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Type 2 Diabetes MellitusPhase 3NCT00917267

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

A Phase 3 study testing exenatide once weekly and exenatide twice daily in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 42 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
exenatide once weekly and exenatide twice daily
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
691 participants
Where
42 sitesin 5 countries
Study dates
Jul 2009to Apr 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

42 sites in 5 countries.

42 sites in 5 countries

Japan16 sites

  • Research Site

    Ageo

  • Research Site

    Chiyoda-ku

  • Research Site

    Izumisano

  • Research Site

    Kashiwara

  • Research Site

    Kitaazumi-gun

  • Research Site

    Kumamoto

  • Research Site

    Kurume

  • Research Site

    Matsumoto

  • Research Site

    Matsuyama

  • Research Site

    Miyazaki

  • Research Site

    Ōita

  • Research Site

    Osaka

  • Research Site

    Ōta-ku

  • Research Site

    Shinjuku-ku

  • Research Site

    Takatsuki

  • Research Site

    Yokohama

Other trials in Japan

India12 sites

  • Research Site

    Ahmedabad

  • Research Site

    Aligarh

  • Research Site

    Bangalore

  • Research Site

    Ghaziabad

  • Research Site

    Hyderabaad

  • Research Site

    Indore

  • Research Site

    Kolkata

  • Research Site

    Mumbai

  • Research Site

    Pune

  • Research Site

    Trivandrum

  • Research Site

    Uttar Pradesh

  • Research Site

    Varanasi

Other trials in India

Taiwan6 sites

  • Research Site

    Changhua

  • Research Site

    Chiayi City

  • Research Site

    Kaohsiung City

  • Research Site

    Tainan

  • Research Site

    Taipei

  • Research Site

    Taoyuan

Other trials in Taiwan

China5 sites

  • Research Site

    Beijing

  • Research Site

    Chengdu

  • Research Site

    Chongqin

  • Research Site

    Guangzhou

  • Research Site

    Shanghai

Other trials in China

South Korea3 sites

  • Research Site

    Bucheon-si

  • Research Site

    Daegu

  • Research Site

    Seoul

Other trials in South Korea

About this study

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

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.

Being tested
exenatide once weekly, exenatide twice daily
Keywords
diabetes, exenatide, once weekly, Byetta, Amylin, Lilly
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exenatide once weeklyDrug

    2.0mg subcutaneous injection, once a week

  • exenatide twice dailyDrug

    Also called Byetta

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

Study groups in NCT00917267
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: exenatide once weekly
2Active comparatorNot described
Receives: Drug: exenatide twice daily

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c From Baseline to Week 26.

    Change in HbA1c from baseline to Week 26.

    Measured: Baseline, Week 26

Secondary outcomes (9)

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

    Percentage of patients achieving HbA1c <=7% at Week 26 (for patients with HbA1c >7% at baseline).

    Measured: Baseline, Week 26

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

    Percentage of patients achieving HbA1c <=6.5% at Week 26 (for patients with HbA1c >6.5% at baseline).

    Measured: Baseline, Week 26

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

    Change in FSG from baseline to Week 26.

    Measured: Baseline, Week 26

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

    Change in BW from baseline to Week 26.

    Measured: Baseline, Week 26

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

    Change in TC from baseline to Week 26.

    Measured: Baseline, Week 26

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

    Change in HDL from baseline to Week 26.

    Measured: Baseline, Week 26

  7. Ratio of Triglycerides (TG) at Week 26 to Baseline

    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.

    Measured: Baseline, Week 26

  8. Change in Blood Pressure From Baseline to Week 26

    Change in systolic blood pressure and diastolic blood pressure from baseline to Week 26.

    Measured: Baseline, Week 26

  9. Assessment of Event Rate of Treatment-emergent Hypoglycemic Events

    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.

    Measured: Baseline to Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionSep 2010
  4. Study completionApr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
691 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00917267
Sponsor's protocol ID
H8O-MC-GWCK
Status last verified
Mar 2015
First submitted
8 Jun 2009
Last updated
9 Apr 2015
Data monitoring committee
No

Publications

  • 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.

    PubMed 24843650

  • 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.

    PubMed 24843631

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exenatide once weekly and exenatide twice daily in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 42 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in Japan, India, Taiwan, China, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c From Baseline to Week 26. (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00917267, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2015.

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