Type 2 Diabetes MellitusPhase 1NCT00830076
A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110)
A Phase 1 study testing sitagliptin phosphate and metformin hydrochloride in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.
Trial summary
This study will assess the effects of sitagliptin and metformin alone and after co-administration on incretin hormone concentrations in patients with Type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- sitagliptin phosphate and metformin hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 2 Dec 2008to 14 May 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects must have a negative pregnancy test
- Subject has type 2 diabetes and is not currently receiving treatment with an oral AHA agent, has not received such treatment for 3 months prior to study, and/or has not received more than 4 total weeks treatment with an oral AHA agent for 12 to 18 months prior to the study
- Subject is a nonsmoker or has not smoked and/or used nicotine for at least 6 months
Who cannot join
- Subject has a history of stroke, seizures, or major neurological disorders
- Female subject is breastfeeding
- Subject cannot refrain from use of any prescription or non-prescription drugs beginning 2 weeks prior to first dose of study drug
- Subject consumes more than 3 alcoholic beverages per day
- Subject consumes more than 6 caffeinated beverages per day
- Subject has had major surgery, or has donated or lost 1 unit of blood within 4 weeks of screening
- Subject has a history of cancer, except certain skin or cervical cancer or other cancers treated more than 10 years prior to screening
- Subject has a history of multiple and/or severe allergies or intolerance to drugs or food
About this study
Official title: A Study to Assess the Effects of Co-Administration of Sitagliptin and Metformin on Incretin Hormone Concentrations
This study will assess the effects of sitagliptin and metformin alone and after co-administration on incretin hormone concentrations in patients with Type 2 diabetes.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- sitagliptin phosphate, metformin hydrochloride, Comparator: placebo sitagliptin, Comparator: placebo metformin
- 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
Also called Januvia
Sitagliptin 100 mg tablet on Day 1 and Day 2 in the morning. There will be a 7-day washout between treatment periods.
metformin hydrochlorideDrug
Also called Glucophage
Metformin 500 mg tablet in the morning and evening on Day 1 and two 500 mg tablets of metformin (total dose 1000 mg) on Day 2 in the morning. There will be a 7-day washout between treatment periods.
Comparator: placebo sitagliptinDrug
Placebo to sitagliptin 100 mg in the morning on Days 1 and 2. There will be a 7-day washout between treatment periods.
Comparator: placebo metforminDrug
Placebo to metformin 500 mg tablet in the morning and evening on Day 1 and two placebo to metformin 500 mg tablets (1000 mg total dose) in the morning of Day 2. There will be a 7-day wash out between treatment periods.
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin + placebo metformin | Experimental | Not described Receives: Drug: sitagliptin phosphate; Drug: Comparator: placebo metformin |
| Metformin + placebo sitagliptin | Experimental | Not described Receives: Drug: metformin hydrochloride; Drug: Comparator: placebo sitagliptin |
| Sitagliptin + metformin | Experimental | Co-administration of sitagliptin and metformin Receives: Drug: sitagliptin phosphate; Drug: metformin hydrochloride |
| Placebo sitagliptin + placebo metformin | Placebo comparator | Co-administration of placebo to sitagliptin and placebo to metformin Receives: Drug: Comparator: placebo sitagliptin; Drug: Comparator: placebo metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations
Meal was given 2 hours postdose. Blood samples for determination of active GLP-1 concentration were collected (4 hours postmeal) on Day 2 in each treatment period.
Measured: 6 hours postdose (4 hours postmeal) on Day 2
Secondary outcomes (2)
β-cell Sensitivity
β-cell sensitivity was defined as the incremental post-prandial
4-hour area under the curve (AUC) for insulin secretion rate (ISR) normalized by the incremental post-prandial 4-hour plasma glucose AUC.
Measured: 6 hour post-dose (4 hour postmeal) on Day 2
Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations
Meal was given 2 hours postdose. Blood samples for determination of glucose concentration were collected (4 hours postmeal) on Day 2 in each treatment period.
Measured: 6 hours postdose (4 hours postmeal) on Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study start2 Dec 2008
- Primary completion30 Apr 2009
- Study completion14 May 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 18 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
- NCT00830076
- Sponsor's protocol ID
- 0431-110
- Other IDs
- 2009_521
- Status last verified
- Apr 2017
- First submitted
- 26 Jan 2009
- Last updated
- 15 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Effects of Co-Administration of Sitagliptin and Metformin on Incretin Hormone Concentrations
- ClinicalTrials.gov ID
- NCT00830076
- Acronym / sponsor ID
- 0431-110
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2008 (actual)
- Primary completion
- 30 Apr 2009 (actual)
- Study completion
- 14 May 2009 (actual)
- First posted
- 27 Jan 2009 (estimated)
- Results
- Posted 3 Nov 2011
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 assess the effects of sitagliptin and metformin alone and after co-administration on incretin hormone concentrations in patients with Type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin + placebo metformin | Experimental | Drug: sitagliptin phosphate, Drug: Comparator: placebo metformin |
| Metformin + placebo sitagliptin | Experimental | Drug: metformin hydrochloride, Drug: Comparator: placebo sitagliptin |
| Sitagliptin + metformin | Experimental | Drug: sitagliptin phosphate, Drug: metformin hydrochlorideCo-administration of sitagliptin and metformin |
| Placebo sitagliptin + placebo metformin | Placebo comparator | Drug: Comparator: placebo sitagliptin, Drug: Comparator: placebo metforminCo-administration of placebo to sitagliptin and placebo to metformin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female subjects must have a negative pregnancy test
- Subject has type 2 diabetes and is not currently receiving treatment with an oral AHA agent, has not received such treatment for 3 months prior to study, and/or has not received more than 4 total weeks treatment with an oral AHA agent for 12 to 18 months prior to the study
- Subject is a nonsmoker or has not smoked and/or used nicotine for at least 6 months
Key exclusion criteria (8 listed)
- Subject has a history of stroke, seizures, or major neurological disorders
- Female subject is breastfeeding
- Subject cannot refrain from use of any prescription or non-prescription drugs beginning 2 weeks prior to first dose of study drug
- Subject consumes more than 3 alcoholic beverages per day
- Subject consumes more than 6 caffeinated beverages per 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 |
|---|---|---|
| sitagliptin phosphateAlso: JanuviaSitagliptin 100 mg tablet on Day 1 and Day 2 in the morning. There will be a 7-day washout between treatment periods. | Drug | Sitagliptin + metformin, Sitagliptin + placebo metformin |
| metformin hydrochlorideAlso: GlucophageMetformin 500 mg tablet in the morning and evening on Day 1 and two 500 mg tablets of metformin (total dose 1000 mg) on Day 2 in the morning. There will be a 7-day washout between treatment periods. | Drug | Metformin + placebo sitagliptin, Sitagliptin + metformin |
| Comparator: placebo sitagliptinPlacebo to sitagliptin 100 mg in the morning on Days 1 and 2. There will be a 7-day washout between treatment periods. | Drug | Metformin + placebo sitagliptin, Placebo sitagliptin + placebo metformin |
| Comparator: placebo metforminPlacebo to metformin 500 mg tablet in the morning and evening on Day 1 and two placebo to metformin 500 mg tablets (1000 mg total dose) in the morning of Day 2. There will be a 7-day wash out between treatment periods. | Drug | Placebo sitagliptin + placebo metformin, Sitagliptin + placebo metformin |
Primary outcome
Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations
Time frame: 6 hours postdose (4 hours postmeal) on Day 2
Meal was given 2 hours postdose. Blood samples for determination of active GLP-1 concentration were collected (4 hours postmeal) on Day 2 in each treatment period.
2 secondary outcomes
β-cell Sensitivity
Time frame: 6 hour post-dose (4 hour postmeal) on Day 2
Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations
Time frame: 6 hours postdose (4 hours postmeal) on Day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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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 and metformin hydrochloride in people with Type 2 Diabetes Mellitus, 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 3 inclusion and 8 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 15 May 2017. 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?
Yes. Results are posted in the registry (first posted 3 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations (time frame: 6 hours postdose (4 hours postmeal) on Day 2). 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 15 May 2017.