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Type 2 DiabetesPhase 3NCT00683878

Add-on to Thiazolidinedione (TZD) Failures

A Phase 3 study testing Dapagliflozin and Thiazolidinedione (Pioglitazone) in people with Type 2 Diabetes, run by AstraZeneca at 89 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 if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on TZD alone. The safety of this treatment will also be studied Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Dapagliflozin and Thiazolidinedione (Pioglitazone)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
972 participants
Where
89 sitesin 9 countries
Study dates
Jul 2008to Jun 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females, ≥ 18 years old, with type 2 diabetes and with inadequate glycemic control
  • All subjects must have central laboratory pre-randomization A1C ≥ 7.0 and ≤ 10.5%
  • C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
  • Body Mass Index ≤ 45.0 kg/m²

Who cannot join

  • AST and /or ALT > 2.5 times the upper limit of normal
  • Serum total bilirubin > 2 mg/dL (34.2 µmol/L)
  • Creatinine kinase > 3.0 times the upper limit of normal
  • Symptoms of severely uncontrolled diabetes
  • Serum creatinine ≥ 2.0 mg/dL
  • Calculated Cr-Clearance < 50 ml/min (calculated by Cockroft-Gault formula)
  • Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Trial locations and contacts

89 sites in 9 countries.

89 sites in 9 countries

United States57 sites

  • Central Florida Clinical Trials

    Altamonte Springs, Florida, 32701

  • Pinnacle Research Group, Llc

    Anniston, Alabama, 36207

  • Aurora Family Medicine Center, P.C.

    Aurora, Colorado, 80012

  • Metrolina Internal Medicine

    Charlotte, North Carolina, 28204

  • The Center For Nutrition & Preventive Medicine, Pllc

    Charlotte, North Carolina, 28277

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607

  • Health First Clinical Research Group, Inc.

    Chipley, Florida, 32428

  • Columbia Clinical Research, Inc.

    Columbia, South Carolina, 29201

  • Clinical Therapeutics Corporation

    Coral Gables, Florida, 33134

  • Clinical Innovations, Inc.

    Costa Mesa, California, 92626

  • Dallas Diabetes & Endocrine Center

    Dallas, Texas, 75230

  • Providence Health Partners - Center For Clinical Research

    Dayton, Ohio, 45439

  • Denver Internal Medicine

    Denver, Colorado, 80209

  • St. Mary'S Center For Diabetes And Endocrinology

    Grand Rapids, Michigan, 49503

  • Marin Endocrine Care And Research, Inc.

    Greenbrae, California, 94904

  • Village Family Practice

    Houston, Texas, 77024

  • Office Of Dr. Michelle Zaniewski Singh

    Houston, Texas, 77090

  • Endocrine Research Associates

    Jackson, Mississippi, 39216

  • Westside Center For Clinical Research

    Jacksonville, Florida, 32205

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Association Of International Professionals

    Las Vegas, Nevada, 89101

  • Northstate Clinical Research

    Lenoir, North Carolina, 28645

  • Family Medical Associates

    Levittown, Pennsylvania, 19056

  • Little Rock Family Practice Clinic

    Little Rock, Arkansas, 72205

  • Torrance Clinical Research

    Lomita, California, 90717

  • Randall Shue, D.O.

    Los Angeles, California, 90023

  • Panhandle Family Care Associates

    Marianna, Florida, 32446

  • Baptist Diabetes Associates, Pa

    Miami, Florida, 33156

  • Suncoast Clinical Res Inc.

    New Port Richey, Florida, 34652

  • Diabetes Medical Center Of California

    Northridge, California, 91325

  • Olive Branch Family Medical Center

    Olive Branch, Mississippi, 38654

  • Iicr

    Ozark, Alabama, 36360

  • Desert Medical Advances

    Palm Desert, California, 92260

  • 43rd Medical Associates, P.C.

    Phoenix, Arizona, 85051

  • Banksville Medical, Pc

    Pittsburgh, Pennsylvania, 15216

  • Brookside Family Practice & Pediatrics

    Pottstown, Pennsylvania, 19464

  • Avastra Clinical Trials

    Redlands, California, 92373

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • Danny W. Jackson P.A.

    Rolling Fork, Mississippi, 39159

  • Sierra Clinical Research

    Roseville, California, 95661

  • Diabetes & Glandular Disease Research Assoc,, Inc.

    San Antonio, Texas, 78229

  • Ritchken & First M.D.'S

    San Diego, California, 92117

  • Advantage Clinical Research

    Santa Ana, California, 92701

  • Searcy Medical Center

    Searcy, Arkansas, 72143

  • William L. Gray, Md

    Spokane, Washington, 99216

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Stone Mountain Clinical Research

    Stone Mountain, Georgia, 30088

  • Southeastern Research Associates, Inc.

    Taylors, South Carolina, 29687

  • Clinical Research Advantage Inc / Desert Clinical Res, Llc

    Tempe, Arizona, 85282

  • Clinical Research Advantage, Inc

    Tempe, Arizona, 85282

  • Physicians Research Center

    Toms River, New Jersey, 08755

  • Diabetes Research Center

    Tustin, California, 92780

  • Northwest Indiana Center For Clinical Research

    Valparaiso, Indiana, 46383

  • Tidewater Integrated Medical Research

    Virginia Beach, Virginia, 23454

  • Professional Research Network Of Kansas

    Wichita, Kansas, 67203

  • New Hanover Medical Research

    Wilmington, North Carolina, 28401

  • Physician Research, Inc.

    Zanesville, Ohio, 43701

Other trials in United States

Mexico8 sites

  • Local Institution

    Chihuahua City, Chihuahua, 31020

  • Local Institution

    Guadalajara, Jalisco, 44100

  • Local Institution

    Guadalajara, Jalisco, 44670

  • Local Institution

    Mérida, Yucatán, 97210

  • Local Institution

    Monterrey, Nuevo León, 64240

  • Local Institution

    Monterrey, Nl, Nuevo León, 64400

  • Local Institution

    Veracruz, Veracruz, 91700

  • Local Institution

    Zapopan, Jalisco, 45200

Other trials in Mexico

Canada7 sites

  • Local Institution

    Halifax, Nova Scotia, B3K 5R3

  • Local Institution

    Mirabel, Quebec, J7J 2K8

  • Local Institution

    Moncton, New Brunswick, E1G 1A7

  • Local Institution

    Mount Pearl, Newfoundland and Labrador, A1N 1W7

  • Local Institution

    Sarnia, Ontario, N7T 4X3

  • Local Institution

    Toronto, Ontario, M8V 3X8

  • Local Institution

    Winnipeg, Manitoba, R3K 0Y8

Other trials in Canada

Argentina4 sites

  • Local Institution

    Buenos Aires, Buenos Aires, B1708IFF

  • Local Institution

    Ciudad Auton, Buenos Aires, C1408INH

  • Local Institution

    Córdoba, Córdoba Province, 5000

  • Local Institution

    Zárate, Buenos Aires, 2800

Other trials in Argentina

India3 sites

  • Local Institution

    Hariyāna, 132001

  • Local Institution

    Mumbai, 400007

  • Local Institution

    Vellore, 632004

Other trials in India

Peru3 sites

  • Local Institution

    Lima, Lima Province, 09

  • Local Institution

    Lima, Lima Province, 17

  • Local Institution

    Lima, Lima Province, 31

Other trials in Peru

Philippines3 sites

  • Local Institution

    Cebu City, 6000

  • Local Institution

    Manila, 1000

  • Local Institution

    Pasig, 1600

Other trials in Philippines

Taiwan3 sites

  • Local Institution

    Changhua, 500

  • Local Institution

    Taichung, 43303

  • Local Institution

    Taipei, 110

Other trials in Taiwan

Puerto Rico1 site

  • Local Institution

    Ponce, 00717

Other trials in Puerto Rico

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin 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 if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on TZD alone. The safety of this treatment will also be studied

Conditions
Type 2 Diabetes
Being tested
Dapagliflozin, Placebo matching Dapagliflozin, Thiazolidinedione (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.

  • DapagliflozinDrug

    Also called BMS-512148

    Tablets, Oral, 5.0 mg, once daily, up to 48 weeks

  • DapagliflozinDrug

    Also called BMS-512148

    Tablets, Oral, 10.0 mg, once daily, up to 48 weeks

  • Placebo matching DapagliflozinDrug

    Tablets, Oral, 0 mg, once daily, up to 48 weeks

  • Thiazolidinedione (Pioglitazone)Drug

    Tablets, ≥ 30 mg, Once daily, up to 48 weeks

Study groups in NCT00683878
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Dapagliflozin; Drug: Thiazolidinedione (Pioglitazone)
Arm 2ExperimentalNot described
Receives: Drug: Dapagliflozin; Drug: Thiazolidinedione (Pioglitazone)
Arm 3Placebo comparatorNot described
Receives: Drug: Placebo matching Dapagliflozin; Drug: Thiazolidinedione (Pioglitazone)

What is being measured

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

  1. Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])

    HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.

    Measured: From Baseline to Week 24

Secondary outcomes (6)

  1. Adjusted Mean Change From Baseline in 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])

    Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. In post oral glucose tolerance test (OGTT), glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained on Day 1 and week 24 in the double-blind period.

    Measured: From Baseline to Week 24

  2. Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])

    Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.

    Measured: From Baseline to Week 24

  3. Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])

    Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period.

    Measured: From Baseline to Week 24

  4. Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])

    Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants were estimated by modified logistic regression model.

    Measured: From Baseline to Week 24

  5. Adjusted Mean Change From Baseline in Waist Circumference (cm) at Week 24 (Last Observation Carried Forward [LOCF])

    Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in waist circumference at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Waist circumference measurements were obtained during the qualification and lead-in periods and on Day 1 and Week 24 of the double-blind period.

    Measured: From Baseline to Week 24

  6. Adjusted Mean Change From Baseline in Total Body Weight (kg) Among Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])

    Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight among subjects with baseline body mass index (BMI) ≥ 27 kg/m^2 at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.

    Measured: From Baseline to 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 posted26 May 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionJan 2010
  4. Study completionJun 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
972 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00683878
Sponsor's protocol ID
MB102-030
Status last verified
Jan 2017
First submitted
22 May 2008
Last updated
23 Feb 2017
Data monitoring committee
No

Publications

  • Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

    PubMed 38770818

  • Shah M, Stolbov L, Yakovleva T, Tang W, Sokolov V, Penland RC, Boulton D, Parkinson J. A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):991-1000. doi: 10.1111/dom.14305. Epub 2021 Jan 25.

    PubMed 33368935

  • 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

  • Rosenstock J, Vico M, Wei L, Salsali A, List JF. Effects of dapagliflozin, an SGLT2 inhibitor, on HbA(1c), body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy. Diabetes Care. 2012 Jul;35(7):1473-8. doi: 10.2337/dc11-1693. Epub 2012 Mar 23.

    PubMed 22446170

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin and Thiazolidinedione (Pioglitazone) in people with Type 2 Diabetes, run by AstraZeneca at 89 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 7 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, Mexico, Canada, Argentina, India 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 23 Feb 2017). 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?

Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) (time frame: From Baseline to 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 NCT00683878, which also lists 4 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 23 Feb 2017.

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