Diabetes Mellitus, Type 2Phase 3NCT00519142
Mitiglinide in Combination With Metformin vs. Metformin Alone in Patients With Type 2 Diabetes Mellitus
A Phase 3 study testing mitiglinide in people with Diabetes Mellitus, Type 2, run by Elixir Pharmaceuticals at 61 sites in 2 countries.
Trial summary
The primary objective of this study is to demonstrate whether mitiglinide administered in combination with metformin is more effective than metformin alone in patients with Type 2 diabetes mellitus (T2DM) whose blood sugar is not well controlled taking metformin alone. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- mitiglinide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 367 participants
- Where
- 61 sitesin 2 countries
- Study dates
- Aug 2007to Oct 2008
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes diagnosed for at least 6 months
- stable metformin usage for at least 4 months
- HbA1c 7.5% - 10.5% inclusive
- no severe diabetic complications
Who cannot join
- chronic insulin use
- use of oral diabetic agent within 12 weeks
- acute or chronic conditions, excluding diabetes, that could compromise end point evaluation
Trial locations and contacts
61 sites in 2 countries.
61 sites in 2 countries
United States57 sites
Elixir Study Site
Akron, Ohio
Elixir Study Site
Atlanta, Georgia, 30080
Elixir Study Site
Austell, Georgia
Elixir Study Site(s)
Chicago, Illinois
Elixir Study Site
Chiefland, Florida, 32626
Elixir Study Site
Cincinnati, Ohio
Elixir Study Site
Columbia, South Carolina
Elixir Study Site
Coral Gables, Florida
Elixir Study Site(s)
Dallas, Texas
Elixir Study Site
El Paso, Texas
Elixir Study Site
Federal Way, Washington
Elixir Study Site(s)
Fort Worth, Texas
Elixir Study Site
Gallipolis, Ohio
Elixir Study Site
Glendale, Arizona
Elixir Study Site
Greenbrae, California
Elixir Study Site
Hamilton, New Jersey
Elixir Study Site
Harleysville, Pennsylvania
Elixir Study Site
Hillsborough, New Jersey
Elixir Study Site(s)
Houston, Texas
Elixir Study Site
Humble, Texas
Elixir Study Site
Kansas City, Missouri, 64132
Elixir Study Site
Kettering, Ohio
Elixir Study Site
Kissimmee, Florida
Elixir Study Site
La Jolla, California
Elixir Study Site
Las Vegas, Nevada
Elixir Study Site
Levittown, Pennsylvania
Elixir Study Site
Los Angeles, California
Elixir Study Site
Los Gatos, California
Elixir Study Site
Medford, Oregon
Elixir Study Site
Memphis, Tennessee
Elixir Study Site(s)
Miami, Florida
Elixir Study Site
Midland, Texas
Elixir Study Site
Mooresville, North Carolina
Elixir Study Site
Morehead City, North Carolina
Elixir Study Site
New Braunfels, Texas
Elixir Study Site(s)
New York, New York
Elixir Study Site
Norfolk, Virginia
Elixir Study Site
North Richland Hills, Texas
Elixir Study Site(s)
Oakland Area, California
Elixir Study Site
Orange, California
Elixir Study Site
Pearland, Texas
Elixir Study Site
Perry, Georgia
Elixir Study Site
Plano, Texas, 75074
Elixir Study Site
Pueblo, Colorado
Elixir Study Site
Saint Cloud, Florida
Elixir Study Site(s)
San Antonio, Texas
Elixir Study Site
Sewell, New Jersey
Elixir Study Site
Simpsonville, South Carolina
Elixir Study Site
St Louis, Missouri, 63110
Elixir Study Site
Temple, Texas
Elixir Study Site
Tullahoma, Tennessee
Elixir Study Site
Uniontown, Pennsylvania
Elixir Study Site(s)
Washington D.C., District of Columbia
Elixir Study Site
West Hills, California, 91307
Elixir Study Site
Westlake Village, California
Elixir Study Site
Wichita, Kansas
Elixir Study Site
Winter Park, Florida
Puerto Rico4 sites
Elixir Study Site
Carolina, 00983
Elixir Study Site
Fajardo, 00738
Elixir Study Site(s)
Ponce
Elixir Study Site(s)
San Juan
About this study
Official title: A Rapid Onset and Short Duration Insulin Secretogogue, Mitiglinide, in Combination With Metformin Versus Metformin Alone in Patients With Type 2 Diabetes Mellitus: A Randomized, Double-blind, Placebo-controlled Trial for 6 Months
The primary objective of this study is to demonstrate whether mitiglinide administered in combination with metformin is more effective than metformin alone in patients with Type 2 diabetes mellitus (T2DM) whose blood sugar is not well controlled taking metformin alone. This is a 24 week study which measures improvement in blood sugar after of treatment.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the efficacy and safety of mitiglinide in combination with metformin in patients with T2DM who are less than adequately controlled on metformin alone. Patients who are receiving metformin alone for T2DM will be randomized equally into one of three treatment groups.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- placebo for mitiglinide, mitiglinide
- 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.
placebo for mitiglinideDrug
three times a day with meals
mitiglinideDrug
three times a day with meals
mitiglinideDrug
two times a day with meals
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | metformin + placebo for mitiglinide Receives: Drug: placebo for mitiglinide |
| 2 | Experimental | metformin + mitiglinide three times a day with meals Receives: Drug: mitiglinide |
| 3 | Experimental | metformin + mitiglinide two times a day with morning and evening meal, placebo for mitiglinide with midday meal Receives: Drug: mitiglinide |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in HbA1c
Measured: after 24 weeks of treatment
Secondary outcomes (2)
change from baseline in 2-hour post-prandial glucose
Measured: after 24 weeks of treatment
change from baseline in fasting plasma glucose
Measured: after 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionOct 2008
- Study completionOct 2008
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.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elixir Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paul Martha, MD, Study director, Elixir Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519142
- Sponsor's protocol ID
- EX-1510-CT-003
- Status last verified
- Sep 2009
- First submitted
- 20 Aug 2007
- Last updated
- 17 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Rapid Onset and Short Duration Insulin Secretogogue, Mitiglinide, in Combination With Metformin Versus Metformin Alone in Patients With Type 2 Diabetes Mellitus: A Randomized, Double-blind, Placebo-controlled Trial for 6 Months
- ClinicalTrials.gov ID
- NCT00519142
- Acronym / sponsor ID
- EX-1510-CT-003
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Elixir PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 22 Aug 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 primary objective of this study is to demonstrate whether mitiglinide administered in combination with metformin is more effective than metformin alone in patients with Type 2 diabetes mellitus (T2DM) whose blood sugar is not well controlled taking metformin alone. This is a 24 week study which measures improvement in blood sugar after of treatment.
Detailed description
This is a randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the efficacy and safety of mitiglinide in combination with metformin in patients with T2DM who are less than adequately controlled on metformin alone. Patients who are receiving metformin alone for T2DM will be randomized equally into one of three treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placebo for mitiglinidemetformin + placebo for mitiglinide |
| 2 | Experimental | Drug: mitiglinidemetformin + mitiglinide three times a day with meals |
| 3 | Experimental | Drug: mitiglinidemetformin + mitiglinide two times a day with morning and evening meal, placebo for mitiglinide with midday meal |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- type 2 diabetes diagnosed for at least 6 months
- stable metformin usage for at least 4 months
- HbA1c 7.5% - 10.5% inclusive
- no severe diabetic complications
Key exclusion criteria (3 listed)
- chronic insulin use
- use of oral diabetic agent within 12 weeks
- acute or chronic conditions, excluding diabetes, that could compromise end point evaluation
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 |
|---|---|---|
| placebo for mitiglinidethree times a day with meals | Drug | 1 |
| mitiglinidethree times a day with meals | Drug | 2 |
| mitiglinidetwo times a day with meals | Drug | 3 |
Primary outcome
change from baseline in HbA1c
Time frame: after 24 weeks of treatment
2 secondary outcomes
change from baseline in 2-hour post-prandial glucose
Time frame: after 24 weeks of treatment
change from baseline in fasting plasma glucose
Time frame: after 24 weeks of treatment
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 17 Sep 2009.
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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.
Paul Martha, MD study director
Elixir Pharmaceuticals
61 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mitiglinide in people with Diabetes Mellitus, Type 2, run by Elixir Pharmaceuticals at 61 sites in 2 countries.
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 4 inclusion and 3 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 17 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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 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?
change from baseline in HbA1c (time frame: after 24 weeks of treatment). 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 17 Sep 2009.