ID

24009

Descripción

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of KRP-104 in Patients With Type 2 Diabetes Inadequately Controlled on Metformin Alone; ODM derived from: https://clinicaltrials.gov/show/NCT00525330

Link

https://clinicaltrials.gov/show/NCT00525330

Palabras clave

  1. 21/7/17 21/7/17 -
Subido en

21 de julio 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.

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 NCT00525330

Eligibility Type 2 Diabetes NCT00525330

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18 to 70 years, inclusive;
Descripción

ID.1

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. males and females of non-childbearing potential;
Descripción

ID.2

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
3. diagnosis of type 2 diabetes mellitus according; and
Descripción

ID.3

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
4. on a stable dose of metformin monotherapy at randomization (can be on other oral therapies or naive at study entry
Descripción

ID.4

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia;
Descripción

ID.5

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0011880
UMLS CUI [1,3]
C0745151
2. history or presence of alcoholism or drug abuse
Descripción

ID.6

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C0013146
3. typical consumption of ≥10 drinks of alcohol weekly;
Descripción

ID.7

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C0556332
significant renal impairment (glomerular filtration rate <60 ml/min [to be calculated by the central laboratory]);
Descripción

ID.9

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1565489
diabetic retinopathy;
Descripción

ID.10

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011884
diabetic gastroparesis;
Descripción

ID.11

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0267176
active liver disease (other than asymptomatic nonalcoholic fatty liver disease), cirrhosis, or symptomatic gallbladder disease;
Descripción

ID.12

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C2924508
UMLS CUI [1,3]
C0016977
5. uncontrolled high blood pressure;
Descripción

ID.13

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020538
6. history or evidence of cardiovascular or pulmonary disease
Descripción

ID.14

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0024115
7. must meet other laboratory and medical history clinical criteria. please contact recruitment center for referrals
Descripción

ID.15

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0022877

Similar models

Eligibility Type 2 Diabetes NCT00525330

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
1. age 18 to 70 years, inclusive;
boolean
C0001779 (UMLS CUI [1])
ID.2
Item
2. males and females of non-childbearing potential;
boolean
C0032961 (UMLS CUI [1])
ID.3
Item
3. diagnosis of type 2 diabetes mellitus according; and
boolean
C0011860 (UMLS CUI [1])
ID.4
Item
4. on a stable dose of metformin monotherapy at randomization (can be on other oral therapies or naive at study entry
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
ID.5
Item
1. history of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia;
boolean
C0011854 (UMLS CUI [1,1])
C0011880 (UMLS CUI [1,2])
C0745151 (UMLS CUI [1,3])
ID.6
Item
2. history or presence of alcoholism or drug abuse
boolean
C0085762 (UMLS CUI [1,1])
C0013146 (UMLS CUI [1,2])
ID.7
Item
3. typical consumption of ≥10 drinks of alcohol weekly;
boolean
C0085762 (UMLS CUI [1,1])
C0556332 (UMLS CUI [1,2])
ID.9
Item
significant renal impairment (glomerular filtration rate <60 ml/min [to be calculated by the central laboratory]);
boolean
C1565489 (UMLS CUI [1])
ID.10
Item
diabetic retinopathy;
boolean
C0011884 (UMLS CUI [1])
ID.11
Item
diabetic gastroparesis;
boolean
C0267176 (UMLS CUI [1])
ID.12
Item
active liver disease (other than asymptomatic nonalcoholic fatty liver disease), cirrhosis, or symptomatic gallbladder disease;
boolean
C0023890 (UMLS CUI [1,1])
C2924508 (UMLS CUI [1,2])
C0016977 (UMLS CUI [1,3])
ID.13
Item
5. uncontrolled high blood pressure;
boolean
C0020538 (UMLS CUI [1])
ID.14
Item
6. history or evidence of cardiovascular or pulmonary disease
boolean
C0007222 (UMLS CUI [1,1])
C0024115 (UMLS CUI [1,2])
ID.15
Item
7. must meet other laboratory and medical history clinical criteria. please contact recruitment center for referrals
boolean
C0262926 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

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