ID

38767

Descripción

A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Alone; ODM derived from: https://clinicaltrials.gov/show/NCT01691846

Link

https://clinicaltrials.gov/show/NCT01691846

Palabras clave

Versiones (1)
  1. 2/11/19 2/11/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

2 de noviembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01691846

Inglés

Eligibility Diabetes Mellitus, Type 2 NCT01691846

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/=18 years of age
Descripción

Adult | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
diagnosis of diabetes mellitus type 2
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
patients treated with stable metformin monotherapy for at least 12 weeks prior to screening
Descripción

Metformin Stable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0205360
hba1c >/=7% and </=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
fasting plasma glucose </=240 mg/dl at pre-randomization visit
Descripción

Plasma fasting glucose measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0583513
agreement to maintain diet and exercise habits during the study
Descripción

Diet therapy Maintenance | Exercise Habits Maintenance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012159
UMLS CUI [1,2]
C0024501
UMLS CUI [2,1]
C0015259
UMLS CUI [2,2]
C0018464
UMLS CUI [2,3]
C0024501
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months
Descripción

Diabetes Mellitus, Insulin-Dependent | Secondary diabetes mellitus | Diabetes Mellitus Due to Injury of pancreas | Complications of Diabetes Mellitus Metabolic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0271640
UMLS CUI [3,1]
C0011849
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0273163
UMLS CUI [4,1]
C0342257
UMLS CUI [4,2]
C0311400
any previous treatment with thiazolidinedione or a dual ppar agonist
Descripción

Thiazolidinediones | Peroxisome Proliferator-Activated Receptor Agonist Dual

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2,1]
C0166418
UMLS CUI [2,2]
C2987634
UMLS CUI [2,3]
C0205173
any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
Descripción

Weight reduction regimen | Lipoprotein modification Therapy | Exception Statins Dose Stable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0311130
UMLS CUI [2,1]
C1158918
UMLS CUI [2,2]
C0087111
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0360714
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0205360
symptomatic congestive heart failure classified as new york heart association class ii-iv at screening
Descripción

Symptomatic congestive heart failure New York Heart Association Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0742758
UMLS CUI [1,2]
C1275491
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01691846

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/=18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosis of diabetes mellitus type 2
boolean
C0011860 (UMLS CUI [1])
Metformin Stable
Item
patients treated with stable metformin monotherapy for at least 12 weeks prior to screening
boolean
C0025598 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c >/=7% and </=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
boolean
C0474680 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fasting plasma glucose </=240 mg/dl at pre-randomization visit
boolean
C0583513 (UMLS CUI [1])
Diet therapy Maintenance | Exercise Habits Maintenance
Item
agreement to maintain diet and exercise habits during the study
boolean
C0012159 (UMLS CUI [1,1])
C0024501 (UMLS CUI [1,2])
C0015259 (UMLS CUI [2,1])
C0018464 (UMLS CUI [2,2])
C0024501 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Secondary diabetes mellitus | Diabetes Mellitus Due to Injury of pancreas | Complications of Diabetes Mellitus Metabolic
Item
patients with type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months
boolean
C0011854 (UMLS CUI [1])
C0271640 (UMLS CUI [2])
C0011849 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0273163 (UMLS CUI [3,3])
C0342257 (UMLS CUI [4,1])
C0311400 (UMLS CUI [4,2])
Thiazolidinediones | Peroxisome Proliferator-Activated Receptor Agonist Dual
Item
any previous treatment with thiazolidinedione or a dual ppar agonist
boolean
C1257987 (UMLS CUI [1])
C0166418 (UMLS CUI [2,1])
C2987634 (UMLS CUI [2,2])
C0205173 (UMLS CUI [2,3])
Weight reduction regimen | Lipoprotein modification Therapy | Exception Statins Dose Stable
Item
any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
boolean
C0311130 (UMLS CUI [1])
C1158918 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0360714 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
Symptomatic congestive heart failure New York Heart Association Classification
Item
symptomatic congestive heart failure classified as new york heart association class ii-iv at screening
boolean
C0742758 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
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