ID

25588

Descripción

Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00508287

Link

https://clinicaltrials.gov/show/NCT00508287

Palabras clave

Versiones (1)
  1. 7/9/17 7/9/17 -
Subido en

7 de septiembre de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Type 2 Diabetes NCT00508287

Inglés

Eligibility Type 2 Diabetes NCT00508287

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of type 2 diabetes for ≥ 3 months treated with metformin, thiazolidinedione, or sulfonylurea (either monotherapy or combination) or diet alone (drug naïve)
Descripción

Diabetes Mellitus, Non-Insulin-Dependent | Metformin | Thiazolidinediones | Sulfonylurea | Combined Modality Therapy | Diet therapy Without Pharmaceutical Preparations

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0025598
UMLS CUI [3]
C1257987
UMLS CUI [4]
C0038766
UMLS CUI [5]
C0009429
UMLS CUI [6,1]
C0012159
UMLS CUI [6,2]
C0332288
UMLS CUI [6,3]
C0013227
fasting plasma glucose: 126 - 240 mg/dl
Descripción

Plasma fasting glucose measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0583513
hemoglobin a1c: 6 - 10%
Descripción

Glycosylated hemoglobin A

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019018
estimated crcl ≥ 60 ml/min
Descripción

Creatinine clearance measurement Estimated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0373595
UMLS CUI [1,2]
C0750572
alt ≤ 1.5 x uln and total bilirubin ≤ 2 x uln
Descripción

Alanine aminotransferase measurement | Serum total bilirubin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C1278039
stable and well controlled hypertension and/or dyslipidemia
Descripción

Hypertensive disease Stable | Hypertension controlled well | Dyslipidemia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0745117
UMLS CUI [2,2]
C0205170
UMLS CUI [3]
C0242339
concomitant medications used for hypertension and/or dyslipidemia, thyroid hormone replacement therapy and low dose aspirin will be allowed if stable for at least 6 weeks
Descripción

Pharmaceutical Preparations Hypertensive disease | Pharmaceutical Preparations Dyslipidemia | Thyroid hormone replacement therapy | Aspirin Low Dose Stable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0020538
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0242339
UMLS CUI [3]
C2242640
UMLS CUI [4,1]
C2608320
UMLS CUI [4,2]
C0205360
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
women of childbearing potential
Descripción

Childbearing Potential

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3831118
symptomatic diabetes with polyuria and/or polydipsia
Descripción

Diabetes Mellitus Symptomatic | Polyuria | Polydipsia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0032617
UMLS CUI [3]
C0085602
history of diabetic ketoacidosis or hyperosmolar nonketotic syndrome
Descripción

Diabetic Ketoacidosis | Hyperglycaemic hyperosmolar nonketotic syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C1504377
history of renal disease including diabetic nephropathy
Descripción

Kidney Disease | Diabetic Nephropathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0011881
Volver a la parte superior de la página

Similar models

Eligibility Type 2 Diabetes NCT00508287

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Metformin | Thiazolidinediones | Sulfonylurea | Combined Modality Therapy | Diet therapy Without Pharmaceutical Preparations
Item
diagnosis of type 2 diabetes for ≥ 3 months treated with metformin, thiazolidinedione, or sulfonylurea (either monotherapy or combination) or diet alone (drug naïve)
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C0009429 (UMLS CUI [5])
C0012159 (UMLS CUI [6,1])
C0332288 (UMLS CUI [6,2])
C0013227 (UMLS CUI [6,3])
Plasma fasting glucose measurement
Item
fasting plasma glucose: 126 - 240 mg/dl
boolean
C0583513 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hemoglobin a1c: 6 - 10%
boolean
C0019018 (UMLS CUI [1])
Creatinine clearance measurement Estimated
Item
estimated crcl ≥ 60 ml/min
boolean
C0373595 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
Alanine aminotransferase measurement | Serum total bilirubin measurement
Item
alt ≤ 1.5 x uln and total bilirubin ≤ 2 x uln
boolean
C0201836 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
Hypertensive disease Stable | Hypertension controlled well | Dyslipidemia
Item
stable and well controlled hypertension and/or dyslipidemia
boolean
C0020538 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0745117 (UMLS CUI [2,1])
C0205170 (UMLS CUI [2,2])
C0242339 (UMLS CUI [3])
Pharmaceutical Preparations Hypertensive disease | Pharmaceutical Preparations Dyslipidemia | Thyroid hormone replacement therapy | Aspirin Low Dose Stable
Item
concomitant medications used for hypertension and/or dyslipidemia, thyroid hormone replacement therapy and low dose aspirin will be allowed if stable for at least 6 weeks
boolean
C0013227 (UMLS CUI [1,1])
C0020538 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0242339 (UMLS CUI [2,2])
C2242640 (UMLS CUI [3])
C2608320 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential
Item
women of childbearing potential
boolean
C3831118 (UMLS CUI [1])
Diabetes Mellitus Symptomatic | Polyuria | Polydipsia
Item
symptomatic diabetes with polyuria and/or polydipsia
boolean
C0011849 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0032617 (UMLS CUI [2])
C0085602 (UMLS CUI [3])
Diabetic Ketoacidosis | Hyperglycaemic hyperosmolar nonketotic syndrome
Item
history of diabetic ketoacidosis or hyperosmolar nonketotic syndrome
boolean
C0011880 (UMLS CUI [1])
C1504377 (UMLS CUI [2])
Kidney Disease | Diabetic Nephropathy
Item
history of renal disease including diabetic nephropathy
boolean
C0022658 (UMLS CUI [1])
C0011881 (UMLS CUI [2])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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