ID

29122

Description

A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00666718

Link

https://clinicaltrials.gov/show/NCT00666718

Keywords

Versions (1)
  1. 2/27/18 2/27/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 27, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00666718

English

Eligibility Diabetes Mellitus, Type 2 NCT00666718

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diabetes mellitus, type 2
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to visit 1 (screening)
Description

Metformin | Oral hypoglycemic Quantity | Sulfonylurea | Thiazolidinediones | Insulin

Data type

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2,1]
C0359086
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0038766
UMLS CUI [4]
C1257987
UMLS CUI [5]
C0021641
hemoglobin a1c (hba1c) greater than or equal to 7.5% and less than or equal to 11.0%
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
body mass index (bmi) greater than or equal to 25 and less than or equal to 45 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
capable and willing to follow the protocol
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
give written consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
are taking any glucose-lowering agents (other than those listed in the inclusion criteria above)
Description

Hypoglycemic Agents | Exception Pharmaceutical Preparations Inclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C1512693
have a history of severe hypoglycemia in the past 6 months
Description

Hypoglycemia Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
are pregnant or may become pregnant
Description

Pregnancy | Pregnancy Possible

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332149
women who are breastfeeding
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
have significant cardiac disease
Description

Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
have significant renal or liver disease
Description

Kidney Disease | Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
undergoing therapy for a malignancy
Description

Cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
contraindications to the study medications
Description

Medical contraindication Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
have an irregular sleep/wake cycle
Description

Sleep-wake cycle disturbance

Data type

boolean

Alias
UMLS CUI [1]
C1833362
have a serious disease or any condition considered by the investigator to be exclusionary
Description

Disease Serious Study Subject Participation Status Exclusion | Condition Study Subject Participation Status Exclusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C2828389
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C2828389
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00666718

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
diabetes mellitus, type 2
boolean
C0011860 (UMLS CUI [1])
Metformin | Oral hypoglycemic Quantity | Sulfonylurea | Thiazolidinediones | Insulin
Item
have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to visit 1 (screening)
boolean
C0025598 (UMLS CUI [1])
C0359086 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0038766 (UMLS CUI [3])
C1257987 (UMLS CUI [4])
C0021641 (UMLS CUI [5])
Glucohemoglobin measurement
Item
hemoglobin a1c (hba1c) greater than or equal to 7.5% and less than or equal to 11.0%
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) greater than or equal to 25 and less than or equal to 45 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Protocol Compliance
Item
capable and willing to follow the protocol
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
give written consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypoglycemic Agents | Exception Pharmaceutical Preparations Inclusion criteria
Item
are taking any glucose-lowering agents (other than those listed in the inclusion criteria above)
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C1512693 (UMLS CUI [2,3])
Hypoglycemia Severe
Item
have a history of severe hypoglycemia in the past 6 months
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Pregnancy | Pregnancy Possible
Item
are pregnant or may become pregnant
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
Breast Feeding
Item
women who are breastfeeding
boolean
C0006147 (UMLS CUI [1])
Heart Disease
Item
have significant cardiac disease
boolean
C0018799 (UMLS CUI [1])
Kidney Disease | Liver disease
Item
have significant renal or liver disease
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
Cancer treatment
Item
undergoing therapy for a malignancy
boolean
C0920425 (UMLS CUI [1])
Medical contraindication Investigational New Drugs
Item
contraindications to the study medications
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Sleep-wake cycle disturbance
Item
have an irregular sleep/wake cycle
boolean
C1833362 (UMLS CUI [1])
Disease Serious Study Subject Participation Status Exclusion | Condition Study Subject Participation Status Exclusion
Item
have a serious disease or any condition considered by the investigator to be exclusionary
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C2828389 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
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