ID

29122

Descripción

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

Palabras clave

Versiones (1)
  1. 27/2/18 27/2/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

27 de febrero de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00666718

Inglés

Eligibility Diabetes Mellitus, Type 2 NCT00666718

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
diabetes mellitus, type 2
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

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)
Descripción

Metformin | Oral hypoglycemic Quantity | Sulfonylurea | Thiazolidinediones | Insulin

Tipo de datos

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%
Descripción

Glucohemoglobin measurement

Tipo de datos

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
Descripción

Body mass index

Tipo de datos

boolean

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

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
give written consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

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

Hypoglycemic Agents | Exception Pharmaceutical Preparations Inclusion criteria

Tipo de datos

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
Descripción

Hypoglycemia Severe

Tipo de datos

boolean

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

Pregnancy | Pregnancy Possible

Tipo de datos

boolean

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

Breast Feeding

Tipo de datos

boolean

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

Heart Disease

Tipo de datos

boolean

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

Kidney Disease | Liver disease

Tipo de datos

boolean

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

Cancer treatment

Tipo de datos

boolean

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

Medical contraindication Investigational New Drugs

Tipo de datos

boolean

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

Sleep-wake cycle disturbance

Tipo de datos

boolean

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

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

Tipo de datos

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 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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