GastroparesisPhase 1NCT00501657
Effects of Sitagliptin on Gastric Emptying in Healthy Subjects
A Phase 1 study testing Sitagliptin in people with Gastroparesis and Diabetes Mellitus, run by Royal Adelaide Hospital at 1 site in Australia.
Trial summary
The purpose of this study is to determine the effects of the drug, sitagliptin, on the rate at which the stomach empties, and the release of gut hormones and blood glucose concentrations, after a mashed potato meal in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis, Diabetes Mellitus
- What is being tested?
- Sitagliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2007to Dec 2011
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female (females must be using an appropriate contraceptive method)
- 18 - 45 years
- Body mass index (BMI) 19 - 25 kg/m2.
Who cannot join
- Subjects with gastrointestinal disease, history of gastrointestinal surgery and/or significant gastrointestinal symptoms
- Subjects taking medication known to influence gastrointestinal function
- Alcohol intake > 20 g per day
- Smoking > 10 cigarettes per day
- Pregnant and/or lactating females
- Calculated creatinine clearance < 60 ml/min
- Exposure to ionising radiation for research purposes in the previous 12 months.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Discipline of Medicine, Royal Adelaide Hospital
Adelaide, South Australia, 5000
About this study
The purpose of this study is to determine the effects of the drug, sitagliptin, on the rate at which the stomach empties, and the release of gut hormones and blood glucose concentrations, after a mashed potato meal in healthy subjects. Sitagliptin has been shown to reduce the blood glucose (sugar) response to a meal and this may potentially be due to slowing of stomach emptying. This is particularly relevant to people who have diabetes, in whom normalization of elevated blood glucose levels is important to maintain health.
Read the detailed description
The purpose of this study is to evaluate the effect of sitagliptin on gastric emptying, intragastric meal distribution, postprandial glycemia and insulinemia in healthy subjects. Glucagon-like peptide-1 (GLP-1) inhibits gastric emptying, thereby slowing the delivery of nutrients, and their absorption, across the small intestine. The rate of entry of carbohydrate into the small intestine is especially important in patients with diabetes mellitus. Sitagliptin is an orally administered inhibitor of dipeptidyl-peptidase-IV (DPP-IV), the enzyme responsible for the degradation of GLP-1. It is hypothesized that sitagliptin will increase the GLP-1 response to, and thereby slow gastric emptying and diminish the glycemic response to, a carbohydrate-containing meal.
Fifteen healthy subjects (male and female) will be studied. Each subject will be studied on two occasions following treatment for 2 days with sitagliptin (100mg once daily) or matching placebo in a randomized, double blind, crossover design. Measurements of gastric emptying, intragastric meal distribution, blood glucose concentrations, gut hormones and appetite will be measured for 4 hours following ingestion of a mashed potato meal.
- Conditions
- Gastroparesis, Diabetes Mellitus
- Being tested
- Sitagliptin, Placebo
- Keywords
- gastric emptying, glycemia, appetite, incretin hormones
- Medical subject headings
- Gastroparesis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called MK-0431-075, Januvia
100mg mane for 2 days
PlaceboDrug
100mg mane for 2 days
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin (100mg) | Experimental | Active drug (sitagliptin) Receives: Drug: Sitagliptin |
| Placebo (sugar pill) | Placebo comparator | Inactive drug (placebo) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying rate
Measured: 4 hours per study
Secondary outcomes (1)
Intragastric distribution, gastrointestinal hormone release (GLP-1, GIP), glycemia, insulinemia, appetite
Measured: 4 hours per study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJun 2008
- Study completionDec 2011
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 GastroparesisStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Adelaide Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Karen Jones, Royal Adelaide Hospital
- Investigators
- Karen L Jones, PhD, Principal investigator, University of Adelaide, Royal Adelaide Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501657
- Sponsor's protocol ID
- 061025
- Status last verified
- Dec 2014
- First submitted
- 13 Jul 2007
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Stevens JE, Horowitz M, Deacon CF, Nauck M, Rayner CK, Jones KL. The effects of sitagliptin on gastric emptying in healthy humans - a randomised, controlled study. Aliment Pharmacol Ther. 2012 Aug;36(4):379-90. doi: 10.1111/j.1365-2036.2012.05198.x. Epub 2012 Jun 28.
PubMed 22738299
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sitagliptin on Gastric Emptying in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00501657
- Acronym / sponsor ID
- 061025
- Conditions
- Gastroparesis, Diabetes Mellitus
- Keywords
- gastric emptying, glycemia, appetite, incretin hormones
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Royal Adelaide HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Jul 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.
The purpose of this study is to determine the effects of the drug, sitagliptin, on the rate at which the stomach empties, and the release of gut hormones and blood glucose concentrations, after a mashed potato meal in healthy subjects. Sitagliptin has been shown to reduce the blood glucose (sugar) response to a meal and this may potentially be due to slowing of stomach emptying. This is particularly relevant to people who have diabetes, in whom normalization of elevated blood glucose levels is important to maintain health.
Detailed description
The purpose of this study is to evaluate the effect of sitagliptin on gastric emptying, intragastric meal distribution, postprandial glycemia and insulinemia in healthy subjects. Glucagon-like peptide-1 (GLP-1) inhibits gastric emptying, thereby slowing the delivery of nutrients, and their absorption, across the small intestine. The rate of entry of carbohydrate into the small intestine is especially important in patients with diabetes mellitus. Sitagliptin is an orally administered inhibitor of dipeptidyl-peptidase-IV (DPP-IV), the enzyme responsible for the degradation of GLP-1. It is hypothesized that sitagliptin will increase the GLP-1 response to, and thereby slow gastric emptying and diminish the glycemic response to, a carbohydrate-containing meal.
Fifteen healthy subjects (male and female) will be studied. Each subject will be studied on two occasions following treatment for 2 days with sitagliptin (100mg once daily) or matching placebo in a randomized, double blind, crossover design. Measurements of gastric emptying, intragastric meal distribution, blood glucose concentrations, gut hormones and appetite will be measured for 4 hours following ingestion of a mashed potato meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin (100mg) | Experimental | Drug: SitagliptinActive drug (sitagliptin) |
| Placebo (sugar pill) | Placebo comparator | Drug: PlaceboInactive drug (placebo) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female (females must be using an appropriate contraceptive method)
- 18 - 45 years
- Body mass index (BMI) 19 - 25 kg/m2.
Key exclusion criteria (7 listed)
- Subjects with gastrointestinal disease, history of gastrointestinal surgery and/or significant gastrointestinal symptoms
- Subjects taking medication known to influence gastrointestinal function
- Alcohol intake > 20 g per day
- Smoking > 10 cigarettes per day
- Pregnant and/or lactating females
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 |
|---|---|---|
| SitagliptinAlso: MK-0431-075, Januvia100mg mane for 2 days | Drug | Sitagliptin (100mg) |
| Placebo100mg mane for 2 days | Drug | Placebo (sugar pill) |
Primary outcome
Gastric emptying rate
Time frame: 4 hours per study
1 secondary outcome
Intragastric distribution, gastrointestinal hormone release (GLP-1, GIP), glycemia, insulinemia, appetite
Time frame: 4 hours per study
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 29 Oct 2015.
- Derived from this study: PubMed 22738299Stevens JE, Horowitz M, Deacon CF, Nauck M, Rayner CK, Jones KL. The effects of sitagliptin on gastric emptying in healthy humans - a randomised, controlled study. Aliment Pharmacol Ther. 2012 Aug;36(4):379-90. doi: 10.1111/j.1365-2036.2012.05198.x. Epub 2012 Jun 28.
- Pubmed abstractLink provided by the sponsor.
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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.
Karen L Jones, PhD principal investigator
University of Adelaide, Royal Adelaide Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sitagliptin in people with Gastroparesis and Diabetes Mellitus, run by Royal Adelaide Hospital at 1 site in Australia.
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 7 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 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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?
Gastric emptying rate (time frame: 4 hours per study). 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 NCT00501657, 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 29 Oct 2015.