ID

17252

Description

Efficacy and Safety of Insulin Glulisine in Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00290927

Link

https://clinicaltrials.gov/show/NCT00290927

Keywords

Versions (1)
  1. 9/2/16 9/2/16 -
Uploaded on

September 2, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00290927

English

Eligibility Diabetes Mellitus, Type 2 NCT00290927

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women with type 2 diabetes mellitus diagnosed at least one year prior to the study with a bmi < 30 kg/m2 , a hba1c of > 8.0 - < 11.0% at screening
Description

Gender | Diabetes Mellitus, Non-Insulin-Dependent | Body mass index | Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0011860
UMLS CUI [3]
C1305855
UMLS CUI [4]
C0019018
fasting serum c-peptide at screening > 0.7 ng/ml
Description

C-Peptide Fasting

Data type

boolean

Alias
UMLS CUI [1,1]
C0006558
UMLS CUI [1,2]
C0015663
subjects who have been on a stable regimen and at the following doses of su for at least 8 weeks prior to signing informed consent
Description

Therapeutic regimen Stable | Sulfonylurea | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0038766
UMLS CUI [3]
C0021430
glibenclamide > 5 mg/day
Description

glibenclamide

Data type

boolean

Alias
UMLS CUI [1]
C0017628
glimepiride > 3 mg/day
Description

glimepiride

Data type

boolean

Alias
UMLS CUI [1]
C0061323
gliclazide > 80 mg/day in addition to receiving the above mentioned su agents, subjects may have been treated with a biguanide at a stable dose for at least 8 weeks prior to signing informed consent.
Description

Gliclazide In addition to Sulfonylurea | Biguanides

Data type

boolean

Alias
UMLS CUI [1,1]
C0017631
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C0038766
UMLS CUI [2]
C0005382
subjects willing to administer three hmr1964 injections per day immediately prior to meals for a 16 week
Description

Insulin Glulisine Injection Quantity per day ante cibus Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C1313386
UMLS CUI [1,2]
C1828121
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0439505
UMLS CUI [1,5]
C1550738
UMLS CUI [1,6]
C0600109
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects unwilling or incapable of receiving a starting dose of ≥ 0.2 iu/kg/day of hmr1964
Description

Insulin Glulisine Receive Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C1313386
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0558080
subjects with the likelihood of requiring concomitant treatment during the study period with the following classes of drugs: additional oha (including thiazolidinediones, α-glucosidase inhibitors, d-phenylalanine derivative) other than those specified in the study protocol, insulin preparations other than hmr1964, systemic corticosteroids, other investigational products
Description

Oral hypoglycemic | Thiazolidinediones | alpha-Glucosidase Inhibitors | D-phenylalanine Derivative | Insulin | Insulin Glulisine | systemic steroids | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0359086
UMLS CUI [2]
C1257987
UMLS CUI [3]
C1299007
UMLS CUI [4,1]
C0771172
UMLS CUI [4,2]
C1527240
UMLS CUI [5]
C0021641
UMLS CUI [6]
C1313386
UMLS CUI [7]
C2825233
UMLS CUI [8]
C0013230
subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine diseases; and active cancer; or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
Description

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

Data type

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]
C0006826
UMLS CUI [6,1]
C0442893
UMLS CUI [6,2]
C0205164
UMLS CUI [6,3]
C0521102
UMLS CUI [6,4]
C0525058
UMLS CUI [7,1]
C0442893
UMLS CUI [7,2]
C0205164
UMLS CUI [7,3]
C0521102
UMLS CUI [7,4]
C0683954
subjects who are pregnant, breast feeding or wish to become pregnant during the study period
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
subjects with diabetic retinopathy who received surgical treatments (laser photocoagulation or vitrectomy) within 12 weeks prior to informed consent, who are expected to have these surgical treatments during the study period, or who were diagnosed newly proliferative diabetic retinopathy within 12 weeks prior to informed consent
Description

Operative Surgical Procedures Diabetic Retinopathy | Laser photocoagulation | Vitrectomy | Proliferative diabetic retinopathy newly

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0011884
UMLS CUI [2]
C0441510
UMLS CUI [3]
C0042903
UMLS CUI [4,1]
C0154830
UMLS CUI [4,2]
C0750546
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00290927

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Diabetes Mellitus, Non-Insulin-Dependent | Body mass index | Glycosylated hemoglobin A
Item
men or women with type 2 diabetes mellitus diagnosed at least one year prior to the study with a bmi < 30 kg/m2 , a hba1c of > 8.0 - < 11.0% at screening
boolean
C0079399 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C1305855 (UMLS CUI [3])
C0019018 (UMLS CUI [4])
C-Peptide Fasting
Item
fasting serum c-peptide at screening > 0.7 ng/ml
boolean
C0006558 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
Therapeutic regimen Stable | Sulfonylurea | Informed Consent
Item
subjects who have been on a stable regimen and at the following doses of su for at least 8 weeks prior to signing informed consent
boolean
C1276413 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0038766 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
glibenclamide
Item
glibenclamide > 5 mg/day
boolean
C0017628 (UMLS CUI [1])
glimepiride
Item
glimepiride > 3 mg/day
boolean
C0061323 (UMLS CUI [1])
Gliclazide In addition to Sulfonylurea | Biguanides
Item
gliclazide > 80 mg/day in addition to receiving the above mentioned su agents, subjects may have been treated with a biguanide at a stable dose for at least 8 weeks prior to signing informed consent.
boolean
C0017631 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0038766 (UMLS CUI [1,3])
C0005382 (UMLS CUI [2])
Insulin Glulisine Injection Quantity per day ante cibus Willing
Item
subjects willing to administer three hmr1964 injections per day immediately prior to meals for a 16 week
boolean
C1313386 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0439505 (UMLS CUI [1,4])
C1550738 (UMLS CUI [1,5])
C0600109 (UMLS CUI [1,6])
Item Group
C0680251 (UMLS CUI)
Insulin Glulisine Receive Unwilling
Item
subjects unwilling or incapable of receiving a starting dose of ≥ 0.2 iu/kg/day of hmr1964
boolean
C1313386 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Oral hypoglycemic | Thiazolidinediones | alpha-Glucosidase Inhibitors | D-phenylalanine Derivative | Insulin | Insulin Glulisine | systemic steroids | Investigational New Drugs
Item
subjects with the likelihood of requiring concomitant treatment during the study period with the following classes of drugs: additional oha (including thiazolidinediones, α-glucosidase inhibitors, d-phenylalanine derivative) other than those specified in the study protocol, insulin preparations other than hmr1964, systemic corticosteroids, other investigational products
boolean
C0359086 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
C1299007 (UMLS CUI [3])
C0771172 (UMLS CUI [4,1])
C1527240 (UMLS CUI [4,2])
C0021641 (UMLS CUI [5])
C1313386 (UMLS CUI [6])
C2825233 (UMLS CUI [7])
C0013230 (UMLS CUI [8])
Cardiovascular Diseases Relevant Clinical | Liver diseases | nervous system disorder | Endocrine System Diseases | Malignant Neoplasms | Systemic disease Major Interferes with Protocol Compliance | Systemic disease Major Interferes with research results
Item
subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine diseases; and active cancer; 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])
C0006826 (UMLS CUI [5])
C0442893 (UMLS CUI [6,1])
C0205164 (UMLS CUI [6,2])
C0521102 (UMLS CUI [6,3])
C0525058 (UMLS CUI [6,4])
C0442893 (UMLS CUI [7,1])
C0205164 (UMLS CUI [7,2])
C0521102 (UMLS CUI [7,3])
C0683954 (UMLS CUI [7,4])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
subjects who are pregnant, breast feeding or wish to become pregnant during the study period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Operative Surgical Procedures Diabetic Retinopathy | Laser photocoagulation | Vitrectomy | Proliferative diabetic retinopathy newly
Item
subjects with diabetic retinopathy who received surgical treatments (laser photocoagulation or vitrectomy) within 12 weeks prior to informed consent, who are expected to have these surgical treatments during the study period, or who were diagnosed newly proliferative diabetic retinopathy within 12 weeks prior to informed consent
boolean
C0543467 (UMLS CUI [1,1])
C0011884 (UMLS CUI [1,2])
C0441510 (UMLS CUI [2])
C0042903 (UMLS CUI [3])
C0154830 (UMLS CUI [4,1])
C0750546 (UMLS CUI [4,2])
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