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CompletedNCT01093794Updated Jul 28, 2015Results posted

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

A Phase 1 interventional study of Co-administration of 50 mg sitagliptin and 500 mg metformin and sitagliptin/metformin 50 mg/500 mg tablet in Type 2 Diabetes, sponsored by Merck Sharp & Dohme LLC. Completed. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-28.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
01

Study 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 AUC(0-t) and Cmax, for both sitagliptin and metformin.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Type 2 Diabetes
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 28 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850

    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

    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

  • Experimental
    2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC

    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

    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

  • Experimental
    3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500

    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

    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

  • Experimental
    4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC

    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

    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

Interventions

  • DrugCo-administration of 50 mg sitagliptin and 500 mg metformin

    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.

  • Drugsitagliptin/metformin 50 mg/500 mg tablet

    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.

  • DrugCo-administration of 50 mg sitagliptin and 850 mg metformin

    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.

  • Drugsitagliptin/metformin 50 mg/850 mg tablet

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline through 72 hours postdose

  2. 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.

    Time frame: baseline through 72 hours postdose

07

Results

Posted Jun 27, 2011

Participant flow

28 participants were randomized in four treatment sequences. Participants had a 7 day minimum washout period between treatments.

Treatment Period 1
Participant flow — Treatment Period 1
Milestone1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met8502. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met5004. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC
Started7777
Completed7777
Not completed0000
Treatment Period 2
Participant flow — Treatment Period 2
Milestone1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met8502. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met5004. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC
Started7767
Completed7767
Not completed0000
Treatment Period 3
Participant flow — Treatment Period 3
Milestone1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met8502. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met5004. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC
Started7767
Completed7767
Not completed0000
Treatment Period 4
Participant flow — Treatment Period 4
Milestone1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met8502. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met5004. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC
Started7767
Completed7767
Not completed0000

Outcome measures

PrimaryArea 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.

Time frame:
baseline through 72 hours postdose
Reported as:
Mean · hr*ng/mL
Area Under the Curve (AUC(0-t)) for Sitagliptin
hr*ng/mLSit 50 mg + Met 500 mgSitMet 50mg/500mg FDCSit 50 mg + Met 850 mgSitMet 50mg/850mg FDC
sitagliptin 50 mg1570 ± 217.401590 ± 186.581520 ± 228.831600 ± 195.05
metformin 500 mg8350 ± 1881.708750 ± 1920.45NA ± NANA ± NA
metformin 850 mgNA ± NANA ± NA11800 ± 2849.3613100 ± 2987.28
PrimaryCmax 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.

Time frame:
baseline through 72 hours postdose
Reported as:
Mean · ng/mL
Cmax for Sitagliptin and Metformin
ng/mLSit 50 mg + Met 500 mgSitMet 50mg/500mg FDCSit 50 mg + Met 850 mgSitMet 50mg/850mg FDC
sitagliptin 50 mg189 ± 37.76182 ± 38.71187 ± 40.31194 ± 32.67
Metformin 500 mg1210 ± 323.831310 ± 383.57NA ± NANA ± NA
Metformin 850 mgNA ± NANA ± NA1790 ± 488.511970 ± 482.69

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sit 50 mg + Met 500 mg—0/28 (0%)4/28 (14.3%)
Sit/Met 50 mg/500 mg FDC—0/28 (0%)3/28 (10.7%)
Sit 50 mg + Met 850 mg—0/28 (0%)4/28 (14.3%)
Sit/Met 50 mg/850 mg FDC—0/28 (0%)2/28 (7.1%)
Most frequent other events
Most frequent other events
EventSit 50 mg + Met 500 mgSit/Met 50 mg/500 mg FDCSit 50 mg + Met 850 mgSit/Met 50 mg/850 mg FDC
DiarrheaGastrointestinal disorders2/281/281/280/28
FlatulenceGastrointestinal disorders0/280/282/280/28
HeadacheNervous system disorders1/280/280/280/28
Abdominal painGastrointestinal disorders1/281/281/281/28
FeverGeneral disorders1/280/280/280/28
VertigoEar and labyrinth disorders1/280/280/280/28
NauseaGastrointestinal disorders1/281/280/280/28
Chest painGeneral disorders0/280/281/280/28
RashSkin and subcutaneous tissue disorders0/280/281/280/28
LeucocytosisBlood and lymphatic system disorders0/280/280/281/28

Baseline characteristics

Age, Continuous
Age, Continuous(years)All Participants
Mean28.6 ± 5.61
Sex: Female, Male
Sex: Female, Male(Participants)All Participants
Female0
Male28
Region of Enrollment
Region of Enrollment(participants)All Participants
China28
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)All Participants
Mean22 ± 1.22
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01093794
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Mar 26, 2010
Start date
Apr 2010
Primary completion
Jun 2010
Completion
Jun 2010
Results posted
Jun 27, 2011
Last update
Jul 28, 2015

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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