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Type 2 DiabetesPhase 3NCT00577824

Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s)

A Phase 3 study testing exenatide in people with Type 2 Diabetes, run by AstraZeneca at 12 sites in Japan.

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

This long term, placebo-controlled trial is intended to assess the efficacy and safety of exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with oral antidiabetic(s) but not well controlled. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
exenatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
181 participants
Where
12 sitesJapan
Study dates
Jan 2008to Nov 2008
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with type 2 diabetes.
  • Has been treated by sulfonylurea (SU) alone, SU and biguanide, or SU and thiazolidinedione for at least 90 days prior to study start. In a patient receiving SU alone, the dose must be within the dose range from maximum maintenance dose to maximum approved dose. The patients with concomitant use of alpha glucosidase inhibitors (acarbose, voglibose or miglitol) or meglitinide derivatives (mitiglinide or nateglinide) can be included in this study, but these drugs must be discontinued at study start.
  • Have HbA1c 7.0% to 10% at study start.
  • Have a body weight >=50 kg.

Who cannot join

  • 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.
  • Have participated in this study previously or any other study using exenatide or glucagon-like peptide-1 (GLP-1) analogs within the last 90 days.
  • Have been treated with any exogenous insulin within 90 days before study start.
  • Have been continuously treated with any drug that directly affects gastrointestinal motility for more than a total of 21 days in the 90 days prior to study start.
  • The combination therapy of sulfonylurea, biguanide and thiazolidinedione is not allowed.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Japan12 sites

  • Research Site

    Chiba

  • Research Site

    Fukuoka

  • Research Site

    Fukushima

  • Research Site

    Hyōgo

  • Research Site

    Ibaraki

  • Research Site

    Kanagawa

  • Research Site

    Kumamoto

  • Research Site

    Kyoto

  • Research Site

    Nagano

  • Research Site

    Ōita

  • Research Site

    Osaka

  • Research Site

    Tokyo

Other trials in Japan

About this study

Official title: Efficacy and Safety of LY2148568 in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) But Not Well Controlled

This long term, placebo-controlled trial is intended to assess the efficacy and safety of exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with oral antidiabetic(s) but not well controlled.

Conditions
Type 2 Diabetes
Being tested
exenatide, placebo
Keywords
diabetes, exenatide, LY2148568, Byetta, Lilly, Amylin
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.

  • exenatideDrug

    Also called LY2148568, Byetta

    subcutaneous injection, 5mcg, twice a day

  • exenatideDrug

    Also called LY2148568, Byetta

    subcutaneous injection, 10mcg, twice a day

  • placeboDrug

    subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day

Study groups in NCT00577824
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: exenatide
2ExperimentalNot described
Receives: Drug: exenatide
3Placebo comparatorNot described
Receives: Drug: placebo

What is being measured

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

  1. Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24

    Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)

    Measured: baseline, 24 weeks

Secondary outcomes (16)

  1. Percentage of Patients Achieving HbA1c < 7.0%

    Percentage of subjects whose HbA1c was >=7.0% at baseline who achieved an HbA1c < 7.0% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 7.0% divided by total number of eligible subjects times 100)

    Measured: 24 weeks

  2. Percentage of Patients Achieving HbA1c < 6.5%

    Percentage of subjects whose HbA1c was >=6.5% at baseline who achieved an HbA1c < 6.5% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 6.5% divided by total number of eligible subjects times 100)

    Measured: 24 weeks

  3. Change in Fasting Blood Glucose

    Change in fasting blood glucose from baseline to endpoint (i.e., fasting blood glucose at week 24 minus fasting blood glucose at week 0)

    Measured: baseline, week 24

  4. Change in Body Weight

    Change in body weight form baseline to endpoint (i.e., body weight at week 24 minus body weight at week 0)

    Measured: baseline, week 24

  5. Change in Total Cholesterol

    Change in total cholesterol from baseline to endpoint (i.e., total cholesterol at week 24 minus total cholesterol at week 0)

    Measured: baseline, week 24

  6. Change in Low Density Lipoprotein Cholesterol (LDL-C)

    Change in LDL-C from baseline to endpoint (i.e., LDL-C at week 24 minus LDL-C at week 0)

    Measured: baseline, week 24

  7. Change in High Density Lipoprotein Cholesterol (HDL-C)

    Change in HDL-C from baseline to endpoint (i.e., HDL-C at week 24 minus HDL-C at week 0)

    Measured: baseline, week 24

  8. Change in Triglycerides

    Change in triglycerides from baseline to endpoint (i.e., triglycerides at week 24 minus triglycerides at week 0)

    Measured: baseline, week 24

  9. Change in Waist Size

    Change in waist size from baseline to endpoint (i.e., waist size at week 24 minus waist size at week 0)

    Measured: baseline, week 24

  10. Change in Waist-to-hip Ratio

    Change in waist-to-hip ratio from baseline to endpoint (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio is waist circumference divided by hip circumference.

    Measured: baseline, week 24

  11. 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24

    Self-monitored blood glucose at 7 different time points during the day (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime).

    Measured: baseline, week 24

  12. Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B)

    Change in HOMA-B from baseline to endpoint (i.e., HOMA-B at week 24 minus HOMA-B at week 0). HOMA-B is a measurement of beta cell function.

    Measured: baseline, week 24

  13. Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R)

    Change in HOMA-R from baseline to endpoint (i.e., HOMA-R at week 24 minus HOMA-R at week 0). HOMA-R is a measurement of insulin resistance.

    Measured: baseline, week 24

  14. Change in Serum Insulin

    Change in serum insulin from baseline to endpoint (i.e., serum insulin at week 24 minus serum insulin at week 0)

    Measured: baseline, week 24

  15. Change in C-peptide

    Change in C-peptide from baseline to endpoint (i.e., C-peptide at week 24 minus C-peptide at week 0)

    Measured: baseline, week 24

  16. Change in 1,5-anhydroglucitol

    Change in 1,5-anhydroglucitol from baseline to endpoint (i.e., 1,5-anhydroglucitol at week 24 minus 1,5-anhydroglucitol at week 0)

    Measured: baseline, week 24

Timeline

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

  1. First posted20 Dec 2007 (estimated)
  2. Study startJan 2008
  3. Primary completionNov 2008
  4. Study completionNov 2008

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
Double blind
Who is masked
Participant, Investigator
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00577824
Sponsor's protocol ID
H8O-JE-GWBB
Status last verified
Mar 2015
First submitted
18 Dec 2007
Last updated
9 Apr 2015
Data monitoring committee
No

Publications

  • Kadowaki T, Namba M, Imaoka T, Yamamura A, Goto W, Boardman MK, Sowa H. Improved glycemic control and reduced bodyweight with exenatide: A double-blind, randomized, phase 3 study in Japanese patients with suboptimally controlled type 2 diabetes over 24 weeks. J Diabetes Investig. 2011 Jun 5;2(3):210-7. doi: 10.1111/j.2040-1124.2010.00084.x.

    PubMed 24843486

  • Inagaki N, Ueki K, Yamamura A, Saito H, Imaoka T. Long-term safety and efficacy of exenatide twice daily in Japanese patients with suboptimally controlled type 2 diabetes. J Diabetes Investig. 2011 Nov 30;2(6):448-56. doi: 10.1111/j.2040-1124.2011.00137.x.

    PubMed 24843529

  • Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.

    PubMed 22913891

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exenatide in people with Type 2 Diabetes, run by AstraZeneca at 12 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 5 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 12 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. Some participants in this study may receive a placebo. 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 2009). 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 Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24 (time frame: baseline, 24 weeks). 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 NCT00577824, which also lists 3 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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