ID

29121

Beschrijving

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

Trefwoorden

Versies (1)
  1. 26-02-18 26-02-18 -
Houder van rechten

See clinicaltrials.gov

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26 februari 2018

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00664534

Engels

Eligibility Diabetes Mellitus, Type 2 NCT00664534

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diabetes mellitus, type 2
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

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
Beschrijving

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

Datatype

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%
Beschrijving

Glucohemoglobin measurement

Datatype

boolean

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

Breakfast Small Regular | Percentage Calorie intake per day

Datatype

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
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
give written consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
are taking a tzd whose country label does not allow in combination with insulin
Beschrijving

Thiazolidinediones | Combination Insulin Illicit

Datatype

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)
Beschrijving

Hypoglycemic Agents | Exception Pharmaceutical Preparations Inclusion criteria

Datatype

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
Beschrijving

Body mass index

Datatype

boolean

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

Hypoglycemia Severe

Datatype

boolean

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

Pregnancy | Pregnancy Possible

Datatype

boolean

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

Breast Feeding

Datatype

boolean

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

Heart Diseases

Datatype

boolean

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

Kidney Disease | Liver disease

Datatype

boolean

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

Cancer treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0920425
contraindications to study medications
Beschrijving

Medical contraindication Investigational New Drugs

Datatype

boolean

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

Sleep-wake cycle disturbance

Datatype

boolean

Alias
UMLS CUI [1]
C1833362
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00664534

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

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