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

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: exenatide once weekly (Drug); exenatide twice daily (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Chief Medical Officer Officer, MD, Study Director, Affiliation: Eli Lilly and Company

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in HbA1c From Baseline to Week 26.

Secondary outcome:

Percentage of Patients Achieving HbA1c Targets <=7% at Week 26

Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26

Change in Fasting Serum Glucose (FSG) From Baseline to Week 26

Change in Body Weight (BW) From Baseline to Week 26

Change in Total Cholesterol (TC) From Baseline to Week 26

Change in High-Density Lipoprotein (HDL) From Baseline to Week 26

Ratio of Triglycerides (TG) at Week 26 to Baseline

Change in Blood Pressure From Baseline to Week 26

Assessment of Event Rate of Treatment-emergent Hypoglycemic Events

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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.

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-shi, Japan

Research Site, Ooita-shi, Japan

Research Site, Osaka, Japan

Research Site, Ota-ku, Japan

Research Site, Shinjuku-ku, Japan

Research Site, Takatsuki, Japan

Research Site, Yokohama, Japan

Research Site, Bucheon, Korea, Republic of

Research Site, Daegu, Korea, Republic of

Research Site, Seoul, Korea, Republic of

Research Site, Changhua, Taiwan

Research Site, Chia-Yi, Taiwan

Research Site, Kaohsiung, Taiwan

Research Site, Tainan, Taiwan

Research Site, Taipei, Taiwan

Research Site, Taoyuan, Taiwan

Starting date: July 2009
Last updated: March 20, 2015