A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients
An Open Label Study Comparing Exenatide With Basal Insulin in Achieving an HbA1c of ≤ 7.4% With Minimum Weight Gain, in Type 2 Diabetes Patients Who Are Not Achieving Adequate HbA1c Control on Oral Anti Diabetic Therapies Alone
1 other identifier
interventional
235
1 country
31
Brief Summary
This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 type-2-diabetes
Started Jun 2006
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 2, 2006
CompletedFirst Posted
Study publicly available on registry
August 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
June 5, 2009
CompletedApril 7, 2015
March 1, 2015
1.8 years
August 2, 2006
April 14, 2009
March 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)
Composite endpoint evaluating effect of treatment on glycemic control and weight
26 weeks
Secondary Outcomes (27)
Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg
26 weeks
Change in Fasting Serum Glucose
26 weeks
Percent of Patients Achieving HbA1c ≤ 7.4%
26 weeks
Percent of Patients Achieving HbA1c < 7%
26 weeks
Percent of Patients Achieving HbA1c < 6.5%
26 weeks
- +22 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
subcutaneous injection, titrated to target blood glucose level, once a day
Eligibility Criteria
You may qualify if:
- Diagnosed with type 2 diabetes
- 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.
You may not qualify if:
- Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to study.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (31)
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
Related Publications (2)
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.
PMID: 19930005RESULTPencek 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.
PMID: 22913891DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Ohman, Medical Science Director
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Mauricio Silva de Lima, MD
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2006
First Posted
August 4, 2006
Study Start
June 1, 2006
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
April 7, 2015
Results First Posted
June 5, 2009
Record last verified: 2015-03