Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy
Efficacy of Exenatide Compared With Insulin Glargine in Patients With Type 2 Diabetes Using Metformin or Sulfonylurea for Whom Insulin is the Next Appropriate Therapy
1 other identifier
interventional
138
6 countries
26
Brief Summary
This is a study with two treatment sequences and two treatment periods that will assess the safety and efficacy of exenatide treatment in patients with type 2 diabetes who have inadequate glycemic control using metformin or sulfonylurea and for whom insulin is the next appropriate step in diabetes treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 type-2-diabetes-mellitus
Started Sep 2004
Shorter than P25 for phase_3 type-2-diabetes-mellitus
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 17, 2004
CompletedFirst Posted
Study publicly available on registry
December 20, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFebruary 23, 2015
January 1, 2015
11 months
December 17, 2004
February 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c (glycosylated hemoglobin) from the baseline of the first period (16-weeks of exenatide or insulin) to the end of each 16-week period.
Change in HbA1c from Baseline to the end of each 16-week period. There is one 16-week period of exenatide treatment and one 16-week period of insulin glargine.
Baseline, Week 16, Week 32
Secondary Outcomes (1)
Change in patient-reported outcomes from Baseline to the end of each 16-week period
Baseline, Week 16, Week 32
Study Arms (2)
exenatide/insulin glargine
EXPERIMENTALArm that first receives exenatide, then crosses over to insulin glargine
Insulin glargine/exenatide
EXPERIMENTALArm that first receives insulin glargine, then crosses over to exenatide
Interventions
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
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
Eligibility Criteria
You may qualify if:
- Treated with a stable dose of metformin or sulfonylurea for at least 3 months prior to screening.
- 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.
You may not qualify if:
- Patient previously in a study involving exenatide or glucagon-like peptide-1 analogs.
- Treated with insulin, thiazolidinediones, alpha-glucosidase inhibitors, or meglitinides within 3 months prior to screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (26)
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
Related Publications (1)
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.
PMID: 22236356DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
James Malone, MD
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2004
First Posted
December 20, 2004
Study Start
September 1, 2004
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
February 23, 2015
Record last verified: 2015-01