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Type 2 DiabetesPhase 2NCT00263276

A Trial of BMS-512148 in Patients With Type 2 Diabetes Mellitus

A Phase 2 study testing dapagliflozin and metformin in people with Type 2 Diabetes, run by AstraZeneca at 144 sites in 4 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

The purpose of this clinical research study is to learn if BMS-512148 is effective in controlling blood sugar levels as determined by HbA1c and fasting plasma glucose in patients who have been diagnosed with Type 2 diabetes. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
dapagliflozin and metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
389 participants
Where
144 sitesin 4 countries
Study dates
Dec 2005to Feb 2007
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 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with Type 2 diabetes mellitus with inadequate glycemic control on diet and exercise. HbA1c >= 7% and <=10%.
  • Patient either has not been previously treated with antihyperglycemic medication or has been treated for <30 days since diagnosis and has received less than 3 consecutive doses or 7 non-consecutive doses in the last 30 days.
  • C-peptide > 1.0 ng/ml
  • Body Mass Index <= 40 kg/m2
  • Serum creatinine < 1.5 mg/dL for men or < 1.4 mg/dL for women.
  • No overt proteinuria (microalbumin/creatinine ratio must be <300 mg/g

Who cannot join

  • Unstable renal disease
  • Patients with significant liver disease including chronic active hepatitis
  • Within the last 6 months has had any of the following cardiovascular event: myocardial infarction, unstable angina, unstable CHF,NYHA Class III or IV CHF, TIA, unstable arrhythmia or cardiac revascularization surgery.
  • Subjects with clinically significant anemia

Trial locations and contacts

144 sites in 4 countries.

144 sites in 4 countries

United States111 sites

  • Local Institution

    Akron, Ohio

  • Local Institution

    Albany, New York

  • Local Institution

    Albuquerque, New Mexico

  • Local Institution

    Anderson, South Carolina

  • Local Institution

    Arkansas City, Kansas

  • Local Institution

    Augusta, Georgia

  • Local Institution

    Austin, Texas

  • Local Institution

    Baton Rouge, Louisiana

  • Local Institution

    Bayou La Batre, Alabama

  • Local Institution

    Beachwood, Ohio

  • Local Institution

    Bellaire, Texas

  • Local Institution

    Bend, Oregon

  • Local Institution

    Bensalem, Pennsylvania

  • Local Institution

    Bethany, Oklahoma

  • Local Institution

    Beverly Hills, California

  • Local Institution

    Birmingham, Alabama

  • Local Institution

    Blue Ridge, Georgia

  • Local Institution

    Boynton Beach, Florida

  • Local Institution

    Brandon, Florida

  • Local Institution

    Bronxville, New York

  • Local Institution

    Brooklyn Center, Minnesota

  • Local Institution

    Bryan, Texas

  • Local Institution

    Burke, Virginia

  • Local Institution

    Camillus, New York

  • Local Institution

    Chandler, Arizona

  • Local Institution

    Charlotte, North Carolina

  • Local Institution

    Chesterfield, Missouri

  • Local Institution

    Cincinnati, Ohio

  • Local Institution

    Cleveland, Ohio

  • Local Institution

    Colorado Springs, Colorado

  • Local Institution

    Columbia, Maryland

  • Local Institution

    Cooperstown, New York

  • Local Institution

    Cumberland, Rhode Island

  • Local Institution

    Dayton, Ohio

  • Local Institution

    Dearborn, Michigan

  • Local Institution

    Delray Beach, Florida

  • Local Institution

    Denver, Colorado

  • Local Insitution

    Edina, Minnesota

  • Local Institution

    Edmonds, Washington

  • Local Institution

    El Paso, Texas

  • Local Institution

    Elkton, Maryland

  • Local Institution

    Eugene, Oregon

  • Local Institution

    Fayetteville, Arkansas

  • Local Institution

    Feasterville, Pennsylvania

  • Local Institution

    Hampton, Virginia

  • Local Institution

    Hattiesburg, Mississippi

  • Local Institution

    High Point, North Carolina

  • Local Institution

    Hillsboro, Oregon

  • Local Institution

    Holly Hill, Florida

  • Local Institution

    Honolulu, Hawaii

  • Local Institution

    Hot Springs, Arkansas

  • Local Institution

    Houston, Texas

  • Local Institution

    Huntsville, Alabama

  • Local Institution

    Indianapolis, Indiana

  • Local Institution

    Irving, Texas

  • Local Institution

    Jackson, Mississippi

  • Local Institution

    Jacksonville, Florida

  • Local Instiuttion

    Jacksonville, Florida

  • Local Institution

    Johnston, Rhode Island

  • Local Institution

    Kansas City, Missouri

  • Local Institution

    Lafayette, Indiana

  • Local Institution

    Levittown, Pennsylvania

  • Local Institution

    Long Beach, California

  • Local Institution

    Los Alamos, New Mexico

  • Local Institution

    Los Gatos, California

  • Local Institution

    Memphis, Tennessee

  • Local Institution

    Milwaukee, Wisconsin

  • Local Institution

    Minneapolis, Minnesota

  • Local Institution

    Mission Viejo, California

  • Local Institution

    Mobile, Alabama

  • Local Institution

    Mogadore, Ohio

  • Local Institution

    Morehead City, North Carolina

  • Local Institution

    Morrisville, Pennsylvania

  • Local Institution

    Nashville, Tennessee

  • Local Instiution

    New Hyde Park, New York

  • Local Institution

    New Port Richey, Florida

  • Local Institution

    Newark, Ohio

  • Local Institution

    Norfolk, Virginia

  • Local Institution

    North Las Vegas, Nevada

  • Local Institution

    Orange, California

  • Local Institution

    Orlando, Florida

  • Local Institution

    Ormond Beach, Florida

  • Local Institution

    Portland, Oregon

  • Local Institution

    Raleigh, North Carolina

  • Local Institution

    Rapid City, South Dakota

  • Local Institution

    Reading, Pennsylvania

  • Local Institution

    Redondo Beach, California

  • Local Institution

    Renton, Washington

  • Local Institution

    Richmond, Virginia

  • Local Institution

    Royal Oak, Michigan

  • Local Institution

    Salt Lake City, Utah

  • Local Institution

    San Antonio, Texas

  • Local Institution

    San Diego, California

  • Local Institution

    Scottsbluff, Nebraska

  • Local Institution

    Selmer, Tennessee

  • Local Institution

    Simpsonville, South Carolina

  • Local Institution

    Spokane, Washington

  • Local Institution

    St Louis, Missouri

  • Local Institution

    Sudbury, Massachusetts

  • Local Institution

    Summerville, South Carolina

  • Local Institution

    Taylors, South Carolina

  • Local Institution

    Torrance, California

  • Local Institution

    Tucson, Arizona

  • Local Institution

    Vancouver, Washington

  • Local Institution

    Virginia Beach, Virginia

  • Local Institution

    West Allis, Wisconsin

  • Local Institution

    West Seneca, New York

  • Local Institution

    Wilmington, North Carolina

  • Local Institution

    Worcester, Massachusetts

  • Local Institution

    Yukon, Oklahoma

  • Local Institution

    Zanesville, Ohio

Other trials in United States

Canada24 sites

  • Local institution

    Bathurst, New Brunswick

  • Local Institution

    Calgary, Alberta

  • Local Institution

    Charlottetown, Prince Edward Island

  • Local Institution

    Corunna, Ontario

  • Local Institution

    Drummondville, Quebec

  • Local Institution

    Edmonton, Alberta

  • Local Institution

    Etobicoke, Ontario

  • Local Institution

    Granby, Quebec

  • Local Institution

    Greenfield Park, Quebec

  • Local Institution

    Kitchener, Ontario

  • Local Institution

    Langley, British Columbia

  • Local Institution

    Moncton, New Brunswick

  • Local Institution

    Newmarket, Ontario

  • Local Institution

    Rimouski, Quebec

  • Local Institution

    Saint John's, New Brunswick

  • Local Institution

    Saint-Léonard, Quebec

  • Local Institution

    Sarnia, Ontario

  • Local Institution

    Saskatoon, Saskatchewan

  • Local Institution

    St. John's, Newfoundland and Labrador

  • Local Institution

    Ste-Foy, Quebec

  • Local Institution

    Surrey, British Columbia

  • Local Institution

    Toronto, Ontario

  • Local Institution

    Vancouver, British Columbia

  • Local Institution

    Winnipeg, Manitoba

Other trials in Canada

Mexico6 sites

  • Local Institution

    Aguascalientes, Aguascalientes

  • Local Institution

    Cuernavaca, Morelos

  • Local Institution

    Durango, Durango

  • Local Institution

    Guadalajara, Jalisco

  • Local Institution

    Monterrey, Nuevo León

  • Local Institution

    Zapopan, Jalisco

Other trials in Mexico

Puerto Rico3 sites

  • Local Institution

    Caguas

  • Local Institution

    Manati

  • Local Institution

    San Juan

Other trials in Puerto Rico

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Safety and Efficacy of BMS-512148 as Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Treatment Naive And Have Inadequate Glycemic Control on Diet and Exercise

The purpose of this clinical research study is to learn if BMS-512148 is effective in controlling blood sugar levels as determined by HbA1c and fasting plasma glucose in patients who have been diagnosed with Type 2 diabetes. Patients should first try to control their diabetes with diet and exercise and should not have previously been treated for their diabetes (very short periods of time are acceptable). The safety of BMS512148 will also be studied

Conditions
Type 2 Diabetes
Being tested
dapagliflozin, placebo, metformin
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.

  • dapagliflozinDrug

    Tablets, Oral, 2.5 mg, Once daily, 12 weeks.

  • dapagliflozinDrug

    Tablets, Oral, 5 mg, Once daily, 12 weeks.

  • dapagliflozinDrug

    Tablets, Oral, 10 mg, Once daily, 12 weeks.

  • dapagliflozinDrug

    Tablets, Oral, 20 mg, Once daily, 12 weeks.

  • dapagliflozinDrug

    Tablets, Oral, 50 mg, Once daily, 12 weeks.

  • placeboDrug

    Tablets, Oral, 0 mg, Once daily, 12 weeks.

  • metforminDrug

    Tablets, Oral, >/= 1500 mg, Once daily, 12 weeks.

Study groups in NCT00263276
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: dapagliflozin
Arm 2ExperimentalNot described
Receives: Drug: dapagliflozin
Arm 3ExperimentalNot described
Receives: Drug: dapagliflozin
Arm 4ExperimentalNot described
Receives: Drug: dapagliflozin
Arm 5ExperimentalNot described
Receives: Drug: dapagliflozin
Arm 6Placebo comparatorNot described
Receives: Drug: placebo
Arm 7Active comparatorNot described
Receives: Drug: metformin

What is being measured

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

  1. Mean change from baseline in HbA1c compared to placebo.

    Measured: at 12 weeks

Secondary outcomes (1)

  1. Mean change from baseline in fasting plasma glucose, evaluate proportion of subjects who achieve a therapeutic response (HbA1c <7%); change from baseline in urinary glucose excretion

    Measured: at Weeks 6 and 12

Timeline

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

  1. First posted8 Dec 2005 (estimated)
  2. Study startDec 2005
  3. Primary completionFeb 2007
  4. Study completionFeb 2007

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
389 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00263276
Sponsor's protocol ID
MB102-008
Status last verified
Nov 2016
First submitted
7 Dec 2005
Last updated
17 Nov 2016
Results posted
No
Data monitoring committee
No

Publications

  • Mellander A, Billger M, Johnsson E, Traff AK, Yoshida S, Johnsson K. Hypersensitivity Events, Including Potentially Hypersensitivity-Related Skin Events, with Dapagliflozin in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis. Clin Drug Investig. 2016 Nov;36(11):925-933. doi: 10.1007/s40261-016-0438-3.

    PubMed 27461213

  • Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19.

    PubMed 26894924

  • List JF, Woo V, Morales E, Tang W, Fiedorek FT. Sodium-glucose cotransport inhibition with dapagliflozin in type 2 diabetes. Diabetes Care. 2009 Apr;32(4):650-7. doi: 10.2337/dc08-1863. Epub 2008 Dec 29.

    PubMed 19114612

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dapagliflozin and metformin in people with Type 2 Diabetes, run by AstraZeneca at 144 sites in 4 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 6 inclusion and 4 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 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 144 sites in United States, Canada, Mexico, 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 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?

Mean change from baseline in HbA1c compared to placebo. (time frame: at 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 NCT00263276, which also lists 3 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 17 Nov 2016.

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