Type 2 Diabetes MellitusPhase 2NCT00846391

A Study to Assess the Safety and Efficacy of MK8245 in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK8245-005 AM2)

A Phase 2 study testing MK8245 5 mg (twice a day) b.i.d. and MK8245 50 mg b.i.d. in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

Terminated

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

Official record

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Trial summary

A study to assess the safety and efficacy of MK8245 as monotherapy compared to placebo. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: MK8245 5 mg (twice a day) b.i.d. and MK8245 50 mg b.i.d.
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: No sites listed yet
Study dates: Dec 2008to Aug 2009
Phase: Phase 2
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

Have Type 2 Diabetes Mellitus
18 to 65 years of age

Who cannot join

History of Type 1 Diabetes or ketoacidosis
Have been treated with lipid lowering medications 4 weeks before starting the study
Have started on a weight loss program and not in the maintenance phase or have started weight loss medication within the last 12 weeks
Have had surgery in the last 30 days
History of active liver disease
History of coronary heart disease or congestive heart failure
Have had a stroke or transient ischemic neurological disorder in the past 6 months
Are Human Immunodeficiency Virus (HIV) Positive

About this study

Official title: A Phase IIa, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK8245 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control

A study to assess the safety and efficacy of MK8245 as monotherapy compared to placebo.

Conditions: Type 2 Diabetes Mellitus
Being tested: MK8245 5 mg (twice a day) b.i.d., MK8245 50 mg b.i.d., 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.

MK8245 5 mg (twice a day) b.i.d.Drug
Also called MK8245
All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily.
Patients randomized to the 5 mg b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
MK8245 50 mg b.i.d.Drug
Also called MK8245
All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily.
Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
PlaceboDrug
All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily.
Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.

Study groups in NCT00846391
Study group	Role	What they receive
MK8245 5 mg b.i.d.	Experimental	MK8245 Receives: Drug: MK8245 5 mg (twice a day) b.i.d.
MK8245 50 mg b.i.d.	Experimental	MK8245 Receives: Drug: MK8245 50 mg b.i.d.
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

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

Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4
The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A "weighted" rather than a "simple" mean is used to avoid overrepresentation of post-meal glucose values.
Blood samples for glucose were to be collected immediately prior to (sample -10 minutes), and 0, 15, 30, 60, 90, 120, and 180 minutes after each meal, and overnight (at midnight, 3 AM, and 5 AM) and fasting at 7 AM. Patients were to be domiciled for approximately 26 hours at the site where standard meals were provided and physical activity monitored.
Measured: Baseline and Week 4

Timeline

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

Dec 2008Aug 2009

First posted18 Feb 2009 (estimated)
Study startDec 2008
Primary completionAug 2009
Study completionAug 2009

Why it stopped: Study was terminated due to inability to recruit patients.

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00846391
Sponsor's protocol ID: 8245-005
Other IDs: 2009_541
Status last verified: Feb 2016
First submitted: 17 Feb 2009
Last updated: 5 Feb 2016
Results posted: Yes, on ClinicalTrials.gov

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 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIa, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK8245 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control
ClinicalTrials.gov ID: NCT00846391
Acronym / sponsor ID: 8245-005
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was terminated due to inability to recruit patients.
Enrolment: 14 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 18 Feb 2009 (estimated)
Results: Posted 21 Sep 2010

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 assess the safety and efficacy of MK8245 as monotherapy compared to placebo.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
MK8245 5 mg b.i.d.	Experimental	Drug: MK8245 5 mg (twice a day) b.i.d.MK8245
MK8245 50 mg b.i.d.	Experimental	Drug: MK8245 50 mg b.i.d.MK8245
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

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

Key inclusion criteria (2 listed)

Have Type 2 Diabetes Mellitus
18 to 65 years of age

Key exclusion criteria (8 listed)

History of Type 1 Diabetes or ketoacidosis
Have been treated with lipid lowering medications 4 weeks before starting the study
Have started on a weight loss program and not in the maintenance phase or have started weight loss medication within the last 12 weeks
Have had surgery in the last 30 days
History of active liver disease

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
MK8245 5 mg (twice a day) b.i.d.Also: MK8245All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily. Patients randomized to the 5 mg b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.	Drug	MK8245 5 mg b.i.d.
MK8245 50 mg b.i.d.Also: MK8245All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily. Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.	Drug	MK8245 50 mg b.i.d.
PlaceboAll patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily. Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.	Drug	Placebo

Primary outcome

Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4
Time frame: Baseline and Week 4
The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A "weighted" rather than a "simple" mean is used to avoid overrepresentation of post-meal glucose values. Blood samples for glucose were to be collected immediately prior to (sample -10 minutes), and 0, 15, 30, 60, 90, 120, and 180 minutes after each meal, and overnight (at midnight, 3 AM, and 5 AM) and fasting at 7 AM. Patients were to be domiciled for approximately 26 hours at the site where standard meals were provided and physical activity monitored.

Results and safety

Results posted to the registry on 21 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK8245 5 mg b.i.d.	4	3
MK8245 50 mg b.i.d.	4	2
Placebo	6	3

Primary outcome: Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4

Time frame: Baseline and Week 4. Mean (Standard Deviation). Unit: mg/dL

Measure	MK8245 5 mg b.i.d. n = 3	MK8245 50 mg b.i.d. n = 2	Placebo n = 3
Value	-18.9 (22.1)	18.7 (6.7)	-12.6 (1.4)

Population analysed: The analysis population included all patients with a baseline value and Week 4 value for this outcome.

Adverse events

Time frame: Adverse experiences were collected from Visit 2 (Week -6) through Visit 6 (Week 4). Serious adverse experiences were collected for up to 14 days after the last dose of study medication.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK8245 5 mg b.i.d.	0 of 4 (0%)	3 of 4 (75%)	Not reported
MK8245 50 mg b.i.d.	0 of 4 (0%)	1 of 4 (25%)	Not reported
Placebo	0 of 6 (0%)	3 of 6 (50%)	Not reported

Limitations and caveats (from the sponsor): This study was terminated due to the continuing inability to recruit patients. No efficacy analysis was performed because of insufficient sample size for meaningful analysis due to early study termination and insufficient sample size.

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.

Related trials for Type 2 Diabetes Mellitus

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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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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
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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 2 study testing MK8245 5 mg (twice a day) b.i.d. and MK8245 50 mg b.i.d. 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 2 inclusion and 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 21 Sep 2010). 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?

Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4 (time frame: Baseline and Week 4). 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 NCT00846391.

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.