AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3NCT00121641

Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

A Phase 3 study testing Saxagliptin and Metformin in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 134 sites in 6 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 (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise 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 and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,035 participants
Where
134 sitesin 6 countries
Study dates
Jul 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
  • Drug naive
  • Hemoglobin (Hb) A1c >= 7.0% and <= 10.0% (>10% and <= 12% for open label arm)
  • Fasting C-peptide >= 1 ng/mL
  • Body mass index <= 40 kg/m2

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 Women of Child Bearing Potential

Trial locations and contacts

134 sites in 6 countries.

134 sites in 6 countries

United States83 sites

  • Local Institution

    Altamonte Springs, Florida

  • Local Institution

    Anaheim, California

  • Local Institution

    Anniston, Alabama

  • Local Institution

    Athens, Ohio

  • Local Institution

    Ayer, Massachusetts

  • 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

    Castle Rock, Colorado

  • Local Institution

    Charleston, South Carolina

  • Local Institution

    Chester, Maryland

  • Local Institution

    Chipley, Florida

  • Local Institution

    Cocoa Beach, Florida

  • Local Institution

    Cooperstown, New York

  • Local Institution

    Coral Gables, Florida

  • Local Institution

    Dallas, Texas

  • Local Institution

    Denver, Colorado

  • Local Institution

    Dubuque, Iowa

  • Local Institution

    Fleetwood, Pennsylvania

  • Local Institution

    Fort Lauderdale, Florida

  • Local Institution

    Fort Worth, Texas

  • Local Institution

    Fountain Valley, California

  • Local Institution

    Franklin, Ohio

  • Local Institution

    Fresno, California

  • Local Institution

    Greensboro, North Carolina

  • Local Institution

    Houston, Texas

  • Local Institution

    Huntersville, North Carolina

  • Local Institution

    Iowa City, Iowa

  • Local Institution

    Jonesboro, Arizona

  • Local Institution

    Jupiter, Florida

  • Local Institution

    Kalispell, Montana

  • Local Institution

    Kansas City, Missouri

  • Local Institution

    Kissimmee, Florida

  • Local Institution

    Las Vegas, Nevada

  • Local Institution

    Lexington, Kentucky

  • Local Institution

    Little Rock, Arkansas

  • Local Institution

    Long Beach, California

  • Local Institution

    Los Angeles, California

  • Local Institution

    Loveland, Colorado

  • Local Institution

    Marianna, Florida

  • Local Institution

    Mesa, Arizona

  • Local Institution

    Middletown, New Jersey

  • Local Institution

    Morristown, Tennessee

  • 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

    Pheonix, Arizona

  • Local Institution

    Philadelphia, Pennsylvania

  • Local Institution

    Pittsburgh, Pennsylvania

  • Local Institution

    Portland, Oregon

  • Local Institution

    Prince Frederick, Maryland

  • Local Institution

    Rolling Fork, Mississippi

  • Local Institution

    Rolling Hills Estates, California

  • Local Institution

    Sacramento, California

  • Local Institution

    Salt Lake City, Utah

  • Local Institution

    San Antonio, Texas

  • Local Institution

    Santa Ana, California

  • Local Institution

    Sparta, North Carolina

  • Local Institution

    Spring Valley, California

  • Local Institution

    Springfield, Missouri

  • Local Institution

    St Louis, Missouri

  • Local Institution

    Statesville, North Carolina

  • Local Institution

    Temple, Texas

  • Local Institution

    Texarkana, Texas

  • Local Institution

    The Colony, Texas

  • Local Institution

    Toms River, New Jersey

  • 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

    West Palm Beach, Florida

  • Local Institution

    Wichita, Kansas

  • Local Institution

    Winston-Salem, North Carolina

Other trials in United States

Canada29 sites

  • Local Institution

    Bathurst, New Brunswick

  • Local Institution

    Calgary, Alberta

  • Local Institution

    Charlottetown, Prince Edward Island

  • Local Institution

    Drummondville, Quebec

  • Local Institution

    Edmonton, Alberta

  • Local Institution

    Fleurimont, Quebec

  • Local Institution

    Gatineau, Quebec

  • Local Institution

    Granby, Quebec

  • Local Institution

    Kelowna, British Columbia

  • Local Institution

    Longueuil, Quebec

  • Local Institution

    Manuels, Newfoundland and Labrador

  • Local Institution

    Moncton, New Brunswick

  • Local Institution

    Montreal, Quebec

  • Local Institution

    Mount Pearl, Newfoundland and Labrador

  • Local Institution

    Newmarket, Ontario

  • Local Institution

    Oakville, Ontario

  • Local Institution

    Peterborough, Ontario

  • Local Institution

    Portage la Prairie, Manitoba

  • Local Institution

    Quesnel, British Columbia

  • 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

    Strathroy, Ontario

  • Local Institution

    Thornhill, Ontario

  • Local Institution

    Toronto, Ontario

  • Local Institution

    Vancouver, British Columbia

  • Local Institution

    Winnipeg, Manitoba

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

Mexico6 sites

  • Local Institution

    Aguascalientes, Aguascalientes

  • Local Institution

    Durango, Durango

  • Local Institution

    Guadalajara, Jalisco

  • Local Institution

    Hermosillo, Sonora

  • Local Institution

    Mexico City, Mexico City

  • Local Institution

    Monterrey, Nuevo León

Other trials in Mexico

Puerto Rico5 sites

  • Local Institution

    Carolina

  • Local Institution

    Guaynabo

  • Local Institution

    Ponce

  • Local Institution

    Rio Piedras

  • 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

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise

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 metformin added onto their blinded study medication. Subjects with screening hemoglobin A1c (A1C) > 10.0% and ≤ 12.0%, who otherwise meet all inclusion/exclusion criteria, were eligible to enroll directly into Open-Label Treatment Cohort (Direct Enrollees) and receive open-label saxagliptin 10 mg. Those who completed the short-term period were eligible to enter into the long-term treatment extension period.Saxagliptin dose titration was not permitted.

Being tested
Saxagliptin, Placebo matching Saxagliptin, Metformin, Placebo matching 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.

  • SaxagliptinDrug

    Also called BMS-477118

    Tablets, Oral, 2.5 mg, Once daily (24 weeks short term [ST], 42 months long term [LT])

  • SaxagliptinDrug

    Also called BMS-477118

    Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT)

  • SaxagliptinDrug

    Also called BMS-477118

    Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT)

  • Placebo matching SaxagliptinDrug

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

  • MetforminDrug

    Tablets, Oral, 500 mg, daily (42 months LT)

  • Placebo matching MetforminDrug

    Tablets, Oral, 0 mg, daily (42 months LT)

  • SaxagliptinDrug

    Also called BMS-477118

    Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) Open Label

  • MetforminDrug

    Tablets, Oral, 500-2000 mg (as needed for rescue)

Study groups in NCT00121641
Study groupRoleWhat they receive
Saxagliptin 2.5 mg (A)ExperimentalMetformin 500-2000 mg (as needed for rescue)
Receives: Drug: Saxagliptin; Drug: Placebo matching Metformin; Drug: Metformin
Saxagliptin 5 mg (B)ExperimentalMetformin 500-2000 mg (as needed for rescue)
Receives: Drug: Saxagliptin; Drug: Placebo matching Metformin; Drug: Metformin
Saxagliptin 10 mg (C)ExperimentalMetformin 500-2000 mg (as needed for rescue)
Receives: Drug: Saxagliptin; Drug: Placebo matching Metformin; Drug: Metformin
Placebo (D)Placebo comparatorMetformin 500-2000 mg (as needed for rescue)
Receives: Drug: Placebo matching Saxagliptin; Drug: Metformin
Open-Label Treatment Cohort (Direct Enrollees) (E)ExperimentalSaxagliptin 10 mg Metformin 500-2000 mg (as needed for rescue)
Receives: Drug: Saxagliptin; Drug: Metformin

What is being measured

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

  1. Hemoglobin A1c (A1C) Changes From Baseline at Week 24

    To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.

    Measured: Baseline, Week 24

  2. A1C Changes From Baseline at Week 24 - Open Label Cohort

    To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.

    Measured: Baseline, Week 24

Secondary outcomes (6)

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

    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)

    Measured: Baseline, Week 24

  4. Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort

    Measured: Baseline, Week 24

  5. Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort

    Measured: Week 24

  6. Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) - Open Label Cohort

    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 startJul 2005
  3. Primary completionAug 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
1,035 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00121641
Sponsor's protocol ID
CV181-011
Status last verified
Mar 2015
First submitted
15 Jul 2005
Last updated
3 Apr 2015

Publications

  • Rosenstock J, Aguilar-Salinas C, Klein E, Nepal S, List J, Chen R; CV181-011 Study Investigators. Effect of saxagliptin monotherapy in treatment-naive patients with type 2 diabetes. Curr Med Res Opin. 2009 Oct;25(10):2401-11. doi: 10.1185/03007990903178735.

    PubMed 19650754

  • Esu E, Berens-Riha N, Pritsch M, Nwachuku N, Loescher T, Meremikwu M. Intermittent screening and treatment with artemether-lumefantrine versus intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in pregnancy: a facility-based, open-label, non-inferiority trial in Nigeria. Malar J. 2018 Jul 6;17(1):251. doi: 10.1186/s12936-018-2394-2.

    PubMed 29976228

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saxagliptin and Metformin in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 134 sites in 6 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 5 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 3 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 134 sites in United States, Canada, Australia, Mexico, Puerto Rico and 1 more country. 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 11 May 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?

Hemoglobin A1c (A1C) Changes From Baseline at Week 24 (time frame: Baseline, Week 24). The study lists 2 primary outcomes in all. 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 NCT00121641, which also lists 5 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 3 Apr 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in