Type 2 DiabetesPhase 1NCT00612794
A Study to Examine Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Exenatide Once Weekly in Japanese Patients With Type 2 Diabetes
A Phase 1 study testing exenatide once weekly in people with Type 2 Diabetes, run by AstraZeneca at 4 sites in Japan.
Trial summary
Exenatide twice daily has been studied in Japanese type 2 diabetes patients. A once-weekly version of exenatide is currently being evaluated. Study GWBW is the first study of exenatide once weekly in Japanese patients. 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 once weekly
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 4 sitesJapan
- Study dates
- Sep 2007to May 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Body weight ≥50 kg.
- Have suboptimal glycemic control as evidenced by an HbA1c defined by the following criteria: *6.5% to 10.0%, inclusive, at study start for patients managed with diet modification and exercise or treated with oral antidiabetics drug but not alpha glucosidase inhibitor or meglitinide derivatives; *6.5% to 9.5%, inclusive, at study start for patients treated with oral antidiabetics including alpha glucosidase inhibitor or meglitinide derivatives.
- Have been treated with diet modification and exercise alone or in combination with a stable regimen of oral antidiabetic drugs (sulfonylurea, metformin and thiazolidinedione) for at least 2 months prior to study start. In the case of patients with concomitant use of sulfonylurea, the dose of sulfonylurea must not be more than maximum recommended dose. The patients with concomitant use of alpha glucosidase inhibitors (Glucobay® [acarbose], Basen® [voglibose], or Seibule® [miglitol]) or meglitinide derivatives (Glufast® [mitiglinide] or Fastic®/Starsis® [nateglinide]) can be included in this study, but these drugs must be discontinued after confirmation of eligibility at study start.
Who cannot join
- Subjects who have donated more than 200 mL of blood and component blood donation within one month of study start, or those who have donated more than 400 mL of blood within three months of study start.
- 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 and received at least one dose of exenatide or other GLP-1 analogs in this study previously, or any other study using exenatide or other GLP-1 analogs.
- Are treated with any exogenous insulin within 3 months of screening.
- Are continuously treated with any of the following excluded medications within 3 months of screening (more than 7 days per 1 month): *Drugs that directly affect gastrointestinal motility, including Nauzelin® (domperidone), Primperan®/Terperan® (metoclopramide), Ganaton® (itopride), Acenalin® (cisapride), Gasmotin® (mosapride), or Cerekinon® (trimebutine).
- Females who are breastfeeding.
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Research Site
Fukuoka
Research Site
Kanagawa
Research Site
Osaka
Research Site
Tokyo
About this study
Official title: Multiple-Dose Study to Examine Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2148568 Long-Acting Release in Japanese Patients With Type 2 Diabetes Mellitus
Exenatide twice daily has been studied in Japanese type 2 diabetes patients. A once-weekly version of exenatide is currently being evaluated. Study GWBW is the first study of exenatide once weekly in Japanese patients. This study is designed to evaluate safety and tolerability of exenatide once weekly in Japanese patients and determine whether the dose selected for US and European development is appropriate for Japanese patients with Type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- exenatide once weekly, placebo
- Keywords
- exenatide, Byetta, diabetes, 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, once weekly
placeboDrug
subcutaneous injection, once weekly
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | exenatide once weekly, 0.8mg Receives: Drug: exenatide once weekly |
| 2 | Experimental | exenatide once weekly, 2.0mg Receives: Drug: exenatide once weekly |
| 3 | Placebo comparator | volume equivalent to 0.8mg of exenatide once weekly Receives: Drug: placebo |
| 4 | Placebo comparator | volume equivalent to 2.0mg of exenatide once weekly Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of exenatide administered once weekly by subcutaneous (SC) injection in subjects with type 2 diabetes mellitus.
Measured: 10 weeks
Secondary outcomes (2)
To assess the pharmacokinetics of exenatide administered once weekly by SC injection in subjects with type 2 diabetes mellitus.
Measured: 10 weeks
To explore the pharmacodynamics of exenatide administered once weekly by SC injection in subjects with type 2 diabetes mellitus regarding the following: *fasting and postprandial glucose concentrations; *HbA1c; *Body weight.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2008 (estimated)
- Study startSep 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, MD, Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612794
- Sponsor's protocol ID
- H8O-JE-GWBW
- Status last verified
- Jan 2015
- First submitted
- 30 Jan 2008
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Iwamoto K, Nasu R, Yamamura A, Kothare PA, Mace K, Wolka AM, Linnebjerg H. Safety, tolerability, pharmacokinetics, and pharmacodynamics of exenatide once weekly in Japanese patients with type 2 diabetes. Endocr J. 2009;56(8):951-62. doi: 10.1507/endocrj.k09e-147. Epub 2009 Aug 25.
PubMed 19706990
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-Dose Study to Examine Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2148568 Long-Acting Release in Japanese Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00612794
- Acronym / sponsor ID
- H8O-JE-GWBW
- Conditions
- Type 2 Diabetes
- Keywords
- exenatide, Byetta, diabetes, Amylin, Lilly
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Sep 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 12 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exenatide twice daily has been studied in Japanese type 2 diabetes patients. A once-weekly version of exenatide is currently being evaluated. Study GWBW is the first study of exenatide once weekly in Japanese patients. This study is designed to evaluate safety and tolerability of exenatide once weekly in Japanese patients and determine whether the dose selected for US and European development is appropriate for Japanese patients with Type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: exenatide once weeklyexenatide once weekly, 0.8mg |
| 2 | Experimental | Drug: exenatide once weeklyexenatide once weekly, 2.0mg |
| 3 | Placebo comparator | Drug: placebovolume equivalent to 0.8mg of exenatide once weekly |
| 4 | Placebo comparator | Drug: placebovolume equivalent to 2.0mg of exenatide once weekly |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body weight ≥50 kg.
- Have suboptimal glycemic control as evidenced by an HbA1c defined by the following criteria: *6.5% to 10.0%, inclusive, at study start for patients managed with diet modification and exercise or treated with oral antidiabetics drug but not alpha glucosidase inhibitor or meglitinide derivatives; *6.5% to 9.5%, inclusive, at study start for patients treated with oral antidiabetics including alpha glucosidase inhibitor or meglitinide derivatives.
- Have been treated with diet modification and exercise alone or in combination with a stable regimen of oral antidiabetic drugs (sulfonylurea, metformin and thiazolidinedione) for at least 2 months prior to study start. In the case of patients with concomitant use of sulfonylurea, the dose of sulfonylurea must not be more than maximum recommended dose. The patients with concomitant use of alpha glucosidase inhibitors (Glucobay® [acarbose], Basen® [voglibose], or Seibule® [miglitol]) or meglitinide derivatives (Glufast® [mitiglinide] or Fastic®/Starsis® [nateglinide]) can be included in this study, but these drugs must be discontinued after confirmation of eligibility at study start.
Key exclusion criteria (6 listed)
- Subjects who have donated more than 200 mL of blood and component blood donation within one month of study start, or those who have donated more than 400 mL of blood within three months of study start.
- 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 and received at least one dose of exenatide or other GLP-1 analogs in this study previously, or any other study using exenatide or other GLP-1 analogs.
- Are treated with any exogenous insulin within 3 months of screening.
- Are continuously treated with any of the following excluded medications within 3 months of screening (more than 7 days per 1 month): *Drugs that directly affect gastrointestinal motility, including Nauzelin® (domperidone), Primperan®/Terperan® (metoclopramide), Ganaton® (itopride), Acenalin® (cisapride), Gasmotin® (mosapride), or Cerekinon® (trimebutine).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exenatide once weeklysubcutaneous injection, once weekly | Drug | 1, 2 |
| placebosubcutaneous injection, once weekly | Drug | 3, 4 |
Primary outcome
To assess the safety and tolerability of exenatide administered once weekly by subcutaneous (SC) injection in subjects with type 2 diabetes mellitus.
Time frame: 10 weeks
2 secondary outcomes
To assess the pharmacokinetics of exenatide administered once weekly by SC injection in subjects with type 2 diabetes mellitus.
Time frame: 10 weeks
To explore the pharmacodynamics of exenatide administered once weekly by SC injection in subjects with type 2 diabetes mellitus regarding the following: *fasting and postprandial glucose concentrations; *HbA1c; *Body weight.
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2015.
- Derived from this study: PubMed 19706990Iwamoto K, Nasu R, Yamamura A, Kothare PA, Mace K, Wolka AM, Linnebjerg H. Safety, tolerability, pharmacokinetics, and pharmacodynamics of exenatide once weekly in Japanese patients with type 2 diabetes. Endocr J. 2009;56(8):951-62. doi: 10.1507/endocrj.k09e-147. Epub 2009 Aug 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer, MD study director
Eli Lilly and Company
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing exenatide once weekly in people with Type 2 Diabetes, run by AstraZeneca at 4 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 3 inclusion and 6 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 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the safety and tolerability of exenatide administered once weekly by subcutaneous (SC) injection in subjects with type 2 diabetes mellitus. (time frame: 10 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 NCT00612794, which also lists 1 linked publication.
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 24 Feb 2015.