Type 2 DiabetesPhase 1NCT00961857
A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Concomitant Administration of Sitagliptin and Metformin as Individual Tablets (0431A-048)
A Phase 1 study testing sitagliptin phosphate (+) metformin hydrochloride, Comparator: metformin 500 mg and Comparator: sitagliptin in people with Type 2 Diabetes, run by Merck Sharp & Dohme LLC.
Trial summary
A two-part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin /metformin (50/500 and 50/1000 mg) Fixed-Dose Combination (FDC) tablet and co-administration of a single dose of sitagliptin (50 mg) and metformin ( 500 or 1000 mg) as individual tablets. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- sitagliptin phosphate (+) metformin hydrochloride, Comparator: metformin 500 mg and Comparator: sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2005to 1 Jan 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 45 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
- Subject is willing to avoid strenuous physical activity during the study
- Subject agrees to refrain from eating grapefruit or grapefruit products during the study
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 consumes excessive amounts of alcohol or caffeinated beverages
- Subject has donated blood, had surgery or participated in another clinical study within the past 4 weeks
- Subject has a history of significant multiple and/or severe allergies to prescription or non-prescription drugs or food
- Subject has a history of hypersensitivity to metformin, sitagliptin, or sitagliptin/Metformin
- Subject is a regular user or past abuser of any illicit drugs
- Subject is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies during the study.
- Subject is a nursing mother
About this study
Official title: An Open-label, Randomized Two-Part, Two-Period Crossover Study to Demonstrate the Definitive Bioequivalence After Administration of Final Market Image (FMI) Sitagliptin /Metformin 50/500 mg and 50/1000 mg Fixed Dose Combination (FDC) and Concomitant Administration of 50 mg Doses of Sitagliptin and 500 or 1000 mg Doses of Metformin as Individual Tablets
A two-part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin /metformin (50/500 and 50/1000 mg) Fixed-Dose Combination (FDC) tablet and co-administration of a single dose of sitagliptin (50 mg) and metformin ( 500 or 1000 mg) as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I) or Treatment C and D (Part II).
- Conditions
- Type 2 Diabetes
- Being tested
- sitagliptin phosphate (+) metformin hydrochloride, Comparator: metformin 500 mg, 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 500 mgDrug
Also called Apotex
A single dose of metformin 500 mg tablets
Comparator: sitagliptinDrug
A single 50 mg tablet of sitagliptin
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: metformin 1000 mgDrug
Also called Apotex
A single dose of metformin 1000 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | Individual Tablets of 50 mg sitagliptin and 500 mg metformin Receives: Drug: sitagliptin phosphate (+) metformin hydrochloride; Drug: Comparator: metformin 500 mg; 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 | Individual Tablets of 50 mg sitagliptin and 1000 mg metformin 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the plasma concentration vs. time curve (AUC) after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets
Measured: 72 hours post dose
Secondary outcomes (1)
Peak plasma concentration (Cmax) of sitagliptin and metformin after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets
Measured: 72 hours post dose
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 start1 Dec 2005
- Primary completion1 Dec 2005
- Study completion1 Jan 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
- None (open label)
- Enrolment
- 48 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
- NCT00961857
- Sponsor's protocol ID
- 0431A-048
- Other IDs
- MK0431A-048, 2009_635
- Status last verified
- Nov 2019
- First submitted
- 18 Aug 2009
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Migoya EM, Miller JL, Gutierrez M, Zheng W, Johnson-Levonas AO, Liu Q, Matthews CZ, Wagner JA, Gottesdiener KM. Bioequivalence of sitagliptin/metformin fixed-dose combination tablets and concomitant administration of sitagliptin and metformin in healthy adult subjects: a randomized, open-label, crossover study. Clin Drug Investig. 2010;30(12):855-66. doi: 10.1007/BF03256914.
PubMed 20923244
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized Two-Part, Two-Period Crossover Study to Demonstrate the Definitive Bioequivalence After Administration of Final Market Image (FMI) Sitagliptin /Metformin 50/500 mg and 50/1000 mg Fixed Dose Combination (FDC) and Concomitant Administration of 50 mg Doses of Sitagliptin and 500 or 1000 mg Doses of Metformin as Individual Tablets
- ClinicalTrials.gov ID
- NCT00961857
- Acronym / sponsor ID
- 0431A-048
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2005 (actual)
- Primary completion
- 1 Dec 2005 (actual)
- Study completion
- 1 Jan 2006 (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 two-part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin /metformin (50/500 and 50/1000 mg) Fixed-Dose Combination (FDC) tablet and co-administration of a single dose of sitagliptin (50 mg) and metformin ( 500 or 1000 mg) as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I) or Treatment C and D (Part II).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: sitagliptin phosphate (+) metformin hydrochloride, Drug: Comparator: metformin 500 mg, Drug: Comparator: sitagliptinIndividual Tablets of 50 mg sitagliptin and 500 mg metformin |
| 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 mgIndividual Tablets of 50 mg sitagliptin and 1000 mg metformin |
| Treatment D | Experimental | Drug: Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tabletsitagliptin/metformin 50 mg/1000 mg tablet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 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
- Subject is willing to avoid strenuous physical activity during the study
- Subject agrees to refrain from eating grapefruit or grapefruit products during the study
Key exclusion criteria (8 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 consumes excessive amounts of alcohol or caffeinated beverages
- Subject has donated blood, had surgery or participated in another clinical study within the past 4 weeks
- Subject has a history of significant multiple and/or severe allergies to prescription or non-prescription drugs or food
- Subject has a history of hypersensitivity to metformin, sitagliptin, or sitagliptin/Metformin
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 500 mgAlso: ApotexA single dose of metformin 500 mg tablets | Drug | Treatment A |
| Comparator: sitagliptinA single 50 mg tablet of sitagliptin | Drug | Treatment A, Treatment C |
| 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: metformin 1000 mgAlso: ApotexA single dose of metformin 1000 mg tablets | Drug | Treatment C |
Primary outcome
The area under the plasma concentration vs. time curve (AUC) after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets
Time frame: 72 hours post dose
1 secondary outcome
Peak plasma concentration (Cmax) of sitagliptin and metformin after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets
Time frame: 72 hours post dose
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 13 Nov 2019.
- Results publication: PubMed 20923244Migoya EM, Miller JL, Gutierrez M, Zheng W, Johnson-Levonas AO, Liu Q, Matthews CZ, Wagner JA, Gottesdiener KM. Bioequivalence of sitagliptin/metformin fixed-dose combination tablets and concomitant administration of sitagliptin and metformin in healthy adult subjects: a randomized, open-label, crossover study. Clin Drug Investig. 2010;30(12):855-66. doi: 10.1007/BF03256914.
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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 500 mg 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 4 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 13 Nov 2019. 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 vs. time curve (AUC) after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets (time frame: 72 hours post dose). 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 NCT00961857, 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 13 Nov 2019.