Type 2 DiabetesPhase 1NCT01093794

Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)

A Phase 1 study testing Co-administration of 50 mg sitagliptin and 500 mg metformin, sitagliptin/metformin 50 mg/500 mg tablet and Co-administration of 50 mg sitagliptin and 850 mg metformin in people with Type 2 Diabetes, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will test the hypothesis that the Final Market Image (FMI) sitagliptin/metformin 50 mg/500 mg and 50 mg/850 mg (Fixed Dose Combination) FDC tablet and co-administration of corresponding doses of sitagliptin and China-sourced metformin as individual tablets will be bioequivalent based on assessment of the… Read more about this study

Who is it for?: Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes
What is being tested?: Co-administration of 50 mg sitagliptin and 500 mg metformin, sitagliptin/metformin 50 mg/500 mg tablet and Co-administration of 50 mg sitagliptin and 850 mg metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: No sites listed yet
Study dates: Apr 2010to Jun 2010
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 40 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Subject is of Chinese descent
Subject is in good health
Subject is a non-smoker

Who cannot join

Subject has a history of stroke or chronic seizures
Subject has a history of cancer
Subject has had major surgery, donated blood or participated in another investigational study within the past 4 weeks

About this study

Official title: A Bioequivalence Study With Two Tablet Strengths of the Final Market Image (FMI) Sitagliptin/Metformin Fixed Dose Combination (FDC) Tablet

Conditions: Type 2 Diabetes
Being tested: Co-administration of 50 mg sitagliptin and 500 mg metformin, sitagliptin/metformin 50 mg/500 mg tablet, Co-administration of 50 mg sitagliptin and 850 mg metformin, sitagliptin/metformin 50 mg/850 mg tablet
Keywords: Type 2 Diabetes
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.

Co-administration of 50 mg sitagliptin and 500 mg metforminDrug
Co-administration of 50 mg sitagliptin and 500 mg China-sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met500) after fasting for at least 10 hours.
sitagliptin/metformin 50 mg/500 mg tabletDrug
Single dose administration of the final marketing image (FMI) sitagliptin/metformin 50 mg/500 mg fixed-dose combination (FDC) tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.
Co-administration of 50 mg sitagliptin and 850 mg metforminDrug
Co-administration of 50 mg sitagliptin and 850 mg China sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met850) after fasting for at least 10 hours.
sitagliptin/metformin 50 mg/850 mg tabletDrug
Single dose administration of the FMI sitagliptin/metformin 50 mg/850 mg FDC tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.

Study groups in NCT01093794
Study group	Role	What they receive
1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850	Experimental	Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * Co-administration of 50 mg sitagliptin and 500 mg metformin * sitagliptin/metformin 50 mg/500 mg FDC tablet * sitagliptin/metformin 50 mg/850 mg FDC tablet * Co-administration of 50 mg sitagliptin and 850 mg metformin Receives: Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin; Drug: sitagliptin/metformin 50 mg/500 mg tablet; Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin; Drug: sitagliptin/metformin 50 mg/850 mg tablet
2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC	Experimental	Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * sitagliptin/metformin 50 mg/500 mg FDC tablet * Co-administration of 50 mg sitagliptin and 850 mg metformin * Co-administration of 50 mg sitagliptin and 500mg metformin * sitagliptin/metformin 50 mg/850 mg FDC tablet Receives: Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin; Drug: sitagliptin/metformin 50 mg/500 mg tablet; Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin; Drug: sitagliptin/metformin 50 mg/850 mg tablet
3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500	Experimental	Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * Co-administration of 50 mg sitagliptin and 850 mg metformin * sitagliptin/metformin 50 mg/850 mg FDC tablet * sitagliptin/metformin 50 mg/500 mg FDC tablet * Co-administration of 50 mg sitagliptin and 500mg metformin Receives: Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin; Drug: sitagliptin/metformin 50 mg/500 mg tablet; Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin; Drug: sitagliptin/metformin 50 mg/850 mg tablet
4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC	Experimental	Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * sitagliptin/metformin 50 mg/850 mg FDC tablet * Co-administration of 50 mg sitagliptin and 500 mg metformin * Co-administration of 50 mg sitagliptin and 850 mg metformin * sitagliptin/metformin 50 mg/500 mg FDC tablet Receives: Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin; Drug: sitagliptin/metformin 50 mg/500 mg tablet; Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin; Drug: sitagliptin/metformin 50 mg/850 mg tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Curve (AUC(0-t)) for Sitagliptin
AUC (0-t) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.
Measured: baseline through 72 hours postdose
Cmax for Sitagliptin and Metformin
Cmax is the peak serum concentration of a therapeutic drug after administration; and is used to determine the rate and extent of drug absorption. Cmax is reported for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.
Measured: baseline through 72 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Jun 2010

First posted26 Mar 2010 (estimated)
Study startApr 2010
Primary completionJun 2010
Study completionJun 2010

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 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: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01093794
Sponsor's protocol ID: 0431A-122
Other IDs: 2010_518
Status last verified: Jul 2015
First submitted: 19 Mar 2010
Last updated: 28 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Bioequivalence Study With Two Tablet Strengths of the Final Market Image (FMI) Sitagliptin/Metformin Fixed Dose Combination (FDC) Tablet
ClinicalTrials.gov ID: NCT01093794
Acronym / sponsor ID: 0431A-122
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 26 Mar 2010 (estimated)
Results: Posted 27 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850	Experimental	Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin, Drug: sitagliptin/metformin 50 mg/500 mg tablet, Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin, Drug: sitagliptin/metformin 50 mg/850 mg tabletParticipants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * Co-administration of 50 mg sitagliptin and 500 mg metformin * sitagliptin/metformin 50 mg/500 mg FDC tablet * sitagliptin/metformin 50 mg/850 mg FDC tablet * Co-administration of 50 mg sitagliptin and 850 mg metformin
2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC	Experimental	Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin, Drug: sitagliptin/metformin 50 mg/500 mg tablet, Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin, Drug: sitagliptin/metformin 50 mg/850 mg tabletParticipants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * sitagliptin/metformin 50 mg/500 mg FDC tablet * Co-administration of 50 mg sitagliptin and 850 mg metformin * Co-administration of 50 mg sitagliptin and 500mg metformin * sitagliptin/metformin 50 mg/850 mg FDC tablet
3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500	Experimental	Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin, Drug: sitagliptin/metformin 50 mg/500 mg tablet, Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin, Drug: sitagliptin/metformin 50 mg/850 mg tabletParticipants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * Co-administration of 50 mg sitagliptin and 850 mg metformin * sitagliptin/metformin 50 mg/850 mg FDC tablet * sitagliptin/metformin 50 mg/500 mg FDC tablet * Co-administration of 50 mg sitagliptin and 500mg metformin
4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC	Experimental	Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin, Drug: sitagliptin/metformin 50 mg/500 mg tablet, Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin, Drug: sitagliptin/metformin 50 mg/850 mg tabletParticipants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * sitagliptin/metformin 50 mg/850 mg FDC tablet * Co-administration of 50 mg sitagliptin and 500 mg metformin * Co-administration of 50 mg sitagliptin and 850 mg metformin * sitagliptin/metformin 50 mg/500 mg FDC tablet

Who may qualify

Ages: 18 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Subject is of Chinese descent
Subject is in good health
Subject is a non-smoker

Key exclusion criteria (3 listed)

Subject has a history of stroke or chronic seizures
Subject has a history of cancer
Subject has had major surgery, donated blood or participated in another investigational 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
Co-administration of 50 mg sitagliptin and 500 mg metforminCo-administration of 50 mg sitagliptin and 500 mg China-sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met500) after fasting for at least 10 hours.	Drug	1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850, 2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC, 3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500, 4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC
sitagliptin/metformin 50 mg/500 mg tabletSingle dose administration of the final marketing image (FMI) sitagliptin/metformin 50 mg/500 mg fixed-dose combination (FDC) tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.	Drug	1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850, 2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC, 3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500, 4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC
Co-administration of 50 mg sitagliptin and 850 mg metforminCo-administration of 50 mg sitagliptin and 850 mg China sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met850) after fasting for at least 10 hours.	Drug	1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850, 2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC, 3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500, 4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC
sitagliptin/metformin 50 mg/850 mg tabletSingle dose administration of the FMI sitagliptin/metformin 50 mg/850 mg FDC tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.	Drug	1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850, 2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC, 3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500, 4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC

Primary outcome

Area Under the Curve (AUC(0-t)) for Sitagliptin
Time frame: baseline through 72 hours postdose
AUC (0-t) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.
Cmax for Sitagliptin and Metformin
Time frame: baseline through 72 hours postdose
Cmax is the peak serum concentration of a therapeutic drug after administration; and is used to determine the rate and extent of drug absorption. Cmax is reported for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.

Results and safety

Results posted to the registry on 27 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850	7	7
2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC	7	7
3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500	7	7
4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC	7	7

Primary outcome: Area Under the Curve (AUC(0-t)) for Sitagliptin

Time frame: baseline through 72 hours postdose. Mean (Standard Deviation). Unit: hr*ng/mL

Measure	Sit 50 mg + Met 500 mg n = 27	SitMet 50mg/500mg FDC n = 27	Sit 50 mg + Met 850 mg n = 27	SitMet 50mg/850mg FDC n = 27
sitagliptin 50 mg	1570 (217.40)	1590 (186.58)	1520 (228.83)	1600 (195.05)
metformin 500 mg	8350 (1881.70)	8750 (1920.45)	NA (NA)	NA (NA)
metformin 850 mg	NA (NA)	NA (NA)	11800 (2849.36)	13100 (2987.28)

Population analysed: Per-Protocol (PP) set: Participants who completed the study according to the protocol. One participant who discontinued after Treatment Period 1 was not included in the analysis.

Primary outcome: Cmax for Sitagliptin and Metformin

Time frame: baseline through 72 hours postdose. Mean (Standard Deviation). Unit: ng/mL

Measure	Sit 50 mg + Met 500 mg n = 27	SitMet 50mg/500mg FDC n = 27	Sit 50 mg + Met 850 mg n = 27	SitMet 50mg/850mg FDC n = 27
sitagliptin 50 mg	189 (37.76)	182 (38.71)	187 (40.31)	194 (32.67)
Metformin 500 mg	1210 (323.83)	1310 (383.57)	NA (NA)	NA (NA)
Metformin 850 mg	NA (NA)	NA (NA)	1790 (488.51)	1970 (482.69)

Population analysed: Per-Protocol (PP) set: Participants who completed the study according to the protocol. One participant who discontinued after Treatment Period 1 was not included in the analysis.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sit 50 mg + Met 500 mg	0 of 28 (0%)	4 of 28 (14.3%)	Not reported
Sit/Met 50 mg/500 mg FDC	0 of 28 (0%)	3 of 28 (10.7%)	Not reported
Sit 50 mg + Met 850 mg	0 of 28 (0%)	4 of 28 (14.3%)	Not reported
Sit/Met 50 mg/850 mg FDC	0 of 28 (0%)	2 of 28 (7.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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?

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 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 28 Jul 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?

Yes. Results are posted in the registry (first posted 27 Jun 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?

Area Under the Curve (AUC(0-t)) for Sitagliptin (time frame: baseline through 72 hours postdose). The study lists 2 primary outcomes in all. 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 NCT01093794.

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 28 Jul 2015.