ID

38755

Descripción

Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01652716

Link

https://clinicaltrials.gov/show/NCT01652716

Palabras clave

Versiones (1)
  1. 31/10/19 31/10/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

31 de octubre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01652716

Inglés

Eligibility Diabetes Mellitus, Type 2 NCT01652716

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
at least 18 years old
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed with type 2 diabetes mellitus
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
hba1c 7.1 to 11%, inclusive, at screening
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
fasting plasma glucose <280 mg/dl (15.5 mmol/l)
Descripción

Plasma fasting glucose measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0583513
body mass index (bmi) <=45 kg/m2, inclusive, at screening
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
treated with diet and exercise or a stable regimen of metformin, sulfonylurea, pioglitazone or any 2 of these agents
Descripción

Diet therapy | Exercise | Metformin Stable | Sulfonylurea Stable | Pioglitazone Stable | Combined Modality Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C0015259
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0205360
UMLS CUI [4,1]
C0038766
UMLS CUI [4,2]
C0205360
UMLS CUI [5,1]
C0071097
UMLS CUI [5,2]
C0205360
UMLS CUI [6]
C0009429
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of pancreatitis or triglycerides >=500 mg/dl
Descripción

Pancreatitis | Triglycerides Dose

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2,1]
C0041004
UMLS CUI [2,2]
C0178602
medullary carcinoma or multiple endocrine neoplasia (men2) or a family history of either
Descripción

Medullary carcinoma | Multiple Endocrine Neoplasia Type | Family history Medullary carcinoma | Family history of multiple endocrine neoplasia Type

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206693
UMLS CUI [2,1]
C0027662
UMLS CUI [2,2]
C0332307
UMLS CUI [3,1]
C0241889
UMLS CUI [3,2]
C0206693
UMLS CUI [4,1]
C4039247
UMLS CUI [4,2]
C0332307
active cardiovascular disease
Descripción

Cardiovascular Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
presence of congestive heart failure
Descripción

Congestive heart failure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018802
liver disease
Descripción

Liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
history of severe gastrointestinal diseases
Descripción

Gastrointestinal Diseases Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0205082
repeated severe hypoglycemia within the last 6 months
Descripción

Hypoglycemia Severe Repeated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205341
any previous use of exenatide or other glucagon-like peptide-1 (glp-1 ) analog
Descripción

exenatide | GLP-1 Analogue

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0167117
UMLS CUI [2]
C3273809
dipeptidyl peptidase-4 (dpp-4) inhibitor use in the last 3 months
Descripción

Dipeptidyl Peptidase 4 Inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2917254
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01652716

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
at least 18 years old
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosed with type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c 7.1 to 11%, inclusive, at screening
boolean
C0474680 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fasting plasma glucose <280 mg/dl (15.5 mmol/l)
boolean
C0583513 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) <=45 kg/m2, inclusive, at screening
boolean
C1305855 (UMLS CUI [1])
Diet therapy | Exercise | Metformin Stable | Sulfonylurea Stable | Pioglitazone Stable | Combined Modality Therapy
Item
treated with diet and exercise or a stable regimen of metformin, sulfonylurea, pioglitazone or any 2 of these agents
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
C0025598 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0038766 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
C0071097 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
C0009429 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Pancreatitis | Triglycerides Dose
Item
history of pancreatitis or triglycerides >=500 mg/dl
boolean
C0030305 (UMLS CUI [1])
C0041004 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Medullary carcinoma | Multiple Endocrine Neoplasia Type | Family history Medullary carcinoma | Family history of multiple endocrine neoplasia Type
Item
medullary carcinoma or multiple endocrine neoplasia (men2) or a family history of either
boolean
C0206693 (UMLS CUI [1])
C0027662 (UMLS CUI [2,1])
C0332307 (UMLS CUI [2,2])
C0241889 (UMLS CUI [3,1])
C0206693 (UMLS CUI [3,2])
C4039247 (UMLS CUI [4,1])
C0332307 (UMLS CUI [4,2])
Cardiovascular Disease
Item
active cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Congestive heart failure
Item
presence of congestive heart failure
boolean
C0018802 (UMLS CUI [1])
Liver disease
Item
liver disease
boolean
C0023895 (UMLS CUI [1])
Gastrointestinal Diseases Severe
Item
history of severe gastrointestinal diseases
boolean
C0017178 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Hypoglycemia Severe Repeated
Item
repeated severe hypoglycemia within the last 6 months
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
exenatide | GLP-1 Analogue
Item
any previous use of exenatide or other glucagon-like peptide-1 (glp-1 ) analog
boolean
C0167117 (UMLS CUI [1])
C3273809 (UMLS CUI [2])
Dipeptidyl Peptidase 4 Inhibitors
Item
dipeptidyl peptidase-4 (dpp-4) inhibitor use in the last 3 months
boolean
C2917254 (UMLS CUI [1])
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