AzTrials
AzTrials

DiabetesPhase 3NCT00313313

A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas

A Phase 3 study testing Saxagliptin, Glyburide and Metformin in people with Diabetes, run by AstraZeneca at 115 sites in 13 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 trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes Read more about this study

Who is it for?
Ages 18 to 77 years
Conditions the study is for
Diabetes
What is being tested?
Saxagliptin, Glyburide and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
768 participants
Where
115 sitesin 13 countries
Study dates
Apr 2006to Sep 2008
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.
  • Treated with a sulfonylurea for at least 2 months.
  • Inadequate blood sugar control.
  • Are not on any other medications to lower blood sugar.
  • No major heart, liver or kidney problems.
  • Women not pregnant or breast feeding.

Who cannot join

None listed.

Trial locations and contacts

115 sites in 13 countries.

115 sites in 13 countries

United States54 sites

  • Daystar Clinical Research, Inc.

    Akron, Ohio, 44313

  • Stewart Medical Group

    Alhambra, California, 91801

  • Central Florida Clinical Trials

    Altamonte Springs, Florida, 32714

  • Capital Medical Clinic, Llp

    Austin, Texas, 78705

  • Community Health Care

    Canal Fulton, Ohio, 44614

  • Metrolina Internal Medicine

    Charlotte, North Carolina, 28204

  • Med Res Assoc Charlotte

    Charlotte, North Carolina, 28211

  • Cedar-Crosse Research Ctr

    Chicago, Illinois, 60607

  • Family Care Assoc & Emerald Care Res Grp

    Chipley, Florida, 32428

  • Columbia Medical Practice

    Columbia, Maryland, 21045

  • Clinical Therapeutics Corporation

    Coral Gables, Florida, 33134

  • Atlanta Pharmaceutical Research Center, Inc

    Dunwoody, Georgia, 30338

  • Cny Family Care

    East Syracuse, New York, 13057

  • Coordinators Plus, Llc

    Eugene, Oregon, 97401

  • Southland Clinical Research Center, Inc.

    Fountain Valley, California, 92708

  • Triphase Research, Ltd.

    Franklin, Ohio, 45005

  • Valley Research

    Fresno, California, 93720

  • New West Physicians

    Golden, Colorado, 80401

  • Regional Physicians Research

    High Point, North Carolina, 27262

  • Texas Center For Drug Development, P.A.

    Houston, Texas, 77081

  • Reserach Solutions, Llc

    Jonesboro, Arkansas, 72401

  • Va Medical Center

    Kansas City, Missouri, 64128

  • Breath Of Life Research Institute

    Katy, Texas, 77450

  • Fpa Clinical Research

    Kissimmee, Florida, 34741

  • Randall Shue, D.O.

    Los Angeles, California, 90023

  • Emerald Coast Research Group

    Marianna, Florida, 32446

  • Albert J Weisbrot,Md&Assoc Inc

    Mason, Ohio, 45040

  • University Of Miami Diabetes Research Inst.

    Miami, Florida, 33136

  • Advanced Healthcare S.C.

    Milwaukee, Wisconsin, 53209

  • Diabetes & Endocrinology Consultants, Pc

    Morehead City, North Carolina, 28557

  • Family Medical Center Of Hart Co.

    Munfordville, Kentucky, 42765

  • Christiana Care Research Institute

    Newark, Delaware, 19713

  • Pearl Clinical Research

    Norristown, Pennsylvania, 19401

  • Nevada Alliance Against Diabetes

    North Las Vegas, Nevada, 89030

  • Oklahoma Cardiovascular And Hypertension Center

    Oklahoma City, Oklahoma, 73132

  • Banksville Medical Pc

    Pittsburgh, Pennsylvania, 15216

  • Oregon Clinical Research

    Portland, Oregon, 97220

  • Clinical Trials Research

    Roseville, California, 95661

  • Diabetes & Glandular Disease Research Assoc, Pa

    San Antonio, Texas, 78229

  • S.A.M. Clinical Research Center

    San Antonio, Texas, 78229

  • Guthrie Clinic, Ltd

    Sayre, Pennsylvania, 18840

  • Searcy Medical Center

    Searcy, Arkansas, 72143

  • Upstate Pharmaceutical Research

    Simsonville, South Carolina, 29681

  • Mountain Top Clinical Research Center

    Sparta, North Carolina, 28675

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • Office Of Dr. Gray

    Spokane, Washington, 99216

  • St. Louis Center For Clinical Research

    St Louis, Missouri, 63128

  • Southeastern Research Assoc

    Taylors, South Carolina, 29687

  • Physicians Research Center

    Toms River, New Jersey, 08755

  • Utica Park Clinic

    Tulsa, Oklahoma, 74104

  • Tidewater Integrated Medical Research

    Virginia Beach, Virginia, 23451

  • Phoenix Internal Medicine Associates, Llc

    Waterbury, Connecticut, 06708

  • Dr Bahagwan Dass Md

    Youngstown, Ohio, 44507

  • Integris Family Care Yukon

    Yukon, Oklahoma, 73109

Other trials in United States

Brazil10 sites

  • Local Institution

    B. Rodolfo Teofilo, Ceará, 60430

  • Local Institution

    Belém, Pará, 66073

  • Local Institution

    Belo Horizonte, Minas Gerais, 30150

  • Local Institution

    Campinas, São Paulo, 13059

  • Local Institution

    Fortaleza, Ceará, 60021

  • Local Institution

    Marília, São Paulo, 17519

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90035003

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90610

  • Local Institution

    Sao Paulo - Sp, São Paulo, 04231

  • Local Institution

    Vila Mariana, São Paulo, 04020

Other trials in Brazil

Mexico9 sites

  • Local Institution

    Cuernavaca, Morelos, 62250

  • Local Institution

    Df, Mexico City, 11800

  • Local Institution

    Durango, Durango, 64710

  • Local Institution

    Guadalajara, Jalisco, 44340

  • Local Institution

    Guadalajara, Jalisco, 44670

  • Local Institution

    Mérida, Yucatán, 97210

  • Local Institution

    Monterrey, Nuevo León, 64060

  • Local Institution

    Monterrey, Nuevo León, 64710

  • Local Institution

    Tijuana, B.C., Estado de Baja California, 22320

Other trials in Mexico

Israel8 sites

  • Local Institution

    Giv‘atayim, 53583

  • Local Institution

    Haifa, 31096

  • Local Institution

    Holon, 58100

  • Local Institution

    Jerusalem, 91120

  • Local Institution

    Rishon LeZiyyon, 75650

  • Local Institution

    Safed, 13100

  • Local Institution

    Tel Aviv, 64353

  • Local Institution

    Tsrifin, 70300

Other trials in Israel

South Korea8 sites

  • Local Institution

    Kyunggi-Do, 420-717

  • Local Institution

    Kyunggi-Do, 463-707

  • Local Institution

    Seoul, 120-752

  • Local Institution

    Seoul, 130-702

  • Local Institution

    Seoul, 135-710

  • Local Institution

    Seoul, 135-720

  • Local Institution

    Seoul, 137040

  • Local Institution

    Suwon, 443721

Other trials in South Korea

South Africa5 sites

  • Local Institution

    Cape Town, 7008

  • Local Institution

    Johannesburg, 2196

  • Local Institution

    Kimberley, Northern Cape, 8301

  • Local Institution

    Tygerberg, Western Cape, 7505

  • Local Institution

    Umhlanga, KwaZulu-Natal, 4319

Other trials in South Africa

Argentina4 sites

  • Local Institution

    Buenos Aires, Buenos Aires, C1406FEQ

  • Local Institution

    Buenos Aires, Buenos Aires, C1425AGC

  • Local Institution

    Córdoba, Córdoba Province, 5000

  • Local Institution

    Mar del Plata, Buenos Aires, 7600

Other trials in Argentina

Peru4 sites

  • Local Institution

    Lima, Lima Province, 18

  • Local Institution

    Lima, Lima Province, LIMA 1

  • Local Institution

    Lima, Lima Province, LIMA 31

  • Local Institution

    San Isidro, Lima region, 27

Other trials in Peru

Puerto Rico4 sites

  • Local Institution

    Carolina, 00983

  • Local Institution

    Guaynabo, 00966

  • Local Institution

    Ponce, 00716

  • Local Institution

    Ponce, 00717

Other trials in Puerto Rico

Philippines3 sites

  • Local Institution

    Cebu, 6000

  • Local Institution

    Manila, 1000

  • Local Institution

    Quezon, 1102

Other trials in Philippines

Taiwan3 sites

  • Local Institution

    Changhua, 500

  • Local Institution

    Taichung, 402

  • Local Institution

    Taipei, 112

Other trials in Taiwan

Hong Kong2 sites

  • Local Institution

    Hong Kong, SAR

  • Local Institution

    Kowloon

Other trials in Hong Kong

Singapore1 site

  • Local Institution

    Singapore, 119074

Other trials in Singapore

About this study

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

The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes

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 (defined as rescue) will be eligible to enter the long-term treatment extension period where they will receive metformin.Rescue treatment with metformin is also available during the long-term extension period for subjects who meet glycemic criteria.

Conditions
Diabetes
Being tested
Saxagliptin, Glyburide, Placebo, Metformin
Medical subject headings
Diabetes Mellitus

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, Daily AM, (24 weeks short-term [ST], 12 months long-term [LT])

  • SaxagliptinDrug

    Also called BMS-477118

    Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT).

  • GlyburideDrug

    Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)

  • PlaceboDrug

    Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT)

  • GlyburideDrug

    Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT)

  • MetforminDrug

    Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)

Study groups in NCT00313313
Study groupRoleWhat they receive
Saxagliptin 2.5 mg + Glyburide 7.5 mg (A)ExperimentalMetformin 500-2500 mg (as needed)
Receives: Drug: Saxagliptin; Drug: Glyburide; Drug: Metformin
Saxagliptin 5 mg + Glyburide 7.5 mg (B)ExperimentalMetformin 500-2500 mg (as needed)
Receives: Drug: Saxagliptin; Drug: Glyburide; Drug: Metformin
Placebo + Glyburide 7.5 mg (C)Placebo comparatorMetformin 500-2500 mg (as needed)
Receives: Drug: Placebo; Drug: Glyburide; Drug: Metformin

What is being measured

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

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

    Mean change from baseline in A1C at Week 24, adjusted for baseline value.

    Measured: Baseline, Week 24

Secondary outcomes (3)

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

    Mean change from baseline in FPG at Week 24, adjusted for baseline value.

    Measured: Baseline, Week 24

  2. Percentage of Participants Achieving A1C < 7% at Week 24

    Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus glyburide versus placebo plus upward titrated glyburide at Week 24.

    Measured: Week 24

  3. Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24

    Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline values.

    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 posted12 Apr 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionSep 2007
  4. Study completionSep 2008

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
768 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00313313
Sponsor's protocol ID
CV181-040
Status last verified
Mar 2015
First submitted
10 Apr 2006
Last updated
4 May 2015

Publications

  • Chacra AR, Tan GH, Apanovitch A, Ravichandran S, List J, Chen R; CV181-040 Investigators. Saxagliptin added to a submaximal dose of sulphonylurea improves glycaemic control compared with uptitration of sulphonylurea in patients with type 2 diabetes: a randomised controlled trial. Int J Clin Pract. 2009 Sep;63(9):1395-406. doi: 10.1111/j.1742-1241.2009.02143.x. Epub 2009 Jul 15.

    PubMed 19614786

  • 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

  • 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

  • Chacra AR, Tan GH, Ravichandran S, List J, Chen R; CV181040 Investigators. Safety and efficacy of saxagliptin in combination with submaximal sulphonylurea versus up-titrated sulphonylurea over 76 weeks. Diab Vasc Dis Res. 2011 Apr;8(2):150-9. doi: 10.1177/1479164111404574.

    PubMed 21562067

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saxagliptin, Glyburide and Metformin in people with Diabetes, run by AstraZeneca at 115 sites in 13 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 0 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 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States, Brazil, Mexico, Israel, South Korea and 8 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 25 Sep 2009). 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?

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 NCT00313313, which also lists 6 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 4 May 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