
C1302105 (UMLS CUI [2])
C0730064 (UMLS CUI [3])
C0042903 (UMLS CUI [4])
C0035309 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C1838681 (UMLS CUI [5,3])
C0543467 (UMLS CUI [6,1])
C0686904 (UMLS CUI [6,2])
C0441510 (UMLS CUI [7])
Cardiovascular Diseases Relevant Clinical | Liver diseases | nervous system disorder | Endocrine System Diseases | Systemic disease Major Interferes with Protocol Compliance | Systemic disease Major Interferes with research results
Item
clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
boolean
C0007222 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0023895 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0014130 (UMLS CUI [4])
C0442893 (UMLS CUI [5,1])
C0205164 (UMLS CUI [5,2])
C0521102 (UMLS CUI [5,3])
C0525058 (UMLS CUI [5,4])
C0442893 (UMLS CUI [6,1])
C0205164 (UMLS CUI [6,2])
C0521102 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
Hepatic Insufficiency | Renal Insufficiency
Item
known impaired hepatic and renal function
boolean
C1306571 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Substance Use Disorders
Item
history of drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Hypersensitivity Insulin | Hypersensitivity Insulin Analogue | Hypersensitivity Insulin Glulisine Excipient
Item
history of hypersensitivity to insulin or insulin analogues or any of the excipients in the insulin glulisine formulation
boolean
C0020517 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2825028 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1313386 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
Investigational New Drugs
Item
treatment with any investigational drug in the last month before visit i
boolean
C0013230 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant or breast-feeding women, or women planning to become pregnant during the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Illicit Drugs Study Protocol
Item
treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
boolean
C0086190 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Night shift worker Compliance behavior Limited
Item
night shift workers if they are unable to comply with the treatment regimen
boolean
C0555008 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
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