Diabetes Mellitus, Type IIPhase 2NCT00482079
A Study of MK0431 in Patients With Type 2 Diabetes (0431-010)
A Phase 2 study testing MK0431, sitagliptin phosphate / Duration of Treatment: 21 Weeks in people with Diabetes Mellitus, Type II, run by Merck Sharp & Dohme LLC.
Trial summary
A dose-ranging study of MK0431 in patients with type 2 diabetes who have inadequate control of their blood sugar. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type II
- What is being tested?
- MK0431, sitagliptin phosphate / Duration of Treatment: 21 Weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 743 participants
- Where
- No sites listed yet
- Study dates
- 13 May 2003to 15 Jun 2006
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 to 70, You are a man or non-pregnant woman
Who cannot join
- Have a history of type I diabetes
- You are on a weight loss program with ongoing weight loss or taking weight loss medications
- You have a history of minor surgery
- You have received investigational drugs within 8 weeks of study start
- You have hepatitis B or C
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled Dose-Range Finding Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
A dose-ranging study of MK0431 in patients with type 2 diabetes who have inadequate control of their blood sugar.
- Conditions
- Diabetes Mellitus, Type II
- Being tested
- MK0431, sitagliptin phosphate / Duration of Treatment: 21 Weeks, Comparator: placebo (unspecified) / Duration of Treatment: 21 Weeks
- 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.
MK0431, sitagliptin phosphate / Duration of Treatment: 21 WeeksDrug
Comparator: placebo (unspecified) / Duration of Treatment: 21 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To asses the effectiveness of MK0431 compared to placebo
Measured: over 12 weeks
Secondary outcomes (1)
To test the safety and tolerability of MK0431 in patients with type 2 diabetes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2007 (estimated)
- Study start13 May 2003
- Primary completion25 Aug 2004
- Study completion15 Jun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type IIStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 743 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
- NCT00482079
- Sponsor's protocol ID
- 0431-010
- Other IDs
- 2007_578
- Status last verified
- Mar 2017
- First submitted
- 1 Jun 2007
- Last updated
- 28 Mar 2017
- Results posted
- No
Publications
Scott R, Wu M, Sanchez M, Stein P. Efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy over 12 weeks in patients with type 2 diabetes. Int J Clin Pract. 2007 Jan;61(1):171-80. doi: 10.1111/j.1742-1241.2006.01246.x. Epub 2006 Dec 5.
PubMed 17156104Ommen ES, Xu L, O'Neill EA, Goldstein BJ, Kaufman KD, Engel SS. Comparison of treatment with sitagliptin or sulfonylurea in patients with type 2 diabetes mellitus and mild renal impairment: a post hoc analysis of clinical trials. Diabetes Ther. 2015 Mar;6(1):29-40. doi: 10.1007/s13300-015-0098-y. Epub 2015 Jan 30.
PubMed 25633134
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled Dose-Range Finding Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
- ClinicalTrials.gov ID
- NCT00482079
- Acronym / sponsor ID
- 0431-010
- Conditions
- Diabetes Mellitus, Type II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 743 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 13 May 2003 (actual)
- Primary completion
- 25 Aug 2004 (actual)
- Study completion
- 15 Jun 2006 (actual)
- First posted
- 4 Jun 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 dose-ranging study of MK0431 in patients with type 2 diabetes who have inadequate control of their blood sugar.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 21 to 70, You are a man or non-pregnant woman
Key exclusion criteria (5 listed)
- Have a history of type I diabetes
- You are on a weight loss program with ongoing weight loss or taking weight loss medications
- You have a history of minor surgery
- You have received investigational drugs within 8 weeks of study start
- You have hepatitis B or C
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 |
|---|---|---|
| MK0431, sitagliptin phosphate / Duration of Treatment: 21 Weeks | Drug | – |
| Comparator: placebo (unspecified) / Duration of Treatment: 21 Weeks | Drug | – |
Primary outcome
To asses the effectiveness of MK0431 compared to placebo
Time frame: over 12 weeks
1 secondary outcome
To test the safety and tolerability of MK0431 in patients with type 2 diabetes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Background: PubMed 17156104Scott R, Wu M, Sanchez M, Stein P. Efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy over 12 weeks in patients with type 2 diabetes. Int J Clin Pract. 2007 Jan;61(1):171-80. doi: 10.1111/j.1742-1241.2006.01246.x. Epub 2006 Dec 5.
- Derived from this study: PubMed 25633134Ommen ES, Xu L, O'Neill EA, Goldstein BJ, Kaufman KD, Engel SS. Comparison of treatment with sitagliptin or sulfonylurea in patients with type 2 diabetes mellitus and mild renal impairment: a post hoc analysis of clinical trials. Diabetes Ther. 2015 Mar;6(1):29-40. doi: 10.1007/s13300-015-0098-y. Epub 2015 Jan 30.
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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 MK0431, sitagliptin phosphate / Duration of Treatment: 21 Weeks in people with Diabetes Mellitus, Type II, 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 1 inclusion and 5 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 28 Mar 2017. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To asses the effectiveness of MK0431 compared to placebo (time frame: over 12 weeks). 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 NCT00482079, which also lists 2 linked publications.
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 28 Mar 2017.