Metabolics Diabetes NosPhase 3NCT00162175

PPAR-COMBO With Sulfonylurea

A Phase 3 study testing Muraglitazar in people with Metabolics Diabetes Nos, run by Bristol-Myers Squibb at 149 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Glyburide Therapy in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Metabolics Diabetes Nos
What is being tested?: Muraglitazar
How many people: 534 participants
Where: 149 sitesin 15 countries
Study dates: Jul 2003to Nov 2005
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 Diabetes, HbA1c > 7.0% and < 10.0%, mean serum triglyceride < 600 mg/dL, body mass index < 41 kg/m2, fasting c-peptide . 1.5 ng/mL.

Who cannot join

History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months, congestive heart failure (NYHA Class III and IV, uncontrolled hypertension, history or renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.

Trial locations and contacts

149 sites in 15 countries.

Country

City, postcode or hospital

149 sites in 15 countries

United States74 sites

Local Institution
Altoona, Pennsylvania
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Anderson, South Carolina
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Anniston, Alabama
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Arden Hills, Minnesota
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Berkley, Michigan
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Bluefield, West Virginia
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Bristol, Tennessee
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Charlotte, North Carolina
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Chester, Maryland
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Chicago, Illinois
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Chipley, Florida
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Cincinnati, Ohio
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Colorado Springs, Colorado
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Corvallis, Oregon
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Cranston, Rhode Island
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Dallas, Texas
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Denver, Colorado
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Detroit, Michigan
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Duncan, South Carolina
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Dunwoody, Georgia
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East Syracuse, New York
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Encinitas, California
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Eugene, Oregon
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Excelsior Springs, Missouri
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Greensboro, North Carolina
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Gulfport, Mississippi
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Hickory, North Carolina
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Hoover, Alabama
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Houston, Texas
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Huntersville, North Carolina
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Huntsville, Alabama
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Irving, Texas
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Kansas City, Missouri
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Kingsport, Tennessee
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Knoxville, Tennessee
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Lake Jackson, Texas
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Lexington, Kentucky
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Little Rock, Arkansas
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Long Beach, California
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Los Angeles, California
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Loveland, Colorado
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Marshfield, Wisconsin
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Memphis, Tennessee
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Mesa, Arizona
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Miami, Florida
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Mission Viejo, California
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Mobile, Alabama
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Morehead City, North Carolina
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New Port Richey, Florida
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Oklahoma City, Oklahoma
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Olympia, Washington
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Overland Park, Kansas
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Pasadena, California
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Pinellas Park, Florida
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Portland, Oregon
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San Antonio, Texas
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San Diego, California
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Silver Springs, Maryland
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Simpsonville, South Carolina
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Slidell, Louisiana
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Springfield, Massachusetts
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St Louis, Missouri
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Summerville, South Carolina
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The Colony, Texas
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Tucson, Arizona
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Tulsa, Oklahoma
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Vero Beach, Florida
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Walnut Creek, California
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Westlake Village, California
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Wheat Ridge, Colorado
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Wilmington, North Carolina
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Winter Park, Florida

Other trials in United States

Spain11 sites

Local Institution
A Coruña
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Alicante
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Cadiz
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Granada
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Las Palmas, DE
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Madrid
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Oviedo
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Santa Cruz de Tenerife
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Santiago, De Compostela
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Teruel
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Zaragoza

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United Kingdom11 sites

Local Institution
Aldershot, Hampshire
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Bath, Wiltshire
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Bexhill-on-Sea, East Sussex
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Blackpool, Lancashire
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Glasgow, Lanarkshire
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Harrow, Middlesex
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Hastings, Sussex
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Inkberrow, Worcestershire
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Soham, Cambridgeshire
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Sunbury-on-Thames, Greater London
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Swan Lane

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Canada7 sites

Local Institution
Corunna, Ontario
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Gatineau, Quebec
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Hawksbury, Ontario
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Laval, Quebec
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Saint-Jérôme, Quebec
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Sarnia, Ontario
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St. John's

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Mexico7 sites

Local Institution
Alburquerque, New Mexico
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Durango, Durango
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León, Guanajuato
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Mérida, Yucatán
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Mexico City, Mexico City
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Monterrey, Nuevo León
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Tijuana, Estado de Baja California

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France6 sites

Local Institution
Broglie
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Chartres
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Gémenos
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Husseren-Wesserling, Wesserling
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Labarthe, Sur Leze
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Rosiers, D'Egletons

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Netherlands6 sites

Local Institution
Deurne
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Ewyk
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Hoogvliet
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Rijswijk
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The Hague
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Zwijndrecht

Other trials in Netherlands

Argentina5 sites

Local Institution
Bahía Blanca, Buenas Aires
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Buenos Aires, Buenos Aires
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Capital Federal, Buenos Aires
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Córdoba, Córdoba Province
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Mendoza, Mendoza Province

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Brazil4 sites

Local Institution
Belém, Pará
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Curitiba, Paraná
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Marília, São Paulo
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Porto Alegre, Rio Grande do Sul

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Germany4 sites

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Dresden
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Hamburg
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Nuremberg
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Viernheim, Schwenningen

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Puerto Rico4 sites

Local Institution
Carolina
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Guaynabo
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Ponce
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Rio Piedras

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Russia4 sites

Local Institution
Moscow
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Saint Petersburg
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Saratov
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Smolensk

Other trials in Russia

Australia3 sites

Local Institution
Brisbane, Queensland
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Canberra, New South Wales
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Wollongong, New South Wales

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Peru2 sites

Local Institution
Arequipa, Arequipa
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Lima, Lima Province

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Italy1 site

Local Institution
Ravenna

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About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Glyburide Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone

Conditions: Metabolics Diabetes Nos
Being tested: Muraglitazar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MuraglitazarDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

Compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + glyburide vs placebo + glyburide

Secondary outcomes (1)

Change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in hs-CRP from baseline to W24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2003Nov 2005

First posted13 Sep 2005 (estimated)
Study startJul 2003
Primary completionNov 2005
Study completionNov 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Metabolics Diabetes NosStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe 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: Parallel groups
Masking: Double blind
Enrolment: 534 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00162175
Sponsor's protocol ID: CV168-021
Status last verified: Sep 2007
First submitted: 9 Sep 2005
Last updated: 14 Sep 2010
Results posted: No

Publications

Rubin CJ, De Pril V, Fiedorek FT. Coadministration of muraglitazar plus glyburide: improvement of glycaemic and lipid profiles in patients with type 2 diabetes. Diab Vasc Dis Res. 2009 Apr;6(2):120-32. doi: 10.1177/1479164109336049.
PubMed 20368202

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Glyburide Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone
ClinicalTrials.gov ID: NCT00162175
Acronym / sponsor ID: CV168-021
Conditions: Metabolics Diabetes Nos
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 534 participants
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: Jul 2003
Primary completion: Nov 2005 (actual)
Study completion: Nov 2005 (actual)
First posted: 13 Sep 2005 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Type 2 Diabetes, HbA1c > 7.0% and < 10.0%, mean serum triglyceride < 600 mg/dL, body mass index < 41 kg/m2, fasting c-peptide . 1.5 ng/mL.

Key exclusion criteria (1 listed)

History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months, congestive heart failure (NYHA Class III and IV, uncontrolled hypertension, history or renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.

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
Muraglitazar	Drug	–

Primary outcome

Compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + glyburide vs placebo + glyburide

1 secondary outcome

Change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in hs-CRP from baseline to W24

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 14 Sep 2010.
Derived from this study: PubMed 20368202Rubin CJ, De Pril V, Fiedorek FT. Coadministration of muraglitazar plus glyburide: improvement of glycaemic and lipid profiles in patients with type 2 diabetes. Diab Vasc Dis Res. 2009 Apr;6(2):120-32. doi: 10.1177/1479164109336049.

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.

149 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Muraglitazar in people with Metabolics Diabetes Nos, run by Bristol-Myers Squibb at 149 sites in 15 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 1 inclusion and 1 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 14 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 149 sites in United States, Spain, United Kingdom, Canada, Mexico and 10 more countries. 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 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?

Compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + glyburide vs placebo + glyburide. 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 NCT00162175, which also lists 1 linked publication.

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 14 Sep 2010.