Diabetes Mellitus, Type 2Phase 3NCT00543361
Study MK0767 and Metformin in Type 2 Diabetic Patients (0767-020)
A Phase 3 study testing MK0767 and Comparator: metformin in people with Diabetes Mellitus, Type 2, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of the study is to assess how MK0767, compared to Metformin, performs in lowering blood glucose levels in patients whose Type II diabetes is not controlled by diet and exercise. Read more about this study
- Who is it for?
- Ages 21 to 78 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- MK0767 and Comparator: metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 382 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Dec 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 21 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are men and non-pregnant women ages 21 to 78 years
- Patients either not on antihyperglycemic medications (>8 weeks), or being treated with a single oral antihyperglycemic agent \& willing to discontinue therapy for the duration of the study
Who cannot join
- Patient has history of type 1 diabetes mellitus and or history of ketoacidosis
- Patients undergoing surgery within 30 days of Visit 1
- Patients taking Warfin or Warfin-like anticoagulants
- Patients on a weight loss program with on-going weight loss or starting an intensive exercise program within 4 weeks of Visit 1/Week 9
About this study
Official title: A Double-Blind, Randomized, Active-Controlled MK0767 and Metformin Comparator Study in Type 2 Diabetic Patients Inadequately Controlled on Diet and Exercise
The purpose of the study is to assess how MK0767, compared to Metformin, performs in lowering blood glucose levels in patients whose Type II diabetes is not controlled by diet and exercise.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- MK0767, Comparator: placebo (unspecified), Comparator: metformin
- 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.
MK0767Drug
Duration of Treatment: 52 Weeks
Comparator: placebo (unspecified)Drug
Duration of Treatment: 52 Weeks
Comparator: metforminDrug
Duration of Treatment: 52 Weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
This study will assess the lipid lowering effectiveness of MK0767 compared to metformin over the course of 52 weeks.
Measured: over the course of 52 weeks
Secondary outcomes (1)
MK0767 will be safe and well tolerated.
Measured: over the course of 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2007 (estimated)
- Study startMay 2003
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 382 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
- NCT00543361
- Sponsor's protocol ID
- 0767-020
- Other IDs
- MK0767-020, 2007_627
- Status last verified
- Jun 2015
- First submitted
- 5 Oct 2007
- Last updated
- 12 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Active-Controlled MK0767 and Metformin Comparator Study in Type 2 Diabetic Patients Inadequately Controlled on Diet and Exercise
- ClinicalTrials.gov ID
- NCT00543361
- Acronym / sponsor ID
- 0767-020
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 15 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess how MK0767, compared to Metformin, performs in lowering blood glucose levels in patients whose Type II diabetes is not controlled by diet and exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 21 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients are men and non-pregnant women ages 21 to 78 years
- Patients either not on antihyperglycemic medications (>8 weeks), or being treated with a single oral antihyperglycemic agent \& willing to discontinue therapy for the duration of the study
Key exclusion criteria (4 listed)
- Patient has history of type 1 diabetes mellitus and or history of ketoacidosis
- Patients undergoing surgery within 30 days of Visit 1
- Patients taking Warfin or Warfin-like anticoagulants
- Patients on a weight loss program with on-going weight loss or starting an intensive exercise program within 4 weeks of Visit 1/Week 9
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 |
|---|---|---|
| MK0767Duration of Treatment: 52 Weeks | Drug | – |
| Comparator: placebo (unspecified)Duration of Treatment: 52 Weeks | Drug | – |
| Comparator: metforminDuration of Treatment: 52 Weeks | Drug | – |
Primary outcome
This study will assess the lipid lowering effectiveness of MK0767 compared to metformin over the course of 52 weeks.
Time frame: over the course of 52 weeks
1 secondary outcome
MK0767 will be safe and well tolerated.
Time frame: over the course of 52 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
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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 3 study testing MK0767 and Comparator: metformin in people with Diabetes Mellitus, Type 2, 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 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: stopped early, as of the sponsor's last update on 12 Jun 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
This study will assess the lipid lowering effectiveness of MK0767 compared to metformin over the course of 52 weeks. (time frame: over the course of 52 weeks). 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 Jun 2015.