Diabetes Mellitus, Non-Insulin-DependentPhase 2NCT00065312
An Evaluation of an Oral Antidiabetic Agent for the Treatment of Type 2 Diabetes
A Phase 2 study testing naveglitazar in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Eli Lilly and Company at 42 sites in United States.
Trial summary
The purpose of this study is to determine if an investigational drug is safe and efficacious for poorly controlled 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, Non-Insulin-Dependent
- What is being tested?
- naveglitazar
- How many people
- Not given
- Where
- 42 sitesUnited States
- Study dates
- Start not givento not given
- 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
- Diagnosis of Type 2 Diabetes for at least 3 months.
- Diabetes managed with diet and exercise alone or with either metformin or sulfonylurea alone as an adjunct to diet and exercise.
- Diabetes therapy must be unchanged for at least 3 months prior to screening.
- Females must be of non-childbearing potential (surgically sterilized or at least 1 year post-menopausal, as defined by cessation of menses). Female patients who are not surgically sterilized and who are less than or equal to 45 years should have their post-menopausal status confirmed by FSH greater that 30ng/mL at screening.
Who cannot join
- Current use of insulin or any antidiabetic agent other than a sulfonylurea agent or metformin.
- Current use of metformin or a sulfonylurea agent in combination.
- History of liver disease.
- History of unstable angina (as defined by the Braunwald system), myocardial infarction, or a coronary revascularization procedure within the past 6 months.
- Currently suspected carcinoma or history of carcinoma in the last 5 years, with the exception of excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
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Allentown, Pennsylvania
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Bakersfield, California
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Baltimore, Maryland
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Birmingham, Alabama
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Charlotte, North Carolina
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Clearwater, Florida
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Decatur, Georgia
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Denver, Colorado
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Edina, Minnesota
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Endwell, New York
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Eugene, Oregon
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Evansville, Indiana
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Fayetteville, North Carolina
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Fleetwood, Pennsylvania
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Great Neck, New York
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Honolulu, Hawaii
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Huntsville, Alabama
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Kissimmee, Florida
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Lansdale, Pennsylvania
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Lebanon, Virginia
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Little Rock, Arkansas
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Louisville, Kentucky
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Minneapolis, Minnesota
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Mt. Pleasant, South Carolina
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Ocala, Florida
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Oklahoma City, Oklahoma
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Orland Park, Illinois
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Peoria, Arizona
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Peoria, Illinois
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Philadelphia, Pennsylvania
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Pico Rivera, California
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Renton, Washington
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Salt Lake City, Utah
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San Antonio, Texas
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San Diego, California
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Santa Ana, California
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Spokane, Washington
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St. Petersburg, Florida
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Tucson, Arizona
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Waterbury, Connecticut
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West Hartford, Connecticut
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Wichita, Kansas
About this study
The purpose of this study is to determine if an investigational drug is safe and efficacious for poorly controlled type 2 diabetes mellitus.
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Being tested
- naveglitazar
- Keywords
- Type 2 diabetes
- 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.
naveglitazarDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2003 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Non-Insulin-DependentStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065312
- Sponsor's protocol ID
- 5837
- Other IDs
- H7R-MC-GCBD
- Status last verified
- Jul 2006
- First submitted
- 21 Jul 2003
- Last updated
- 19 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of an Oral Antidiabetic Agent for the Treatment of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00065312
- Acronym / sponsor ID
- 5837
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Keywords
- Type 2 diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- First posted
- 22 Jul 2003 (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 this study is to determine if an investigational drug is safe and efficacious for poorly controlled type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Type 2 Diabetes for at least 3 months.
- Diabetes managed with diet and exercise alone or with either metformin or sulfonylurea alone as an adjunct to diet and exercise.
- Diabetes therapy must be unchanged for at least 3 months prior to screening.
- Females must be of non-childbearing potential (surgically sterilized or at least 1 year post-menopausal, as defined by cessation of menses). Female patients who are not surgically sterilized and who are less than or equal to 45 years should have their post-menopausal status confirmed by FSH greater that 30ng/mL at screening.
Key exclusion criteria (5 listed)
- Current use of insulin or any antidiabetic agent other than a sulfonylurea agent or metformin.
- Current use of metformin or a sulfonylurea agent in combination.
- History of liver disease.
- History of unstable angina (as defined by the Braunwald system), myocardial infarction, or a coronary revascularization procedure within the past 6 months.
- Currently suspected carcinoma or history of carcinoma in the last 5 years, with the exception of excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.
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 |
|---|---|---|
| naveglitazar | Drug | – |
Primary outcome
Not reported in the source record.
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 19 Jul 2006.
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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.
The record lists no contact. Use the official record to reach the sponsor.
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing naveglitazar in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Eli Lilly and Company at 42 sites in United States.
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 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 19 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States. 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. 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.
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 19 Jul 2006.