ID

29152

Descripción

A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.; ODM derived from: https://clinicaltrials.gov/show/NCT00755287

Link

https://clinicaltrials.gov/show/NCT00755287

Palabras clave

Versiones (1)
  1. 1/3/18 1/3/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

1 de marzo de 2018

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 Diabetes Mellitus, Type 2 NCT00755287

Inglés

Eligibility Diabetes Mellitus, Type 2 NCT00755287

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, 18-75 years of age;
Descripción

Adult | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
type 2 diabetes treated with a stable dose of metformin and sulphonylurea for at least 12 weeks;
Descripción

Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable | Sulfonylurea Dose Stable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0038766
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
c-peptide (fasting) >=1.0ng/ml;
Descripción

Fasting C-peptide level

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2208720
hba1c >=7.0% and <=10.0% at screening;
Descripción

Glucohemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202054
bmi >=25 (>23 for asians) and <=45kg/m2 at screening;
Descripción

Body mass index | Asians

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0078988
stable weight +-5% for at least 12 weeks prior to screening.
Descripción

Stable body weight Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0517386
UMLS CUI [1,2]
C0449238
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
Descripción

Diabetes Mellitus, Insulin-Dependent | Complications of Diabetes Mellitus Metabolic | Ketoacidosis | Hyperosmolar Coma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0342257
UMLS CUI [2,2]
C0311400
UMLS CUI [3]
C0220982
UMLS CUI [4]
C0020457
evidence of clinically significant diabetic complications;
Descripción

Complications of Diabetes Mellitus

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0342257
symptomatic poorly controlled diabetes;
Descripción

Poorly controlled diabetes mellitus Symptomatic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0554876
UMLS CUI [1,2]
C0231220
clinically symptomatic gastrointestinal disease;
Descripción

Gastrointestinal Diseases Symptomatic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0231220
myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
Descripción

Myocardial Infarction | Coronary Artery Bypass Surgery | Cardiomyopathy Post Transplantation | Cerebrovascular accident

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0010055
UMLS CUI [3,1]
C0878544
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0040732
UMLS CUI [4]
C0038454
known hemoglobinopathy or chronic anemia.
Descripción

Hemoglobinopathy | Chronic anemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019045
UMLS CUI [2]
C0581384
Volver a la parte superior de la página

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00755287

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, 18-75 years of age;
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable | Sulfonylurea Dose Stable
Item
type 2 diabetes treated with a stable dose of metformin and sulphonylurea for at least 12 weeks;
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0038766 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Fasting C-peptide level
Item
c-peptide (fasting) >=1.0ng/ml;
boolean
C2208720 (UMLS CUI [1])
Glucohemoglobin measurement
Item
hba1c >=7.0% and <=10.0% at screening;
boolean
C0202054 (UMLS CUI [1])
Body mass index | Asians
Item
bmi >=25 (>23 for asians) and <=45kg/m2 at screening;
boolean
C1305855 (UMLS CUI [1])
C0078988 (UMLS CUI [2])
Stable body weight Duration
Item
stable weight +-5% for at least 12 weeks prior to screening.
boolean
C0517386 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Complications of Diabetes Mellitus Metabolic | Ketoacidosis | Hyperosmolar Coma
Item
history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
boolean
C0011854 (UMLS CUI [1])
C0342257 (UMLS CUI [2,1])
C0311400 (UMLS CUI [2,2])
C0220982 (UMLS CUI [3])
C0020457 (UMLS CUI [4])
Complications of Diabetes Mellitus
Item
evidence of clinically significant diabetic complications;
boolean
C0342257 (UMLS CUI [1])
Poorly controlled diabetes mellitus Symptomatic
Item
symptomatic poorly controlled diabetes;
boolean
C0554876 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Gastrointestinal Diseases Symptomatic
Item
clinically symptomatic gastrointestinal disease;
boolean
C0017178 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Myocardial Infarction | Coronary Artery Bypass Surgery | Cardiomyopathy Post Transplantation | Cerebrovascular accident
Item
myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
boolean
C0027051 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C0878544 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0040732 (UMLS CUI [3,3])
C0038454 (UMLS CUI [4])
Hemoglobinopathy | Chronic anemia
Item
known hemoglobinopathy or chronic anemia.
boolean
C0019045 (UMLS CUI [1])
C0581384 (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