Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes
NCT ID: NCT01003184
Last Updated: 2015-04-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
222 participants
INTERVENTIONAL
2009-10-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
exenatide once weekly
subcutaneous injection, 2mg, once a week
2
insulin detemir
subcutaneous injection, with dosage titrated according to the determir label and published titration schedule, once or twice a day
Interventions
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exenatide once weekly
subcutaneous injection, 2mg, once a week
insulin detemir
subcutaneous injection, with dosage titrated according to the determir label and published titration schedule, once or twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive
* Are receiving metformin at a stable dose (consistent with country specific requirements) of a minimum of 1000mg for at least 3 months prior to start start OR are receiving metformin at a minimum dose (consistent with country specific requirements) of 1000mg and sulphonylurea (as separate medications not as a fixed dose combination) at stable doses for 3 months prior to study start
Exclusion Criteria
* Have a known allergy or hypersensitivity to insulin detemir, exenatide or excipients contained in these agents
* Have been treated within 4 weeks of screening with systemic glucocorticoid therapy by oral, intravenous (IV) or intramuscular (IM) route, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption. Exceptions to this criterion include patients who are receiving glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g. Addison disease)
* Have been treated with drugs that promote weight loss, within 3 months of screening
* Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: insulin, alpha-glucosidase, Byetta® (exenatide BID formulation), thiazolidinediones (TZD), dipeptidyl peptidase (DPP)-4 inhibitors
* Have previously completed or withdrawn from this study or any other study investigating exenatide QW
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer, MD
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Research Site
Dublin, , Ireland
Research Site
Addlestone, England, United Kingdom
Research Site
Bath, England, United Kingdom
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Birmingham, England, United Kingdom
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Blackburn, England, United Kingdom
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Bournemouth, England, United Kingdom
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Chippenham, England, United Kingdom
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Derby, England, United Kingdom
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Exeter, England, United Kingdom
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High Wycombe, England, United Kingdom
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Hull, England, United Kingdom
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Leicester, England, United Kingdom
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Liverpool, England, United Kingdom
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London, England, United Kingdom
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Manchester, England, United Kingdom
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Merseyside, England, United Kingdom
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Middlesbrough, England, United Kingdom
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Newcastle, England, United Kingdom
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Northampton, England, United Kingdom
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Oldham, England, United Kingdom
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Plymouth, England, United Kingdom
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Portsmouth, England, United Kingdom
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Sheffield, England, United Kingdom
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Stevenage, England, United Kingdom
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Suffolk, England, United Kingdom
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Wakefield, England, United Kingdom
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Wiltshire, England, United Kingdom
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Aberdeen, Scotland, United Kingdom
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Dundee, Scotland, United Kingdom
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Carmathen, Wales, United Kingdom
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Swansea, Wales, United Kingdom
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Wrexham, Wales, United Kingdom
Research Site
Leytonstone, , United Kingdom
Research Site
Livingston, , United Kingdom
Countries
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References
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Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.
Other Identifiers
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H8O-EW-GWDL
Identifier Type: -
Identifier Source: org_study_id
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