Single Doses of MK-0941 in Type 2 Diabetics (MK-0941-027)

A Phase 1 study testing MK-0941 in people with Type 2 Diabetes, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will evaluate the safety and tolerability of single doses of MK-0941 based on assessment of clinical and laboratory adverse experiences 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-0941
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 13 participants
Where: No sites listed yet
Study dates: Oct 2009to 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

Female participants of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control
Diagnosis of Type 2 Diabetes and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent
No treatment with three of more anti-hyperglycemic agents or any treatment regimen that includes insulin
In good health (except for Type 2 Diabetes)
Willingness to follow a specific diet throughout the study (consisting of 50% carbohydrates, 20%protein and 30% fat)
Nonsmoker

Who cannot join

History of stroke, chronic seizure or major neurological disorder
History of cancer
History of Type 1 Diabetes
Recent history of eye infection
Glaucoma or blindness
Eye surgery (by incision or laser) within the past three months

About this study

Official title: A Study of Higher Single Doses of MK-0941 in Type 2 Diabetics

This study will evaluate the safety and tolerability of single doses of MK-0941 based on assessment of clinical and laboratory adverse experiences

Conditions: Type 2 Diabetes
Being tested: MK-0941, Comparator: 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-0941Drug
A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period
Comparator: PlaceboDrug
a single oral placebo will be administered in the designated period (Periods 1-5)

Study groups in NCT01106287
Study group	Role	What they receive
Treatment Sequence 1	Experimental	Period 1: Placebo - Period 2: 80 mg - Period 3: 100 mg - Period 4: Placebo - Period 5: 140 mg Receives: Drug: MK-0941; Drug: Comparator: Placebo
Treatment Sequence 2	Experimental	Period 1: 60 mg - Period 2: 80 mg - Period 3: 100 mg - Period 4: 120 mg - Period 5: Placebo Receives: Drug: MK-0941; Drug: Comparator: Placebo
Treatment Sequence 3	Experimental	Period 1: 60 mg - Period 2: Placebo - Period 3: 100 mg - Period 4: 120 mg - Period 5: 140 mg Receives: Drug: MK-0941; Drug: Comparator: Placebo
Treatment Sequence 4	Experimental	Period 1: 60 mg - Period 2: 80 mg - Period 3: Placebo - Period 4: 120 mg - Period 5: 140 mg Receives: Drug: MK-0941; Drug: Comparator: Placebo

What is being measured

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

Number of Participants Who Experienced One or More Adverse Events During the Study
Measured: Up to 30 days after the last dose of study drug
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Only treatment-emergent adverse events were examined for this outcome measure.
Measured: Up to 6 weeks after the first dose of study drug

Timeline

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

Oct 2009Mar 2010

First posted19 Apr 2010 (estimated)
Study startOct 2009
Primary completionJan 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: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01106287
Sponsor's protocol ID: 0941-027
Other IDs: 2010_526, MK-0941-027
Status last verified: Feb 2016
First submitted: 16 Apr 2010
Last updated: 4 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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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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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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Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of Higher Single Doses of MK-0941 in Type 2 Diabetics
ClinicalTrials.gov ID: NCT01106287
Acronym / sponsor ID: 0941-027
Conditions: Type 2 Diabetes
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Jan 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 19 Apr 2010 (estimated)
Results: Posted 13 Dec 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 evaluate the safety and tolerability of single doses of MK-0941 based on assessment of clinical and laboratory adverse experiences

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Treatment Sequence 1	Experimental	Drug: MK-0941, Drug: Comparator: PlaceboPeriod 1: Placebo - Period 2: 80 mg - Period 3: 100 mg - Period 4: Placebo - Period 5: 140 mg
Treatment Sequence 2	Experimental	Drug: MK-0941, Drug: Comparator: PlaceboPeriod 1: 60 mg - Period 2: 80 mg - Period 3: 100 mg - Period 4: 120 mg - Period 5: Placebo
Treatment Sequence 3	Experimental	Drug: MK-0941, Drug: Comparator: PlaceboPeriod 1: 60 mg - Period 2: Placebo - Period 3: 100 mg - Period 4: 120 mg - Period 5: 140 mg
Treatment Sequence 4	Experimental	Drug: MK-0941, Drug: Comparator: PlaceboPeriod 1: 60 mg - Period 2: 80 mg - Period 3: Placebo - Period 4: 120 mg - Period 5: 140 mg

Who may qualify

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

Key inclusion criteria (6 listed)

Female participants of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control
Diagnosis of Type 2 Diabetes and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent
No treatment with three of more anti-hyperglycemic agents or any treatment regimen that includes insulin
In good health (except for Type 2 Diabetes)
Willingness to follow a specific diet throughout the study (consisting of 50% carbohydrates, 20%protein and 30% fat)

Key exclusion criteria (6 listed)

History of stroke, chronic seizure or major neurological disorder
History of cancer
History of Type 1 Diabetes
Recent history of eye infection
Glaucoma or blindness

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-0941A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period	Drug	Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4
Comparator: Placeboa single oral placebo will be administered in the designated period (Periods 1-5)	Drug	Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4

Primary outcome

Number of Participants Who Experienced One or More Adverse Events During the Study
Time frame: Up to 30 days after the last dose of study drug
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Time frame: Up to 6 weeks after the first dose of study drug
Only treatment-emergent adverse events were examined for this outcome measure.

Results and safety

Results posted to the registry on 13 Dec 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-0941 60/80/100/120 mg/Pbo	4	3
MK-0941 60/80 mg/Pbo/MK-0941 120/140 mg	3	3
MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg	3	3
Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg	3	3

Primary outcome: Number of Participants Who Experienced One or More Adverse Events During the Study

Time frame: Up to 30 days after the last dose of study drug. Number. Unit: participants

Measure	MK-0941 60 mg n = 10	MK-0941 80 mg n = 9	MK-0941 100 mg n = 9	MK-0941 120 mg n = 9	MK-0941 140 mg n = 9	Placebo n = 13
Adverse Event	2	6	4	9	4	5
Drug-Related Adverse Event	1	1	2	6	3	1

Population analysed: All participants receiving any dose of MK-0941 or placebo

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

Time frame: Up to 6 weeks after the first dose of study drug. Number. Unit: participants

Measure	MK-0941 60 mg n = 10	MK-0941 80 mg n = 9	MK-0941 100 mg n = 9	MK-0941 120 mg n = 9	MK-0941 140 mg n = 9	Placebo n = 13
Value	0	0	0	0	0	0

Population analysed: All participants receiving any dose of MK-0941 of placebo.

Adverse events

Time frame: Up to 30 days after the last dose of study drug. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-0941 60 mg	0 of 10 (0%)	2 of 10 (20%)	Not reported
MK-0941 80 mg	0 of 9 (0%)	6 of 9 (66.7%)	Not reported
MK-0941 100 mg	0 of 9 (0%)	4 of 9 (44.4%)	Not reported
MK-0941 120 mg	0 of 9 (0%)	9 of 9 (100%)	Not reported
MK-0941 140 mg	0 of 9 (0%)	4 of 9 (44.4%)	Not reported
Placebo	0 of 13 (0%)	4 of 13 (30.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Type 2 Diabetes

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
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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
Obesity, Overweight
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 MK-0941 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 6 inclusion and 6 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 4 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. 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 13 Dec 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 One or More Adverse Events During the Study (time frame: Up to 30 days after the last dose of study drug). 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 NCT01106287.

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 4 Feb 2016.