Type 2 DiabetesPhase 3NCT00359879
Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes
A Phase 3 study testing exenatide in people with Type 2 Diabetes, run by AstraZeneca at 15 sites in 2 countries.
Trial summary
This trial is designed to compare the effects of twice-daily (before lunch and before dinner) exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 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?
- No, everyone receives an active treatment
- How many people
- 377 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Sep 2006to Jul 2007
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes.
- Have been treated with one of the following treatment regimens for at least three months prior to screening: *metformin alone; *sulfonylurea (SU) alone; *thiazolidinedione (TZD) alone; *a combination of metformin and SU; *a combination of metformin and TZD.
- HbA1c between 7.1% and 10.0%, inclusive.
- Body Mass Index (BMI) > 25 kg/m^2 and < 45 kg/m^2
Who cannot join
- Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental drug, medical, or surgical treatment was given) within 30 days prior to screening.
- Have characteristics contraindicating metformin, SU, or TZD use.
- Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.
- Have used any prescription drug to promote weight loss within 3 months prior to screening.
- Are currently treated (for greater than 2 consecutive weeks) with any of the following excluded medications: *insulin within 3 months prior to screening; *alpha-glucosidase inhibitors within 3 months prior to screening; *meglitinides within 3 months prior to screening; *drugs that directly affect gastrointestinal motility
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
Brazil9 sites
Research Site
Campinas
Research Site
Curitiba
Research Site
Fortaleza
Research Site
Goiânia
Research Site
Porto Alegre
Research Site
Rio de Janeiro
Research Site
Salvador
Research Site
São José do Rio Preto
Research Site
São Paulo
Mexico6 sites
Research Site
Aguascalientes, Aguascalientes
Research Site
Guadalajara, Jalisco
Research Site
Mérida, Yucatán
Research Site
Mexico City
Research Site
Monterrey, Nuevo León
Research Site
San Luis Potosí City, San Luis Potosí
About this study
Official title: Safety and Efficacy of Exenatide Taken Before Lunch and Before Dinner Compared With Before Breakfast and Before Dinner in Patients With Type 2 Diabetes Using Oral Antidiabetic Therapy
This trial is designed to compare the effects of twice-daily (before lunch and before dinner) exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- exenatide
- Keywords
- diabetes, exenatide, 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 Byetta
subcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner)
exenatideDrug
Also called Byetta
subcutaneous injection, 5mcg or 10mcg, twice a day (before breakfast and dinner)
| Study group | Role | What they receive |
|---|---|---|
| 1 - exenatide before breakfast and dinner | Experimental | Not described Receives: Drug: exenatide |
| 2 - exenatide before lunch and dinner | Active comparator | Not described Receives: Drug: exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12
Evaluate the change in glycemic control as measured by HbA1c from Baseline to Week 12
Measured: Baseline, Week 12
Secondary outcomes (3)
Change in body weight from Baseline to Week 12, and if measured, at each visit
Change in body weight (kg) from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8)
Measured: Baseline, Weeks 4, 8, 12
Change in fasting serum glucose (FGS) from Baseline to Week 12, and if measured, at each visit
Change in FGS from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8)
Measured: Baseline, Weeks 4, 8, 12
Changes in self-monitored blood glucose (SMBG) profile from Baseline through Week 12
Changes in glucose measured at different times throughout the day derived from 7-point SMBG profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)
Measured: Baseline, Weeks 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionJul 2007
- Study completionJul 2007
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- James Malone, MD, Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359879
- Sponsor's protocol ID
- H8O-CR-GWBH
- Status last verified
- Jan 2015
- First submitted
- 1 Aug 2006
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Forti A, Garcia EG, Yu MB, Jimenez MC, Brodows RG, Oliveira JH. Efficacy and safety of exenatide administered before the two largest daily meals of Latin American patients with type 2 diabetes. Curr Med Res Opin. 2008 Sep;24(9):2437-47. doi: 10.1185/03007990802282398. Epub 2008 Jul 24.
PubMed 18662495
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Exenatide Taken Before Lunch and Before Dinner Compared With Before Breakfast and Before Dinner in Patients With Type 2 Diabetes Using Oral Antidiabetic Therapy
- ClinicalTrials.gov ID
- NCT00359879
- Acronym / sponsor ID
- H8O-CR-GWBH
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes, exenatide, Lilly, Amylin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Sep 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 3 Aug 2006 (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.
This trial is designed to compare the effects of twice-daily (before lunch and before dinner) exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - exenatide before breakfast and dinner | Experimental | Drug: exenatide |
| 2 - exenatide before lunch and dinner | Active comparator | Drug: exenatide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with type 2 diabetes.
- Have been treated with one of the following treatment regimens for at least three months prior to screening: *metformin alone; *sulfonylurea (SU) alone; *thiazolidinedione (TZD) alone; *a combination of metformin and SU; *a combination of metformin and TZD.
- HbA1c between 7.1% and 10.0%, inclusive.
- Body Mass Index (BMI) > 25 kg/m^2 and < 45 kg/m^2
Key exclusion criteria (5 listed)
- Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental drug, medical, or surgical treatment was given) within 30 days prior to screening.
- Have characteristics contraindicating metformin, SU, or TZD use.
- Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.
- Have used any prescription drug to promote weight loss within 3 months prior to screening.
- Are currently treated (for greater than 2 consecutive weeks) with any of the following excluded medications: *insulin within 3 months prior to screening; *alpha-glucosidase inhibitors within 3 months prior to screening; *meglitinides within 3 months prior to screening; *drugs that directly affect gastrointestinal motility
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 |
|---|---|---|
| exenatideAlso: Byettasubcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner) | Drug | 2 - exenatide before lunch and dinner |
| exenatideAlso: Byettasubcutaneous injection, 5mcg or 10mcg, twice a day (before breakfast and dinner) | Drug | 1 - exenatide before breakfast and dinner |
Primary outcome
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12
Time frame: Baseline, Week 12
Evaluate the change in glycemic control as measured by HbA1c from Baseline to Week 12
3 secondary outcomes
Change in body weight from Baseline to Week 12, and if measured, at each visit
Time frame: Baseline, Weeks 4, 8, 12
Change in fasting serum glucose (FGS) from Baseline to Week 12, and if measured, at each visit
Time frame: Baseline, Weeks 4, 8, 12
Changes in self-monitored blood glucose (SMBG) profile from Baseline through Week 12
Time frame: Baseline, Weeks 4, 8, 12
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 23 Feb 2015.
- Derived from this study: PubMed 18662495Forti A, Garcia EG, Yu MB, Jimenez MC, Brodows RG, Oliveira JH. Efficacy and safety of exenatide administered before the two largest daily meals of Latin American patients with type 2 diabetes. Curr Med Res Opin. 2008 Sep;24(9):2437-47. doi: 10.1185/03007990802282398. Epub 2008 Jul 24.
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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.
James Malone, MD study director
Eli Lilly and Company
15 sites in 2 countries: see every site and its status.
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 15 sites in 2 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 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 23 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 15 sites in Brazil, Mexico. 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?
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?
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12 (time frame: Baseline, Week 12). 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 NCT00359879, 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 23 Feb 2015.