A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects

NCT ID: NCT00917267

Last Updated: 2015-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 691 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2011-04-30

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

exenatide once weekly

Intervention Type: DRUG

2.0mg subcutaneous injection, once a week

2

Group Type: ACTIVE_COMPARATOR

exenatide twice daily

Intervention Type: DRUG

5mcg subcutaneous injection twice a day (4 weeks), 10mcg subcutaneous injection twice a day (22 weeks)

Interventions

exenatide once weekly

2.0mg subcutaneous injection, once a week

Intervention Type: DRUG

exenatide twice daily

5mcg subcutaneous injection twice a day (4 weeks), 10mcg subcutaneous injection twice a day (22 weeks)

Intervention Type: DRUG

Other Intervention Names

Byetta

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chief Medical Officer Officer, MD

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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 City, , Taiwan

Research Site

Taipei, , Taiwan

Research Site

Taoyuan District, , Taiwan

Countries

China; India; Japan; South Korea; Taiwan

References

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.

Reference Type: DERIVED

PMID: 24843650 (View on PubMed)

Ji 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.

Reference Type: DERIVED

PMID: 24843631 (View on PubMed)

Other Identifiers

H8O-MC-GWCK

Identifier Type: -

Identifier Source: org_study_id