ID

32899

Beskrivning

A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5); ODM derived from: https://clinicaltrials.gov/show/NCT00877890

Länk

https://clinicaltrials.gov/show/NCT00877890

Nyckelord

Versioner (1)
  1. 2018-11-19 2018-11-19 -
Rättsinnehavare

See clinicaltrials.gov

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19 november 2018

DOI

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Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00877890

Engelsk

Eligibility Type 2 Diabetes Mellitus NCT00877890

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
has been diagnosed with type 2 diabetes mellitus
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
has hemoglobin-specific a1c fraction (hba1c) of 7.1% to 11.0%, inclusive, at screening
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
has a body mass index (bmi) of 25 kg/m2 to 45 kg/m2, inclusive, at screening
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
has been treated with diet and exercise alone or in combination with a stable regimen of metformin (met), a sulfonylurea (su), a thiazolidinedione (tzd), a combination of metformin and an su, a combination of metformin and a tzd, or a combination of an su and a tzd for a minimum of 2 months prior to screening
Beskrivning

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

Datatyp

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]
C1257987
UMLS CUI [5,2]
C0205360
UMLS CUI [6]
C0009429
either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to screening:
Beskrivning

Pharmaceutical Preparations Following Absent | Pharmaceutical Preparations Following Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332282
UMLS CUI [2,3]
C0205360
hormone replacement therapy (female subjects)
Beskrivning

Hormone replacement therapy | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0282402
UMLS CUI [2]
C0079399
oral contraceptives (female subjects)
Beskrivning

Contraceptives, Oral | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0009905
UMLS CUI [2]
C0079399
antihypertensive agents
Beskrivning

Antihypertensive Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0003364
lipid-lowering agents
Beskrivning

Hypolipidemic Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0086440
thyroid replacement therapy
Beskrivning

Thyroid hormone replacement therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C2242640
antidepressant agents
Beskrivning

Antidepressive Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0003289
drugs known to affect body weight, including prescription medications (e.g. orlistat [xenical®], sibutramine [meridia®], topiramate [topamax®]) and over the counter antiobesity agents
Beskrivning

Pharmaceutical Preparations Affecting Body Weight | orlistat | Xenical | sibutramine | Meridia | topiramate | Topamax | Over-the-counter Anti-Obesity Agents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005910
UMLS CUI [2]
C0076275
UMLS CUI [3]
C0732649
UMLS CUI [4]
C0074493
UMLS CUI [5]
C0635898
UMLS CUI [6]
C0076829
UMLS CUI [7]
C0723778
UMLS CUI [8,1]
C0013231
UMLS CUI [8,2]
C0376607
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
has ever been exposed to exenatide (exenatide once weekly [exenatide lar], exenatide bid, byetta, or any other formulation) or any glucagon-like peptide-1 (glp-1) analog
Beskrivning

Exposure to Exenatide | Exposure to Byetta | Exposure to GLP-1 analogues

Datatyp

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]
C4301632
has received any investigational drug within one month (or five half-lives of the investigational drug, whichever is greater) of screening
Beskrivning

Investigational New Drugs

Datatyp

boolean

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

Pharmaceutical Preparations Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332196
any dipeptidyl peptidase 4 (dpp-4) inhibitor within 3 months prior to screening
Beskrivning

Dipeptidyl-Peptidase IV Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C1827106
alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (symlin®) within 30 days of screening
Beskrivning

alpha-Glucosidase Inhibitors | Meglitinide | nateglinide | Pramlintide | Symlin

Datatyp

boolean

Alias
UMLS CUI [1]
C1299007
UMLS CUI [2]
C0065880
UMLS CUI [3]
C0903898
UMLS CUI [4]
C0537551
UMLS CUI [5]
C1174780
insulin within 2 weeks of screening or for more than 1 week within 3 months of screening
Beskrivning

Insulin

Datatyp

boolean

Alias
UMLS CUI [1]
C0021641
systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including advair®) steroids known to have a high rate of systemic absorption
Beskrivning

CORTICOSTEROIDS FOR SYSTEMIC USE Oral | CORTICOSTEROIDS FOR SYSTEMIC USE Intravenous | CORTICOSTEROIDS FOR SYSTEMIC USE Intramuscular | Inhaled steroids | Steroids Intrapulmonary | Advair

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3653708
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C3653708
UMLS CUI [2,2]
C1522726
UMLS CUI [3,1]
C3653708
UMLS CUI [3,2]
C1556154
UMLS CUI [4]
C2065041
UMLS CUI [5,1]
C0038317
UMLS CUI [5,2]
C1522224
UMLS CUI [6]
C0965130
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00877890

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
has been diagnosed with type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
has hemoglobin-specific a1c fraction (hba1c) of 7.1% to 11.0%, inclusive, at screening
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
has a body mass index (bmi) of 25 kg/m2 to 45 kg/m2, inclusive, at screening
boolean
C1305855 (UMLS CUI [1])
Diet therapy | Exercise | Metformin Stable | Sulfonylurea Stable | Thiazolidinediones Stable | Combined Modality Therapy
Item
has been treated with diet and exercise alone or in combination with a stable regimen of metformin (met), a sulfonylurea (su), a thiazolidinedione (tzd), a combination of metformin and an su, a combination of metformin and a tzd, or a combination of an su and a tzd for a minimum of 2 months prior to screening
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])
C1257987 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
C0009429 (UMLS CUI [6])
Pharmaceutical Preparations Following Absent | Pharmaceutical Preparations Following Stable
Item
either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to screening:
boolean
C0013227 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Hormone replacement therapy | Gender
Item
hormone replacement therapy (female subjects)
boolean
C0282402 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Contraceptives, Oral | Gender
Item
oral contraceptives (female subjects)
boolean
C0009905 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Antihypertensive Agents
Item
antihypertensive agents
boolean
C0003364 (UMLS CUI [1])
Hypolipidemic Agents
Item
lipid-lowering agents
boolean
C0086440 (UMLS CUI [1])
Thyroid hormone replacement therapy
Item
thyroid replacement therapy
boolean
C2242640 (UMLS CUI [1])
Antidepressive Agents
Item
antidepressant agents
boolean
C0003289 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Body Weight | orlistat | Xenical | sibutramine | Meridia | topiramate | Topamax | Over-the-counter Anti-Obesity Agents
Item
drugs known to affect body weight, including prescription medications (e.g. orlistat [xenical®], sibutramine [meridia®], topiramate [topamax®]) and over the counter antiobesity agents
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,3])
C0076275 (UMLS CUI [2])
C0732649 (UMLS CUI [3])
C0074493 (UMLS CUI [4])
C0635898 (UMLS CUI [5])
C0076829 (UMLS CUI [6])
C0723778 (UMLS CUI [7])
C0013231 (UMLS CUI [8,1])
C0376607 (UMLS CUI [8,2])
Item Group
C0680251 (UMLS CUI)
Exposure to Exenatide | Exposure to Byetta | Exposure to GLP-1 analogues
Item
has ever been exposed to exenatide (exenatide once weekly [exenatide lar], exenatide bid, byetta, or any other formulation) or any glucagon-like peptide-1 (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])
C4301632 (UMLS CUI [3,2])
Investigational New Drugs
Item
has received any investigational drug within one month (or five half-lives of the investigational drug, whichever is greater) of screening
boolean
C0013230 (UMLS CUI [1])
Pharmaceutical Preparations Excluded
Item
has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:
boolean
C0013227 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
Dipeptidyl-Peptidase IV Inhibitors
Item
any dipeptidyl peptidase 4 (dpp-4) inhibitor within 3 months prior to screening
boolean
C1827106 (UMLS CUI [1])
alpha-Glucosidase Inhibitors | Meglitinide | nateglinide | Pramlintide | Symlin
Item
alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (symlin®) within 30 days of screening
boolean
C1299007 (UMLS CUI [1])
C0065880 (UMLS CUI [2])
C0903898 (UMLS CUI [3])
C0537551 (UMLS CUI [4])
C1174780 (UMLS CUI [5])
Insulin
Item
insulin within 2 weeks of screening or for more than 1 week within 3 months of screening
boolean
C0021641 (UMLS CUI [1])
CORTICOSTEROIDS FOR SYSTEMIC USE Oral | CORTICOSTEROIDS FOR SYSTEMIC USE Intravenous | CORTICOSTEROIDS FOR SYSTEMIC USE Intramuscular | Inhaled steroids | Steroids Intrapulmonary | Advair
Item
systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including advair®) steroids known to have a high rate of systemic absorption
boolean
C3653708 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C3653708 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C3653708 (UMLS CUI [3,1])
C1556154 (UMLS CUI [3,2])
C2065041 (UMLS CUI [4])
C0038317 (UMLS CUI [5,1])
C1522224 (UMLS CUI [5,2])
C0965130 (UMLS CUI [6])
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