A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects
A Comparator-Controlled Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control (HbA1c) and Safety in Asian Subjects With Type 2 Diabetes Mellitus Managed With Oral Antidiabetic Medications
1 other identifier
interventional
691
5 countries
42
Brief Summary
Previous studies have suggested that a once-weekly formulation of exenatide may provide sustained glycemic control. These previous studies of exenatide once weekly have been conducted in non-Asian populations, so this study has been developed to support the local regulatory requirements of China, Korea, Japan, India, and Taiwan.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Jul 2009
42 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
First Submitted
Initial submission to the registry
June 8, 2009
CompletedFirst Posted
Study publicly available on registry
June 10, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
December 31, 2012
CompletedApril 9, 2015
March 1, 2015
1.2 years
June 8, 2009
February 14, 2012
March 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c From Baseline to Week 26.
Change in HbA1c from baseline to Week 26.
Baseline, Week 26
Secondary Outcomes (9)
Percentage of Patients Achieving HbA1c Targets <=7% at Week 26
Baseline, Week 26
Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26
Baseline, Week 26
Change in Fasting Serum Glucose (FSG) From Baseline to Week 26
Baseline, Week 26
Change in Body Weight (BW) From Baseline to Week 26
Baseline, Week 26
Change in Total Cholesterol (TC) From Baseline to Week 26
Baseline, Week 26
- +4 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
5mcg subcutaneous injection twice a day (4 weeks), 10mcg subcutaneous injection twice a day (22 weeks)
Eligibility Criteria
You may qualify if:
- Have been diagnosed with type 2 diabetes.
- Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11.0% inclusive.
- Have a body mass index (BMI) of \>21 kg/m2 and \<35 kg/m2, inclusive.
- Have a history of stable body weight (not varying by \>5% for at least 90 days prior to study start).
- Have been treated with a stable dose regimen of Met, SU, TZD, Met plus SU, Met plus TZD, or SU plus TZD for at least 90 days prior to study start.
You may not qualify if:
- Have any contraindication for the OAD(s) that they use.
- Have a known allergy or hypersensitivity to exenatide BID, exenatide QW, or excipients contained in these agents.
- Have received chronic \>14 consecutive days) systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route or intra-articular steroid injection within 4 weeks prior to study start or are regularly treated with potent, inhaled steroids that are known to have a high rate of systemic absorption.
- Have been treated with drugs that promote weight loss (for example, GLP-1 analogue, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 90 days of study start.
- Have been treated for \>2 weeks with any of the following excluded medications within 90 days prior to study start:
- Insulin
- Dipeptidyl peptidase (DPP)-4 inhibitors (for example, sitagliptin or vildagliptin)
- Pramlintide acetate
- Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.
- Have had prior exposure to exenatide
- Have previously completed or withdrawn from this study or any other study investigating exenatide BID or 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 any other clinical study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (42)
Research Site
Beijing, China
Research Site
Chengdu, China
Research Site
Chongqin, China
Research Site
Guangzhou, China
Research Site
Shanghai, China
Research Site
Ahmedabad, India
Research Site
Aligarh, India
Research Site
Bangalore, India
Research Site
Ghaziabad, India
Research Site
Hyderabaad, India
Research Site
Indore, India
Research Site
Kolkata, India
Research Site
Mumbai, India
Research Site
Pune, India
Research Site
Trivandrum, India
Research Site
Uttar Pradesh, India
Research Site
Varanasi, India
Research Site
Ageo, Japan
Research Site
Chiyoda-ku, Japan
Research Site
Izumisano, Japan
Research Site
Kashiwara, Japan
Research Site
Kitaazumi-gun, Japan
Research Site
Kumamoto, Japan
Research Site
Kurume, Japan
Research Site
Matsumoto, Japan
Research Site
Matsuyama, Japan
Research Site
Miyazaki, Japan
Research Site
Osaka, Japan
Research Site
Ōita, Japan
Research Site
Ōta-ku, Japan
Research Site
Shinjuku-ku, Japan
Research Site
Takatsuki, Japan
Research Site
Yokohama, Japan
Research Site
Bucheon-si, South Korea
Research Site
Daegu, South Korea
Research Site
Seoul, South Korea
Research Site
Changhua, Taiwan
Research Site
Chiayi City, Taiwan
Research Site
Kaohsiung City, Taiwan
Research Site
Tainan, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taoyuan District, Taiwan
Related Publications (2)
Onishi Y, Koshiyama H, Imaoka T, Haber H, Scism-Bacon J, Boardman MK. Safety of exenatide once weekly for 52 weeks in Japanese patients with type 2 diabetes mellitus. J Diabetes Investig. 2013 Mar 18;4(2):182-9. doi: 10.1111/jdi.12000. Epub 2012 Oct 22.
PMID: 24843650DERIVEDJi L, Onishi Y, Ahn CW, Agarwal P, Chou CW, Haber H, Guerrettaz K, Boardman MK. Efficacy and safety of exenatide once-weekly vs exenatide twice-daily in Asian patients with type 2 diabetes mellitus. J Diabetes Investig. 2013 Jan 29;4(1):53-61. doi: 10.1111/j.2040-1124.2012.00238.x. Epub 2012 Sep 14.
PMID: 24843631DERIVED
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
Chief Medical Officer Officer, 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
June 8, 2009
First Posted
June 10, 2009
Study Start
July 1, 2009
Primary Completion
September 1, 2010
Study Completion
April 1, 2011
Last Updated
April 9, 2015
Results First Posted
December 31, 2012
Record last verified: 2015-03