ID

23562

Beschreibung

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

Stichworte

Versionen (1)
  1. 09.07.17 09.07.17 -
Rechteinhaber

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

Hochgeladen am

9. Juli 2017

DOI

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Lizenz

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

Englisch

Eligibility Type 2 Diabetes Mellitus NCT00308139

1 Formulare  
Inclusion Criteria
Beschreibung

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.
Beschreibung

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

Datentyp

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.
Beschreibung

hba1c

Datentyp

boolean

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

bmi

Datentyp

boolean

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

study participation

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

exenatide, glucagon-like peptide 1

Datentyp

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.
Beschreibung

investigational drug, study participation

Datentyp

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:
Beschreibung

excluded medications

Datentyp

boolean

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

alpha glucosidase inhibitor, meglitinide

Datentyp

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;
Beschreibung

insulin

Datentyp

boolean

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

gastrointestinal motility affecting drugs

Datentyp

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;
Beschreibung

systemic corticosteroids

Datentyp

boolean

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

addictive drugs

Datentyp

boolean

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

over-the-counter weight loss medication

Datentyp

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
Beschreibung

study participation

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
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Ähnliche Modelle

Eligibility Type 2 Diabetes Mellitus NCT00308139

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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