Type 2 Diabetes MellitusPhase 3NCT01031680

Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension

A Phase 3 study testing Dapagliflozin in people with Type 2 Diabetes Mellitus and Cardiovascular Disease, run by AstraZeneca at 140 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 45 years and older
Conditions the study is for: Type 2 Diabetes Mellitus, Cardiovascular Disease, Hypertension
What is being tested?: Dapagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 922 participants
Where: 140 sitesin 9 countries
Study dates: Feb 2010to Dec 2012
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 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes mellitus.
Cardiovascular disease
Hypertension

Who cannot join

Patients with type 1 diabetes or diabetes insipidus
Patients with 3 or more oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes
Any clinically significant illness, which would compromise the patient's safety and their participation in the study

Trial locations and contacts

140 sites in 9 countries.

Country

City, postcode or hospital

140 sites in 9 countries

United States60 sites

Research Site
Baltimore, Maryland
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Baton Rouge, Louisiana
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Brick, New Jersey
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Burbank, California
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Carrollton, Texas
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Charleston, South Carolina
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Chicago, Illinois
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Cincinnati, Ohio
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Clearwater, Florida
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Colorado Springs, Colorado
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Columbus, Georgia
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Dallas, Texas
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Danville, Virginia
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Dayton, Ohio
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Decatur, Georgia
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Deerfield Beach, Florida
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Fort Worth, Texas
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Garden Grove, California
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Gulf Shores, Alabama
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Hialeah, Florida
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Hollywood, Florida
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Honolulu, Hawaii
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Houston, Texas
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Huntington Park, California
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Jacksonville, Florida
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Kansas City, Missouri
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Kingsport, Tennessee
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Lake Charles, Louisiana
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Lancaster, California
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Las Vegas, Nevada
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Miami, Florida
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New Hyde Park, New York
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North Richland Hills, Texas
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Ogden, Utah
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Oklahoma City, Oklahoma
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Oradell, New Jersey
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Phoenixville, Pennsylvania
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Pittsburgh, Pennsylvania
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Plano, Texas
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Port Charlotte, Florida
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Port Orange, Florida
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Reading, Pennsylvania
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Salinas, California
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San Antonio, Texas
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San Marino, California
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San Ramon, California
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Spokane, Washington
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St Louis, Missouri
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Stone Mountain, Georgia
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Tacoma, Washington
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Tampa, Florida
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The Bronx, New York
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Tomball, Texas
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Tustin, California
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Waterbury, Connecticut
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West Monroe, Louisiana
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Wichita, Kansas
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Winter Park, Florida

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Canada17 sites

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Calgary, Alberta
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Carbonear, Newfoundland and Labrador
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Courtice, Ontario
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Hamilton, Ontario
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Lachine, Quebec
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Laval, Quebec
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Mississauga, Ontario
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Montreal, Quebec
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Mount Pearl, Newfoundland and Labrador
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New Westminster, British Columbia
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Ottawa, Ontario
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Saint-Marc-des-Carrieres, Quebec
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Sherbrooke, Quebec
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Smiths Falls, Ontario
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St. John's, Newfoundland and Labrador
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Toronto, Ontario
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Winnipeg, Manitoba

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Slovakia14 sites

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Banská Bystrica
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Bratislava
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Dolný Kubín
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Komárno
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Košice
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Kysucké Nové Mesto
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Liptovský Hrádok
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Lučenec
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Nitra
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Považská Bystrica
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Prievidza
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Rimavská Sobota
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Ružomberok
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Žilina

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Germany13 sites

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Bad Nauheim
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Berlin
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Erdmannhausen
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Frankfurt
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Hamburg
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Heilbronn
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Hildesheim
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Mainz
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Münster
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Potsdam, BR
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Potsdam
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Speyer
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Wahlstedt

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Spain13 sites

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A Coruña, Galicia
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Barcelona, Catalonia
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Córdoba, Andalusia
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Granada, Andalusia
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Lleida, Catalonia
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Majadahonda, Madrid
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Olot (girona), Catalonia
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Oviedo, Principality of Asturias
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Palma de Mallorca, Balearic Islands
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San Juan (alicante), Valencia
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Santiago de Compostela, Galicia
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Seville, Andalusia
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Valencia, Valencia

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Argentina8 sites

Research Site
Buenos Aires, Buenos Aires F.D.
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Buenos Aires
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Caba, Buenos Aires F.D.
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Ciudad de Buenos Aires
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Córdoba, Córdoba Province
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La Plata, Buenos Aires
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Mendoza, Mendoza Province
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Santa Fe, Santa Fe Province

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Romania7 sites

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Brăila
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Brasov, Brașov County
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Bucharest
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Constanța
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Iași
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Sibiu
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Suceava, Suceava

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Taiwan6 sites

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Changhua
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Kaohsiung City
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Taichung
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Tainan County, Taiwan
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Taipei
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Taoyuan

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Vietnam2 sites

Research Site
Hanoi, Vietnam
Research Site
Ho Chi Minh City

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About this study

Official title: A 24-week, Multicentre, Randomised, Double-blind, Age-stratified, Placebo Controlled, Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin 10 mg Once Daily in Pts With T2DM, CV Disease and Hypertension Who Exhibit Inadequate Glycaemic Control on Usual Care

This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight and blood pressure, when added to patients existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes, cardiovascular disease and hypertension.

Conditions: Type 2 Diabetes Mellitus, Cardiovascular Disease, Hypertension, Inadequate Glycaemic Control
Being tested: Dapagliflozin, Placebo
Keywords: dapagliflozin, diabetes, cardiovascular disease, hypertension
Medical subject headings: Diabetes Mellitus, Type 2, Cardiovascular Diseases, Hypertension, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DapagliflozinDrug
10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period
PlaceboDrug
Matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period

Study groups in NCT01031680
Study group	Role	What they receive
1	Experimental	Dapagliflozin 10 mg tablet Receives: Drug: Dapagliflozin
2	Placebo comparator	Matching placebo tablet Receives: Drug: Placebo

What is being measured

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

Adjusted Mean Change in HbA1c Levels
To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension, measured as the mean change in HbA1c from baseline to week 24.
Measured: Baseline to Week 24
Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit
To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.
Measured: Baseline to week 24

Secondary outcomes (4)

Adjusted Mean Change in Seated Systolic Blood Pressure (SBP)
To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo.
Measured: Baseline to Week 8
Adjusted Mean Percent Change in Body Weight
To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo.
Measured: Baseline to Week 24
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 24 (LOCF)
To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo.
Measured: Baseline to Week 24
Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²
To compare the proportion of participants with BMI baseline ≥27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24. Least Squares Mean represents the percent of participants adjusted for baseline body weight and age stratum.
Measured: 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.

Feb 2010Dec 2012

First posted14 Dec 2009 (estimated)
Study startFeb 2010
Primary completionMay 2011
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 922 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01031680
Sponsor's protocol ID: D1690C00018
Status last verified: Sep 2013
First submitted: 10 Dec 2009
Last updated: 29 Oct 2013
Results posted: Yes, on ClinicalTrials.gov

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
Cefalu WT, Leiter LA, de Bruin TW, Gause-Nilsson I, Sugg J, Parikh SJ. Dapagliflozin's Effects on Glycemia and Cardiovascular Risk Factors in High-Risk Patients With Type 2 Diabetes: A 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a 28-Week Extension. Diabetes Care. 2015 Jul;38(7):1218-27. doi: 10.2337/dc14-0315. Epub 2015 Apr 7.
PubMed 25852208

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 24-week, Multicentre, Randomised, Double-blind, Age-stratified, Placebo Controlled, Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin 10 mg Once Daily in Pts With T2DM, CV Disease and Hypertension Who Exhibit Inadequate Glycaemic Control on Usual Care
ClinicalTrials.gov ID: NCT01031680
Acronym / sponsor ID: D1690C00018
Conditions: Type 2 Diabetes Mellitus, Cardiovascular Disease, Hypertension, Inadequate Glycaemic Control
Keywords: dapagliflozin, diabetes, cardiovascular disease, hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 922 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Feb 2010
Primary completion: May 2011 (actual)
Study completion: Dec 2012 (actual)
First posted: 14 Dec 2009 (estimated)
Results: Posted 23 Aug 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: DapagliflozinDapagliflozin 10 mg tablet
2	Placebo comparator	Drug: PlaceboMatching placebo tablet

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Type 2 diabetes mellitus.
Cardiovascular disease
Hypertension

Key exclusion criteria (3 listed)

Patients with type 1 diabetes or diabetes insipidus
Patients with 3 or more oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes
Any clinically significant illness, which would compromise the patient's safety and their participation in the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dapagliflozin10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period	Drug	1
PlaceboMatching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period	Drug	2

Primary outcome

Adjusted Mean Change in HbA1c Levels
Time frame: Baseline to Week 24
To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension, measured as the mean change in HbA1c from baseline to week 24.
Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit
Time frame: Baseline to week 24
To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.

4 secondary outcomes

Adjusted Mean Change in Seated Systolic Blood Pressure (SBP)
Time frame: Baseline to Week 8
Adjusted Mean Percent Change in Body Weight
Time frame: Baseline to Week 24
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 24 (LOCF)
Time frame: Baseline to Week 24
Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²
Time frame: Baseline to Week 24

Results and safety

Results posted to the registry on 23 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental	460	403
Placebo Comparator	462	404

Primary outcome: Adjusted Mean Change in HbA1c Levels

Time frame: Baseline to Week 24. Least squares mean (95% Confidence Interval). Unit: Percent

Measure	Experimental n = 448	Placebo Comparator n = 451
Value	-0.38 (-0.46 to -0.30)	0.08 (0.01 to 0.16)

Experimental vs Placebo Comparator: Mean Difference (Final Values): -0.46 (95% CI -0.56 to -0.37), p <0.0001, ANCOVA

Population analysed: Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values

Primary outcome: Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit

Time frame: Baseline to week 24. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Experimental n = 444	Placebo Comparator n = 451
Value	11.7 (8.7 to 14.7)	0.9 (0.0 to 1.8)

Experimental vs Placebo Comparator: Risk Difference (RD): 9.9 (95% CI 7.0 to 12.9), p <0.0001, Cochran-Mantel-Haenszel

Population analysed: Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period if earlier.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental	27 of 460 (5.9%)	89 of 460 (19.3%)	Not reported
Placebo Comparator	26 of 462 (5.6%)	84 of 462 (18.2%)	Not reported

Limitations and caveats (from the sponsor): For participants who did not complete 8 and/or 24 weeks, respectively, LOCF was used. For HbA1c: excluding data after glycemic rescue, Weight: including data after rescue, SBP: excluding data after anti-hypertensive rescue.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38770818Natale 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.
Derived from this study: PubMed 25852208Cefalu WT, Leiter LA, de Bruin TW, Gause-Nilsson I, Sugg J, Parikh SJ. Dapagliflozin's Effects on Glycemia and Cardiovascular Risk Factors in High-Risk Patients With Type 2 Diabetes: A 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a 28-Week Extension. Diabetes Care. 2015 Jul;38(7):1218-27. doi: 10.2337/dc14-0315. Epub 2015 Apr 7.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dr. William Cefalu principal investigator

Pennington Biomedical Research Center

140 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin in people with Type 2 Diabetes Mellitus and Cardiovascular Disease, run by AstraZeneca at 140 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 3 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 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, Canada, Slovakia, Germany, Spain 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 Aug 2013). 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 in HbA1c Levels (time frame: Baseline to 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 NCT01031680, which also lists 2 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 29 Oct 2013.