A Multiple-Dose Study of MK-1006 (MK-1006-004)(TERMINATED)

A Phase 1 study testing MK-1006 in people with Type 2 Diabetes, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This study will asses the safety, tolerability, multiple-dose pharmacokinetics and pharmacodynamics of MK1006 in participants with type 2 diabetes. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Type 2 Diabetes
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: 112 participants
Where: No sites listed yet
Study dates: Aug 2008to Mar 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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant has a BMI less than or equal to 42 kg/m^2 at the screening visit
Participant has been diagnosed with Type 2 Diabetes that is being treated either by diet and exercise alone or by single or combination oral anti-hyperglycemic medications
Participant is willing to follow a diet containing approximately 50% carbohydrates, 20% protein, and 30% fat during the study
Participant is a nonsmoker and has not used nicotine containing products for ~ 6 months before start of study

Who cannot join

Participant must not be treated with three or more oral anti-hyperglycemic medications, insulin, or PPAR-gamma agonists
Participant has a history of stroke, chronic seizures, or a major neurological disorder
Participant has had an eye infection or other inflammatory eye condition within 2 weeks of first dose of study drug
Participant has glaucoma or is blind
Participant has a condition known to be related to cataract development
Participant has had or will have incisional eye surgery within 6 months before screening or has had laser surgery (other than Lasik) within 3 months of screening

Show all 12Show fewer

Participant has a history of type 1 diabetes or ketoacidosis
Participant cannot stop taking certain current medications during the study
Participant consumes greater than 3 alcoholic beverages per day
Participant consumes more than 6 servings of caffeinated beverages per day (1 serving is ~ 120 mg caffeine)
Participant has a history of significant multiple or severe allergies or has had a reaction to or is intolerant of prescription/non-prescription drugs or food
Participant uses recreational drugs or has had a history of drug abuse within 6 months of start of study

About this study

Official title: A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1006.

This study will asses the safety, tolerability, multiple-dose pharmacokinetics and pharmacodynamics of MK1006 in participants with type 2 diabetes.

Conditions: Type 2 Diabetes
Being tested: MK-1006, Comparator: Placebo comparator
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 (10 mg and 20 mg) administered orally from 20 mg to 120 mg per dose over a multiple dosing period.
Comparator: Placebo comparatorDrug
Dose-matched MK-1006 placebo capsules (1 mg, 10 mg and 20 mg) administered orally over a multiple dosing period.

Study groups in NCT00758680
Study group	Role	What they receive
MK-1006 20 mg Once Daily (Panel A)	Experimental	After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU). Receives: Drug: MK-1006
MK-1006 40 mg Once Daily (Panel B)	Experimental	After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU. Receives: Drug: MK-1006
MK-1006 80 mg Once Daily (Panel C)	Experimental	After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU. Receives: Drug: MK-1006
MK-1006 120 mg Once Daily (Panel D)	Experimental	After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU. Receives: Drug: MK-1006
MK-1006 20 mg Twice Daily (Panel E)	Experimental	After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU. Receives: Drug: MK-1006
MK-1006 30 mg Twice Daily (Panel F)	Experimental	After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU. Receives: Drug: MK-1006
MK-1006 50 mg Twice Daily (Panel G)	Experimental	After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU. Receives: Drug: MK-1006
MK-1006 120 mg Once Daily Outpatient (Panel H)	Experimental	After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients. Receives: Drug: MK-1006
MK-1006 50 mg Twice Daily Outpatient (Panel I)	Experimental	After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients. Receives: Drug: MK-1006
Placebo	Placebo comparator	After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU. Receives: Drug: Comparator: Placebo comparator

What is being measured

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

Number of Participants Experiencing Adverse Events (AEs) On Study
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.
Measured: From Day 1 through the end of poststudy period (up to Day 25)
Number of Participants Who Discontinued Treatment Due to an AE
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.
Measured: From Day 1 through the end of poststudy period (up to Day 25)

Secondary outcomes (1)

Least Squares Mean Change From Baseline in 24-Hour Weighted Mean Glucose (WMG)
Plasma glucose concentration was determined using a glucometer and measured before drug was given to establish a baseline fasting plasma glucose concentration. Plasma glucose concentrations were then measured every ~30 minutes over a 24 hour period after the Day 1 dose (First Dosing Day) and after the Day 10 dose (Last Dosing Day) to obtain a weighted mean average value for Day 1 and for Day 10. Results were expressed as the change from baseline to the Day 1 weighted average (First Dosing Day), and as the change from baseline to the Day 10 weighted average (Last Dosing Day).
Measured: Day -1 (pre-dose baseline), Day 1 (First Dosing Day), Day 10 (Last Dosing Day)

Timeline

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

Aug 2008Mar 2010

First posted25 Sep 2008 (estimated)
Study startAug 2008
Primary completionMar 2010
Study completionMar 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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00758680
Sponsor's protocol ID: 1006-004
Other IDs: 2008_550
Status last verified: Feb 2016
First submitted: 23 Sep 2008
Last updated: 5 Feb 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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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1006.
ClinicalTrials.gov ID: NCT00758680
Acronym / sponsor ID: 1006-004
Conditions: Type 2 Diabetes
Phase: Phase 1
Study type: Interventional
Recruitment status: Terminated
Enrolment: 112 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 25 Sep 2008 (estimated)
Results: Posted 28 Aug 2012

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 asses the safety, tolerability, multiple-dose pharmacokinetics and pharmacodynamics of MK1006 in participants with type 2 diabetes.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 10

Arm	Type	Receives
MK-1006 20 mg Once Daily (Panel A)	Experimental	Drug: MK-1006After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
MK-1006 40 mg Once Daily (Panel B)	Experimental	Drug: MK-1006After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
MK-1006 80 mg Once Daily (Panel C)	Experimental	Drug: MK-1006After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
MK-1006 120 mg Once Daily (Panel D)	Experimental	Drug: MK-1006After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
MK-1006 20 mg Twice Daily (Panel E)	Experimental	Drug: MK-1006After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
MK-1006 30 mg Twice Daily (Panel F)	Experimental	Drug: MK-1006After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
MK-1006 50 mg Twice Daily (Panel G)	Experimental	Drug: MK-1006After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
MK-1006 120 mg Once Daily Outpatient (Panel H)	Experimental	Drug: MK-1006After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
MK-1006 50 mg Twice Daily Outpatient (Panel I)	Experimental	Drug: MK-1006After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
Placebo	Placebo comparator	Drug: Comparator: Placebo comparatorAfter a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Participant has a BMI less than or equal to 42 kg/m^2 at the screening visit
Participant has been diagnosed with Type 2 Diabetes that is being treated either by diet and exercise alone or by single or combination oral anti-hyperglycemic medications
Participant is willing to follow a diet containing approximately 50% carbohydrates, 20% protein, and 30% fat during the study
Participant is a nonsmoker and has not used nicotine containing products for ~ 6 months before start of study

Key exclusion criteria (12 listed)

Participant must not be treated with three or more oral anti-hyperglycemic medications, insulin, or PPAR-gamma agonists
Participant has a history of stroke, chronic seizures, or a major neurological disorder
Participant has had an eye infection or other inflammatory eye condition within 2 weeks of first dose of study drug
Participant has glaucoma or is blind
Participant has a condition known to be related to cataract development

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 (10 mg and 20 mg) administered orally from 20 mg to 120 mg per dose over a multiple dosing period.	Drug	MK-1006 120 mg Once Daily (Panel D), MK-1006 120 mg Once Daily Outpatient (Panel H), MK-1006 20 mg Once Daily (Panel A), MK-1006 20 mg Twice Daily (Panel E), MK-1006 30 mg Twice Daily (Panel F), MK-1006 40 mg Once Daily (Panel B), MK-1006 50 mg Twice Daily (Panel G), MK-1006 50 mg Twice Daily Outpatient (Panel I), MK-1006 80 mg Once Daily (Panel C)
Comparator: Placebo comparatorDose-matched MK-1006 placebo capsules (1 mg, 10 mg and 20 mg) administered orally over a multiple dosing period.	Drug	Placebo

Primary outcome

Number of Participants Experiencing Adverse Events (AEs) On Study
Time frame: From Day 1 through the end of poststudy period (up to Day 25)
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.
Number of Participants Who Discontinued Treatment Due to an AE
Time frame: From Day 1 through the end of poststudy period (up to Day 25)
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.

1 secondary outcome

Least Squares Mean Change From Baseline in 24-Hour Weighted Mean Glucose (WMG)
Time frame: Day -1 (pre-dose baseline), Day 1 (First Dosing Day), Day 10 (Last Dosing Day)

Results and safety

Results posted to the registry on 28 Aug 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
MK-1006 20 mg Once Daily (Panel A)	6	6
MK-1006 40 mg Once Daily (Panel B)	6	6
MK-1006 80 mg Once Daily (Panel C)	6	6
MK-1006 120 mg Once Daily (Panel D)	6	6
MK-1006 20 mg Twice Daily (Panel E)	6	6
MK-1006 30 mg Twice Daily (Panel F)	6	6
MK-1006 50 mg Twice Daily (Panel G)	7	6
MK-1006 120 mg Once Daily Outpatient (Panel H)	20	19
MK-1006 50 mg Twice Daily Outpatient (Panel I)	20	18
Placebo	29	28

Primary outcome: Number of Participants Experiencing Adverse Events (AEs) On Study

Time frame: From Day 1 through the end of poststudy period (up to Day 25). Number. Unit: participants

Measure	MK-1006 20 mg Once Daily (Panel A) n = 6	MK-1006 40 mg Once Daily (Panel B) n = 6	MK-1006 80 mg Once Daily (Panel C) n = 6	MK-1006 120 mg Once Daily (Panel D) n = 6	MK-1006 20 mg Twice Daily (Panel E) n = 6	MK-1006 30 mg Twice Daily (Panel F) n = 6	MK-1006 50 mg Twice Daily (Panel G) n = 7	MK-1006 120 mg Once Daily Outpatient (Panel H) n = 20	MK-1006 50 mg Twice Daily Outpatient (Panel I) n = 20	Placebo n = 29
Value	1	1	4	5	4	4	6	15	16	22

Population analysed: All Participants as Treated (APaT); All participants who received at least one dose of the investigational drug

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

Time frame: From Day 1 through the end of poststudy period (up to Day 25). Number. Unit: participants

Measure	MK-1006 20 mg Once Daily (Panel A) n = 6	MK-1006 40 mg Once Daily (Panel B) n = 6	MK-1006 80 mg Once Daily (Panel C) n = 6	MK-1006 120 mg Once Daily (Panel D) n = 6	MK-1006 20 mg Twice Daily (Panel E) n = 6	MK-1006 30 mg Twice Daily (Panel F) n = 6	MK-1006 50 mg Twice Daily (Panel G) n = 7	MK-1006 120 mg Once Daily Outpatient (Panel H) n = 20	MK-1006 50 mg Twice Daily Outpatient (Panel I) n = 20	Placebo n = 29
Value	0	0	0	0	0	0	0	1	1	1

Population analysed: All Participants as Treated (APaT); All participants who received at least one dose of the investigational drug

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-1006 20 mg Once Daily (Panel A)	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
MK-1006 40 mg Once Daily (Panel B)	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
MK-1006 80 mg Once Daily (Panel C)	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
MK-1006 120 mg Once Daily (Panel D)	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
MK-1006 20 mg Twice Daily (Panel E)	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
MK-1006 30 mg Twice Daily (Panel F)	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
MK-1006 50 mg Twice Daily (Panel G)	0 of 7 (0%)	6 of 7 (85.7%)	Not reported
MK-1006 120 mg Once Daily Outpatient (Panel H)	1 of 20 (5%)	15 of 20 (75%)	Not reported
MK-1006 50 mg Twice Daily Outpatient (Panel I)	0 of 20 (0%)	16 of 20 (80%)	Not reported
Placebo	1 of 29 (3.4%)	22 of 29 (75.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 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 Type 2 Diabetes, 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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 5 Feb 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. Some participants in this study may receive a placebo. 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 28 Aug 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 Experiencing Adverse Events (AEs) On Study (time frame: From Day 1 through the end of poststudy period (up to Day 25)). 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 NCT00758680.

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 5 Feb 2016.