Type 2 Diabetes MellitusPhase 3NCT00381342
Safety and Efficacy of Exenatide as Monotherapy
A Phase 3 study testing exenatide in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 19 sites in 5 countries.
Trial summary
This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- 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
- 233 participants
- Where
- 19 sitesin 5 countries
- Study dates
- Sep 2006to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes
- Treating diabetes with diet and exercise
- HbA1c between 6.5% and 10.0%, inclusive
- Body Mass Index (BMI) between 25 kg/m^2 and 45 kg/m^2, inclusive
Who cannot join
- Have previously completed or withdrawn from this study
- 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 been treated with any antidiabetic agent
- Have used drugs for weight loss (for example, Xenical, Meridia, Acutrim, or similar over-the counter medications) within 3 months of screening
- Are currently treated with any of the following excluded medications: * drugs that directly affect gastrointestinal motility; * systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous, or intramuscular route used regularly (longer than 2 weeks) or used within 2 weeks immediately prior to screening for this study
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
India7 sites
Research Site
Aligarh
Research Site
Bangalore
Research Site
Chennai
Research Site
Indore
Research Site
Karnāl
Research Site
New Delhi
Research Site
Vellore
Romania6 sites
Research Site
Alba Iulia
Research Site
Baia Mare
Research Site
Bucharest
Research Site
Galati
Research Site
Oradea
Research Site
Târgu Mureş
United States2 sites
Research Site
Idaho Falls, Idaho
Research Site
Indianapolis, Indiana
About this study
Official title: Safety and Efficacy of Exenatide as Monotherapy in Drug Naive Patients With Type 2 Diabetes
This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- exenatide, placebo
- Keywords
- diabetes, exenatide, Amylin, Lilly, monotherapy
- 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
Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day
exenatideDrug
Also called Byetta
Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day, then exenatide subcutaneous injection, 10 mcg twice a day
placeboDrug
subcutaneous injection, volume equivalent to appropriate dose of exenatide, twice a day
| Study group | Role | What they receive |
|---|---|---|
| Exenatide 5 mcg/exenatide 5 mcg | Experimental | Exenatide 5 mcg; then exenatide 5 mcg Receives: Drug: exenatide |
| Exenatide 5 mcg/exenatide 10 mcg | Experimental | Exenatide 5 mcg, then exenatide 10 mcg Receives: Drug: exenatide |
| Placebo | Placebo comparator | Placebo in volumes equivalent to exenatide Receives: Drug: placebo |
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 24
Change in HbA1c from Baseline to Week 24
Measured: Baseline, Week 24
Secondary outcomes (6)
Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less
Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less
Measured: Baseline, Weeks 4, 8, 12, 16, 24
Change in fasting serum glucose (FSG) from Baseline to Week 24
Change in fasting serum glucose (FSG) from Baseline to Week 24 and, if measured, at all visits in between
Measured: Baseline, Weeks 4, 8, 12, 16, and 24
Change in body weight from Baseline to Week 24
Change in body weight (kg) from Baseline to Week 24 and, if measured, at all visits in between
Measured: Baseline, Weeks 4, 8, 12, 16, and 24
Change in glucose measurements from Baseline to Week 24
Change in fasting SMBG profiles (glucose measurements before and 2 hours after meals) from Baseline to Week 24 and, if measured, at all visits in between
Measured: Baseline, Weeks 4, 8, 12, 16, 24
Changes in beta-cell function and insulin sensitivity from Baseline to Week 24
Changes in beta-cell function and insulin sensitivity as assessed by homeostasis model assessment (HOMA) analyses from Baseline to Week 24 and, if measured, at all visits in between
Measured: Baseline, Weeks 4, 8, 12, 16, and 24
Changes in fasting and 30, 60, 120 and 180-minute glucose measurements
Changes in fasting and 30, 60, 120, 180-minute post glucose load blood concentrations of glucose and insulin
Measured: Immediately before glucose load, then 30, 60, 120, and 180 minutes post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 233 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
- NCT00381342
- Sponsor's protocol ID
- H8O-MC-GWBJ
- Status last verified
- Jan 2015
- First submitted
- 25 Sep 2006
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Moretto TJ, Milton DR, Ridge TD, Macconell LA, Okerson T, Wolka AM, Brodows RG. Efficacy and tolerability of exenatide monotherapy over 24 weeks in antidiabetic drug-naive patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2008 Aug;30(8):1448-60. doi: 10.1016/j.clinthera.2008.08.006.
PubMed 18803987Pencek 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 22913891Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
PubMed 22236356
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 as Monotherapy in Drug Naive Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00381342
- Acronym / sponsor ID
- H8O-MC-GWBJ
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes, exenatide, Amylin, Lilly, monotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Sep 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 27 Sep 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 Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exenatide 5 mcg/exenatide 5 mcg | Experimental | Drug: exenatideExenatide 5 mcg; then exenatide 5 mcg |
| Exenatide 5 mcg/exenatide 10 mcg | Experimental | Drug: exenatideExenatide 5 mcg, then exenatide 10 mcg |
| Placebo | Placebo comparator | Drug: placeboPlacebo in volumes equivalent to exenatide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with type 2 diabetes
- Treating diabetes with diet and exercise
- HbA1c between 6.5% and 10.0%, inclusive
- Body Mass Index (BMI) between 25 kg/m^2 and 45 kg/m^2, inclusive
Key exclusion criteria (5 listed)
- Have previously completed or withdrawn from this study
- 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 been treated with any antidiabetic agent
- Have used drugs for weight loss (for example, Xenical, Meridia, Acutrim, or similar over-the counter medications) within 3 months of screening
- Are currently treated with any of the following excluded medications: * drugs that directly affect gastrointestinal motility; * systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous, or intramuscular route used regularly (longer than 2 weeks) or used within 2 weeks immediately prior to screening for this study
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: ByettaPlacebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day | Drug | Exenatide 5 mcg/exenatide 5 mcg |
| exenatideAlso: ByettaPlacebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day, then exenatide subcutaneous injection, 10 mcg twice a day | Drug | Exenatide 5 mcg/exenatide 10 mcg |
| placebosubcutaneous injection, volume equivalent to appropriate dose of exenatide, twice a day | Drug | Placebo |
Primary outcome
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24
Time frame: Baseline, Week 24
Change in HbA1c from Baseline to Week 24
6 secondary outcomes
Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less
Time frame: Baseline, Weeks 4, 8, 12, 16, 24
Change in fasting serum glucose (FSG) from Baseline to Week 24
Time frame: Baseline, Weeks 4, 8, 12, 16, and 24
Change in body weight from Baseline to Week 24
Time frame: Baseline, Weeks 4, 8, 12, 16, and 24
Change in glucose measurements from Baseline to Week 24
Time frame: Baseline, Weeks 4, 8, 12, 16, 24
Changes in beta-cell function and insulin sensitivity from Baseline to Week 24
Time frame: Baseline, Weeks 4, 8, 12, 16, and 24
Changes in fasting and 30, 60, 120 and 180-minute glucose measurements
Time frame: Immediately before glucose load, then 30, 60, 120, and 180 minutes post
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.
- Results publication: PubMed 18803987Moretto TJ, Milton DR, Ridge TD, Macconell LA, Okerson T, Wolka AM, Brodows RG. Efficacy and tolerability of exenatide monotherapy over 24 weeks in antidiabetic drug-naive patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2008 Aug;30(8):1448-60. doi: 10.1016/j.clinthera.2008.08.006.
- Derived from this study: PubMed 22913891Pencek 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.
- Derived from this study: PubMed 22236356Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
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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
19 sites in 5 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 Mellitus, run by AstraZeneca at 19 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 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 19 sites in India, Romania, United States, Puerto Rico, Russia. 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?
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 24 (time frame: Baseline, Week 24). 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 NCT00381342, 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 23 Feb 2015.