ID

39010

Descripción

Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01652729

Link

https://clinicaltrials.gov/show/NCT01652729

Palabras clave

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

See clinicaltrials.gov

Subido en

19 de noviembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Type 2 NCT01652729

Inglés

Eligibility Diabetes Type 2 NCT01652729

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 of 7.1% to 11.0%, inclusive, at screening
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
has stable body weight, i.e., not varying by >3% for at least 3 months prior to screening
Descripción

Stable body weight

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0517386
fasting plasma glucose concentration <280 mg/dl (15.5 mmol/l) at screening
Descripción

Plasma fasting glucose measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0583513
body mass index of <45 kg/m2 at screening
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2 months prior to visit 1 (screening)
Descripción

Metformin Dose Stable U/day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0456683
Exclusion Criteria
Descripción

Exclusion Criteria

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

Pancreatitis | Triglycerides measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0202236
medullary carcinoma or multiple endocrine neoplasia (men2) or a family history of either
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2]
C1833921
UMLS CUI [3,1]
C0027662
UMLS CUI [3,2]
C0332307
UMLS CUI [4,1]
C4039247
UMLS CUI [4,2]
C0332307
history of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance <50 ml/min
Descripción

Kidney Transplantation | Dialysis procedure | Estimated creatine clearance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022671
UMLS CUI [2]
C0011946
UMLS CUI [3]
C1273051
active cardiovascular disease
Descripción

Cardiovascular Disease

Tipo de datos

boolean

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

Congestive heart failure Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0205082
central nervous system disease, including epilepsy
Descripción

CNS disorder | Epilepsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2]
C0014544
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
clinically significant malignant disease
Descripción

Malignant disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0442867
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 exposure to exenatide (byetta® or bydureon™) or any glp-1 analog
Descripción

Exposure to Exenatide | Exposure to Byetta | Exposure to Bydureon | Exposure to GLP-1 Analogue

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0167117
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C1636686
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C3257792
UMLS CUI [4,1]
C0332157
UMLS CUI [4,2]
C3273809
any dpp-4 inhibitor within 3 months prior screening
Descripción

Dipeptidyl Peptidase-4 Inhibitor

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3537225
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Similar models

Eligibility Diabetes Type 2 NCT01652729

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 of 7.1% to 11.0%, inclusive, at screening
boolean
C0474680 (UMLS CUI [1])
Stable body weight
Item
has stable body weight, i.e., not varying by >3% for at least 3 months prior to screening
boolean
C0517386 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fasting plasma glucose concentration <280 mg/dl (15.5 mmol/l) at screening
boolean
C0583513 (UMLS CUI [1])
Body mass index
Item
body mass index of <45 kg/m2 at screening
boolean
C1305855 (UMLS CUI [1])
Metformin Dose Stable U/day
Item
has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2 months prior to visit 1 (screening)
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Pancreatitis | Triglycerides measurement
Item
history of pancreatitis or triglycerides >=500 mg/dl
boolean
C0030305 (UMLS CUI [1])
C0202236 (UMLS CUI [2])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type
Item
medullary carcinoma or multiple endocrine neoplasia (men2) or a family history of either
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C4039247 (UMLS CUI [4,1])
C0332307 (UMLS CUI [4,2])
Kidney Transplantation | Dialysis procedure | Estimated creatine clearance
Item
history of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance <50 ml/min
boolean
C0022671 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
C1273051 (UMLS CUI [3])
Cardiovascular Disease
Item
active cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Congestive heart failure Severe
Item
presence or history of severe congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
CNS disorder | Epilepsy
Item
central nervous system disease, including epilepsy
boolean
C0007682 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
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])
Malignant disease
Item
clinically significant malignant disease
boolean
C0442867 (UMLS CUI [1])
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])
Exposure to Exenatide | Exposure to Byetta | Exposure to Bydureon | Exposure to GLP-1 Analogue
Item
any exposure to exenatide (byetta® or bydureon™) or any glp-1 analog
boolean
C0332157 (UMLS CUI [1,1])
C0167117 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C1636686 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C3257792 (UMLS CUI [3,2])
C0332157 (UMLS CUI [4,1])
C3273809 (UMLS CUI [4,2])
Dipeptidyl Peptidase-4 Inhibitor
Item
any dpp-4 inhibitor within 3 months prior screening
boolean
C3537225 (UMLS CUI [1])
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