Diabetes Mellitus IIPhase 2/3NCT00240383

Dose Ranging Study With LT, Monotherapy, PPAR

A Phase 2/3 study testing Muraglitazar in people with Diabetes Mellitus II, run by Bristol-Myers Squibb at 272 sites in 16 countries.

Completed

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

Official record

Search all trials

Trial summary

A Randomized, Double-Blind, Dose-Ranging, Dose Comparison-Controlled Trial to Determine the Safety and Efficacy of BMS-298585 in Subjects with Type 2 Diabetes Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diabetes Mellitus II
What is being tested?: Muraglitazar
How many people: 1,260 participants
Where: 272 sitesin 16 countries
Study dates: May 2002to Jun 2006
Phase: Phase 2/3
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

1. HbA1c > 7.0% and ≤ 10.0% obtained at the Screening visit.
2. Men and women, 18-70 years of age Established Type 2 diabetes

Who cannot join

1. Symptomatic Type 2 diabetes defined as marked polyuria and polydipsia with greater than 10% weight loss during the last three months.
2. Administration of antihyperglycemic agents (other than thiazolidinediones) for more than three consecutive or a total of seven non-consecutive days during the four weeks prior to screening.
3. Administration of thiazolidinediones for more than three consecutive or a total of seven non-consecutive days during the six weeks prior to screening.

Trial locations and contacts

272 sites in 16 countries.

Country

City, postcode or hospital

272 sites in 16 countries

United States149 sites

Local Institution
Albuquerque, New Mexico
Local Institution
Anderson, South Carolina
Local Institution
Anniston, Alabama
Local Institution
Arden Hills, Minnesota
Local Institution
Arkansas City, Kansas
Local Institution
Atlanta, Georgia
Local Institution
Austin, Texas
Local Institution
Avon, Ohio
Local Institution
Bakersfield, California
Local Institution
Baltimore, Maryland
Local Institution
Bangor, Maine
Local Institution
Bardstown, Kentucky
Local Institution
Bay Saint Louis, Mississippi
Local Institution
Beavercreek, Ohio
Local Institution
Bellbrook, Ohio
Local Institution
Birmingham, Alabama
Local Institution
Birmingham, Michigan
Local Institution
Brandon, Florida
Local Institution
Bristol, Tennessee
Local Institution
Buffalo, New York
Local Institution
Camillus, New York
Local Institution
Canton, Ohio
Local Institution
Cary, North Carolina
Local Institution
Charleston, South Carolina
Local Institution
Charlotte, North Carolina
Local Institution
Chevy Chase, Maryland
Local Institution
Chicago, Illinois
Local Institution
Chipley, Florida
Local Institution
Cincinnati, Ohio
Local Institution
Cleveland, Mississippi
Local Institution
Cleveland, Ohio
Local Institution
Colombus, Ohio
Local Institution
Colorado Springs, Colorado
Local Institution
Concord, California
Local Institution
Coral Gables, Florida
Local Institution
Corpus Christi, Texas
Local Institution
Cranston, Rhode Island
Local Institution
Dallas, Texas
Local Institution
Daytona Beach, Florida
Local Institution
Dunwoody, Georgia
Local Institution
East Providence, Rhode Island
Local Institution
Edmonds, Washington
Local Institution
Encinitas, California
Local Institution
Endicott, New York
Local Institution
Eugene, Oregon
Local Institution
Excelsior Springs, Missouri
Local Institution
Fair Oaks, California
Local Institution
Fayette, Arkansas
Local Institution
Federal Way, Washington
Local Institution
Fort Lauderdale, Florida
Local Institution
Fort Worth, Texas
Local Institution
Fountain Valley, California
Local Institution
Fresno, California
Local Institution
Golden, Colorado
Local Institution
Greensboro, North Carolina
Local Institution
Greer, South Carolina
Local Institution
High Point, North Carolina
Local Institution
Hollywood, Florida
Local Institution
Honolulu, Hawaii
Local Institution
Hot Springs, Arizona
Local Institution
Houston, Texas
Local Institution
Huntsville, Alabama
Local Institution
Irving, Texas
Local Institution
Jackson, Mississippi
Local Institution
Jacksonville, Florida
Local Institution
Johnson City, New York
Local Institution
Johnson City, Tennessee
Local Institution
Johnston, Rhode Island
Local Institution
Jupiter, Florida
Local Institution
Kansas City, Missouri
Local Institution
La Jolla, California
Local Institution
Lake Jackson, Texas
Local Institution
Las Vegas, Nevada
Local Institution
Lexington, Kentucky
Local Institution
Little Rock, Arkansas
Local Institution
Littleton, Colorado
Local Institution
Los Gatos, California
Local Institution
Louisville, Kentucky
Local Institution
Lyndhurst, Ohio
Local Institution
Madison, Wisconsin
Local Institution
Massillon, Ohio
Local Institution
Medford, Oregon
Local Institution
Melbourne, Florida
Local Institution
Memphis, Tennessee
Local Institution
Mesa, Arizona
Local Institution
Metairie, Louisiana
Local Institution
Miami, Florida
Local Institution
Moorehead City, North Carolina
Local Institution
Nederland, Colorado
Local Institution
New Berlin, Wisconsin
Local Institution
New Britain, Connecticut
Local Institution
New Hyde Park, New York
Local Institution
New York, New York
Local Institution
Norwood, Massachusetts
Local Institution
Ocala, Florida
Local Institution
Ocoee, Florida
Local Institution
Olive Branch, Mississippi
Local Institution
Omaha, Nebraska
Local Institution
Orange, California
Local Institution
Orlando, Florida
Local Institution
Pensacola, Florida
Local Institution
Petoskey, Michigan
Local Institution
Phoenix, Arizona
Local Institution
Portland, Oregon
Local Institution
Providence, Rhode Island
Local Institution
Raleigh, California
Local Institution
Raleigh, North Carolina
Local Institution
Reading, Pennsylvania
Local Institution
Renton, Washington
Local Institution
Richmond, Kentucky
Local Institution
Richmond, Virginia
Local Institution
Riverside, California
Local Institution
Rolling Fork, Mississippi
Local Institution
Rolling Hills Estate, California
Local Institution
Roseville, California
Local Institution
Sacramento, California
Local Institution
Salt Lake City, Utah
Local Institution
San Antonio, Texas
Local Institution
San Diego, California
Local Institution
Santa Ana, California
Local Institution
Santa Barbara, California
Local Institution
Shawnee Mission, Kansas
Local Institution
Simpsonville, South Carolina
Local Institution
Slidell, Louisiana
Local Institution
Spartanburg, South Carolina
Local Institution
Spokane, Washington
Local Institution
Spring Valley, California
Local Institution
Springfield, Massachusetts
Local Institution
Springfield, Missouri
Local Institution
St Louis, Missouri
Local Institution
St. Petersburg, Florida
Local Institution
Swansea, Massachusetts
Local Institution
Tallahassee, Florida
Local Institution
Tamarac, Florida
Local Institution
Tempe, Arizona
Local Institution
Titusville, Florida
Local Institution
Toms River, New Jersey
Local Institution
Tucson, Arizona
Local Institution
Tulsa, Oklahoma
Local Institution
Tustin, California
Local Institution
Vernon Hills, Illinois
Local Institution
Virginia Beach, Virginia
Local Institution
Walla Walla, Washington
Local Institution
Walnut Creek, California
Local Institution
West Palm Beach, Florida
Local Institution
Wheat Ridge, Colorado
Local Institution
Wichita, Kansas
Local Institution
Worcester, Massachusetts
Local Institution
Zanesville, Ohio

Other trials in United States

United Kingdom35 sites

Local Institution
Annan, Dumfries & Galloway
Local Institution
Atherstone, Warwickshire
Local Institution
Balsall Common, Warwickshire
Local Institution
Bexhill-on-Sea, East Sussex
Local Institution
Blantyre, Central
Local Institution
Burnbank, Lanarkshire
Local Institution
Caerleon, Gwent
Local Institution
Chapelhall, Central
Local Institution
Chelmsley Wod, West Midlands
Local Institution
Chippenham, Wiltshire
Local Institution
Coatbridge, Lanarkshire
Local Institution
Cookstown, Tyrone
Local Institution
Cumbernauld, Dumbartonshire
Local Institution
Dunscore, Dumfries & Galloway
Local Institution
East Horsley, Surrey
Local Institution
Edinburgh, Lothian
Local Institution
Ely, Cambridgeshire
Local Institution
Glasgow
Local Institution
Hamilton, Lothian
Local Institution
High Valleyfield, Fife
Local Institution
Kilsyth, Stirlingshire
Local Institution
Lanarkshire, Strathclyde
Local Institution
Llandough, Mid Glamorgan
Local Institution
Moffat, Dumfriesshire
Local Institution
Moodiesburn, Dumbartonshire
Local Institution
Neilston, Renfrewshire
Local Institution
Newtonabbey, Armach
Local Institution
Paisley, Central
Local Institution
Paisley, Renfrewshire
Local Institution
Pont-y-clun, Mid Glamorgan
Local Institution
Riddrie, Central
Local Institution
Soham, Cambridgeshire
Local Institution
Stranraer, Dumfries & Galloway
Local Institution
Stratford-upon-Avon, Warwickshire
Local Institution
Sunbury-on-Thames, Greater London

Other trials in United Kingdom

Brazil10 sites

Local Institution
Belém, Pará
Local Institution
Campinas, São Paulo
Local Institution
Campo Grande, Mato Grosso
Local Institution
Fortaleza, Ceará
Local Institution
Marília, São Paulo
Local Institution
Porto Alegre, Rio Grande do Sul
Local Institution
Rio de Janeiro, Rio de Janeiro
Local Institution
S. J. Rio Preto, São Paulo
Local Institution
São Paulo, São Paulo
Local Institution
Taubaté, São Paulo

Other trials in Brazil

Poland10 sites

Local Institution
Bydgoszcz
Local Institution
Gorzów, Wielkopolski
Local Institution
Lublin
Local Institution
Olsztyn
Local Institution
Stalowa, Wola
Local Institution
Szczecin
Local Institution
Warsaw
Local Institution
Wroclaw
Local Institution
Zabrze
Local Institution
Zielona Góra

Other trials in Poland

Canada9 sites

Local Institution
Calgary, Alberta
Local Institution
Drummonville, Quebec
Local Institution
Edmonton, Alberta
Local Institution
Longueuil, Quebec
Local Institution
Ottawa, Ontario
Local Institution
Ottawa, Quebec
Local Institution
Sherbrooke, Quebec
Local Institution
St. John's, Newfoundland and Labrador
Local Institution
Winnipeg, Manitoba

Other trials in Canada

Spain9 sites

Local Institution
Barcelona, ESP
Local Institution
Cadiz, ESP
Local Institution
Girona
Local Institution
Granada
Local Institution
Herston, Queensland
Local Institution
Las Palmas de Gran Canaria
Local Institution
Madrid
Local Institution
Oviedo
Local Institution
Santiago, De Compostela

Other trials in Spain

Sweden8 sites

Local Institution
Gothenburg
Local Institution
Helsingborg
Local Institution
Linköping
Local Institution
Malmö
Local Institution
Motala
Local Institution
Sävedalen
Local Institution
Stockholm
Local Institution
Vällingby

Other trials in Sweden

Australia7 sites

Local Institution
Box Hill, Victoria
Local Institution
Fitzroy, Victoria
Local Institution
Fullerton, South Australia
Local Institution
Melbourne, Victoria
Local Institution
Parkville, Victoria
Local Institution
Perth, Western Australia
Local Institution
Wollongong, New South Wales

Other trials in Australia

Netherlands7 sites

Local Institution
Deventer
Local Institution
Ewijk
Local Institution
Hengelo
Local Institution
Lichtenvoorde
Local Institution
Losser
Local Institution
Ryswyk
Local Institution
Utrecht

Other trials in Netherlands

France6 sites

Local Institution
Albens
Local Institution
Orthez
Local Institution
Rennes
Local Institution
Rosiers-d'Égletons
Local Institution
Savigny-en-Véron
Local Institution
Strasbourg

Other trials in France

Czechia5 sites

Local Institution
Brno, CZE
Local Institution
České Budějovice
Local Institution
Jihlava
Local Institution
Liberec
Local Institution
Prague

Other trials in Czechia

South Africa5 sites

Local Institution
George, Northern Cape
Local Institution
Noordheuwel, Gauteng
Local Institution
Pretoria, Gauteng
Local Institution
Tygerberg, Western Cape
Local Institution
Vanderbijlpark, Gauteng

Other trials in South Africa

Mexico4 sites

Local Institution
Aguascalientes, Aguascalientes
Local Institution
Distrito Federal, Mexico City
Local Institution
Mexico City, Mexico City
Local Institution
Tijuana, Estado de Baja California

Other trials in Mexico

Argentina3 sites

Local Institution
Buenos Aires, Buenos Aires
Local Institution
Chacabuco, Buenos Aires
Local Institution
Mendoza, Mendoza Province

Other trials in Argentina

Italy3 sites

Local Institution
Milan
Local Institution
Modena
Local Institution
Roma

Other trials in Italy

Puerto Rico2 sites

Local Institution
Ponce
Local Institution
San Juan

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-Blind, Dose Ranging, Dose Comparison-Controlled Trial to Determine the Safety and Efficacy of BMS-298585 in Subjects With Type 2 Diabetes

A Randomized, Double-Blind, Dose-Ranging, Dose Comparison-Controlled Trial to Determine the Safety and Efficacy of BMS-298585 in Subjects with Type 2 Diabetes

Conditions: Diabetes Mellitus II
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.

To compare, after 24 weeks of oral administration of double-blind treatment, the change from baseline in hemoglobin A1c (HbA1c) achieved with the highest dose and subsequent doses of BMS-298585 versus the lowest dose of BMS-298585 in subjects with Type 2

Secondary outcomes (1)

To assess, after 12 and 24 weeks of oral administration of double-blind therapy, the percent change from baseline in fasting lipids (total cholesterol,low density lipoprotein cholesterol,HDL-C, TG, non-HDL chol

Timeline

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

May 2002Jun 2006

First posted18 Oct 2005 (estimated)
Study startMay 2002
Primary completionJun 2006
Study completionJun 2006

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 Diabetes Mellitus IIStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 1,260 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00240383
Sponsor's protocol ID: CV168-006
Status last verified: Jun 2008
First submitted: 17 Oct 2005
Last updated: 14 Sep 2010
Results posted: No

Publications

Rubin CJ, Viraswami-Appanna K, Fiedorek FT. Efficacy and safety of muraglitazar: a double-blind, 24-week, dose-ranging study in patients with type 2 diabetes. Diab Vasc Dis Res. 2009 Jul;6(3):205-15. doi: 10.1177/1479164109336048.
PubMed 20368213

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1/2
cfMSC Therapy for Diabetes
Type II Diabetes Mellitus
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Active, not recruitingPhase 1/2
A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight
Overweight and Obesity
Active, not recruiting
The GRoceries Aimed at Increasing Nutrition Study
Type 2 Diabetes, Type II Diabetes Mellitus

All Diabetes Mellitus II trials

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 Randomized, Double-Blind, Dose Ranging, Dose Comparison-Controlled Trial to Determine the Safety and Efficacy of BMS-298585 in Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00240383
Acronym / sponsor ID: CV168-006
Conditions: Diabetes Mellitus II
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,260 participants
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: May 2002
Primary completion: Jun 2006 (actual)
Study completion: Jun 2006 (actual)
First posted: 18 Oct 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.

A Randomized, Double-Blind, Dose-Ranging, Dose Comparison-Controlled Trial to Determine the Safety and Efficacy of BMS-298585 in Subjects with Type 2 Diabetes

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 (2 listed)

1. HbA1c > 7.0% and ≤ 10.0% obtained at the Screening visit.
2. Men and women, 18-70 years of age Established Type 2 diabetes

Key exclusion criteria (3 listed)

1. Symptomatic Type 2 diabetes defined as marked polyuria and polydipsia with greater than 10% weight loss during the last three months.
2. Administration of antihyperglycemic agents (other than thiazolidinediones) for more than three consecutive or a total of seven non-consecutive days during the four weeks prior to screening.
3. Administration of thiazolidinediones for more than three consecutive or a total of seven non-consecutive days during the six weeks prior to screening.

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

To compare, after 24 weeks of oral administration of double-blind treatment, the change from baseline in hemoglobin A1c (HbA1c) achieved with the highest dose and subsequent doses of BMS-298585 versus the lowest dose of BMS-298585 in subjects with Type 2

1 secondary outcome

To assess, after 12 and 24 weeks of oral administration of double-blind therapy, the percent change from baseline in fasting lipids (total cholesterol,low density lipoprotein cholesterol,HDL-C, TG, non-HDL chol

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 20368213Rubin CJ, Viraswami-Appanna K, Fiedorek FT. Efficacy and safety of muraglitazar: a double-blind, 24-week, dose-ranging study in patients with type 2 diabetes. Diab Vasc Dis Res. 2009 Jul;6(3):205-15. doi: 10.1177/1479164109336048.

Related trials for Diabetes Mellitus II

Not yet recruitingPhase 1/2
cfMSC Therapy for Diabetes
Type II Diabetes Mellitus
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Active, not recruitingPhase 1/2
A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight
Overweight and Obesity
Active, not recruiting
The GRoceries Aimed at Increasing Nutrition Study
Type 2 Diabetes, Type II Diabetes Mellitus

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.

272 sites in 16 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Muraglitazar in people with Diabetes Mellitus II, run by Bristol-Myers Squibb at 272 sites in 16 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 2 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 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 272 sites in United States, United Kingdom, Brazil, Poland, Canada and 11 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 combined 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.

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?

To compare, after 24 weeks of oral administration of double-blind treatment, the change from baseline in hemoglobin A1c (HbA1c) achieved with the highest dose and subsequent doses of BMS-298585 versus the lowest dose of BMS-298585 in subjects with Type 2. 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 NCT00240383, 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.