Diabetes Mellitus, Non-Insulin-DependentPhase 1NCT00754130
MK-0941 Multiple Dose Study in Japanese Patients With Type 2 Diabetes (MK-0941-011).
A Phase 1 study testing MK-0941 in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Merck Sharp & Dohme LLC.
Trial summary
The multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-0941 in Japanese patients with Type 2 Diabetes. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Non-Insulin-Dependent
- 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
- 16 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Oct 2008
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese Male or Female between 20 to 65 years of age
- Diagnosis of Type 2 Diabetes
- Patient being treated by diet and exercise alone
Who cannot join
- Patient has a history of Type 1 Diabetes
- Patient is being treated with glaucoma medications
- Patient has donated blood or participated in another clinical study in the past 12 weeks
- Patient is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse
About this study
Official title: A Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0941 in Japanese Patients With Type 2 Diabetes
The multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-0941 in Japanese patients with Type 2 Diabetes.
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Being tested
- Placebo, MK-0941
- 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.
PlaceboDrug
Placebo tablets before every meal (q.a.c) Treatment period is 5 days.
MK-0941Drug
MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo/MK-0941 20mg | Experimental | Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. Receives: Drug: Placebo; Drug: MK-0941 |
| MK-0941 5mg/Placebo | Experimental | Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods. Receives: Drug: Placebo; Drug: MK-0941 |
| MK-0941 5mg/MK-0941 20mg | Experimental | Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. Receives: Drug: MK-0941 |
| Placebo/MK-0941 40mg | Experimental | Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. Receives: Drug: Placebo; Drug: MK-0941 |
| MK-0941 10mg/Placebo | Experimental | Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods. Receives: Drug: Placebo; Drug: MK-0941 |
| MK-0941 10mg/MK-0941 40mg | Experimental | Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. Receives: Drug: MK-0941 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced at Least One Adverse Event (AE)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
Measured: Up to 14 days after last dose of study drug
Number of Participants Who Discontinued Study Drug Due to an AE
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
Measured: Up to 14 days after last dose of study drug
Secondary outcomes (6)
Plasma Pharmacokinetic Parameter: Area Under the Concentration-time Curve (AUC)(0-24hr) of MK-0941
Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.
Measured: Up to 72 hours after study drug administration
Plasma Pharmacokinetic Parameter: Maximum Concentration (Cmax) of MK-0941
Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.
Measured: Up to 72 hours after study drug administration
Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941
Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.
Measured: Up to 72 hours after study drug administration
Plasma Pharmacokinetic Parameter: Concentration of MK-0941 at 24 Hours (C24hr)
Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.
Measured: Up to 72 hours after study drug administration
Plasma Pharmacokinetic Parameter: Apparent Terminal Elimination Half-life (t1/2) of MK-0941
Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.
Measured: Up to 72 hours after study drug administration
Plasma Pharmacokinetic Parameter: Day 5 to Day 1 Accumulation Ratio for AUC (0-24hr), Cmax, and C24hr
Geometric Mean of the Day 5 to Day 1 Accumulation Ratio
Measured: Day 5 and Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionOct 2008
- Study completionOct 2008
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 Diabetes Mellitus, Non-Insulin-DependentStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754130
- Sponsor's protocol ID
- 0941-011
- Other IDs
- 2008_023, MK-0941-011
- Status last verified
- Feb 2015
- First submitted
- 16 Sep 2008
- Last updated
- 12 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0941 in Japanese Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00754130
- Acronym / sponsor ID
- 0941-011
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 17 Sep 2008 (estimated)
- Results
- Posted 3 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-0941 in Japanese patients with Type 2 Diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo/MK-0941 20mg | Experimental | Drug: Placebo, Drug: MK-0941Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. |
| MK-0941 5mg/Placebo | Experimental | Drug: Placebo, Drug: MK-0941Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods. |
| MK-0941 5mg/MK-0941 20mg | Experimental | Drug: MK-0941Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. |
| Placebo/MK-0941 40mg | Experimental | Drug: Placebo, Drug: MK-0941Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. |
| MK-0941 10mg/Placebo | Experimental | Drug: Placebo, Drug: MK-0941Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods. |
| MK-0941 10mg/MK-0941 40mg | Experimental | Drug: MK-0941Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Japanese Male or Female between 20 to 65 years of age
- Diagnosis of Type 2 Diabetes
- Patient being treated by diet and exercise alone
Key exclusion criteria (4 listed)
- Patient has a history of Type 1 Diabetes
- Patient is being treated with glaucoma medications
- Patient has donated blood or participated in another clinical study in the past 12 weeks
- Patient is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse
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 |
|---|---|---|
| PlaceboPlacebo tablets before every meal (q.a.c) Treatment period is 5 days. | Drug | MK-0941 10mg/Placebo, MK-0941 5mg/Placebo, Placebo/MK-0941 20mg, Placebo/MK-0941 40mg |
| MK-0941MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days. | Drug | MK-0941 10mg/MK-0941 40mg, MK-0941 10mg/Placebo, MK-0941 5mg/MK-0941 20mg, MK-0941 5mg/Placebo, Placebo/MK-0941 20mg, Placebo/MK-0941 40mg |
Primary outcome
Number of Participants Who Experienced at Least One Adverse Event (AE)
Time frame: Up to 14 days after last dose of study drug
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
Number of Participants Who Discontinued Study Drug Due to an AE
Time frame: Up to 14 days after last dose of study drug
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
6 secondary outcomes
Plasma Pharmacokinetic Parameter: Area Under the Concentration-time Curve (AUC)(0-24hr) of MK-0941
Time frame: Up to 72 hours after study drug administration
Plasma Pharmacokinetic Parameter: Maximum Concentration (Cmax) of MK-0941
Time frame: Up to 72 hours after study drug administration
Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941
Time frame: Up to 72 hours after study drug administration
Plasma Pharmacokinetic Parameter: Concentration of MK-0941 at 24 Hours (C24hr)
Time frame: Up to 72 hours after study drug administration
Plasma Pharmacokinetic Parameter: Apparent Terminal Elimination Half-life (t1/2) of MK-0941
Time frame: Up to 72 hours after study drug administration
Plasma Pharmacokinetic Parameter: Day 5 to Day 1 Accumulation Ratio for AUC (0-24hr), Cmax, and C24hr
Time frame: Day 5 and Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2015.
- 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 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 Diabetes Mellitus, Non-Insulin-Dependent, 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 4 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 12 Mar 2015. 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 3 Oct 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 at Least One Adverse Event (AE) (time frame: Up to 14 days after 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?
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 12 Mar 2015.