ID

17174

Description

Efficacy and Safety of Insulin Glulisine in Type 1 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00290979

Link

https://clinicaltrials.gov/show/NCT00290979

Keywords

Versions (1)
  1. 8/30/16 8/30/16 -
Uploaded on

August 30, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT00290979

English

Eligibility Diabetes Mellitus, Type 1 NCT00290979

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women with type 1 diabetes mellitus, an hba1c range of >=6.0 - =<11.0%, and on a basal-bolus insulin regimen. they must have had at least 1 year of continuous insulin treatment at the date of informed consent.
Description

Gender | Diabetes Mellitus, Insulin-Dependent | Glycosylated hemoglobin A | Insulin regime Basal insulin Bolus | Insulin regime Duration Informed Consent Date

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0011854
UMLS CUI [3]
C0019018
UMLS CUI [4,1]
C0557978
UMLS CUI [4,2]
C0650607
UMLS CUI [4,3]
C1705509
UMLS CUI [5,1]
C0557978
UMLS CUI [5,2]
C0449238
UMLS CUI [5,3]
C2985782
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who received an oral hypoglycemic agent other than insulin within 4 weeks prior to informed consent
Description

Oral hypoglycemic | Insulin

Data type

boolean

Alias
UMLS CUI [1]
C0359086
UMLS CUI [2]
C0021641
subjects who received oral or intravenous corticosteroid within 4 weeks prior to informed consent
Description

Adrenal Cortex Hormones Intravenous

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1522726
subjects who were treated with another investigational product within 12 weeks prior to informed consent
Description

Investigational New Drug

Data type

boolean

Alias
UMLS CUI [1]
C0013230
subjects with likelihood of requiring concomitant treatment during the study period with drugs not permitted by this study protocol
Description

Illicit drug use Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0281875
UMLS CUI [1,2]
C2348563
subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine, active cancer, other serious complication or 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 | Complication Serious Limiting Protocol Compliance | Complication Serious Limiting research results | Systemic disease Limiting Protocol Compliance | Systemic disease Limiting 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]
C0009566
UMLS CUI [6,2]
C0205404
UMLS CUI [6,3]
C0439801
UMLS CUI [6,4]
C0525058
UMLS CUI [7,1]
C0009566
UMLS CUI [7,2]
C0205404
UMLS CUI [7,3]
C0439801
UMLS CUI [7,4]
C0683954
UMLS CUI [8,1]
C0442893
UMLS CUI [8,2]
C0439801
UMLS CUI [8,3]
C0525058
UMLS CUI [9,1]
C0442893
UMLS CUI [9,2]
C0439801
UMLS CUI [9,3]
C0683954
subjects who have undergone pancreatectomy or pancreas/islet cell transplant
Description

Pancreatectomy | Pancreas Transplantation | Islets of Langerhans Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0030279
UMLS CUI [2]
C0030275
UMLS CUI [3]
C0079646
night shift workers
Description

Night shift worker

Data type

boolean

Alias
UMLS CUI [1]
C0555008
subjects unlikely to comply with the study protocol, e.g., inability to periodic return for follow-up visits, and unlikelihood of completing the study
Description

Protocol Compliance Unlikely | Clinical Study Follow-up Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0750558
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C1272705
subjects who have previously been treated with hmr1964
Description

Insulin, Glulisine, Human

Data type

boolean

Alias
UMLS CUI [1]
C1313386
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
female subjects who are possibly pregnant [female subjects of reproductive potential who have serum human chorionic gonadotropin (hcg) level > 0.7 miu/ml as determined by central laboratory, srl medisearch inc., during screening phase]
Description

Pregnancy Possible | Childbearing Potential | serum human chorionic gonadotropin (hCG) measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332149
UMLS CUI [2]
C3831118
UMLS CUI [3]
C2208823
subjects with diabetic retinopathy who received surgical treatments (laser photocoagulation or vitrectomy) within 24 weeks prior to informed consent, or who are expected to have these surgical treatments during the study period
Description

Diabetic Retinopathy | Operative Surgical Procedures | Laser photocoagulation | Vitrectomy

Data type

boolean

Alias
UMLS CUI [1]
C0011884
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0441510
UMLS CUI [4]
C0042903
subjects with history of alcohol abuse
Description

Alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0085762
subjects with hypersensitivity to insulin preparations
Description

Hypersensitivity Insulin

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0021641
subjects with impaired hepatic function (sgot or sgpt ³=<80 iu/l determined by central laboratory, srl medisearch inc., during screening phase) or impaired renal function (serum creatinine =<2.0 mg/dl determined by central laboratory, srl medisearch inc., during screening phase)
Description

Hepatic impairment | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal Insufficiency | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0948807
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C1565489
UMLS CUI [5]
C0201976
subjects who are judged by the investigator or subinvestigator as inappropriate as the subjects of this study for any other reason
Description

Other Reason Study Subject Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C1548788
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Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00290979

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Diabetes Mellitus, Insulin-Dependent | Glycosylated hemoglobin A | Insulin regime Basal insulin Bolus | Insulin regime Duration Informed Consent Date
Item
men or women with type 1 diabetes mellitus, an hba1c range of >=6.0 - =<11.0%, and on a basal-bolus insulin regimen. they must have had at least 1 year of continuous insulin treatment at the date of informed consent.
boolean
C0079399 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
C0019018 (UMLS CUI [3])
C0557978 (UMLS CUI [4,1])
C0650607 (UMLS CUI [4,2])
C1705509 (UMLS CUI [4,3])
C0557978 (UMLS CUI [5,1])
C0449238 (UMLS CUI [5,2])
C2985782 (UMLS CUI [5,3])
Item Group
C0680251 (UMLS CUI)
Oral hypoglycemic | Insulin
Item
subjects who received an oral hypoglycemic agent other than insulin within 4 weeks prior to informed consent
boolean
C0359086 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
Adrenal Cortex Hormones Intravenous
Item
subjects who received oral or intravenous corticosteroid within 4 weeks prior to informed consent
boolean
C0001617 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
Investigational New Drug
Item
subjects who were treated with another investigational product within 12 weeks prior to informed consent
boolean
C0013230 (UMLS CUI [1])
Illicit drug use Study Protocol
Item
subjects with likelihood of requiring concomitant treatment during the study period with drugs not permitted by this study protocol
boolean
C0281875 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Cardiovascular Diseases Relevant Clinical | Liver diseases | nervous system disorder | Endocrine System Diseases | Malignant Neoplasms | Complication Serious Limiting Protocol Compliance | Complication Serious Limiting research results | Systemic disease Limiting Protocol Compliance | Systemic disease Limiting research results
Item
subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine, active cancer, other serious complication or 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])
C0009566 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
C0525058 (UMLS CUI [6,4])
C0009566 (UMLS CUI [7,1])
C0205404 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
C0683954 (UMLS CUI [7,4])
C0442893 (UMLS CUI [8,1])
C0439801 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
C0442893 (UMLS CUI [9,1])
C0439801 (UMLS CUI [9,2])
C0683954 (UMLS CUI [9,3])
Pancreatectomy | Pancreas Transplantation | Islets of Langerhans Transplantation
Item
subjects who have undergone pancreatectomy or pancreas/islet cell transplant
boolean
C0030279 (UMLS CUI [1])
C0030275 (UMLS CUI [2])
C0079646 (UMLS CUI [3])
Night shift worker
Item
night shift workers
boolean
C0555008 (UMLS CUI [1])
Protocol Compliance Unlikely | Clinical Study Follow-up Unsuccessful
Item
subjects unlikely to comply with the study protocol, e.g., inability to periodic return for follow-up visits, and unlikelihood of completing the study
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Insulin, Glulisine, Human
Item
subjects who have previously been treated with hmr1964
boolean
C1313386 (UMLS CUI [1])
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])
Pregnancy Possible | Childbearing Potential | serum human chorionic gonadotropin (hCG) measurement
Item
female subjects who are possibly pregnant [female subjects of reproductive potential who have serum human chorionic gonadotropin (hcg) level > 0.7 miu/ml as determined by central laboratory, srl medisearch inc., during screening phase]
boolean
C0032961 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2])
C2208823 (UMLS CUI [3])
Diabetic Retinopathy | Operative Surgical Procedures | Laser photocoagulation | Vitrectomy
Item
subjects with diabetic retinopathy who received surgical treatments (laser photocoagulation or vitrectomy) within 24 weeks prior to informed consent, or who are expected to have these surgical treatments during the study period
boolean
C0011884 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C0441510 (UMLS CUI [3])
C0042903 (UMLS CUI [4])
Alcohol abuse
Item
subjects with history of alcohol abuse
boolean
C0085762 (UMLS CUI [1])
Hypersensitivity Insulin
Item
subjects with hypersensitivity to insulin preparations
boolean
C0020517 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
Hepatic impairment | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal Insufficiency | Creatinine measurement, serum
Item
subjects with impaired hepatic function (sgot or sgpt ³=<80 iu/l determined by central laboratory, srl medisearch inc., during screening phase) or impaired renal function (serum creatinine =<2.0 mg/dl determined by central laboratory, srl medisearch inc., during screening phase)
boolean
C0948807 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C1565489 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Other Reason Study Subject Inappropriate
Item
subjects who are judged by the investigator or subinvestigator as inappropriate as the subjects of this study for any other reason
boolean
C3840932 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
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