Type 2 DiabetesPhase 1NCT00975052
A Study of the Effects of Sitagliptin (MK0431) and Metformin on Incretin Hormone Concentrations (0431-050)(COMPLETED)
A Phase 1 study testing sitagliptin phosphate, Comparator: metformin and Comparator: sitagliptin and metformin in people with Type 2 Diabetes, run by Merck Sharp & Dohme LLC.
Trial summary
This study will determine the effect of concomitant administration of sitagliptin and metformin on post-meal incretin hormone concentrations in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- sitagliptin phosphate, Comparator: metformin and Comparator: sitagliptin and metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Mar 2006
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is in good health
- Subject has been a nonsmoker for at least 6 months
- Subject is willing to avoid strenuous activity from the screening visit until the end of the study
- Subject agrees not to consume grapefruit products during the study and to avoid all fruit juices 24 hours before and after study drug administration
Who cannot join
- Any history of stroke or neurological disorder
- Subject has a history of cardiovascular, blood, endocrine or liver diseases
- Subject has a history of cancer
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Double-Dummy, Four-Period Crossover Study to Assess the Effects of Concomitant Administration of MK0431 and Metformin Alone and in Combination on Post-Meal Incretin Hormone Concentrations in Healthy Adult Subjects
This study will determine the effect of concomitant administration of sitagliptin and metformin on post-meal incretin hormone concentrations in healthy adults.
- Conditions
- Type 2 Diabetes
- Being tested
- sitagliptin phosphate, Comparator: metformin, Comparator: sitagliptin and metformin, Comparator: placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sitagliptin phosphateDrug
100 mg sitagliptin daily for two days in one out of four treatment periods
Comparator: metforminDrug
500 mg twice daily on Day 1 and 1000 mg once daily on Day 2 in one of four treatment periods.
Comparator: sitagliptin and metforminDrug
100 mg sitagliptin once daily and 500 mg metformin twice daily on Day 1 and 100 mg sitagliptin once daily and 1000 mg metformin once daily on Day 2 in one of four treatment periods.
Comparator: placeboDrug
Placebo only on Days 1 and 2 in one of four treatment periods.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Sitagliptin alone Receives: Drug: sitagliptin phosphate |
| B | Active comparator | Metformin alone Receives: Drug: Comparator: metformin |
| C | Experimental | Sitagliptin and metformin concomitantly Receives: Drug: Comparator: sitagliptin and metformin |
| D | Placebo comparator | Placebo Receives: Drug: Comparator: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weighted average active GLP-1 (glucagonlike peptide-1) concentrations
Measured: 4 hours after the postdose meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startJan 2006
- Primary completionMar 2006
- Study completionMar 2006
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 DiabetesStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975052
- Sponsor's protocol ID
- 0431-050
- Other IDs
- MK0431-050, 2009_661
- Status last verified
- Aug 2015
- First submitted
- 10 Sep 2009
- Last updated
- 19 Aug 2015
- Results posted
- No
Publications
Migoya EM, Bergeron R, Miller JL, Snyder RN, Tanen M, Hilliard D, Weiss B, Larson P, Gutierrez M, Jiang G, Liu F, Pryor KA, Yao J, Zhu L, Holst JJ, Deacon C, Herman G, Thornberry N, Amatruda J, Williams-Herman D, Wagner JA, SinhaRoy R. Dipeptidyl peptidase-4 inhibitors administered in combination with metformin result in an additive increase in the plasma concentration of active GLP-1. Clin Pharmacol Ther. 2010 Dec;88(6):801-8. doi: 10.1038/clpt.2010.184. Epub 2010 Nov 3.
PubMed 21048706
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Double-Dummy, Four-Period Crossover Study to Assess the Effects of Concomitant Administration of MK0431 and Metformin Alone and in Combination on Post-Meal Incretin Hormone Concentrations in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00975052
- Acronym / sponsor ID
- 0431-050
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 11 Sep 2009 (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 study will determine the effect of concomitant administration of sitagliptin and metformin on post-meal incretin hormone concentrations in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: sitagliptin phosphateSitagliptin alone |
| B | Active comparator | Drug: Comparator: metforminMetformin alone |
| C | Experimental | Drug: Comparator: sitagliptin and metforminSitagliptin and metformin concomitantly |
| D | Placebo comparator | Drug: Comparator: placeboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject is in good health
- Subject has been a nonsmoker for at least 6 months
- Subject is willing to avoid strenuous activity from the screening visit until the end of the study
- Subject agrees not to consume grapefruit products during the study and to avoid all fruit juices 24 hours before and after study drug administration
Key exclusion criteria (3 listed)
- Any history of stroke or neurological disorder
- Subject has a history of cardiovascular, blood, endocrine or liver diseases
- Subject has a history of cancer
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 |
|---|---|---|
| sitagliptin phosphate100 mg sitagliptin daily for two days in one out of four treatment periods | Drug | A |
| Comparator: metformin500 mg twice daily on Day 1 and 1000 mg once daily on Day 2 in one of four treatment periods. | Drug | B |
| Comparator: sitagliptin and metformin100 mg sitagliptin once daily and 500 mg metformin twice daily on Day 1 and 100 mg sitagliptin once daily and 1000 mg metformin once daily on Day 2 in one of four treatment periods. | Drug | C |
| Comparator: placeboPlacebo only on Days 1 and 2 in one of four treatment periods. | Drug | D |
Primary outcome
Weighted average active GLP-1 (glucagonlike peptide-1) concentrations
Time frame: 4 hours after the postdose meal
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 19 Aug 2015.
- Results publication: PubMed 21048706Migoya EM, Bergeron R, Miller JL, Snyder RN, Tanen M, Hilliard D, Weiss B, Larson P, Gutierrez M, Jiang G, Liu F, Pryor KA, Yao J, Zhu L, Holst JJ, Deacon C, Herman G, Thornberry N, Amatruda J, Williams-Herman D, Wagner JA, SinhaRoy R. Dipeptidyl peptidase-4 inhibitors administered in combination with metformin result in an additive increase in the plasma concentration of active GLP-1. Clin Pharmacol Ther. 2010 Dec;88(6):801-8. doi: 10.1038/clpt.2010.184. Epub 2010 Nov 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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sitagliptin phosphate, Comparator: metformin and Comparator: sitagliptin and metformin in people with Type 2 Diabetes, run by Merck Sharp & Dohme LLC.
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 3 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 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Weighted average active GLP-1 (glucagonlike peptide-1) concentrations (time frame: 4 hours after the postdose meal). 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 NCT00975052, 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 19 Aug 2015.