Type 2 Diabetes MellitusPhase 1NCT00567112

Study to Evaluate the Pharmacokinetics & Food Effect of MK-0941 in Adults With Type 2 Diabetes (MK-0941-009)

A Phase 1 study testing 10 mg MK-0941 DFC (fasted), 10 mg MK-0941 OCT (after meal) and 10 mg MK-0941 OCT (before meal) 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

A study to compare the pharmacokinetics (PK) of the dry filled capsule (DFC) \& oral compressed tablet (OCT) formulations of MK-0941-009 \& to assess the effect of food on the OCT formulation. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: 10 mg MK-0941 DFC (fasted), 10 mg MK-0941 OCT (after meal) and 10 mg MK-0941 OCT (before meal)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: No sites listed yet
Study dates: Nov 2007to Apr 2008
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females (of non-childbearing potential) between the ages of 18 to 70
Participants have been diagnosed with Type 2 Diabetes
Participants are nonsmokers for at least 6 months

Who cannot join

Participant should not be diagnosed with Type 1 diabetes
Participant should not be receiving insulin or PPAR gamma agonists for 12 weeks prior to study start
Participant has a recent history of eye infection or other inflammatory eye condition within 2 weeks prior to study start
Participant has been diagnosed with glaucoma or is blind
Participant has had trauma to one or both eyes
Participant has had major surgery, donated blood or participated in another clinical study in the past 4 weeks
Participant is a regular user of illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months

About this study

Official title: An Open-Label, Randomized, Partially Fixed-Sequence, 4-Period Crossover Study to Assess the Pharmacokinetics After Administration of the DFC and OCT Formulations and the Food Effect on the OCT Formulation of MK-0941 in Patients With Type 2 Diabetes

A study to compare the pharmacokinetics (PK) of the dry filled capsule (DFC) \& oral compressed tablet (OCT) formulations of MK-0941-009 \& to assess the effect of food on the OCT formulation.

Conditions: Type 2 Diabetes Mellitus
Being tested: 10 mg MK-0941 DFC (fasted), 10 mg MK-0941 OCT (after meal), 10 mg MK-0941 OCT (before meal), 10 mg MK-0941 OCT (fasted)
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.

10 mg MK-0941 DFC (fasted)Drug
single dose of 10 mg MK-0941 dry filled capsules (DFC) administered in a fasted state
10 mg MK-0941 OCT (after meal)Drug
single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered after consumption of a high-fat meal
10 mg MK-0941 OCT (before meal)Drug
single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered before consumption of a standard breakfast
10 mg MK-0941 OCT (fasted)Drug
single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered in a fasted state

Study groups in NCT00567112
Study group	Role	What they receive
DFC (fasted)	Experimental	Not described Receives: Drug: 10 mg MK-0941 DFC (fasted)
OCT (fasted)	Experimental	Not described Receives: Drug: 10 mg MK-0941 OCT (fasted)
OCT (after meal)	Experimental	Not described Receives: Drug: 10 mg MK-0941 OCT (after meal)
OCT (before meal)	Active comparator	Not described Receives: Drug: 10 mg MK-0941 OCT (before meal)

What is being measured

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

Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted)
Measured: From study drug administration to 72 hours post-administration
Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted)
Measured: From study drug administration to 72 hours post-administration
Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted)
Measured: From study drug administration to 72 hours post-administration
Half Life (t½) for OCT (Fasted) and DFC (Fasted)
Measured: From study drug administration to 72 hours post-administration

Secondary outcomes (4)

AUC(0-∞) for OCT (Fasted) and OCT (After Meal)
Measured: From study drug administration to 72 hours post-administration
Cmax of OCT (Fasted) and OCT (After Meal)
Measured: From study drug administration to 72 hours post-administration
Tmax for OCT (Fasted) and OCT (After Meal)
Measured: From study drug administration to 72 hours post-administration
t1/2 for OCT (Fasted) and OCT (After Meal)
Measured: From study drug administration to 72 hours post-administration

Timeline

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

Nov 2007Apr 2008

First posted4 Dec 2007 (estimated)
Study startNov 2007
Primary completionFeb 2008
Study completionApr 2008

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: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00567112
Sponsor's protocol ID: 0941-009
Other IDs: 2007_652, MK-0941-009
Status last verified: Mar 2015
First submitted: 30 Nov 2007
Last updated: 23 Mar 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 Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized, Partially Fixed-Sequence, 4-Period Crossover Study to Assess the Pharmacokinetics After Administration of the DFC and OCT Formulations and the Food Effect on the OCT Formulation of MK-0941 in Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00567112
Acronym / sponsor ID: 0941-009
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Feb 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 4 Dec 2007 (estimated)
Results: Posted 5 Sep 2012

Clinical summary

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

A study to compare the pharmacokinetics (PK) of the dry filled capsule (DFC) \& oral compressed tablet (OCT) formulations of MK-0941-009 \& to assess the effect of food on the OCT formulation.

Study design

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

Arm	Type	Receives
DFC (fasted)	Experimental	Drug: 10 mg MK-0941 DFC (fasted)
OCT (fasted)	Experimental	Drug: 10 mg MK-0941 OCT (fasted)
OCT (after meal)	Experimental	Drug: 10 mg MK-0941 OCT (after meal)
OCT (before meal)	Active comparator	Drug: 10 mg MK-0941 OCT (before meal)

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Males or females (of non-childbearing potential) between the ages of 18 to 70
Participants have been diagnosed with Type 2 Diabetes
Participants are nonsmokers for at least 6 months

Key exclusion criteria (7 listed)

Participant should not be diagnosed with Type 1 diabetes
Participant should not be receiving insulin or PPAR gamma agonists for 12 weeks prior to study start
Participant has a recent history of eye infection or other inflammatory eye condition within 2 weeks prior to study start
Participant has been diagnosed with glaucoma or is blind
Participant has had trauma to one or both eyes

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
10 mg MK-0941 DFC (fasted)single dose of 10 mg MK-0941 dry filled capsules (DFC) administered in a fasted state	Drug	DFC (fasted)
10 mg MK-0941 OCT (after meal)single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered after consumption of a high-fat meal	Drug	OCT (after meal)
10 mg MK-0941 OCT (before meal)single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered before consumption of a standard breakfast	Drug	OCT (before meal)
10 mg MK-0941 OCT (fasted)single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered in a fasted state	Drug	OCT (fasted)

Primary outcome

Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted)
Time frame: From study drug administration to 72 hours post-administration
Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted)
Time frame: From study drug administration to 72 hours post-administration
Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted)
Time frame: From study drug administration to 72 hours post-administration
Half Life (t½) for OCT (Fasted) and DFC (Fasted)
Time frame: From study drug administration to 72 hours post-administration

4 secondary outcomes

AUC(0-∞) for OCT (Fasted) and OCT (After Meal)
Time frame: From study drug administration to 72 hours post-administration
Cmax of OCT (Fasted) and OCT (After Meal)
Time frame: From study drug administration to 72 hours post-administration
Tmax for OCT (Fasted) and OCT (After Meal)
Time frame: From study drug administration to 72 hours post-administration
t1/2 for OCT (Fasted) and OCT (After Meal)
Time frame: From study drug administration to 72 hours post-administration

Results and safety

Results posted to the registry on 5 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Group ABCD	7	7
Treatment Group BACD	8	8
Treatment Group BCD	0	0

Primary outcome: Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted)

Time frame: From study drug administration to 72 hours post-administration. Least squares mean (Full Range). Unit: nM*hr

Measure	OCT (Fasted) n = 18	DFC (Fasted) n = 14
Value	763.76 (579.52 to 1681.47)	776.41 (470.04 to 1698.00)

OCT (Fasted) vs DFC (Fasted): Geometric Mean Ratio: 0.98 (90% CI 0.92 to 1.05), p >0.200, ANOVA

Population analysed: Participants with AUC(0-∞) measurements

Primary outcome: Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted)

Time frame: From study drug administration to 72 hours post-administration. Least squares mean (Full Range). Unit: nM

Measure	OCT (Fasted) n = 18	DFC (Fasted) n = 15
Value	241.37 (96.84 to 607.42)	246.92 (78.17 to 539.93)

OCT (Fasted) vs DFC (Fasted): Geometric Mean Ratio: 0.98 (90% CI 0.80 to 1.19), p >0.200, ANOVA

Population analysed: Participants with Cmax measurements

Primary outcome: Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted)

Time frame: From study drug administration to 72 hours post-administration. Median (Full Range). Unit: hours

Measure	OCT (Fasted) n = 18	DFC (Fasted) n = 15
Value	1.00 (0.50 to 4.00)	1.00 (0.20 to 1.50)

OCT (Fasted) vs DFC (Fasted): p >0.200, ANOVA

Population analysed: Participants with Tmax measurements

Primary outcome: Half Life (t½) for OCT (Fasted) and DFC (Fasted)

Time frame: From study drug administration to 72 hours post-administration. Median (Full Range). Unit: hours

Measure	OCT (Fasted) n = 18	DFC (Fasted) n = 14
Value	9.85 (3.90 to 27.00)	8.05 (5.30 to 38.40)

OCT (Fasted) vs DFC (Fasted): p >0.200, ANOVA

Population analysed: Participants with t1/2 measurements

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug administration through to 72 hours post-administration. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OCT (Fasted)	0 of 18 (0%)	6 of 18 (33.3%)	Not reported
OCT (After Meal)	0 of 17 (0%)	7 of 17 (41.2%)	Not reported
OCT (Before Meal)	0 of 14 (0%)	3 of 14 (21.4%)	Not reported
DFC (Fasted)	0 of 15 (0%)	4 of 15 (26.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 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?

A Phase 1 study testing 10 mg MK-0941 DFC (fasted), 10 mg MK-0941 OCT (after meal) and 10 mg MK-0941 OCT (before meal) 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 3 inclusion and 7 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 23 Mar 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 5 Sep 2012). 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-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted) (time frame: From study drug administration to 72 hours post-administration). The study lists 4 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 NCT00567112.

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 23 Mar 2015.