ID

29121

Description

Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast; ODM derived from: https://clinicaltrials.gov/show/NCT00664534

Link

https://clinicaltrials.gov/show/NCT00664534

Keywords

Versions (1)
  1. 2/26/18 2/26/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 26, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Diabetes Mellitus, Type 2 NCT00664534

English

Eligibility Diabetes Mellitus, Type 2 NCT00664534

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 plus at least one other oral antihyperglycemic medication (oam) (sulfonylurea or thiazolidinedione [tzd]) without insulin, for at least 90 days prior to visit 1
Description

Metformin | Oral hypoglycemic Quantity | Sulfonylurea | Thiazolidinediones | Insulin Absent

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 [5,1]
C0021641
UMLS CUI [5,2]
C0332197
glycosylated hemoglobin (hba1c) greater than or equal to 7.0% and less than 11.0%
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
regularly consume a light breakfast (less than 15% of total daily calorie intake)
Description

Breakfast Small Regular | Percentage Calorie intake per day

Data type

boolean

Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0700321
UMLS CUI [1,3]
C0205272
UMLS CUI [2,1]
C0439165
UMLS CUI [2,2]
C2095644
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 a tzd whose country label does not allow in combination with insulin
Description

Thiazolidinediones | Combination Insulin Illicit

Data type

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2,1]
C0205195
UMLS CUI [2,2]
C0021641
UMLS CUI [2,3]
C0332266
are taking any glucose-lowering agents (other than specified 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 body mass index greater than 40 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
have a history of severe hypoglycemia in past 24 weeks
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 Diseases

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 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
Back to the top of the page

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00664534

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 Absent
Item
have been receiving metformin plus at least one other oral antihyperglycemic medication (oam) (sulfonylurea or thiazolidinedione [tzd]) without insulin, for at least 90 days prior to visit 1
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 [5,1])
C0332197 (UMLS CUI [5,2])
Glucohemoglobin measurement
Item
glycosylated hemoglobin (hba1c) greater than or equal to 7.0% and less than 11.0%
boolean
C0202054 (UMLS CUI [1])
Breakfast Small Regular | Percentage Calorie intake per day
Item
regularly consume a light breakfast (less than 15% of total daily calorie intake)
boolean
C2698559 (UMLS CUI [1,1])
C0700321 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
C0439165 (UMLS CUI [2,1])
C2095644 (UMLS CUI [2,2])
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)
Thiazolidinediones | Combination Insulin Illicit
Item
are taking a tzd whose country label does not allow in combination with insulin
boolean
C1257987 (UMLS CUI [1])
C0205195 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C0332266 (UMLS CUI [2,3])
Hypoglycemic Agents | Exception Pharmaceutical Preparations Inclusion criteria
Item
are taking any glucose-lowering agents (other than specified 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])
Body mass index
Item
have a body mass index greater than 40 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Hypoglycemia Severe
Item
have a history of severe hypoglycemia in past 24 weeks
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 Diseases
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 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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial