Type 2 DiabetesPhase 1NCT01640873
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002)
A Phase 1 study testing MK-8655 in people with Type 2 Diabetes, run by Merck Sharp & Dohme LLC.
Trial summary
This study will assess the initial safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-8655, after single and multiple daily oral administrations to participants with Type 2 Diabetes (T2DM). 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-8655
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 19 Sep 2012to 20 Dec 2012
- 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
- Male or female of non-child bearing potential
- Body Mass Index ≤40 kg/m^2
- Diagnosis of Type 2 Diabetes (T2DM) and is either drug naive or is being treated with metformin only
- In good health except for T2DM
- Willing to follow a standard diet
- Nonsmoker and/or no use of nicotine or nicotine-containing products for 6 months
Who cannot join
- Mentally or legally incapacitated
- History of stroke, chronic seizures, or major neurological disorder
- History of clinically significant endocrine (except T2DM), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- History of neoplastic or myeloproliferative diseases
- Has clinical unstable or rapidly progressing diabetic retinopathy, neuropathy, and/or frequent nausea, bloating or vomiting, severe gastroesophageal reflux or early satiety
- Has a history of Type 1 Diabetes and/or history of ketoacidosis
Show all 12Show fewer
- Use of any lipid-lowering therapies in the past 3 months
- Non-permitted medication for a co-morbid condition
- Excessive alcohol or caffeine use
- Participation in another investigational study within 4 weeks prior to this study
- A history of significant multiple and/or severe allergies or anaphylactic reactions
- Regular user of any illicit drugs or history of alcohol abuse within 6 months
About this study
Official title: A Randomized Double-Blind Placebo-Controlled Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Subjects With Type 2 Diabetes
This study will assess the initial safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-8655, after single and multiple daily oral administrations to participants with Type 2 Diabetes (T2DM). The study will assess the reduction in fasting plasma glucose concentrations from baseline after multiple daily administrations of MK-8655.
- Conditions
- Type 2 Diabetes
- Being tested
- MK-8655, Placebo
- Keywords
- Type 2 Diabetes
- 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-8655Drug
Participants will receive MK-8655 as a single dose on Day 1. Participants will receive MK-8655, once a day (q.d.), for 14 consecutive days (Day 3 through Day 16). MK-8655 doses may be adjusted downward based on the results of ongoing studies.
PlaceboDrug
Participants will receive Placebo as a single dose on Day 1. Participants will receive Placebo, q.d., for 14 consecutive days (Day 3 through Day 16).
| Study group | Role | What they receive |
|---|---|---|
| MK-8655 80 mg/MK-8655 320 mg | Experimental | Participants received a single dose of MK-8655, 80 mg on Day 1 and then MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days. Receives: Drug: MK-8655 |
| Placebo | Placebo comparator | Participants received a single dose of placebo to MK-8655, 80 mg on Day 1 and then placebo to MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With One or More Adverse Events
An adverse event 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 14 days after the last dose of study drug (Up to 31 days)
Number of Participants Discontinuing Study Drug Due to an Adverse Event
An adverse event 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 17 days
Fasting Plasma Glucose (FPG)
Blood for fasting plasma glucose (central laboratory) was obtained after at least 10 hours overnight fast.
Measured: Day 16 (Predose)
Secondary outcomes (3)
True Geometric Mean Plasma Concentrations of MK-8655 After Single and Multiple Drug Doses at 24 Hours Post Dose (C24)
C24hr was log transformed and analyzed based on a linear mixed effects model containing fixed effects for treatment, day and treatment by day interaction and a random effect for the participant.
Measured: 24 hours post dose on Days 1, 7, and 14
24-Hour Weighted Mean Glucose (WMG)
The WMG provides an integrated assessment of the glycemic exposure over the 24-hour period. To reduce variability of the baseline (before any study drug administration) WMG, participants were domiciled in the test facility at least 36 hours prior to Day 1, where standard meals were provided, and physical activity was monitored. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The sample scheme for the 18 point glucose measurements used in this study had many samples taken in the very early morning hours, as well as the first three hours after meals. WMG was calculated as the area under the curve (AUC) of the glucose concentrations divided by the duration of time of samples collected.
Measured: Day 15: Predose, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 18, 21, 23 hours post-dose.
Change From Baseline at 2 Hours Oral Glucose Tolerance Test
Plasma glucose excursion was assessed during an oral glucose tolerance test (oGTT) following a single dose administration of MK-8655 in participants with T2DM.
Measured: Baseline and 2 hours after dosing on Days 1, 3, and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study start19 Sep 2012
- Primary completion20 Dec 2012
- Study completion20 Dec 2012
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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640873
- Sponsor's protocol ID
- 8655-002
- Other IDs
- MK-8655-002
- Status last verified
- Apr 2018
- First submitted
- 12 Jul 2012
- Last updated
- 13 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Placebo-Controlled Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01640873
- Acronym / sponsor ID
- 8655-002
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2012 (actual)
- Primary completion
- 20 Dec 2012 (actual)
- Study completion
- 20 Dec 2012 (actual)
- First posted
- 16 Jul 2012 (estimated)
- Results
- Posted 13 Nov 2018
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 assess the initial safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-8655, after single and multiple daily oral administrations to participants with Type 2 Diabetes (T2DM). The study will assess the reduction in fasting plasma glucose concentrations from baseline after multiple daily administrations of MK-8655.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-8655 80 mg/MK-8655 320 mg | Experimental | Drug: MK-8655Participants received a single dose of MK-8655, 80 mg on Day 1 and then MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received a single dose of placebo to MK-8655, 80 mg on Day 1 and then placebo to MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female of non-child bearing potential
- Body Mass Index ≤40 kg/m^2
- Diagnosis of Type 2 Diabetes (T2DM) and is either drug naive or is being treated with metformin only
- In good health except for T2DM
- Willing to follow a standard diet
Key exclusion criteria (12 listed)
- Mentally or legally incapacitated
- History of stroke, chronic seizures, or major neurological disorder
- History of clinically significant endocrine (except T2DM), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- History of neoplastic or myeloproliferative diseases
- Has clinical unstable or rapidly progressing diabetic retinopathy, neuropathy, and/or frequent nausea, bloating or vomiting, severe gastroesophageal reflux or early satiety
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-8655Participants will receive MK-8655 as a single dose on Day 1. Participants will receive MK-8655, once a day (q.d.), for 14 consecutive days (Day 3 through Day 16). MK-8655 doses may be adjusted downward based on the results of ongoing studies. | Drug | MK-8655 80 mg/MK-8655 320 mg |
| PlaceboParticipants will receive Placebo as a single dose on Day 1. Participants will receive Placebo, q.d., for 14 consecutive days (Day 3 through Day 16). | Drug | Placebo |
Primary outcome
Number of Participants With One or More Adverse Events
Time frame: Up to 14 days after the last dose of study drug (Up to 31 days)
An adverse event 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.
Number of Participants Discontinuing Study Drug Due to an Adverse Event
Time frame: Up to 17 days
An adverse event 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.
Fasting Plasma Glucose (FPG)
Time frame: Day 16 (Predose)
Blood for fasting plasma glucose (central laboratory) was obtained after at least 10 hours overnight fast.
3 secondary outcomes
True Geometric Mean Plasma Concentrations of MK-8655 After Single and Multiple Drug Doses at 24 Hours Post Dose (C24)
Time frame: 24 hours post dose on Days 1, 7, and 14
24-Hour Weighted Mean Glucose (WMG)
Time frame: Day 15: Predose, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 18, 21, 23 hours post-dose.
Change From Baseline at 2 Hours Oral Glucose Tolerance Test
Time frame: Baseline and 2 hours after dosing on Days 1, 3, and 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- 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 Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-8655 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 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: finished, as of the sponsor's last update on 13 Nov 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 13 Nov 2018). 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 With One or More Adverse Events (time frame: Up to 14 days after the last dose of study drug (Up to 31 days)). 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?
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 13 Nov 2018; AzTrials last refreshed its copy on 8 Nov 2026.