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

March 20, 2015 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

691

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Research Site
      • Chengdu, China
        • Research Site
      • Chongqin, China
        • Research Site
      • Guangzhou, China
        • Research Site
      • Shanghai, China
        • Research Site
  • India
      • 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
  • Japan
      • 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
  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Research Site
      • Daegu, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
  • Taiwan
      • Changhua, Taiwan
        • Research Site
      • Chia-Yi, Taiwan
        • Research Site
      • Kaohsiung, Taiwan
        • Research Site
      • Tainan, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • Taoyuan, Taiwan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Drug: exenatide twice daily
5mcg subcutaneous injection twice a day (4 weeks), 10mcg subcutaneous injection twice a day (22 weeks)
Other Names:
  • Byetta
EXPERIMENTAL: 1
Drug: exenatide once weekly
2.0mg subcutaneous injection, once a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline to Week 26.
Time Frame: Baseline, Week 26
Change in HbA1c from baseline to Week 26.
Baseline, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Event Rate of Treatment-emergent Hypoglycemic Events
Time Frame: Baseline to Week 26
Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.
Baseline to Week 26
Percentage of Patients Achieving HbA1c Targets <=7% at Week 26
Time Frame: Baseline, Week 26
Percentage of patients achieving HbA1c <=7% at Week 26 (for patients with HbA1c >7% at baseline).
Baseline, Week 26
Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26
Time Frame: Baseline, Week 26
Percentage of patients achieving HbA1c <=6.5% at Week 26 (for patients with HbA1c >6.5% at baseline).
Baseline, Week 26
Change in Fasting Serum Glucose (FSG) From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in FSG from baseline to Week 26.
Baseline, Week 26
Change in Body Weight (BW) From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in BW from baseline to Week 26.
Baseline, Week 26
Change in Total Cholesterol (TC) From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in TC from baseline to Week 26.
Baseline, Week 26
Change in High-Density Lipoprotein (HDL) From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in HDL from baseline to Week 26.
Baseline, Week 26
Ratio of Triglycerides (TG) at Week 26 to Baseline
Time Frame: Baseline, Week 26
Ratio of TG (measured in mg/dL) at Week 26 to baseline. Log(Post-baseline TG) - log(Baseline TG); change from baseline to Week 26 is presented as ratio of Week 26 to baseline.
Baseline, Week 26
Change in Blood Pressure From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in systolic blood pressure and diastolic blood pressure from baseline to Week 26.
Baseline, Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Eli Lilly and Company

Investigators

  • Study Director: Chief Medical Officer Officer, MD, Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

June 8, 2009

First Submitted That Met QC Criteria

June 8, 2009

First Posted (ESTIMATE)

June 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 9, 2015

Last Update Submitted That Met QC Criteria

March 20, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H8O-MC-GWCK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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