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Type 2 DiabetesPhase 3NCT01606007

Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes

A Phase 3 study testing Saxagliptin, Metformin XR and Dapagliflozin in people with Type 2 Diabetes, run by AstraZeneca at 139 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 study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. 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?
Saxagliptin, Metformin XR and Dapagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,282 participants
Where
139 sitesin 8 countries
Study dates
Jul 2012to Jan 2014
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

  • Subjects with Type 2 diabetes mellitus (T2DM) with HbA1c ≥ 8.0% and ≤ 12.0%
  • Stable metformin therapy dose of ≥ 1500mg for at least 8 weeks prior to screening
  • Body mass index (BMI) ≤ 45.0kg/m2

Who cannot join

  • Estimated glomerular filtration rate (eGFR) < 60mL/min/1,73m2 and Serum Creatinine (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females
  • Uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 160mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100mmHg
  • Hepatic disease
  • Cardiovascular disease within 3 months

Trial locations and contacts

139 sites in 8 countries.

139 sites in 8 countries

United States80 sites

  • Daystar Clinical Resarch, Inc.

    Akron, Ohio, 44313

  • Arlington Family Research Center, Inc.

    Arlington, Texas, 76012

  • Associated Internal Medicine Specialists

    Battle Creek, Michigan, 49015

  • Heritage Valley Medical Group

    Beaver, Pennsylvania, 15009

  • Bellevue Family Practice

    Bellevue, Nebraska, 68005

  • Southwestern Vermont Med Cntr

    Bennington, Vermont, 05201

  • Central Alabama Research

    Birmingham, Alabama, 35209

  • South Jersey Medical Associates, P.A.

    Blackwood, New Jersey, 08012

  • Val R. Hansen, M.D.

    Bountiful, Utah, 84010

  • Holston Medical Group

    Bristol, Tennessee, 37620

  • Metrolina Internal Medicine

    Charlotte, North Carolina, 28204

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607-4559

  • Southeast Clinical Research, Llc

    Chiefland, Florida, 32626

  • Sterling Research Grp, Ltd.

    Cincinnati, Ohio, 45246

  • Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

  • Clinical Research Advantage

    Colorado Springs, Colorado, 80906

  • Tlm Medical Services

    Columbia, South Carolina, 29204

  • Clinical Therapeutics Corporation

    Coral Gables, Florida, 33134

  • Padre Coast Clinical Research

    Corpus Christi, Texas, 78404

  • Clinical Research Advantage

    Council Bluffs, Iowa, 51503

  • Dallas Diabetes & Endocrine Center

    Dallas, Texas, 75230-2548

  • Primed Clinical Research

    Dayton, Ohio, 45419

  • Infocus Clinical Research

    Denver, Colorado, 80211

  • Lynn Institute Of Denver

    Denver, Colorado, 80246

  • Harris And Associates, P.C.

    Detroit, Michigan, 48235

  • Central Jersey Health And Medical Research

    Elizabeth, New Jersey, 07205

  • Clinical Research Advantage

    Elkhorn, Nebraska, 68022

  • Willamette Valley Clinical Studies

    Eugene, Oregon, 97404

  • Horizon Research Group Of Opelousas, Llc

    Eunice, Louisiana, 70535

  • Patterson Medical Clinic

    Florissant, Missouri, 63031

  • Palmetto Clinical Trial Services Llc

    Fountain Inn, South Carolina, 29644

  • Southland Clinical Research Center, Inc.

    Fountain Valley, California, 92708

  • Clinical Research Advantage

    Fremont, Nebraska, 68025

  • Triad Clinical Trials, Llc

    Greensboro, North Carolina, 27410

  • Central Alabama Research

    Homewood, Alabama, 35244

  • Excel Clinical Research, Llc

    Houston, Texas, 77035

  • Southeast Clinical Research, Llc

    Jacksonville, Florida, 32216

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Fpa Clinical Research

    Kissimmee, Florida, 34741

  • Pmg Research Of Knoxville

    Knoxville, Tennessee, 37912

  • Medical Investigations, Inc.

    Little Rock, Arkansas, 72205

  • Aureus Research, Inc.

    Little Rock, Arkansas, 72211

  • Torrance Clinical Research

    Lomita, California, 90717

  • National Research Inst

    Los Angeles, California, 90057

  • Clinical Research Advantage

    Mesa, Arizona, 85206

  • Clinical Research Of Miami, Inc.

    Miami, Florida, 33126

  • Advanced Pharma Cr, Llc

    Miami, Florida, 33136

  • Newphase Clinical Trials, Inc.

    Miami Beach, Florida, 33140

  • Diabetes & Endocrinology Consultants

    Morehead City, North Carolina, 28557

  • Terence T. Hart, Md

    Muscle Shoals, Alabama, 35662

  • Lynn Institute Of Norman

    Norman, Oklahoma, 73069

  • Providence Clinical Research

    North Hollywood, California, 91606

  • North Hills Medical Research, Inc.

    North Richland Hills, Texas, 76180

  • Diabetes Medical Center Of California

    Northridge, California, 91325

  • Mehrdad Kevin Ariani Md, Inc.

    Northridge, California, 91325

  • Lucita M. Cruz,Md.,Inc.

    Norwalk, California, 90650

  • Clinical Research Advantage

    Omaha, Nebraska, 68130

  • Omega Research Consultants, Llc

    Orlando, Florida, 32804

  • International Institute Of Clinical Research

    Ozark, Alabama, 36360

  • Palm Harbor Medical Associates

    Palm Harbor, Florida, 34684

  • Center For Clinical Trials, Llc.

    Paramount, California, 90723

  • Med-Olam Clinical Research

    Pasadena, Texas, 77504

  • Andres Patron, Do Pa

    Pembroke Pines, Florida, 33026

  • Elite Clinical Studies, Llc

    Phoenix, Arizona, 85018

  • Oregon Clinical Research

    Portland, Oregon, 97220

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia, 30076

  • Center For Clinical Trials Of Sacramento, Inc.

    Sacramento, California, 95823

  • Highland Clinical Research

    Salt Lake City, Utah, 84124

  • Sam Clinical Research Center

    San Antoinio, Texas, 78229

  • Covenant Clinical Research, Pa

    San Antonio, Texas, 78229

  • Trinitas Research, Inc

    San Jose, California, 95116

  • Wellmon Family Practice

    Shippensburg, Pennsylvania, 17257

  • Hampton Roads Center For Clinical Research, Inc.

    Suffolk, Virginia, 23435

  • Genova Clinical Research

    Tucson, Arizona, 85704

  • Orange County Research Center

    Tustin, California, 92780

  • Deerbrook Medical Associates

    Vernon Hills, Illinois, 60061

  • Hillcrest Family Health Center

    Waco, Texas, 76710

  • Southgate Medical Group

    West Seneca, New York, 14224

  • Pmg Research Of Winston-Salem, Llc

    Winston-Salem, North Carolina, 27103

  • Physicians Research, Inc.

    Zanesville, Ohio, 43701

Other trials in United States

Romania10 sites

  • Local Institution

    Bucharest, 020359

  • Local Institution

    Bucharest, 020475

  • Local Institution

    Bucharest, 050538

  • Local Institution

    Bucharest, 11794

  • Local Institution

    Cluj Napoca Cluj, 400006

  • Local Institution

    Craiova, 200349

  • Local Institution

    Galati, Galați County, 800098

  • Local Institution

    Ploieşti, Prahova, 100018

  • Local Institution

    Ploieşti, Prahova, 100163

  • Local Institution

    Timișoara, Timiș County, 300736

Other trials in Romania

South Africa10 sites

  • Local Institution

    Cape Town, Western Cape, 7500

  • Local Institution

    Durban, KwaZulu-Natal, 4001

  • Local Institution

    Gauteng, Johannesburg, 1818

  • Local Institution

    Goodwood, Western Cape, 7460

  • Local Institution

    Johannesburg, Johannesburg, 2129

  • Local Institution

    Johannesburg, 1829

  • Local Institution

    Paarl, Western Cape, 7646

  • Local Institution

    Rondebosch, Western Cape, 7700

  • Local Institution

    Somerset West, Western Cape, 7130

  • Local Institution

    Soweto, Gauteng, 2013

Other trials in South Africa

Poland9 sites

  • Local Institution

    Gdansk, 80-546

  • Local Institution

    Katowice, 40-057

  • Local Institution

    Katowice, 40954

  • Local Institution

    Krakow, 30-015

  • Local Institution

    Lodz, 90-242

  • Local Institution

    Opole, 45-367

  • Local Institution

    Poznan, 61-655

  • Local Institution

    Puławy, 24-100

  • Local Institution

    Warsaw, 03-580

Other trials in Poland

Canada8 sites

  • Local Institution

    Brampton, Ontario, L6T 0G1

  • Local Institution

    Coquitlam, British Columbia, V3K 3V9

  • Local Institution

    Granby, Quebec, J2G 8Z9

  • Local Institution

    Québec, Quebec, G1N 4V3

  • Local Institution

    Saskatoon, Saskatchewan, S7K 3H3

  • Local Institution

    Smiths Falls, Ontario, K7A 4W8

  • Local Institution

    Toronto, Ontario, M9W 4L6

  • Local Institution

    Winnipeg, Manitoba, R3E3P4

Other trials in Canada

Mexico8 sites

  • Local Institution

    Aguascalientes, Aguascalientes, 20230

  • Local Institution

    Chihuahua City, Chihuahua, 31217

  • Local Institution

    Cuautla, Morelos, 62744

  • Local Institution

    Durango, Durango, 34000

  • Local Institution

    Guadalajara, Jalisco, 44670

  • Local Institution

    Mérida, Yucatán, 97070

  • Local Institution

    Monterrey, Nuevo León, 64460

  • Local Institution

    Monterrey, Nuevo León, 64710

Other trials in Mexico

Puerto Rico7 sites

  • Local Institution

    Cidra, 00739

  • Local Institution

    Manati, 00674

  • Local Institution

    Ponce, 00716

  • Local Institution

    San Juan, 00909

  • Local Institution

    San Juan, 00926

  • Local Institution

    San Juan, 00935

  • Local Institution

    Villa Fontana, 00983

Other trials in Puerto Rico

South Korea7 sites

  • Local Institution

    Bucheon-si, Gyeonggi-do, 420-717

  • Local Institution

    Daegu, 700-721

  • Local Institution

    Incheon, 405-760

  • Local Institution

    Seoul, 110-774

  • Local Institution

    Seoul, 120-752

  • Local Institution

    Seoul, 137-701

  • Local Institution

    Sungnam-si, Gyeonggi-do, 463-712

Other trials in South Korea

About this study

Official title: A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy With Saxagliptin and Dapagliflozin Added to Metformin Compared to Add-On Therapy With Saxagliptin in Combination With Metformin or Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone.

The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also be studied.

Conditions
Type 2 Diabetes
Being tested
Saxagliptin, Metformin XR, Dapagliflozin, Placebo matching with Dapagliflozin, Placebo matching with Saxagliptin
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 Onglyza

    Tablets, Oral, 5mg , Once daily, 24 weeks

  • Metformin XRDrug

    Also called Glucophage XR

    Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks

  • DapagliflozinDrug

    Also called BMS-512148

    Tablets, Oral, 10mg , Once daily, 24 weeks

  • Placebo matching with DapagliflozinDrug

    Tablets, Oral, 0mg, Once daily, 24 weeks

  • Placebo matching with SaxagliptinDrug

    Tablets, Oral, 0mg, Once daily, 24 weeks

Study groups in NCT01606007
Study groupRoleWhat they receive
Arm 1: Saxagliptin+Metformin XR+PlaceboActive comparatorNot described
Receives: Drug: Saxagliptin; Drug: Metformin XR; Drug: Placebo matching with Dapagliflozin
Arm 2: Dapagliflozin+Metformin XR+PlaceboActive comparatorNot described
Receives: Drug: Metformin XR; Drug: Dapagliflozin; Drug: Placebo matching with Saxagliptin
Arm 3: Saxagliptin+Dapagliflozin+Metformin XRExperimentalNot described
Receives: Drug: Saxagliptin; Drug: Metformin XR; Drug: Dapagliflozin

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

    HbA1c was measured as percent of hemoglobin by a central laboratory. 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 at Week 24 in the double-blind period, including observations prior to rescue.

    Measured: Baseline (Week 0) and at Week 24

Secondary outcomes (4)

  1. Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24 (Last Observation Carried Forward [LOCF])

    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 at week 24 in the doubleblind period, including observations prior to rescue.

    Measured: Baseline (Week 0) and at Week 24

  2. Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

    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 at Week 24 in the doubleblind period, including observations prior to rescue.

    Measured: Baseline (Week 0) and at Week 24

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

    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.

    Measured: At Week 24

  4. Adjusted Mean Change From Baseline in Body Weight at Week 24

    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 at Week 24 in the doubleblind period, including observations prior to rescue.

    Measured: Baseline (Week 0) and at 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 posted25 May 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionJan 2014
  4. Study completionJan 2014

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01606007
Sponsor's protocol ID
CV181-169
Other IDs
2012-000679-18
Status last verified
Mar 2017
First submitted
23 May 2012
Last updated
15 May 2017
Data monitoring committee
Yes

Publications

  • Rosenstock J, Hansen L, Zee P, Li Y, Cook W, Hirshberg B, Iqbal N. Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin. Diabetes Care. 2015 Mar;38(3):376-83. doi: 10.2337/dc14-1142. Epub 2014 Oct 28.

    PubMed 25352655

  • 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

  • Rosenstock J, Mathieu C, Chen H, Garcia-Sanchez R, Saraiva GL. Dapagliflozin versus saxagliptin as add-on therapy in patients with type 2 diabetes inadequately controlled with metformin. Arch Endocrinol Metab. 2018 Aug;62(4):424-430. doi: 10.20945/2359-3997000000056.

    PubMed 30304106

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saxagliptin, Metformin XR and Dapagliflozin in people with Type 2 Diabetes, run by AstraZeneca at 139 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 3 inclusion and 4 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 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 139 sites in United States, Romania, South Africa, Poland, Canada 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. 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 20 Oct 2015). 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 (time frame: Baseline (Week 0) and at 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 NCT01606007, which also lists 3 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 15 May 2017.

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