Diabetes Mellitus, Non-Insulin-DependentPhase 1NCT00791661

MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005)

A Phase 1 study testing MK-1006 in people with Diabetes Mellitus, Non-Insulin-Dependent, 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 single rising dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-1006 in Japanese participants with Type 2 Diabetes Mellitus (T2DM). The primary hypothesis of the study is that single doses of MK-1006 will be sufficiently safe and well tolerated, based on the assessment of… Read more about this study

Who is it for?: Ages 20 to 64 years
Conditions the study is for: Diabetes Mellitus, Non-Insulin-Dependent
What is being tested?: MK-1006
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: No sites listed yet
Study dates: Nov 2008to Mar 2009
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 20 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Japanese male or female between 20 to 64 years of age
Diagnosis of type 2 diabetes
Patient is being treated with diet and exercise alone or single oral anti-hyperglycemic agent

Who cannot join

Subject has a history of type 1 diabetes mellitus
Subject has a clinical diagnosis of glaucoma
Subject has donated blood or participated in another clinical study in the past 12 weeks
Subject is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months

About this study

Official title: A Single Dose Clinical Trial to Study the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-1006 in Japanese Subject With Type 2 Diabetes

Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Being tested: MK-1006, Placebo
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.

MK-1006Drug
MK-1006 capsules in single oral doses beginning at 15 mg and rising to 45 mg in Panel A, beginning at 60 mg and rising to 80 mg and 60 mg fed state in Panel B, or beginning at 100 mg and rising to 170 mg in Panel C.
PlaceboDrug
Matching placebo to MK-1006 in a single oral dose

Study groups in NCT00791661
Study group	Role	What they receive
Panel A: MK-1006 15/30/45	Experimental	Participants received a single rising dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods. Receives: Drug: MK-1006; Drug: Placebo
Panel B: MK-1006 60/80/60 fed	Experimental	Participants received a single rising dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods. Receives: Drug: MK-1006; Drug: Placebo
Panel C: MK-1006 100/140/170	Experimental	Participants received a single rising dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods. Receives: Drug: MK-1006; Drug: Placebo

What is being measured

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

Number of Participants Who Experienced at Least One Adverse Event
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Measured: from the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to approximately 31 days)
Number of Participants Who Discontinued Treatment Due to an Adverse Event
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Measured: up to approximately 17 days

Secondary outcomes (6)

Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006
AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. The placebo group was not evaluated for this outcome measure.
Measured: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)
Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006
AUC(0 to 24 hours) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose. The placebo group was not evaluated for this outcome measure.
Measured: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)
Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006
The placebo group was not evaluated for this outcome measure.
Measured: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)
Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006
The placebo group was not evaluated for this outcome measure.
Measured: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)
Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006
The apparent half-life was defined as the time required for the plasma concentration of MK-1006 to decrease 50% in the final stage of its elimination. The means and standard deviations displayed as are the harmonic means and pseudo-standard deviations, respectively. The placebo group was not evaluated for this outcome measure.
Measured: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)
24-hour Weighted Mean Glucose (WMG) Concentration
Weighted mean glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24.
Measured: Up to 36 hours

Timeline

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

Nov 2008Mar 2009

First posted14 Nov 2008 (estimated)
Study startNov 2008
Primary completionMar 2009
Study completionMar 2009

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 Diabetes Mellitus, Non-Insulin-DependentStudies 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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00791661
Sponsor's protocol ID: 1006-005
Other IDs: 2008_584
Status last verified: Jan 2016
First submitted: 10 Nov 2008
Last updated: 7 Jan 2016
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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Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Dose Clinical Trial to Study the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-1006 in Japanese Subject With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00791661
Acronym / sponsor ID: 1006-005
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 14 Nov 2008 (estimated)
Results: Posted 10 Oct 2012

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: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Panel A: MK-1006 15/30/45	Experimental	Drug: MK-1006, Drug: PlaceboParticipants received a single rising dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
Panel B: MK-1006 60/80/60 fed	Experimental	Drug: MK-1006, Drug: PlaceboParticipants received a single rising dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
Panel C: MK-1006 100/140/170	Experimental	Drug: MK-1006, Drug: PlaceboParticipants received a single rising dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.

Who may qualify

Ages: 20 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Japanese male or female between 20 to 64 years of age
Diagnosis of type 2 diabetes
Patient is being treated with diet and exercise alone or single oral anti-hyperglycemic agent

Key exclusion criteria (4 listed)

Subject has a history of type 1 diabetes mellitus
Subject has a clinical diagnosis of glaucoma
Subject has donated blood or participated in another clinical study in the past 12 weeks
Subject is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months

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
MK-1006MK-1006 capsules in single oral doses beginning at 15 mg and rising to 45 mg in Panel A, beginning at 60 mg and rising to 80 mg and 60 mg fed state in Panel B, or beginning at 100 mg and rising to 170 mg in Panel C.	Drug	Panel A: MK-1006 15/30/45, Panel B: MK-1006 60/80/60 fed, Panel C: MK-1006 100/140/170
PlaceboMatching placebo to MK-1006 in a single oral dose	Drug	Panel A: MK-1006 15/30/45, Panel B: MK-1006 60/80/60 fed, Panel C: MK-1006 100/140/170

Primary outcome

Number of Participants Who Experienced at Least One Adverse Event
Time frame: from the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to approximately 31 days)
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Number of Participants Who Discontinued Treatment Due to an Adverse Event
Time frame: up to approximately 17 days
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.

6 secondary outcomes

Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006
Time frame: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)
Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006
Time frame: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)
Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006
Time frame: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)
Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006
Time frame: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)
Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006
Time frame: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)
24-hour Weighted Mean Glucose (WMG) Concentration
Time frame: Up to 36 hours

Results and safety

Results posted to the registry on 10 Oct 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
Panel A: MK-1006 15/30/45	8	8
Panel B: MK-1006 60/80/60 Fed	8	8
Panel C: MK-1006 100/140/170	8	8

Primary outcome: Number of Participants Who Experienced at Least One Adverse Event

Time frame: from the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to approximately 31 days). Number. Unit: participants

Measure	MK-1006 15 mg n = 6	MK-1006 30 mg n = 6	MK-1006 45 mg n = 6	MK-1006 60 mg n = 6	MK-1006 60 mg Fed n = 6	MK-1006 80 mg n = 6	MK-1006 100 mg n = 6	MK-1006 140 mg n = 4	MK-1006 170 mg n = 5	Placebo n = 15	Placebo Fed n = 2
Value	1	1	0	1	1	3	0	1	1	1	1

Population analysed: Participants who received study drug. The same participant may appear in more than one treatment arm.

Primary outcome: Number of Participants Who Discontinued Treatment Due to an Adverse Event

Time frame: up to approximately 17 days. Number. Unit: participants

Measure	MK-1006 15 mg n = 6	MK-1006 30 mg n = 6	MK-1006 45 mg n = 6	MK-1006 60 mg n = 6	MK-1006 60 mg Fed n = 6	MK-1006 80 mg n = 6	MK-1006 100 mg n = 6	MK-1006 140 mg n = 4	MK-1006 170 mg n = 5	Placebo n = 15	Placebo Fed n = 2
Value	0	0	0	0	0	0	1	0	0	0	0

Population analysed: Participants who received study drug. The same participant may appear in more than one treatment arm.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-1006 15 mg	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
MK-1006 30 mg	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
MK-1006 45 mg	0 of 6 (0%)	0 of 6 (0%)	Not reported
MK-1006 60 mg	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
MK-1006 60 mg Fed	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
MK-1006 80 mg	0 of 6 (0%)	3 of 6 (50%)	Not reported
MK-1006 100 mg	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
MK-1006 140 mg	0 of 4 (0%)	1 of 4 (25%)	Not reported
MK-1006 170 mg	0 of 5 (0%)	1 of 5 (20%)	Not reported
Placebo	0 of 15 (0%)	1 of 15 (6.7%)	Not reported
Placebo Fed	0 of 2 (0%)	1 of 2 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
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 MK-1006 in people with Diabetes Mellitus, Non-Insulin-Dependent, 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 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 7 Jan 2016. 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 10 Oct 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?

Number of Participants Who Experienced at Least One Adverse Event (time frame: from the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to approximately 31 days)). 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 NCT00791661.

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 7 Jan 2016.