ID

29224

Description

Safety and Efficacy of Insulin NPH Compared to a New Insulin Formulation in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00660374

Link

https://clinicaltrials.gov/show/NCT00660374

Keywords

Versions (1)
  1. 3/9/18 3/9/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 9, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT00660374

English

Eligibility Diabetes NCT00660374

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00660374
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes for at least 12 months
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
current nph treatment for at least 3 months - alone or as the only insulin in combination with oads
Description

NPH insulin | Antidiabetics Oral | Combined Modality Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0021658
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [3]
C0009429
body mass index (bmi) less than or equal to 40 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
hba1c less than or equal to 9.5%
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
fpg less than or equal to 12 mmol/l
Description

Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with glucagon-like peptide 1 mimetics or dipeptityl peptidase iv inhibitors
Description

GLP-1 Mimetics | Dipeptidyl Peptidase 4 Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C3273809
UMLS CUI [2]
C2917254
treatment with more than 1 iu/kg nph insulin daily
Description

NPH insulin IU/kg Daily

Data type

boolean

Alias
UMLS CUI [1,1]
C0021658
UMLS CUI [1,2]
C0439463
UMLS CUI [1,3]
C0332173
known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the investigator
Description

Loss of hypoglycemic warning | Recurrent severe hypoglycemia

Data type

boolean

Alias
UMLS CUI [1]
C0342317
UMLS CUI [2]
C0342316
known or suspected allergy to trial products or related products
Description

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

Data type

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
receipt of any investigational drug within one month prior to this trial
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
any other condition that the investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
Description

Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results | Shift worker

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
UMLS CUI [2,4]
C0683954
UMLS CUI [3]
C0425104
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Similar models

Eligibility Diabetes NCT00660374

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00660374
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes for at least 12 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
NPH insulin | Antidiabetics Oral | Combined Modality Therapy
Item
current nph treatment for at least 3 months - alone or as the only insulin in combination with oads
boolean
C0021658 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0009429 (UMLS CUI [3])
Body mass index
Item
body mass index (bmi) less than or equal to 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glucohemoglobin measurement
Item
hba1c less than or equal to 9.5%
boolean
C0202054 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fpg less than or equal to 12 mmol/l
boolean
C0583513 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
GLP-1 Mimetics | Dipeptidyl Peptidase 4 Inhibitors
Item
treatment with glucagon-like peptide 1 mimetics or dipeptityl peptidase iv inhibitors
boolean
C3273809 (UMLS CUI [1])
C2917254 (UMLS CUI [2])
NPH insulin IU/kg Daily
Item
treatment with more than 1 iu/kg nph insulin daily
boolean
C0021658 (UMLS CUI [1,1])
C0439463 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
Loss of hypoglycemic warning | Recurrent severe hypoglycemia
Item
known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the investigator
boolean
C0342317 (UMLS CUI [1])
C0342316 (UMLS CUI [2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected allergy to trial products 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])
Investigational New Drugs
Item
receipt of any investigational drug within one month prior to this trial
boolean
C0013230 (UMLS CUI [1])
Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results | Shift worker
Item
any other condition that the investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C0425104 (UMLS CUI [3])
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