A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients
NCT ID: NCT00360334
Last Updated: 2015-04-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
235 participants
INTERVENTIONAL
2006-06-30
2008-04-30
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
subcutaneous injection, 5mcg or 10mcg, twice a day
2
insulin glargine
subcutaneous injection, titrated to target blood glucose level, once a day
Interventions
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exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
insulin glargine
subcutaneous injection, titrated to target blood glucose level, once a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months.
* HbA1c between 7.5% and 10.0%.
* BMI \>27.
Exclusion Criteria
* Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.
* Treatment with the following medications: \*Insulin as outpatient therapy within last 3 months; \*Meglitinides, or acarbose within the last 3 months; \*Regular use of any drugs that directly affect gastrointestinal motility; \*Any previous (study) therapy with exenatide or glucagon-like peptide-1 (GLP-1) analogue; \*Anti-obesity agent use within the last 3 months.
* 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.
30 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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Mauricio Silva de Lima, MD
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Research Site
Aberdeen, , United Kingdom
Research Site
Bath, , United Kingdom
Research Site
Blackburn, , United Kingdom
Research Site
Bolton, , United Kingdom
Research Site
Bournemouth, , United Kingdom
Research Site
Bristol, , United Kingdom
Research Site
Chippenham, , United Kingdom
Research Site
Edinburgh, , United Kingdom
Research Site
Glasgow, , United Kingdom
Research Site
Haywards Heath, , United Kingdom
Research Site
High Wycombe, , United Kingdom
Research Site
Hull, , United Kingdom
Research Site
Ipswich, , United Kingdom
Research Site
Kent, , United Kingdom
Research Site
Leicester, , United Kingdom
Research Site
Liverpool, , United Kingdom
Research Site
Livingstone, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Metropolitan Borough of Wirral, , United Kingdom
Research Site
Middlesbrough, , United Kingdom
Research Site
Norwich, , United Kingdom
Research Site
Nottingham, , United Kingdom
Research Site
Oldham, , United Kingdom
Research Site
Oxford, , United Kingdom
Research Site
Plymouth, , United Kingdom
Research Site
Rochdale, , United Kingdom
Research Site
Salford, , United Kingdom
Research Site
Swansea, , United Kingdom
Research Site
Torquay, , United Kingdom
Research Site
Wakefield, , United Kingdom
Countries
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References
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Davies MJ, Donnelly R, Barnett AH, Jones S, Nicolay C, Kilcoyne A. Exenatide compared with long-acting insulin to achieve glycaemic control with minimal weight gain in patients with type 2 diabetes: results of the Helping Evaluate Exenatide in patients with diabetes compared with Long-Acting insulin (HEELA) study. Diabetes Obes Metab. 2009 Dec;11(12):1153-62. doi: 10.1111/j.1463-1326.2009.01154.x.
Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
Other Identifiers
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H8O-BP-GWBG
Identifier Type: -
Identifier Source: org_study_id
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