HealthyPhase 1NCT01820104
Effects of Lansoprazole on Sitagliptin Glucose-lowering Ability in Healthy Males: a Randomised Crossover Study
A Phase 1 study testing lansoprazole, 30 mg per day for 6 days in people with Healthy, run by Xijing Hospital at 1 site in China.
Trial summary
Oral hypoglycemic medications sometimes do not control type 2 diabetes well. Proton pump inhibitors (PPIs) as adjunctive therapy might improve diabetes control and could enhance the hypoglycemic activity of DPP4, but there is little clinical data on efficacy of this therapeutic strategy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- lansoprazole, 30 mg per day for 6 days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to May 2013
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- General good health condition
- Male subject, between 18 and 50 years
Who cannot join
- Overweight (Body Mass Index ≥30)
- Metabolic disorders
- History of gastrointestinal disorders
- Regular (daily) intake of medication
- Smoking more than 10 cigarettes/day
- History of drug abuse
Show all 11Show fewer
- Exhaustive (> 3 units/day) alcohol consumption
- Exhaustive (> 5 units/day) caffeine consumption (coffee, tea, cola, or other caffeine based drinks)
- Recent (in the last 14 days) donation of blood
- Recent (in the last 2 days) donation of blood plasma
- Participation in another trial within 4 weeks before the start of the study
Trial locations and contacts
1 site in 1 country.
China1 site
Department of pharmacy, Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi
About this study
Official title: Effects of Lansoprazole on Sitagliptin Glucose-lowering Ability in Healthy Males
Oral hypoglycemic medications sometimes do not control type 2 diabetes well. Proton pump inhibitors (PPIs) as adjunctive therapy might improve diabetes control and could enhance the hypoglycemic activity of DPP4, but there is little clinical data on efficacy of this therapeutic strategy. The investigators sought to examine the effect of PPI lansoprazole, DPP-4 inhibitor sitagliptin, and their combination therapy on insulin and glucose regulation in healthy subjects in oral glucose tolerance (OGTT).
Read the detailed description
Oral hypoglycemic medications sometimes do not control type 2 diabetes well. Proton pump inhibitors (PPIs) as adjunctive therapy might improve diabetes control and could enhance the hypoglycemic activity of DPP4, but there is little clinical data on efficacy of this therapeutic strategy. We sought to examine the effect of PPI (lansoprazole), DPP4 (sitagliptin), and their combination therapy on insulin and glucose regulation in healthy subjects in oral glucose tolerance (OGTT).
- Conditions
- Healthy
- Being tested
- lansoprazole, 30 mg per day for 6 days
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lansoprazole, 30 mg per day for 6 daysDrug
Also called Oral glucose tolerance test (OGTT)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | oral sitagliptin 100 mg on day 6 after administration of placebo (30 mg per day) for 6 days |
| Combination of lansoprazole and sitagliptin | Experimental | oral sitagliptin 100 mg on day 6 after administration of lansoprazole (30 mg per day) for 6 days Receives: Drug: lansoprazole, 30 mg per day for 6 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Tolerance
Measured: 0, 15, 30, 60, 90, 120, 180 min. after glucose administration
Secondary outcomes (1)
Plasma insulin and C-peptide concentrations during oral glucose tolerance test
Measured: 0, 15, 30, 60, 90, 120, 180 min. after glucose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820104
- Sponsor's protocol ID
- 20130301
- Status last verified
- May 2013
- First submitted
- 17 Mar 2013
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lansoprazole on Sitagliptin Glucose-lowering Ability in Healthy Males
- ClinicalTrials.gov ID
- NCT01820104
- Acronym / sponsor ID
- 20130301
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 28 Mar 2013 (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.
Oral hypoglycemic medications sometimes do not control type 2 diabetes well. Proton pump inhibitors (PPIs) as adjunctive therapy might improve diabetes control and could enhance the hypoglycemic activity of DPP4, but there is little clinical data on efficacy of this therapeutic strategy. The investigators sought to examine the effect of PPI lansoprazole, DPP-4 inhibitor sitagliptin, and their combination therapy on insulin and glucose regulation in healthy subjects in oral glucose tolerance (OGTT).
Detailed description
Oral hypoglycemic medications sometimes do not control type 2 diabetes well. Proton pump inhibitors (PPIs) as adjunctive therapy might improve diabetes control and could enhance the hypoglycemic activity of DPP4, but there is little clinical data on efficacy of this therapeutic strategy. We sought to examine the effect of PPI (lansoprazole), DPP4 (sitagliptin), and their combination therapy on insulin and glucose regulation in healthy subjects in oral glucose tolerance (OGTT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | –oral sitagliptin 100 mg on day 6 after administration of placebo (30 mg per day) for 6 days |
| Combination of lansoprazole and sitagliptin | Experimental | Drug: lansoprazole, 30 mg per day for 6 daysoral sitagliptin 100 mg on day 6 after administration of lansoprazole (30 mg per day) for 6 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- General good health condition
- Male subject, between 18 and 50 years
Key exclusion criteria (11 listed)
- Overweight (Body Mass Index ≥30)
- Metabolic disorders
- History of gastrointestinal disorders
- Regular (daily) intake of medication
- Smoking more than 10 cigarettes/day
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 |
|---|---|---|
| lansoprazole, 30 mg per day for 6 daysAlso: Oral glucose tolerance test (OGTT) | Drug | Combination of lansoprazole and sitagliptin |
Primary outcome
Glucose Tolerance
Time frame: 0, 15, 30, 60, 90, 120, 180 min. after glucose administration
1 secondary outcome
Plasma insulin and C-peptide concentrations during oral glucose tolerance test
Time frame: 0, 15, 30, 60, 90, 120, 180 min. after glucose administration
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 3 May 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 lansoprazole, 30 mg per day for 6 days in people with Healthy, run by Xijing Hospital at 1 site in China.
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 2 inclusion and 11 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 3 May 2013. 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 China. 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?
Glucose Tolerance (time frame: 0, 15, 30, 60, 90, 120, 180 min. after glucose administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2013.