AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 3NCT00935532

Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus

A Phase 3 study testing exenatide once weekly and insulin glargine in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 22 sites in Japan.

Completed

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

Official record
Search all trials

Trial summary

The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability. 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 insulin glargine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
427 participants
Where
22 sitesJapan
Study dates
Jul 2009to Jul 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

  • present with type 2 diabetes mellitus
  • HbA1c between 7.1% and 11.0% inclusive
  • body mass index (BMI) of >18kg/m2 and <35kg/m2, inclusive
  • treated with a stable dose regimen of either of biguanide (BG) alone, BG + thiazolidinedione (TZD), BG + sulfonylurea (SU), or BG + TZD + SU for 90 days prior to study start

Who cannot join

  • Have received chronic (>14 consecutive days) systemic adrenocorticosteroid therapy by oral, intravenous, or intramuscular route or intraarticular steroid injection within 4 weeks prior to study start.
  • Have been treated with drugs that promote weight loss within 90 days prior to study start.
  • Have been treated with drugs that directly affect gastrointestinal motility for > 21 consecutive days within 90 days prior to study start.
  • Have had prior exposure to exenatide BID or QW or participated in the clinical trial of exenatide BID or QW (including the case that the study drug was not administered).
  • Have been treated for >2 consecutive weeks with any of the following excluded medications within 90 days prior to study start: Insulin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1 analogs
  • Have received treatment within 30 days prior to study start drug that has not received regulatory approval for any indication.
  • Are currently enrolled in any other clinical study or participated in and completed the clinical study within 30 days prior to study start.
  • Have donated blood within 30 days prior to study start.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Japan22 sites

  • Research Site

    Aomori

  • Research Site

    Chiba

  • Research Site

    Ehime

  • Research Site

    Fukuoka

  • Research Site

    Gunma

  • Research Site

    Hiroshima

  • Research Site

    Hokkaido

  • Research Site

    Hyōgo

  • Research Site

    Ibaraki

  • Research Site

    Kagawa

  • Research Site

    Kanagawa

  • Research Site

    Kumamoto

  • Research Site

    Kyoto

  • Research Site

    Nagano

  • Research Site

    Nagasaki

  • Research Site

    Nara

  • Research Site

    Ōita

  • Research Site

    Osaka

  • Research Site

    Saitama

  • Research Site

    Shizuoka

  • Research Site

    Tokyo

  • Research Site

    Toyama

Other trials in Japan

About this study

Official title: Parallel Group Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus Treated With Oral Antidiabetic(s)

The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.

Being tested
exenatide once weekly, insulin glargine
Keywords
diabetes; exenatide once weekly; Byetta; glargine; Lantus; 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

    subcutaneous injection, 2.0mg, once a week;

  • insulin glargineDrug

    Also called insulin glargine-Lantus

    subcutaneous injection, titrated to achieve fasting serum glucose target, once a day

Study groups in NCT00935532
Study groupRoleWhat they receive
exenatide once weeklyExperimentalNot described
Receives: Drug: exenatide once weekly
insulin glargineActive comparatorNot described
Receives: Drug: insulin glargine

What is being measured

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

  1. Change in HbA1c From Baseline to Endpoint (Week 26)

    Change in HbA1c from baseline to endpoint (Week 26).

    Measured: Baseline, Week 26

Secondary outcomes (10)

  1. Percentage of Subjects Achieving HbA1c<=7%

    Percentage of subjects achieving HbA1c <=7.0% (for subjects with HbA1c >7% at baseline)

    Measured: Baseline, Week 26

  2. Percentage of Subjects Achieving HbA1c<=6.5%

    Percentage of subjects achieving HbA1c <=6.5% (for subjects with HbA1c >6.5% at baseline)

    Measured: Baseline, Week 26

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

    Change in FSG (centralized measurement) from baseline to endpoint (Week 26)

    Measured: Baseline, Week 26

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

    Change in Body Weight from baseline to endpoint (Week 26)

    Measured: Baseline, Week 26

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

    Change in Total Cholesterol from baseline to endpoint (Week 26)

    Measured: Baseline, Week 26

  6. Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)

    Change in HDL-C from baseline to endpoint (Week 26)

    Measured: Baseline, Week 26

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

    Ratio of Triglycerides (measured in mg/dL) at endpoint (Week 26) to Baseline. Log(Postbaseline Triglycerides) - log(Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.

    Measured: Baseline, Week 26

  8. Change in Blood Pressure From Baseline to Endpoint (Week 26)

    Change in Blood Pressure from baseline to endpoint (Week 26)

    Measured: Baseline, Week 26

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

    Major confirmed hypoglycemia was defined as (1) any event accompanying symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure but resolved promptly in response to administration of glucagon or (2) glucose, or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) requiring assistance because of severe impairment in consciousness or motor activity whether or not symptoms of hypoglycemia were felt by the patient. 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 postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.

    Measured: Baseline to Week 26

  10. Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events

    Minor confirmed hypoglycemia was defined as any event a patient felt that he or she was experiencing a sign or symptom associated with hypoglycemia that resolved by self-treatment or on its own, and a concurrent self-monitoring fingerstick 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 postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.

    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 posted9 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionSep 2010
  4. Study completionJul 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
427 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00935532
Sponsor's protocol ID
H8O-JE-GWBX
Status last verified
May 2015
First submitted
8 Jul 2009
Last updated
15 Jun 2015
Data monitoring committee
No

Publications

  • Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.

    PubMed 32306296

  • Inagaki N, Atsumi Y, Oura T, Saito H, Imaoka T. Efficacy and safety profile of exenatide once weekly compared with insulin once daily in Japanese patients with type 2 diabetes treated with oral antidiabetes drug(s): results from a 26-week, randomized, open-label, parallel-group, multicenter, noninferiority study. Clin Ther. 2012 Sep;34(9):1892-908.e1. doi: 10.1016/j.clinthera.2012.07.007. Epub 2012 Aug 9.

    PubMed 22884767

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exenatide once weekly and insulin glargine in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 22 sites in Japan.

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 4 inclusion and 8 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 15 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Japan. 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 24 Oct 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 Endpoint (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 NCT00935532, 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 15 Jun 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in