Type 2 Diabetes MellitusPhase 1NCT00944450

Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)

A Phase 1 study testing Sitagliptin phosphate anhydrous formulation and Comparator: sitagliptin phosphate monohydrate form in people with Type 2 Diabetes Mellitus, 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 establish that the MK0431 100 mg anhydrous formulation tablets are bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) 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 Mellitus
What is being tested?: Sitagliptin phosphate anhydrous formulation and Comparator: sitagliptin phosphate monohydrate form
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: No sites listed yet
Study dates: Aug 2004to Nov 2004
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subject is in good health
Female subjects must have a negative pregnancy test
Subject is within 30% of ideal body weight
Subject does not smoke
Subject agrees to follow the study guidelines

Who cannot join

Subject has a history of any illness that might confound the results of the study or make participation unsafe for the subject
Subject has a history of hypoglycemia
Subject has a history of any hepatic disease
Subject is taking any oral, parenteral, topical or implantable contraceptives

About this study

Official title: An Open-Label, Randomized, 2-Period, Single-Dose, Balanced, Crossover Study in Healthy Subjects to Establish the Bioequivalence of Tablet Formulations Containing the Anhydrous and Monohydrate (FMI) Forms of MK0431

This study will establish that the MK0431 100 mg anhydrous formulation tablets are bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) tablets.

Conditions: Type 2 Diabetes Mellitus
Being tested: Sitagliptin phosphate anhydrous formulation, Comparator: sitagliptin phosphate monohydrate form
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 anhydrous formulationDrug
Single dose sitagliptin 100 mg tablets (anhydrous form) in one of two treatment periods.
Comparator: sitagliptin phosphate monohydrate formDrug
Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods.

Study groups in NCT00944450
Study group	Role	What they receive
1	Active comparator	Sitagliptin anhydrous formulation Receives: Drug: Sitagliptin phosphate anhydrous formulation
2	Active comparator	Sitagliptin monohydrate FMI formulation Receives: Drug: Comparator: sitagliptin phosphate monohydrate form

What is being measured

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

Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
Area Under the Plasma Concentration-Time Curve and peak concentration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
Measured: Through 72 Hours Following the Administration of the Medication
Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
Peak Plasma concentration (Cmax) for the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
Measured: Through 72 Hours Following the Administration of the Medication

Timeline

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

Aug 2004Nov 2004

First posted23 Jul 2009 (estimated)
Study startAug 2004
Primary completionSep 2004
Study completionNov 2004

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: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00944450
Sponsor's protocol ID: 0431-027
Other IDs: MK0431-027, 2009_614
Status last verified: Aug 2015
First submitted: 21 Jul 2009
Last updated: 19 Aug 2015
Results posted: Yes, on ClinicalTrials.gov

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 Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized, 2-Period, Single-Dose, Balanced, Crossover Study in Healthy Subjects to Establish the Bioequivalence of Tablet Formulations Containing the Anhydrous and Monohydrate (FMI) Forms of MK0431
ClinicalTrials.gov ID: NCT00944450
Acronym / sponsor ID: 0431-027
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Aug 2004
Primary completion: Sep 2004 (actual)
Study completion: Nov 2004 (actual)
First posted: 23 Jul 2009 (estimated)
Results: Posted 27 Apr 2010

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 establish that the MK0431 100 mg anhydrous formulation tablets are bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) tablets.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: Sitagliptin phosphate anhydrous formulationSitagliptin anhydrous formulation
2	Active comparator	Drug: Comparator: sitagliptin phosphate monohydrate formSitagliptin monohydrate FMI formulation

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Subject is in good health
Female subjects must have a negative pregnancy test
Subject is within 30% of ideal body weight
Subject does not smoke
Subject agrees to follow the study guidelines

Key exclusion criteria (4 listed)

Subject has a history of any illness that might confound the results of the study or make participation unsafe for the subject
Subject has a history of hypoglycemia
Subject has a history of any hepatic disease
Subject is taking any oral, parenteral, topical or implantable contraceptives

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 anhydrous formulationSingle dose sitagliptin 100 mg tablets (anhydrous form) in one of two treatment periods.	Drug	1
Comparator: sitagliptin phosphate monohydrate formSingle dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods.	Drug	2

Primary outcome

Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
Time frame: Through 72 Hours Following the Administration of the Medication
Area Under the Plasma Concentration-Time Curve and peak concentration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
Time frame: Through 72 Hours Following the Administration of the Medication
Peak Plasma concentration (Cmax) for the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)

Results and safety

Results posted to the registry on 27 Apr 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate	6	6
100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous	6	6

Primary outcome: Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)

Time frame: Through 72 Hours Following the Administration of the Medication. Geometric mean (Standard Deviation). Unit: μmol*hr/L

Measure	100 mg MK0431 Anhydrous n = 12	100 mg MK0431 Monohydrate n = 12
Value	8.38 (0.77)	8.78 (0.86)

100 mg MK0431 Anhydrous vs 100 mg MK0431 Monohydrate: Geometric Mean Ratio: 1.05 (90% CI 1.02 to 1.07)

Population analysed: Healthy Male and Female Subjects

Primary outcome: Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)

Time frame: Through 72 Hours Following the Administration of the Medication. Geometric mean (Standard Deviation). Unit: μmol/L

Measure	100 mg MK0431 Anhydrous n = 12	100 mg MK0431 Monohydrate n = 12
Value	799 (164)	856 (180)

100 mg MK0431 Anhydrous vs 100 mg MK0431 Monohydrate: Geometric Mean Ratio: 1.07 (90% CI 0.94 to 1.22)

Population analysed: Healthy Male and Female Subjects

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate	0 of 12 (0%)	3 of 12 (25%)	Not reported
100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous	0 of 12 (0%)	5 of 12 (41.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
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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 anhydrous formulation and Comparator: sitagliptin phosphate monohydrate form 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 5 inclusion and 4 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 19 Aug 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 Apr 2010). 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 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) (time frame: Through 72 Hours Following the Administration of the Medication). 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 NCT00944450.

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 19 Aug 2015.