ID

23562

Descripción

Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1); ODM derived from: https://clinicaltrials.gov/show/NCT00308139

Link

https://clinicaltrials.gov/show/NCT00308139

Palabras clave

Versiones (1)
  1. 9/7/17 9/7/17 -
Titular de derechos de autor

Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.

Subido en

9 de julio de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Type 2 Diabetes Mellitus NCT00308139

Inglés

Eligibility Type 2 Diabetes Mellitus NCT00308139

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
has type 2 diabetes mellitus treated with diet modification and exercise alone or in combination with a stable regimen of a combination of metformin, sulphonylureas, and thiazolidinediones for a minimum of 2 months at screening.
Descripción

diabetes mellitus type 2 with diet modification, exercise, metformin, sulfonylureas, thiazolidinediones

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0086153
UMLS CUI [1,3]
C0015259
UMLS CUI [1,4]
C0025598
UMLS CUI [1,5]
C3653359
UMLS CUI [1,6]
C1257987
hemoglobin a1c (hba1c) of 7.1% to 11.0%, inclusive, at screening.
Descripción

hba1c

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019018
body mass index (bmi) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
Descripción

bmi

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
(for sub-study) currently participating in open ended assessment period of main study 2993 lar105
Descripción

study participation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
has been previously exposed to exenatide (byetta®), exenatide lar, or any glucagon-like peptide-1 (glp-1) analog.
Descripción

exenatide, glucagon-like peptide 1

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0167117
UMLS CUI [2]
C0061355
received any investigational drug or has participated in any type of clinical trial within 30 days prior to screening.
Descripción

investigational drug, study participation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
has been treated, is currently treated, or is expected to require or undergo treatment with any of the following excluded medications:
Descripción

excluded medications

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2828389
alpha glucosidase inhibitor or meglitinide within 30 days of screening;
Descripción

alpha glucosidase inhibitor, meglitinide

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3539108
UMLS CUI [2]
C0065880
insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;
Descripción

insulin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021641
regular use (> 14 days) of drugs that directly affect gastrointestinal motility;
Descripción

gastrointestinal motility affecting drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0017184
regular use (> 14 days) of systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption;
Descripción

systemic corticosteroids

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2825233
regular use (> 14 days) of medications with addictive potential such as opiates and opioids;
Descripción

addictive drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0813966
prescription or over-the-counter weight loss medications within 6 months of screening.
Descripción

over-the-counter weight loss medication

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013231
UMLS CUI [1,2]
C0376606
(for sub-study) subjects will be terminated from study who do not participate in the dual chamber pen substudy
Descripción

study participation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00308139

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
diabetes mellitus type 2 with diet modification, exercise, metformin, sulfonylureas, thiazolidinediones
Item
has type 2 diabetes mellitus treated with diet modification and exercise alone or in combination with a stable regimen of a combination of metformin, sulphonylureas, and thiazolidinediones for a minimum of 2 months at screening.
boolean
C0011860 (UMLS CUI [1,1])
C0086153 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
C0025598 (UMLS CUI [1,4])
C3653359 (UMLS CUI [1,5])
C1257987 (UMLS CUI [1,6])
hba1c
Item
hemoglobin a1c (hba1c) of 7.1% to 11.0%, inclusive, at screening.
boolean
C0019018 (UMLS CUI [1])
bmi
Item
body mass index (bmi) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
boolean
C1305855 (UMLS CUI [1])
study participation
Item
(for sub-study) currently participating in open ended assessment period of main study 2993 lar105
boolean
C2348568 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
exenatide, glucagon-like peptide 1
Item
has been previously exposed to exenatide (byetta®), exenatide lar, or any glucagon-like peptide-1 (glp-1) analog.
boolean
C0167117 (UMLS CUI [1])
C0061355 (UMLS CUI [2])
investigational drug, study participation
Item
received any investigational drug or has participated in any type of clinical trial within 30 days prior to screening.
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
excluded medications
Item
has been treated, is currently treated, or is expected to require or undergo treatment with any of the following excluded medications:
boolean
C0013227 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
alpha glucosidase inhibitor, meglitinide
Item
alpha glucosidase inhibitor or meglitinide within 30 days of screening;
boolean
C3539108 (UMLS CUI [1])
C0065880 (UMLS CUI [2])
insulin
Item
insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;
boolean
C0021641 (UMLS CUI [1])
gastrointestinal motility affecting drugs
Item
regular use (> 14 days) of drugs that directly affect gastrointestinal motility;
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0017184 (UMLS CUI [1,3])
systemic corticosteroids
Item
regular use (> 14 days) of systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption;
boolean
C2825233 (UMLS CUI [1])
addictive drugs
Item
regular use (> 14 days) of medications with addictive potential such as opiates and opioids;
boolean
C0813966 (UMLS CUI [1])
over-the-counter weight loss medication
Item
prescription or over-the-counter weight loss medications within 6 months of screening.
boolean
C0013231 (UMLS CUI [1,1])
C0376606 (UMLS CUI [1,2])
study participation
Item
(for sub-study) subjects will be terminated from study who do not participate in the dual chamber pen substudy
boolean
C2348568 (UMLS CUI [1])
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