Type 2 Diabetes MellitusPhase 2NCT00241423
Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes
A Phase 2 study testing exenatide in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 2 sites in United States.
Trial summary
The purpose of this study is to test the hypothesis that in patients with type 2 diabetes, the addition of exenatide will result in lower time-averaged serum glucose during a 24-hour period, compared with placebo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- exenatide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2005to Jun 2007
- Phase
- Phase 2
- 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
- Subject has an HbA1c between 7.0% and 10.0%, inclusive.
- Subject has a body mass index (BMI) >25 kg/m^2 and <50 kg/m^2.
- Subject is on a stable dose of metformin or metformin plus a thiazolidinedione.
Who cannot join
- Subject has been treated with any of the following medications: *exogenous insulin for more than 1 week within 3 months of screening, *sulfonylureas or meglitinides within 2 months of screening, *alpha-glucosidase inhibitors within 2 months of screening, *pramlintide acetate injection within 2 months of screening.
- Subject has received exenatide, GLP-1 analogs, DPP-IV inhibitors, or has participated in this study previously.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
San Antonio, Texas
Research Site
Washington D.C., District of Columbia
About this study
Official title: Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes Using Metformin or Metformin Plus a Thiazolidinedione
The purpose of this study is to test the hypothesis that in patients with type 2 diabetes, the addition of exenatide will result in lower time-averaged serum glucose during a 24-hour period, compared with placebo.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- exenatide, Placebo
- Keywords
- exenatide, 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.
exenatideDrug
Also called Byetta, AC2993, synthetic enxendin-4
subcutaneous injection, 5mcg twice a day for one week; then 10 mcg twice a day for one week
PlaceboDrug
subcutaneous injection, equivalent volume to 5 mcg exenatide twice a day for one week; then equivalent volume to 10 mcg exenatide twice a day for one week
| Study group | Role | What they receive |
|---|---|---|
| Exenatide | Experimental | Exenatide and the subject's current oral antidiabetic agent regimen Receives: Drug: exenatide |
| Placebo | Placebo comparator | Placebo and the subject's current oral antidiabetic agent regimen Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-averaged serum glucose during a 24-hour period
Time-averaged serum glucose during a 24-hour period
Measured: Every half-hour to hour for 24 hours
Secondary outcomes (1)
To compare the effects of exenatide and placebo on serum glucose
To compare the effects of exenatide and placebo on serum glucose measured as averaged daytime glucose, averaged nighttime glucose, time-averaged postprandial glucose 2 hours after each meal, time-averaged postprandial glucose 4 hours after each meal, 2-hour postprandial glucose averaged across morning and evening meals, and averaged across the three meals, and fluctuation evaluations
Measured: Each half-hour to 2 hours for 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionJun 2007
- Study completionJun 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 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 2
- 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
- James Malone, MD, Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241423
- Sponsor's protocol ID
- H8O-US-GWAW
- Status last verified
- Jan 2015
- First submitted
- 17 Oct 2005
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Brodows RG, Qu Y, Johns D, Kim D, Holcombe JH. Quantifying the effect of exenatide and insulin glargine on postprandial glucose excursions in patients with type 2 diabetes. Curr Med Res Opin. 2008 May;24(5):1395-7. doi: 10.1185/030079908x297268. Epub 2008 Apr 3.
PubMed 18394265
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
- Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes Using Metformin or Metformin Plus a Thiazolidinedione
- ClinicalTrials.gov ID
- NCT00241423
- Acronym / sponsor ID
- H8O-US-GWAW
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- exenatide, diabetes, Amylin, Lilly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Oct 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 19 Oct 2005 (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.
The purpose of this study is to test the hypothesis that in patients with type 2 diabetes, the addition of exenatide will result in lower time-averaged serum glucose during a 24-hour period, compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exenatide | Experimental | Drug: exenatideExenatide and the subject's current oral antidiabetic agent regimen |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo and the subject's current oral antidiabetic agent regimen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has an HbA1c between 7.0% and 10.0%, inclusive.
- Subject has a body mass index (BMI) >25 kg/m^2 and <50 kg/m^2.
- Subject is on a stable dose of metformin or metformin plus a thiazolidinedione.
Key exclusion criteria (2 listed)
- Subject has been treated with any of the following medications: *exogenous insulin for more than 1 week within 3 months of screening, *sulfonylureas or meglitinides within 2 months of screening, *alpha-glucosidase inhibitors within 2 months of screening, *pramlintide acetate injection within 2 months of screening.
- Subject has received exenatide, GLP-1 analogs, DPP-IV inhibitors, or has participated in this study previously.
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: Byetta, AC2993, synthetic enxendin-4subcutaneous injection, 5mcg twice a day for one week; then 10 mcg twice a day for one week | Drug | Exenatide |
| Placebosubcutaneous injection, equivalent volume to 5 mcg exenatide twice a day for one week; then equivalent volume to 10 mcg exenatide twice a day for one week | Drug | Placebo |
Primary outcome
Time-averaged serum glucose during a 24-hour period
Time frame: Every half-hour to hour for 24 hours
Time-averaged serum glucose during a 24-hour period
1 secondary outcome
To compare the effects of exenatide and placebo on serum glucose
Time frame: Each half-hour to 2 hours for 24 hours
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 18394265Brodows RG, Qu Y, Johns D, Kim D, Holcombe JH. Quantifying the effect of exenatide and insulin glargine on postprandial glucose excursions in patients with type 2 diabetes. Curr Med Res Opin. 2008 May;24(5):1395-7. doi: 10.1185/030079908x297268. Epub 2008 Apr 3.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing exenatide in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 2 sites in United States.
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 2 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 2 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Time-averaged serum glucose during a 24-hour period (time frame: Every half-hour to hour for 24 hours). 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 NCT00241423, 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.