Type 2 Diabetes MellitusPhase 4NCT00477581
A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus
A Phase 4 study testing exenatide and sitagliptin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 19 sites in United States.
Trial summary
This purpose of this study is to compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- exenatide and sitagliptin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 19 sitesUnited States
- Study dates
- May 2007to Sep 2007
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment with metformin for at least 2 months
- Has HbA1c 7.0% to 11.0%, inclusive, at screening
- Body mass index (BMI)25 kg/m^2 to 45 kg/m^2, inclusive
- List of medications that are not allowed or the patient has been on stable treatment for at least 2 months:
- Hormone replacement therapy (female subjects)
- Oral contraceptives (female subjects)
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- Antihypertensive agents
- Lipid-lowering agents
- Thyroid replacement therapy
Who cannot join
- Has been treated with exenatide (BYETTA®) or any DPP-4 inhibitor prior to screening
- Received any study medication or participated in any type of clinical trial within 30 days prior to screening
- Has donated blood within 60 days of screening visit or is planning to donate blood during the study
- Treated with any of the following medications:
- Sulfonylurea or Thiazolidinedione within 3 months of screening;
- Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®)within 30 days of screening;
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- Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 6 months of screening;
- Drugs that directly affect gastrointestinal motility, including but not limited to, anticholinergics, macrolide antibiotics, dopamine antagonists, opioids, and Reglan®(metoclopramide);
- Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption;
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Research Site
Austin, Texas
Research Site
Butte, Montana
Research Site
Charleston, South Carolina
Research Site
Chicago, Illinois
Research Site
Cincinnati, Ohio
Research Site
Corpus Christi, Texas
Research Site
Detroit, Michigan
Research Site
Eugene, Oregon
Research Site
Greer, South Carolina
Research Site
Indianapolis, Indiana, 46260
Research Site
Indianapolis, Indiana
Research Site
Los Angeles, California
Research Site
Marion, Ohio
Research Site
Miami, Florida
Research Site
Pembroke Pines, Florida
Research Site
Portland, Oregon
Research Site
San Antonio, Texas
Research Site
Spring Valley, California
Research Site
Winston-Salem, North Carolina
About this study
Official title: A Randomized, Double-Blind, Crossover Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus
This purpose of this study is to compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- exenatide, sitagliptin
- Keywords
- diabetes, exenatide, sitagliptin, 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
subcutaneous injection (5mcg or 10mcg), twice a day
sitagliptinDrug
Also called Januvia
oral administration (100mg), once a day in the morning
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Not described Receives: Drug: exenatide; Drug: sitagliptin |
| Sequence B | Experimental | Not described Receives: Drug: exenatide; Drug: sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Exenatide on postprandial glucose
To compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus
Measured: 28 days
Secondary outcomes (1)
Assessment of effect of exenatide to the effect of sitagliptin the acetaminophen absorption test, and 6-point self-monitored blood glucose (SMBG) profiles
To compare the effect of exenatide to the effect of sitagliptin on the following endpoints in subjects with type 2 diabetes mellitus: postprandial glucose, insulin, insulin secretion rate, glucagon, and triglycerides; gastric emptying, as assessed by the acetaminophen absorption test, and 6-point self-monitored blood glucose (SMBG) profiles
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2007 (estimated)
- Study startMay 2007
- 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 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Lisa Porter, MD, Study director, Amylin Pharmaceuticals, LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477581
- Sponsor's protocol ID
- BCA403
- Status last verified
- Aug 2015
- First submitted
- 21 May 2007
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
DeFronzo RA, Okerson T, Viswanathan P, Guan X, Holcombe JH, MacConell L. Effects of exenatide versus sitagliptin on postprandial glucose, insulin and glucagon secretion, gastric emptying, and caloric intake: a randomized, cross-over study. Curr Med Res Opin. 2008 Oct;24(10):2943-52. doi: 10.1185/03007990802418851. Epub 2008 Sep 10.
PubMed 18786299
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Crossover Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00477581
- Acronym / sponsor ID
- BCA403
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes, exenatide, sitagliptin, Amylin, Lilly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- May 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 23 May 2007 (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 purpose of this study is to compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: exenatide, Drug: sitagliptin |
| Sequence B | Experimental | Drug: exenatide, Drug: sitagliptin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Treatment with metformin for at least 2 months
- Has HbA1c 7.0% to 11.0%, inclusive, at screening
- Body mass index (BMI)25 kg/m^2 to 45 kg/m^2, inclusive
- List of medications that are not allowed or the patient has been on stable treatment for at least 2 months:
Key exclusion criteria (9 listed)
- Has been treated with exenatide (BYETTA®) or any DPP-4 inhibitor prior to screening
- Received any study medication or participated in any type of clinical trial within 30 days prior to screening
- Has donated blood within 60 days of screening visit or is planning to donate blood during the study
- Treated with any of the following medications:
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 | Drug | Sequence A, Sequence B |
| sitagliptinAlso: Januviaoral administration (100mg), once a day in the morning | Drug | Sequence A, Sequence B |
Primary outcome
Effect of Exenatide on postprandial glucose
Time frame: 28 days
To compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus
1 secondary outcome
Assessment of effect of exenatide to the effect of sitagliptin the acetaminophen absorption test, and 6-point self-monitored blood glucose (SMBG) profiles
Time frame: 28 days
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 26 Aug 2015.
- Derived from this study: PubMed 18786299DeFronzo RA, Okerson T, Viswanathan P, Guan X, Holcombe JH, MacConell L. Effects of exenatide versus sitagliptin on postprandial glucose, insulin and glucagon secretion, gastric emptying, and caloric intake: a randomized, cross-over study. Curr Med Res Opin. 2008 Oct;24(10):2943-52. doi: 10.1185/03007990802418851. Epub 2008 Sep 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.
Lisa Porter, MD study director
Amylin Pharmaceuticals, LLC.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing exenatide and sitagliptin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 19 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 9 inclusion and 9 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 26 Aug 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 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Effect of Exenatide on postprandial glucose (time frame: 28 days). 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 NCT00477581, 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 26 Aug 2015.