Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy
NCT ID: NCT00099619
Last Updated: 2015-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
138 participants
INTERVENTIONAL
2004-09-30
2005-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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exenatide/insulin glargine
Arm that first receives exenatide, then crosses over to insulin glargine
exenatide/insulin glargine
Subcutaneously injected exenaide 10 mcg twice daily for 16 weeks; then insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels
Insulin glargine/exenatide
Arm that first receives insulin glargine, then crosses over to exenatide
insulin glargine/exenatide
Subcutaneously injected insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels; then exenaide 10 mcg twice daily for 16 weeks
Interventions
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exenatide/insulin glargine
Subcutaneously injected exenaide 10 mcg twice daily for 16 weeks; then insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels
insulin glargine/exenatide
Subcutaneously injected insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels; then exenaide 10 mcg twice daily for 16 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HbA1c between 7.1% and 11.0%, inclusive.
* Insulin therapy should be the next appropriate step of diabetes treatment.
* Body Mass Index (BMI) \>25 kg/m2 and \<40 kg/m2.
Exclusion Criteria
* Treated with insulin, thiazolidinediones, alpha-glucosidase inhibitors, or meglitinides within 3 months prior to screening.
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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James Malone, MD
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Research Site
Westmead, New South Wales, Australia
Research Site
Daw Park, South Australia, Australia
Research Site
Fullarton, South Australia, Australia
Research Site
Box Hill, Victoria, Australia
Research Site
East Ringwood, Victoria, Australia
Research Site
Athens, , Greece
Research Site
Piraeus, , Greece
Research Site
Thessaloniki, , Greece
Research Site
Budapest, , Hungary
Research Site
Gyula, , Hungary
Research Site
Pécs, , Hungary
Research Site
Veszprém, , Hungary
Research Site
Zalaegerszeg, , Hungary
Research Site
Bari, , Italy
Research Site
Bergamo, , Italy
Research Site
Catania, , Italy
Research Site
Milan, , Italy
Research Site
Perugia, , Italy
Research Site
Rome, , Italy
Research Site
Guadalajara, Jalisco, Mexico
Research Site
Zapopan, Jalisco, Mexico
Research Site
Monterrey, N.l., Mexico
Research Site
Mexico City, , Mexico
Research Site
Bydgoszcz, , Poland
Research Site
Gdansk, , Poland
Research Site
Lublin, , Poland
Countries
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References
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Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
Other Identifiers
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H8O-MC-GWAO
Identifier Type: -
Identifier Source: org_study_id
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