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Diabetes Mellitus, Type 2Phase 3NCT00295633

A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone

A Phase 3 study testing Saxagliptin, pioglitazone and rosiglitazone in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 133 sites in 8 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 thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD 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, pioglitazone and rosiglitazone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
565 participants
Where
133 sitesin 8 countries
Study dates
Mar 2006to Oct 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 diabetics currently receiving a stable dose of TZD monotherapy (pioglitazone 30mg or 45mg, or rosiglitazone 4mg or 8mg) for at least 12 weeks prior to screening.
  • Hemoglobin A1c (HbA1c) > = 7.0% and < = 10.5%
  • Body mass index < = 45kg/m2
  • Fasting C-peptide > = 1 ng/mL

Who cannot join

  • Symptomatic poorly controlled diabetes
  • Recent cardiac or cerebrovascular event
  • Serum creatinine > = 2.0 mg/dL

Trial locations and contacts

133 sites in 8 countries.

133 sites in 8 countries

United States79 sites

  • East Tennessee Medical Group

    Alcoa, Tennessee, 37701

  • Central Florida Clinical Trials, Inc.

    Altamonte Springs, Florida, 32714

  • Capital Medical Clinic, Llp

    Austin, Texas, 78705

  • Texas Diabetes And Endocrinology, P.A.

    Austin, Texas, 78731

  • Radiant Research-Austin

    Austin, Texas, 78752

  • Impact Clinical Trials

    Beverly Hills, California, 90211

  • Lovelace Scientific Resources, Inc.

    Beverly Hills, California, 90211

  • Community Health Care

    Canal Fulton, Ohio, 44614

  • Clinical Research Limited

    Canton, Ohio, 44718

  • Medical Research Associates Of Charlotte, Inc.

    Charlotte, North Carolina, 28211

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • Southern Family Healthcare, Pa

    Chipley, Florida, 32428

  • Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

  • Three Rivers Medical Associates, Pa

    Columbia, South Carolina, 29201

  • Priscilla Hollander, Md, Phd

    Dallas, Texas, 75246

  • Providence Health Partners - Center For Clinical Research

    Dayton, Ohio, 45439

  • Doctors Medical Center Of Walton County

    DeFuniak Springs, Florida, 32435

  • Denver Internal Medicine Group

    Denver, Colorado, 80209

  • Alan B. Miller, Md

    Dunwoody, Georgia, 30338

  • Medical Group Of Encino

    Encino, California, 91436

  • David Witkin, Md

    Eugene, Oregon, 97401

  • The Medical Group Of Texas

    Fort Worth, Texas, 76104

  • Holzer Clinic

    Gallipolis, Ohio, 45631

  • Marin Endocrine Care And Research, Inc.

    Greenbrae, California, 94904

  • Radiant Research, Greer

    Greer, South Carolina, 29651

  • Winston Technology, Inc.

    Haleyville, Alabama, 35565

  • Harleysville Medical Associates

    Harleysville, Pennsylvania, 19438

  • Horizon Institute For Clinical Research

    Hollywood, Florida, 33021

  • Office Of Ammar Bazerbashi, Md

    Holmdel, New Jersey, 07733

  • Mobley Research Center

    Houston, Texas, 77024

  • Family Physician, Pa

    Houston, Texas, 77074

  • Mapleridge Medical Center

    Houston, Texas, 77081

  • Del Rosario Medical Clinic, Inc.

    Huntington Park, California, 90255

  • Southeast Idaho Family Practice

    Idaho Falls, Idaho, 83404

  • Physicians Research Group

    Indianapolis, Indiana, 46250

  • Lipid Research Clinic

    Iowa City, Iowa, 52242

  • Jacksonville Center For Clinical Research

    Jacksonville, Florida, 32205

  • Nea Clinic

    Jonesboro, Arkansas, 72401

  • D. Thomas Rogers, Md, Facs

    Kahului, Hawaii, 96732

  • Wells Institute For Health Awareness

    Kettering, Ohio, 45429

  • Radiant Research Las Vegas

    Las Vegas, Nevada, 89146

  • Family Medical Associates

    Levittown, Pennsylvania, 19056

  • Little Rock Family Practice Clinic

    Little Rock, Arkansas, 72205

  • Loma Linda Va Healthcare Systems

    Loma Linda, California, 92357

  • Peak Health Medical Group

    Los Angeles, California, 90025

  • Richard Cherlin, Md

    Los Gatos, California, 95032

  • Panhandle Family Care Associates

    Marianna, Florida, 32446

  • Marietta Clinical Research, Inc.

    Marietta, Georgia, 30060

  • Clinical Research Advantage, Inc

    Mesa, Arizona, 85213

  • Nextphase Clinical Trials, Inc

    Miami, Florida, 33145

  • Baptist Diabetes Associates

    Miami, Florida, 33156

  • Diabetes Center Of The Southwest

    Midland, Texas, 79705

  • Mission Internal Medical Group

    Mission Viejo, California, 92691

  • Sunbelt Research Group, Llc

    Mobile, Alabama, 36606

  • Healthstar Physicians

    Morristown, Tennessee, 37813

  • Hayes Endocrine And Diabetes Center

    Nashville, Tennessee, 37209

  • Nevada Alliance Against Diabetes

    North Las Vegas, Nevada, 89030

  • Olive Branch Family Medical Center

    Olive Branch, Mississippi, 38654

  • Iicr, Inc.

    Ozark, Alabama, 36360

  • Desert Medical Advances

    Palm Desert, California, 92260

  • Pearland Primary Care Associates, Llp

    Pearland, Texas, 77584

  • Banksville Medical Pc

    Pittsburgh, Pennsylvania, 15216

  • Promed Physicians Family Practice

    Portage, Michigan, 49024

  • National Clinical Research, Inc.

    Richmond, Virginia, 23294

  • Med-Cure

    Rosenberg, Texas, 77471

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia, 30076

  • Radiant Research San Antonio

    San Antonio, Texas, 78229

  • S.A.M. Clinical Research Center

    San Antonio, Texas, 78229

  • Heart & Vascular Center Research, Inc.

    Sarasota, Florida, 34239

  • Upstate Pharmaceutical Research

    Simpsonville, South Carolina, 29681

  • Urgentmed, P.C.

    South Bound Brook, New Jersey, 08880

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

  • Carolina Pharmaceutical Research

    Statesville, North Carolina, 28625

  • Collom And Carney Clinic

    Texarkana, Texas, 75503

  • Northwest Indiana Center For Clinical Research

    Valparaiso, Indiana, 46383

  • Tidewater Integrated Medical Research

    Virginia Beach, Virginia, 23451

  • Phoenix Internal Medicine Associates, Llc

    Waterbury, Connecticut, 06708

  • Mouhaffel, Assad H.

    West Monroe, Louisiana, 71291

  • Professional Research Network Of Kansas

    Wichita, Kansas, 67203

Other trials in United States

India15 sites

  • Local Institution

    Bangalore, 560010

  • Local Institution

    Bangalore, 560054

  • Local Institution

    Chennai, 600010

  • Local Institution

    Chennai, 600013

  • Local Institution

    Chennai, 600086

  • Local Institution

    Chennai, 680004

  • Local Institution

    Hariyāna, 132001

  • Local Institution

    Hyderabad, 500082

  • Local Institution

    Indore, 452001

  • Local Institution

    Maharashtra, 411011

  • Local Institution

    Mangalore, 575001

  • Local Institution

    Mumbai, 400021

  • Local Institution

    Mumbai, 400067

  • Local Institution

    Pune, 411011

  • Local Institution

    Vellore, 632004

Other trials in India

Argentina10 sites

  • Local Institution

    Belgrano, Buenos Aires, C1426EGP

  • Local Institution

    Buenos Aires, Buenos Aires, C1408INH

  • Local Institution

    Buenos Aires, C1425AGC

  • Local Institution

    Chacabuco, Buenos Aires, B6740CWC

  • Local Institution

    Ciudad Auton., Buenos Aires, C1505CWB

  • Local Institution

    La Plata, Buenos Aires, 1900

  • Local Institution

    Lanus Este, Tucumán Province, 1824

  • Local Institution

    Mendoza, Mendoza Province, M5519XAC

  • Local Institution

    Morón, Buenos Aires, B17081FF

  • Local Institution

    Rosario, Santa Fe Province, S2000CVD

Other trials in Argentina

Canada7 sites

  • Local Institution

    Halifax, Nova Scotia, B3H 2Y9

  • Local Institution

    Saint-Léonard, Quebec, H1S 3A9

  • Local Institution

    Sarnia, Ontario, N7T 4X3

  • Local Institution

    Saskatoon, Saskatchewan, S7K 3H3

  • Local Institution

    St. Catharines, Ontario, L2R 7P3

  • Local Institution

    St. John's, Newfoundland and Labrador, A1E 2C2

  • Local Institution

    Ste-Foy, Quebec, G1V 4G2

Other trials in Canada

Mexico6 sites

  • Local Institution

    Aguascalientes, Aguascalientes, 20232

  • Local Institution

    Angeles Del Pedregal, Mexico City, 10700

  • Local Institution

    Chichuahua, Chihuahua, 31000

  • Local Institution

    Michoacan, Morelos, 58000

  • Local Institution

    Monterrey, Nuevo León, 66260

  • Local Institution

    Zapopan, Jalisco, 45200

Other trials in Mexico

Peru6 sites

  • Local Institution

    La Victoria, Lima region, 13

  • Local Institution

    Lima Cercado, Lima region, 1

  • Local Institution

    Miraflores, Lima region, 18

  • Local Institution

    San Isidro, Lima region, 27

  • Local Institution

    San Martín de Porres, Lima region, 31

  • Local Institution

    Santiago de Surco, Lima region, 33

Other trials in Peru

Philippines5 sites

  • Local Institution

    Cebu City, 1600

  • Local Institution

    Cebu City, 6000

  • Local Institution

    Iloilo City, 5000

  • Local Institution

    Las Piñas, 1740

  • Local Institution

    Pasig, 1600

Other trials in Philippines

Puerto Rico5 sites

  • Local Institution

    Carolina, 00983

  • Local Institution

    Ponce, 00716

  • Local Institution

    Ponce, 00717

  • Local Institution

    Rio Piedras, 00926

  • Local Institution

    San Juan, 00920

Other trials in Puerto Rico

About this study

Official title: A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS477118) in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone

The purpose of this clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD 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 metformin (defined as rescue medication) added onto their blinded study medication

Being tested
Saxagliptin, Placebo, pioglitazone, rosiglitazone, 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 (6 months ST, 12 months LT)

  • SaxagliptinDrug

    Also called BMS-477118

    Tablets, Oral, 5 mg, once daily (6 months ST, 12 months LT)

  • PlaceboDrug

    Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT)

  • pioglitazoneDrug

    Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT)

  • rosiglitazoneDrug

    Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT)

  • metforminDrug

    Tablets, Oral, 500-2500 mg, as needed (12 months LT)

Study groups in NCT00295633
Study groupRoleWhat they receive
Saxagliptin plus open-label TZD (A)ExperimentalSaxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Receives: Drug: Saxagliptin; Drug: pioglitazone; Drug: rosiglitazone; Drug: metformin
Saxagliptin plus open-label TZD (B)ExperimentalSaxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Receives: Drug: Saxagliptin; Drug: pioglitazone; Drug: rosiglitazone; Drug: metformin
Placebo plus open-label TZD (C)Placebo comparatorPlacebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Receives: Drug: Placebo; Drug: pioglitazone; Drug: rosiglitazone; 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 Diabetic Association's defined goal for glycemia, at each dose of saxagliptin plus TZD versus placebo plus TZD 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 achieved at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24, 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 posted24 Feb 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionOct 2007
  4. Study completionOct 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
565 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00295633
Sponsor's protocol ID
CV181-013
Status last verified
Mar 2015
First submitted
22 Feb 2006
Last updated
7 Apr 2015

Publications

  • Hollander P, Li J, Allen E, Chen R; CV181-013 Investigators. Saxagliptin added to a thiazolidinedione improves glycemic control in patients with type 2 diabetes and inadequate control on thiazolidinedione alone. J Clin Endocrinol Metab. 2009 Dec;94(12):4810-9. doi: 10.1210/jc.2009-0550. Epub 2009 Oct 28.

    PubMed 19864452

  • 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

  • Hollander PL, Li J, Frederich R, Allen E, Chen R; CV181013 Investigators. Safety and efficacy of saxagliptin added to thiazolidinedione over 76 weeks in patients with type 2 diabetes mellitus. Diab Vasc Dis Res. 2011 Apr;8(2):125-35. doi: 10.1177/1479164111404575.

    PubMed 21562064

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saxagliptin, pioglitazone and rosiglitazone in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 133 sites in 8 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 7 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 133 sites in United States, India, Argentina, Canada, Mexico and 3 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 NCT00295633, 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 7 Apr 2015.

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