Diabetes Mellitus Type 2Phase 2NCT00543959
Efficacy and Tolerability of MK0533 in Patients With Type 2 Diabetes (0533-005)
A Phase 2 study testing MK0533 and Comparator: pioglitazone in people with Diabetes Mellitus Type 2, run by Merck Sharp & Dohme LLC.
Trial summary
A study to evaluate the effectiveness and tolerability of MK0533 and pioglitazone in patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- MK0533 and Comparator: pioglitazone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 346 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Aug 2007
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18 to 70 years with Type 2 diabetes who have not been able to adequately control their blood glucose levels
- Note: Only patients who have not been taking any antihyperglycemic medicine for 3 months will be screened
Who cannot join
- Patients taking any medicines that affect body fluid level such as a diuretic or water pill
- Patients taking niacin or other certain medications
- Patients with any of the following conditions: liver or kidney disease, poorly controlled high blood pressure, heart disease or certain blood disorders
- Patients with abnormal laboratory results from a blood test that will be given before each patient starts the study
About this study
Official title: An Efficacy and Tolerability Study of MK0533 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
A study to evaluate the effectiveness and tolerability of MK0533 and pioglitazone in patients with type 2 diabetes mellitus.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- MK0533, Comparator: Placebo (unspecified), Comparator: pioglitazone
- 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.
MK0533Drug
Initially a 12-wk study of MK0533 30mg, switching at week 12 to a study of daily administration MK0533 5mg, MK0533 15mg, MK0533 30mg. Study period is a total of 24-wks.
Comparator: Placebo (unspecified)Drug
MK0533 Placebo; MK0533 5mg; MK0533 15mg; MK0533 30mg. Study period is a total of 24 wks.
Comparator: pioglitazoneDrug
pioglitazone 45mg. Study period is a total of 24 wks.
| Study group | Role | What they receive |
|---|---|---|
| Part1 - Arm 1 | Experimental | Part1: Arm 1: drug Receives: Drug: MK0533 |
| Part1 - Arm 2 | Placebo comparator | Part1 - Arm 2: Pbo comparator Receives: Drug: Comparator: Placebo (unspecified) |
| Part 2 - Arm 1 | Placebo comparator | Part 2 - Arm 1: Pbo Receives: Drug: Comparator: Placebo (unspecified) |
| Part 2 - Arm 2 | Experimental | Part 2- Arm 2: drug 5mg Receives: Drug: MK0533 |
| Part 2 - Arm 3 | Experimental | Part 2 - Arm 3: drug 15mg Receives: Drug: MK0533 |
| Part 2 - Arm 4 | Experimental | Part 2 - Arm 4: drug 30mg Receives: Drug: MK0533 |
| Part 2 - Arm 5 | Active comparator | Part 2 - Arm 5: active comparator Receives: Drug: Comparator: pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fluid gain from baseline after 12 weeks
Measured: 12 weeks
Secondary outcomes (1)
Fasting plasma glucose after 12 weeks
Measured: 12 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 startJun 2006
- Primary completionAug 2007
- Study completionAug 2007
Why it stopped: This study is being discontinued based on data suggesting that none of the doses tested demonstrated both glycemic \& body fluid benefits vs. the comparitor
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 346 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
- NCT00543959
- Sponsor's protocol ID
- 0533-005
- Other IDs
- MK0533-005, 2007_544
- Status last verified
- Jun 2015
- First submitted
- 5 Oct 2007
- Last updated
- 23 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy and Tolerability Study of MK0533 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
- ClinicalTrials.gov ID
- NCT00543959
- Acronym / sponsor ID
- 0533-005
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study is being discontinued based on data suggesting that none of the doses tested demonstrated both glycemic \& body fluid benefits vs. the comparitor
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (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.
A study to evaluate the effectiveness and tolerability of MK0533 and pioglitazone in patients with type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part1 - Arm 1 | Experimental | Drug: MK0533Part1: Arm 1: drug |
| Part1 - Arm 2 | Placebo comparator | Drug: Comparator: Placebo (unspecified)Part1 - Arm 2: Pbo comparator |
| Part 2 - Arm 1 | Placebo comparator | Drug: Comparator: Placebo (unspecified)Part 2 - Arm 1: Pbo |
| Part 2 - Arm 2 | Experimental | Drug: MK0533Part 2- Arm 2: drug 5mg |
| Part 2 - Arm 3 | Experimental | Drug: MK0533Part 2 - Arm 3: drug 15mg |
| Part 2 - Arm 4 | Experimental | Drug: MK0533Part 2 - Arm 4: drug 30mg |
| Part 2 - Arm 5 | Active comparator | Drug: Comparator: pioglitazonePart 2 - Arm 5: active comparator |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between the ages of 18 to 70 years with Type 2 diabetes who have not been able to adequately control their blood glucose levels
- Note: Only patients who have not been taking any antihyperglycemic medicine for 3 months will be screened
Key exclusion criteria (4 listed)
- Patients taking any medicines that affect body fluid level such as a diuretic or water pill
- Patients taking niacin or other certain medications
- Patients with any of the following conditions: liver or kidney disease, poorly controlled high blood pressure, heart disease or certain blood disorders
- Patients with abnormal laboratory results from a blood test that will be given before each patient starts the study
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 |
|---|---|---|
| MK0533Initially a 12-wk study of MK0533 30mg, switching at week 12 to a study of daily administration MK0533 5mg, MK0533 15mg, MK0533 30mg. Study period is a total of 24-wks. | Drug | Part 2 - Arm 2, Part 2 - Arm 3, Part 2 - Arm 4, Part1 - Arm 1 |
| Comparator: Placebo (unspecified)MK0533 Placebo; MK0533 5mg; MK0533 15mg; MK0533 30mg. Study period is a total of 24 wks. | Drug | Part 2 - Arm 1, Part1 - Arm 2 |
| Comparator: pioglitazonepioglitazone 45mg. Study period is a total of 24 wks. | Drug | Part 2 - Arm 5 |
Primary outcome
Body fluid gain from baseline after 12 weeks
Time frame: 12 weeks
1 secondary outcome
Fasting plasma glucose after 12 weeks
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: This study is being discontinued based on data suggesting that none of the doses tested demonstrated both glycemic \& body fluid benefits vs. the comparitor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 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 2 study testing MK0533 and Comparator: pioglitazone 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 23 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. 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?
The study was stopped early (reason given: This study is being discontinued based on data suggesting that none of the doses tested demonstrated both glycemic \& body fluid benefits vs. the comparitor). 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?
Body fluid gain from baseline after 12 weeks (time frame: 12 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 23 Jun 2015.