Type 2 DiabetesPhase 1NCT00961480
A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets (0431A-095)
A Phase 1 study testing sitagliptin phosphate (+) metformin hydrochloride, Comparator: metformin 500mg and Comparator: sitagliptin in people with Type 2 Diabetes, run by Merck Sharp & Dohme LLC.
Trial summary
A three part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin/metformin 50/500, 50/850 and 50/1000 mg Fixed-Dose Combination (FDC) tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets. 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 (+) metformin hydrochloride, Comparator: metformin 500mg and Comparator: sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Nov 2007
- 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
- Female subjects of reproductive potential test negative for pregnancy and agree to use appropriate contraception
- Subject is in good health and is a non-smoker
Who cannot join
- Subject has a history of neoplastic disease (cancer), stroke, chronic seizures, or major neurological disorder
- Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- Subject is a nursing mother
- Subject consumes excessive amounts of alcohol or caffeine
- Subject has donated blood, had surgery or participated in another clinical study within the past 4 weeks
About this study
Official title: A 3-Part, Open-Label, Randomized, 2-Period Crossover Study to Demonstrate the Definitive Bioequivalence After Administration of the FMI Sitagliptin/Metformin 50/500 mg, 50/850 mg and 50/1000 mg FDC Tablet and Co-administration of Corresponding Doses of Sitagliptin and Metformin as Individual Tablets
A three part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin/metformin 50/500, 50/850 and 50/1000 mg Fixed-Dose Combination (FDC) tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I), Treatment C and D (Part II) or Treatment E and F (Part III).
- Conditions
- Type 2 Diabetes
- Being tested
- sitagliptin phosphate (+) metformin hydrochloride, Comparator: metformin 500mg, Comparator: sitagliptin, Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet, Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet
- 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 phosphate (+) metformin hydrochlorideDrug
place holder - do not post
Comparator: metformin 500mgDrug
Also called Glucophage
A single dose of metformin 500 mg tablet
Comparator: sitagliptinDrug
Also called Januvia
A single dose of 50 mg sitagliptin tablet
Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tabletDrug
A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet
Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tabletDrug
A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet
Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tabletDrug
A single dose of FMI sitagliptin/metformin 50 mg/850 mg FDC tablet
Comparator: metformin 1000 mgDrug
Also called Glucophage
A single dose of metformin 1000 mg tablet
Comparator: metformin 850 mgDrug
Also called Glucophage
A single dose of metformin 850 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | 50 mg sitagliptin and 500 mg metformin as individual tablets Receives: Drug: sitagliptin phosphate (+) metformin hydrochloride; Drug: Comparator: metformin 500mg; Drug: Comparator: sitagliptin |
| Treatment B | Experimental | sitagliptin/metformin 50 mg/500 mg tablet Receives: Drug: Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet |
| Treatment C | Active comparator | 50 mg sitagliptin and 1000 mg metformin as individual tablets Receives: Drug: Comparator: sitagliptin; Drug: Comparator: metformin 1000 mg |
| Treatment D | Experimental | sitagliptin/metformin 50 mg/1000 mg tablet Receives: Drug: Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet |
| Treatment E | Active comparator | 50 mg sitagliptin and 850 mg metformin as individual tablets Receives: Drug: Comparator: sitagliptin; Drug: Comparator: metformin 850 mg |
| Treatment F | Experimental | sitagliptin/metformin 50 mg/850 mg tablet Receives: Drug: Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the plasma concentration-time curve (AUC) after administration of sitagliptin/metformin (50/500; 50/850; 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets.
Measured: Up to 72 hours postdose
Secondary outcomes (1)
Peak plasma concentration (Cmax) for metformin after administration of sitagliptin/metformin (50/500; 50/850, 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets.
Measured: Up to 72 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startOct 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 24 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
- NCT00961480
- Sponsor's protocol ID
- 0431A-095
- Other IDs
- MK0431A-095, 2009_636
- Status last verified
- Jun 2015
- First submitted
- 18 Aug 2009
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-Part, Open-Label, Randomized, 2-Period Crossover Study to Demonstrate the Definitive Bioequivalence After Administration of the FMI Sitagliptin/Metformin 50/500 mg, 50/850 mg and 50/1000 mg FDC Tablet and Co-administration of Corresponding Doses of Sitagliptin and Metformin as Individual Tablets
- ClinicalTrials.gov ID
- NCT00961480
- Acronym / sponsor ID
- 0431A-095
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 19 Aug 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.
A three part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin/metformin 50/500, 50/850 and 50/1000 mg Fixed-Dose Combination (FDC) tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I), Treatment C and D (Part II) or Treatment E and F (Part III).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: sitagliptin phosphate (+) metformin hydrochloride, Drug: Comparator: metformin 500mg, Drug: Comparator: sitagliptin50 mg sitagliptin and 500 mg metformin as individual tablets |
| Treatment B | Experimental | Drug: Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tabletsitagliptin/metformin 50 mg/500 mg tablet |
| Treatment C | Active comparator | Drug: Comparator: sitagliptin, Drug: Comparator: metformin 1000 mg50 mg sitagliptin and 1000 mg metformin as individual tablets |
| Treatment D | Experimental | Drug: Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tabletsitagliptin/metformin 50 mg/1000 mg tablet |
| Treatment E | Active comparator | Drug: Comparator: sitagliptin, Drug: Comparator: metformin 850 mg50 mg sitagliptin and 850 mg metformin as individual tablets |
| Treatment F | Experimental | Drug: Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tabletsitagliptin/metformin 50 mg/850 mg tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female subjects of reproductive potential test negative for pregnancy and agree to use appropriate contraception
- Subject is in good health and is a non-smoker
Key exclusion criteria (5 listed)
- Subject has a history of neoplastic disease (cancer), stroke, chronic seizures, or major neurological disorder
- Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- Subject is a nursing mother
- Subject consumes excessive amounts of alcohol or caffeine
- Subject has donated blood, had surgery or participated in another clinical study within the past 4 weeks
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 phosphate (+) metformin hydrochlorideplace holder - do not post | Drug | Treatment A |
| Comparator: metformin 500mgAlso: GlucophageA single dose of metformin 500 mg tablet | Drug | Treatment A |
| Comparator: sitagliptinAlso: JanuviaA single dose of 50 mg sitagliptin tablet | Drug | Treatment A, Treatment C, Treatment E |
| Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tabletA single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet | Drug | Treatment B |
| Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tabletA single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet | Drug | Treatment D |
| Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tabletA single dose of FMI sitagliptin/metformin 50 mg/850 mg FDC tablet | Drug | Treatment F |
| Comparator: metformin 1000 mgAlso: GlucophageA single dose of metformin 1000 mg tablet | Drug | Treatment C |
| Comparator: metformin 850 mgAlso: GlucophageA single dose of metformin 850 mg tablet | Drug | Treatment E |
Primary outcome
The area under the plasma concentration-time curve (AUC) after administration of sitagliptin/metformin (50/500; 50/850; 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets.
Time frame: Up to 72 hours postdose
1 secondary outcome
Peak plasma concentration (Cmax) for metformin after administration of sitagliptin/metformin (50/500; 50/850, 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets.
Time frame: Up to 72 hours postdose
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 9 Jun 2015.
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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 (+) metformin hydrochloride, Comparator: metformin 500mg and Comparator: sitagliptin 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 2 inclusion and 5 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 9 Jun 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. 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?
The area under the plasma concentration-time curve (AUC) after administration of sitagliptin/metformin (50/500; 50/850; 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets. (time frame: Up to 72 hours postdose). 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 9 Jun 2015.