Type 2 Diabetes MellitusPhase 1NCT00972322

Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012)

A Phase 1 study testing MK-8245 in people with Type 2 Diabetes Mellitus, 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 assess the safety, tolerability, pharmacokinetics, and glucose lowering activity of MK-8245 in participants with type 2 diabetes. The primary hypothesis of the study is that after 4 weeks of treatment, MK-8245 produces a greater reduction in 24 hour weighted mean glucose (WMG) from baseline than… 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?: MK-8245
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: No sites listed yet
Study dates: 24 Aug 2009to 26 Jan 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

Subject has a diagnosis of type 2 diabetes and is being treated with diet and exercise alone, a single oral anti-hyperglycemic agent or a combination of two oral anti-hyperglycemic agents
Subject is willing to follow a weight-maintaining diet and exercise program during the study
Subject is a nonsmoker or is willing to limit smoking to 10 cigarettes per day while in the clinical research unit

Who cannot join

Subject has a history of stroke, chronic seizures, or major neurological disorder
Subject has a history of cancer, except certain skin and cervical cancers or cancer that was successfully treated 10 or more years prior to screening
Subject has a history of type 1 diabetes
Subject has used contact lenses within the last 6 months
Subject has used any lipid-lowering therapy in the last 3 months, except statins, Zetia, or Vytorin
Subject has more than 3 alcoholic beverages per day
Subject has more than 6 servings of caffeine a day
Subject has participated in a previous MK8245 study

About this study

Official title: A Placebo-Controlled Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacokinetics of MK-8245 in Subjects With Type 2 Diabetes

Conditions: Type 2 Diabetes Mellitus
Being tested: MK-8245, 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-8245Drug
MK-8245 50 mg twice daily for 28 days
Comparator: placeboDrug
matching placebo to MK-8245 twice daily for 28 days

Study groups in NCT00972322
Study group	Role	What they receive
MK-8245 50 mg	Experimental	MK-8245, 50 mg, twice daily for 28 days Receives: Drug: MK-8245
Placebo	Placebo comparator	Placebo to MK-8245, 50 mg, twice daily Receives: Drug: Comparator: placebo

What is being measured

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

Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)
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 collected immediately prior to, and after each meal, and overnight and fasting one hour pre-dose.
Measured: Baseline and Day 28
Number of Participants Who Experienced Serious or Non-serious Adverse Events
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. A serious AE is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Measured: Up to Day 31
Number of Participants Discontinuing Study Drug Due to an AE
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Measured: Up to Day 28

Timeline

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

24 Aug 200926 Jan 2010

First posted4 Sep 2009 (estimated)
Study start24 Aug 2009
Primary completion12 Jan 2010
Study completion26 Jan 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 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00972322
Sponsor's protocol ID: 8245-012
Other IDs: MK-8245-012, 2009_655
Status last verified: Aug 2018
First submitted: 3 Sep 2009
Last updated: 10 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Placebo-Controlled Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacokinetics of MK-8245 in Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00972322
Acronym / sponsor ID: 8245-012
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 24 Aug 2009 (actual)
Primary completion: 12 Jan 2010 (actual)
Study completion: 26 Jan 2010 (actual)
First posted: 4 Sep 2009 (estimated)
Results: Posted 12 Jun 2014

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: 2

Arm	Type	Receives
MK-8245 50 mg	Experimental	Drug: MK-8245MK-8245, 50 mg, twice daily for 28 days
Placebo	Placebo comparator	Drug: Comparator: placeboPlacebo to MK-8245, 50 mg, twice daily

Who may qualify

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

Key inclusion criteria (3 listed)

Subject has a diagnosis of type 2 diabetes and is being treated with diet and exercise alone, a single oral anti-hyperglycemic agent or a combination of two oral anti-hyperglycemic agents
Subject is willing to follow a weight-maintaining diet and exercise program during the study
Subject is a nonsmoker or is willing to limit smoking to 10 cigarettes per day while in the clinical research unit

Key exclusion criteria (8 listed)

Subject has a history of stroke, chronic seizures, or major neurological disorder
Subject has a history of cancer, except certain skin and cervical cancers or cancer that was successfully treated 10 or more years prior to screening
Subject has a history of type 1 diabetes
Subject has used contact lenses within the last 6 months
Subject has used any lipid-lowering therapy in the last 3 months, except statins, Zetia, or Vytorin

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-8245MK-8245 50 mg twice daily for 28 days	Drug	MK-8245 50 mg
Comparator: placebomatching placebo to MK-8245 twice daily for 28 days	Drug	Placebo

Primary outcome

Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)
Time frame: Baseline and Day 28
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 collected immediately prior to, and after each meal, and overnight and fasting one hour pre-dose.
Number of Participants Who Experienced Serious or Non-serious Adverse Events
Time frame: Up to Day 31
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. A serious AE is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Number of Participants Discontinuing Study Drug Due to an AE
Time frame: Up to Day 28
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Results and safety

Results posted to the registry on 12 Jun 2014, 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-8245 100 mg	28	25
Placebo	28	25

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

Time frame: Baseline and Day 28. Least squares mean (Standard Deviation). Unit: mg/dL

Measure	MK-8245 100 mg n = 25	Placebo n = 26
Value	11.0 (27.6)	-4.4 (31.7)

MK-8245 100 mg vs Placebo: Mean Difference (Final Values): -15.34 (90% CI -29.87 to -0.82), p = 0.083, Least Squares Means Difference

Population analysed: All participants who were compliant with the study procedures and have available data from at least one treatment were included in the primary analysis dataset.

Primary outcome: Number of Participants Who Experienced Serious or Non-serious Adverse Events

Time frame: Up to Day 31. Number. Unit: Participants

Measure	MK-8245 100 mg n = 28	Placebo n = 28
Serious Adverse Events	0	0
Non-Serious Adverse Events	16	10

Population analysed: All participants who received at least one dose of the investigational drug.

Primary outcome: Number of Participants Discontinuing Study Drug Due to an AE

Time frame: Up to Day 28. Number. Unit: Participants

Measure	MK-8245 100 mg n = 28	Placebo n = 28
Value	2	1

Population analysed: All participants who received at least one dose of the investigational drug.

Adverse events

Time frame: Up to Day 31. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-8245 100 mg	0 of 28 (0%)	16 of 28 (57.1%)	Not reported
Placebo	0 of 28 (0%)	8 of 28 (28.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Type 2 Diabetes Mellitus

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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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Recruiting
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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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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-8245 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 3 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: finished, as of the sponsor's last update on 10 Sep 2018. 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 12 Jun 2014). 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 the 24-hour Weighted Mean Glucose (WMG) (time frame: Baseline and Day 28). The study lists 3 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 NCT00972322.

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 10 Sep 2018.