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Diabetes Mellitus, Type 2Phase 3NCT00121667

Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone

A Phase 3 study testing Saxagliptin + Metformin and Pioglitazone in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 152 sites in 9 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

The purpose of this clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with Metformin alone Read more about this study

Who is it for?
Ages 18 to 77 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Saxagliptin + Metformin and Pioglitazone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,462 participants
Where
152 sitesin 9 countries
Study dates
Aug 2005to Feb 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 77 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 diabetes mellitus requiring treatment with at least 1500 mg but not greater than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks prior to screening.
  • HbA1c >= 7.0% and <= 10.0 %
  • Body mass index <= 40 kg/m2
  • Fasting C-peptide >= 1 ng/dL

Who cannot join

  • Symptomatic poorly controlled diabetes
  • Recent cardiac or cerebrovascular event
  • Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for females

Trial locations and contacts

152 sites in 9 countries.

152 sites in 9 countries

United States95 sites

  • Local Institution

    Albuquerque, New Mexico

  • Local Institution

    Altamonte Springs, Florida

  • Local Institution

    Anniston, Alabama

  • Local Institution

    Athens, Ohio

  • Local Institution

    Austin, Texas

  • Local Institution

    Baltimore, Maryland

  • Local Institution

    Birmingham, Alabama

  • Local Institution

    Boston, Massachusetts

  • Local Institution

    Bristol, Tennessee

  • Local Institution

    Bryan, Texas

  • Local Institution

    Calera, Alabama

  • Local Institution

    Carlisle, Pennsylvania

  • Local Institution

    Carrollton, Texas

  • Local Institution

    Castle Rock, Colorado

  • Local Institution

    Charleston, South Carolina

  • Local Institution

    Charlotte, North Carolina

  • Local Institution

    Chester, Maryland

  • Local Institution

    Chicago, Illinois

  • Local Institution

    Chipley, Florida

  • Local Institution

    Cocoa Beach, Florida

  • Local Institution

    Colorado Springs, Colorado

  • Local Institution

    Columbus, Ohio

  • Local Institution

    Coral Gables, Florida

  • Local Institution

    Dallas, Texas

  • Local Institution

    Decatur, Georgia

  • Local Institution

    Denver, Colorado

  • Local Institution

    Duncan, South Carolina

  • Local Institution

    Elkhart, Indiana

  • Local Institution

    Encino, California

  • Local Institution

    Eugene, Oregon

  • Local Institution

    Fort Lauderdale, Florida

  • Local Institution

    Fountain Valley, California

  • Local Institution

    Fresno, California

  • Local Institution

    Golden, Colorado

  • Local Institution

    Greensboro, North Carolina

  • Local Institution

    Haleyville, Alabama

  • Local Institution

    Hampton, Virginia

  • Local Institution

    Houston, Texas

  • Local Institution

    Iowa City, Iowa

  • Local Institution

    Jacksonville, Florida

  • Local Institution

    Jonesboro, Arkansas

  • Local Institution

    Kalispell, Montana

  • Local Institution

    Kansas City, Missouri

  • Local Institution

    Kissimmee, Florida

  • Local Institution

    Lafayette, Indiana

  • Local Institution

    Langhorne, Pennsylvania

  • Local Institution

    Las Vegas, Nevada

  • Local Institution

    Levittown, Pennsylvania

  • Local Institution

    Lexington, Kentucky

  • Local Institution

    Little Rock, Arkansas

  • Local Institution

    Los Angeles, California

  • Local Institution

    Loveland, Colorado

  • Local Institution

    Lyndhurst, Ohio

  • Local Institution

    Marianna, Florida

  • Local Institution

    Mesa, Arizona

  • Local Institution

    Miami, Florida

  • Local Institution

    Mission Viejo, California

  • Local Institution

    Morehead City, North Carolina

  • Local Institution

    Munfordville, Kentucky

  • Local Institution

    New Orleans, Louisiana

  • Local Institution

    New Port Richey, Florida

  • Local Institution

    Northridge, California

  • Local Institution

    Ocala, Florida

  • Local Institution

    Oklahoma City, Oklahoma

  • Local Institution

    Olympia, Washington

  • Local Institution

    Omaha, Nebraska

  • Local Institution

    Orange, California

  • Local Institution

    Philadelphia, Pennsylvania

  • Local Institution

    Phoenix, Arizona

  • Local Institution

    Pittsburgh, Pennsylvania

  • Local Institution

    Portland, Oregon

  • Local Institution

    Prince Frederick, Maryland

  • Local Institution

    Roseville, California

  • Local Institution

    Sacramento, California

  • Local Institution

    Salisbury, North Carolina

  • Local Institution

    Salt Lake City, Utah

  • Local Institution

    San Antonio, Texas

  • Local Institution

    Sherwood, Arkansas

  • Local Institution

    Sparta, North Carolina

  • Local Institution

    Spokane, Washington

  • Local Institution

    Spring Valley, California

  • Local Institution

    St Louis, Missouri

  • Local Institution

    Tallahassee, Florida

  • Local Institution

    Tampa, Florida

  • Local Institution

    Temple, Texas

  • Local Institution

    Toms River, New Jersey

  • Local Institution

    Topeka, Kansas

  • Local Institution

    Tulsa, Oklahoma

  • Local Institution

    Tustin, California

  • Local Institution

    Vernon Hills, Illinois

  • Local Institution

    Virginia Beach, Virginia

  • Local Institution

    Waterloo, Iowa

  • Local Institution

    West Monroe, Louisiana

  • Local Institution

    Wilmington, North Carolina

  • Local Institution

    Winston-Salem, North Carolina

Other trials in United States

Canada23 sites

  • Local Institution

    Aylmer, Ontario

  • Local Institution

    Bathurst, New Brunswick

  • Local Institution

    Brandon, Manitoba

  • Local Institution

    Calgary, Alberta

  • Local Institution

    Charlottetown, Prince Edward Island

  • Local Institution

    Coquitlam, British Columbia

  • Local Institution

    Drummondville, Quebec

  • Local Institution

    Fleurimont, Quebec

  • Local Institution

    Kelowna, British Columbia

  • Local Institution

    London, Ontario

  • Local Institution

    Longueuil, Quebec

  • Local Institution

    Mount Pearl, Newfoundland and Labrador

  • Local Institution

    Oakville, Ontario

  • Local Institution

    Portage la Prairie, Manitoba

  • Local Institution

    Saint-Léonard, Quebec

  • Local Institution

    Sarnia, Ontario

  • Local Institution

    Saskatoon, Saskatchewan

  • Local Institution

    St. John's, Newfoundland and Labrador

  • Local Institution

    Surrey, British Columbia

  • Local Institution

    Thornhill, Ontario

  • Local Institution

    Toronto, Ontario

  • Local Institution

    Winnipeg, Manitoba

  • Local Institution

    Woodstock, Ontario

Other trials in Canada

Australia8 sites

  • Local Institution

    Adelaide, South Australia

  • Local Institution

    Brisbane, Queensland

  • Local Institution

    Kippa-Ring, Queensland

  • Local Institution

    Meadowbrook, Queensland

  • Local Institution

    Perth, Western Australia

  • Local Institution

    Sydney, New South Wales

  • Local Institution

    Woodville South, South Australia

  • Local Institution

    Woollongong, New South Wales

Other trials in Australia

Mexico8 sites

  • Local Institution

    Celaya, Guanajuato

  • Local Institution

    Distrito Federal, Mexico City

  • Local Institution

    Durango, Durango

  • Local Institution

    Guadalajara, Jalisco

  • Local Institution

    Hermosillo, Sonora

  • Local Institution

    Mérida, Yucatán

  • Local Institution

    Monterrey, Nuevo León

  • Local Institution

    Morelia, Michioacan

Other trials in Mexico

Brazil6 sites

  • Local Institution

    Belém, Pará

  • Local Institution

    Campinas, São Paulo

  • Local Institution

    Fortaleza, Ceará

  • Local Institution

    Marília, São Paulo

  • Local Institution

    Porto Alegre, Rio Grande do Sul

  • Local Institution

    São Paulo, São Paulo

Other trials in Brazil

Argentina4 sites

  • Local Institution

    Buenos Aires, Buenos Aires

  • Local Institution

    Córdoba, Córdoba Province

  • Local Institution

    Mar del Plata, Buenos Aires

  • Local Institution

    Rosario, Santa Fe Province

Other trials in Argentina

Puerto Rico4 sites

  • Local Institution

    Carolina

  • Local Institution

    Ponce

  • Local Institution

    Rio Pieoras

  • Local Institution

    San Juan

Other trials in Puerto Rico

Taiwan3 sites

  • Local Institution

    Hualien City

  • Local Institution

    Taichung

  • Local Institution

    Taipei

Other trials in Taiwan

Chile1 site

  • Local Institution

    Santiago, Santiago Metropolitan

Other trials in Chile

About this study

Official title: "A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial to Evaluate the Efficacy and Safety of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone"

The purpose of this clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with Metformin alone

Read the detailed description

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive pioglitizone added onto their blinded study medication

Being tested
Saxagliptin + Metformin, Placebo + Metformin, Pioglitazone
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.

  • Saxagliptin + MetforminDrug

    Also called BMS-477118

    Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)

  • Saxagliptin + MetforminDrug

    Also called BMS-477118

    Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)

  • Saxagliptin + MetforminDrug

    Also called BMS-477118

    Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)

  • Placebo + MetforminDrug

    Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT)

  • PioglitazoneDrug

    Tablets, Oral, 15 - 45 mg (as needed for rescue)

Study groups in NCT00121667
Study groupRoleWhat they receive
Saxagliptin + Metformin (A)ExperimentalPioglitazone 15-45 mg (as needed for rescue)
Receives: Drug: Saxagliptin + Metformin; Drug: Pioglitazone
Saxagliptin + Metformin (B)ExperimentalPioglitazone 15-45 mg (as needed for rescue)
Receives: Drug: Saxagliptin + Metformin; Drug: Pioglitazone
Saxagliptin + Metformin (C)ExperimentalPioglitazone 15-45 mg (as needed for rescue)
Receives: Drug: Saxagliptin + Metformin; Drug: Pioglitazone
Placebo+ Metformin (D)Placebo comparatorPioglitazone 15-45 mg (as needed for rescue)
Receives: Drug: Placebo + Metformin; Drug: Pioglitazone

What is being measured

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

  1. Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24

    Mean change from baseline is adjusted for baseline value.

    Measured: Baseline, Week 24

Secondary outcomes (3)

  1. Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

    Mean change from baseline is adjusted for baseline value.

    Measured: Baseline, Week 24

  2. Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24

    Measured: Week 24

  3. Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)

    Mean change from baseline is adjusted for baseline value.

    Measured: Baseline, Week 24

Timeline

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

  1. First posted21 Jul 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionOct 2006
  4. Study completionFeb 2010

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,462 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00121667
Sponsor's protocol ID
CV181-014
Status last verified
Mar 2015
First submitted
18 Jul 2005
Last updated
29 Apr 2015

Publications

  • DeFronzo RA, Hissa MN, Garber AJ, Luiz Gross J, Yuyan Duan R, Ravichandran S, Chen RS; Saxagliptin 014 Study Group. The efficacy and safety of saxagliptin when added to metformin therapy in patients with inadequately controlled type 2 diabetes with metformin alone. Diabetes Care. 2009 Sep;32(9):1649-55. doi: 10.2337/dc08-1984. Epub 2009 May 28.

    PubMed 19478198

  • Bailey CJ, Del Prato S, Wei C, Reyner D, Saraiva G. Durability of glycaemic control with dapagliflozin, an SGLT2 inhibitor, compared with saxagliptin, a DPP4 inhibitor, in patients with inadequately controlled type 2 diabetes. Diabetes Obes Metab. 2019 Nov;21(11):2564-2569. doi: 10.1111/dom.13841. Epub 2019 Aug 26.

    PubMed 31364269

  • Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.

    PubMed 27402391

  • Bonora E, Bryzinski B, Hirshberg B, Cook W. A post hoc analysis of saxagliptin efficacy and safety in patients with type 2 diabetes stratified by UKPDS 10-year cardiovascular risk score. Nutr Metab Cardiovasc Dis. 2016 May;26(5):374-9. doi: 10.1016/j.numecd.2015.11.004. Epub 2015 Dec 1.

    PubMed 27033025

  • Rosenstock J, Gross JL, Aguilar-Salinas C, Hissa M, Berglind N, Ravichandran S, Fleming D. Long-term 4-year safety of saxagliptin in drug-naive and metformin-treated patients with Type 2 diabetes. Diabet Med. 2013 Dec;30(12):1472-6. doi: 10.1111/dme.12267. Epub 2013 Jul 19.

    PubMed 23802840

  • Karyekar CS, Frederich R, Ravichandran S. Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin. Int J Clin Pract. 2013 Aug;67(8):759-67. doi: 10.1111/ijcp.12212. Epub 2013 Jun 24.

    PubMed 23795975

  • Karyekar C, Donovan M, Allen E, Fleming D, Ravichandran S, Chen R. Efficacy and safety of saxagliptin combination therapy in US patients with type 2 diabetes. Postgrad Med. 2011 Jul;123(4):63-70. doi: 10.3810/pgm.2011.07.2305.

    PubMed 21680990

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saxagliptin + Metformin and Pioglitazone in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 152 sites in 9 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 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 152 sites in United States, Canada, Australia, Mexico, Brazil and 4 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. 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?

Yes. Results are posted in the registry (first posted 8 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (time frame: Baseline, Week 24). 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 NCT00121667, which also lists 7 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 29 Apr 2015.

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