CompletedNCT01106287Updated Feb 4, 2016Results posted

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

A Phase 1 interventional study of MK-0941 and Comparator: Placebo in Type 2 Diabetes, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-02-04.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 13
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

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

Conditions studied

Type 2 Diabetes

In context

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 13 participants (actual)

Study arms

Experimental
Treatment Sequence 1
Period 1: Placebo - Period 2: 80 mg - Period 3: 100 mg - Period 4: Placebo - Period 5: 140 mg
Drug: MK-0941 · Drug: Comparator: Placebo
Experimental
Treatment Sequence 2
Period 1: 60 mg - Period 2: 80 mg - Period 3: 100 mg - Period 4: 120 mg - Period 5: Placebo
Drug: MK-0941 · Drug: Comparator: Placebo
Experimental
Treatment Sequence 3
Period 1: 60 mg - Period 2: Placebo - Period 3: 100 mg - Period 4: 120 mg - Period 5: 140 mg
Drug: MK-0941 · Drug: Comparator: Placebo
Experimental
Treatment Sequence 4
Period 1: 60 mg - Period 2: 80 mg - Period 3: Placebo - Period 4: 120 mg - Period 5: 140 mg
Drug: MK-0941 · Drug: Comparator: Placebo

Interventions

DrugMK-0941
A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period
DrugComparator: Placebo
a single oral placebo will be administered in the designated period (Periods 1-5)

What researchers measure

Primary outcomes

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
Only treatment-emergent adverse events were examined for this outcome measure.
Time frame: Up to 6 weeks after the first dose of study drug

Results

Posted Dec 13, 2012

Participant flow

Participant flow — Overall Study
Milestone	MK-0941 60/80/100/120 mg/Pbo	MK-0941 60/80 mg/Pbo/MK-0941 120/140 mg	MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg	Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg
Started	4	3	3	3
Completed	3	3	3	3
Not completed	1	0	0	0
Withdrew: Adverse event	1	0	0	0

Outcome measures

PrimaryNumber 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
Reported as:: Number · participants

Number of Participants Who Experienced One or More Adverse Events During the Study
participants	MK-0941 60 mg	MK-0941 80 mg	MK-0941 100 mg	MK-0941 120 mg	MK-0941 140 mg	Placebo
Adverse Event	2	6	4	9	4	5
Drug-Related Adverse Event	1	1	2	6	3	1

PrimaryNumber of Participants Who Discontinued Study Drug Due to an Adverse Event

Only treatment-emergent adverse events were examined for this outcome measure.

Time frame:: Up to 6 weeks after the first dose of study drug
Reported as:: Number · participants

Number of Participants Who Discontinued Study Drug Due to an Adverse Event
participants	MK-0941 60 mg	MK-0941 80 mg	MK-0941 100 mg	MK-0941 120 mg	MK-0941 140 mg	Placebo
Number of Participants Who Discontinued Study Drug Due to an Adverse Event	0	0	0	0	0	0

Adverse events

Collected over Up to 30 days after the last dose of study drug. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
MK-0941 60 mg	—	0/10 (0%)	2/10 (20%)
MK-0941 80 mg	—	0/9 (0%)	6/9 (66.7%)
MK-0941 100 mg	—	0/9 (0%)	4/9 (44.4%)
MK-0941 120 mg	—	0/9 (0%)	9/9 (100%)
MK-0941 140 mg	—	0/9 (0%)	4/9 (44.4%)
Placebo	—	0/13 (0%)	4/13 (30.8%)

Most frequent other events

Showing 10 of 29

Most frequent other events
Event	MK-0941 60 mg	MK-0941 80 mg	MK-0941 100 mg	MK-0941 120 mg	MK-0941 140 mg	Placebo
HypoglycaemiaMetabolism and nutrition disorders	1/10	1/9	1/9	3/9	0/9	0/13
Blood glucose increasedInvestigations	0/10	3/9	0/9	1/9	0/9	1/13
Dry mouthGastrointestinal disorders	0/10	0/9	0/9	2/9	0/9	0/13
NauseaGastrointestinal disorders	0/10	0/9	0/9	2/9	0/9	1/13
HeadacheNervous system disorders	0/10	0/9	0/9	2/9	1/9	0/13
Ear painEar and labyrinth disorders	0/10	0/9	0/9	1/9	0/9	0/13
TinnitusEar and labyrinth disorders	0/10	0/9	0/9	1/9	0/9	0/13
ConstipationGastrointestinal disorders	0/10	1/9	0/9	1/9	0/9	0/13
VomitingGastrointestinal disorders	0/10	0/9	0/9	1/9	0/9	0/13
Application site irritationGeneral disorders	0/10	1/9	0/9	0/9	0/9	1/13

Baseline characteristics

Age, Continuous
Age, Continuous(years)	MK-0941 60/80/100/120 mg/Pbo	MK-0941 60/80/Pbo/ MK-0941 120/140 mg	MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg	Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg	Total
Mean	45.5 ± 7.19	55.0 ± 7.81	54.7 ± 12.10	52.3 ± 7.51	51.4 ± 8.64

Sex: Female, Male
Sex: Female, Male(Participants)	MK-0941 60/80/100/120 mg/Pbo	MK-0941 60/80/Pbo/ MK-0941 120/140 mg	MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg	Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg	Total
Female	0	2	2	2	6
Male	4	1	1	1	7

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01106287
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Apr 19, 2010
Start date: Oct 2009
Primary completion: Jan 2010
Completion: Mar 2010
Results posted: Dec 13, 2012
Last update: Feb 4, 2016

Study contacts

Medical Monitor

study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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