Dapagliflozin DPPIV Inhibitor add-on Study

A Phase 3 study testing Dapagliflozin in people with Type 2 Diabetes, run by AstraZeneca at 88 sites in 6 countries.

Completed

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

Trial summary

This study aims to investigate how dapagliflozin can control blood sugar in patients with type 2 diabetes when added to existing treatments (sitagliptin alone or in combination with metformin). The effect of dapagliflozin on weight and blood pressure 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 833 participants
Where: 88 sitesin 6 countries
Study dates: Oct 2009to Sep 2011
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

Patients with type 2 diabetes
Patients who are not receiving treatment , or those who currently receive metformin, sitagliptin or vildagliptin or the combination of these
Patients will be screened by a blood test and only those who need additional therapy can be enrolled

Who cannot join

Patients with type 1 diabetes
Patients with very poorly controlled diabetes
Any clinically significant illness, which in the judgement of the investigator would compromise the patient's safety or successful participation in the clinical study

Trial locations and contacts

88 sites in 6 countries.

Country

City, postcode or hospital

88 sites in 6 countries

United States45 sites

Research Site
Anaheim, California
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Boca Raton, Florida
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Bristol, Tennessee
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Burke, Virginia
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Chula Vista, California
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Cincinnati, Ohio
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Columbus, Ohio
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Corpus Christi, Texas
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Dallas, Texas
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Dayton, Ohio
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DeLand, Florida
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Edina, Minnesota
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Greenbrae, California
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Huntsville, Alabama
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Jacksonville, Florida
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Laguna Hills, California
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Lake Charles, Louisiana
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Lakewood, Washington
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Lancaster, Pennsylvania
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Las Vegas, Nevada
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Longwood, Florida
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Los Angeles, California
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Manassas, Virginia
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Medord, Oregon
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Miami, Florida
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Mt. Pleasant, South Carolina
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Myrtle Beach, South Carolina
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North Richland Hills, Texas
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Oklahoma City, Oklahoma
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Ozark, Alabama
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Pahrump, Nevada
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Philadelphia, Pennsylvania
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Port Orange, Florida
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Richmond, Virginia
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Riverside, California
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Salt Lake City, Utah
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San Antonio, Texas
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Simpsonville, South Carolina
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St Louis, Missouri
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Staten Island, New York
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Stone Mountain, Georgia
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West Hills, California
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West Palm Beach, Florida
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Wichita, Kansas
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Wilmington, North Carolina

Other trials in United States

Poland12 sites

Research Site
Ciechocinek
Research Site
Czechowice-Dziedzice
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Gdansk
Research Site
Gniewkowo
Research Site
Krakow
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Krotoszyn
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Łęczyca
Research Site
Mrągowo
Research Site
Poznan
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Sopot
Research Site
Torun
Research Site
Zabrze

Other trials in Poland

United Kingdom11 sites

Research Site
Addlestone, Surrey
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Bath
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Belfast
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Blackpool
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Bolton, Lancs
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Burbage, Leicester
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Coventry
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Ecclesfield, Sheffield
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Harrow
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Sunbury-on-Thames, Middlesex
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Wansford, Peterborough

Other trials in United Kingdom

Argentina10 sites

Research Site
Berazategui, Buenos Aires
Research Site
Buenos Aires, Buenos Aires F.D.
Research Site
Caba, Buenos Aires F.D.
Research Site
Córdoba, Córdoba Province
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La Plata, Buenos Aires
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Lanus, Buenos Aires
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Mar del Plata, Buenos Aires
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Morón, Buenos Aires
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Salta, Salta Province
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Santa Fe, Santa Fe Province

Other trials in Argentina

Germany8 sites

Research Site
Bad Nauheim
Research Site
Berlin
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Dresden
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Hamburg
Research Site
Meissen
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Münster
Research Site
Pirna
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Wangen

Other trials in Germany

Mexico2 sites

Research Site
Guadalajara, Jalisco
Research Site
Mexico City, Mexico City

Other trials in Mexico

About this study

Official title: A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study With 24 Week Extension to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg/Day in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on a DPP-4 Inhibitor Sitagliptin+/-Metformin

Conditions: Type 2 Diabetes
Being tested: Dapagliflozin, Placebo
Keywords: Dapagliflozin DPP IV inhibitor add on study, Inadequate control
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
10 mg tablet, oral, once daily, 48 weeks
PlaceboDrug
Matching placebo tablet

Study groups in NCT00984867
Study group	Role	What they receive
1	Active comparator	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 change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin.
Measured: Baseline to Week 24

Secondary outcomes (6)

Adjusted Mean Change in Body Weight
To compare the change in total body weight achieved with dapagliflozin versus placebo from baseline to week 24.
Measured: Baseline to Week 24
Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8%
To compare the change in HbA1c in participants with baseline HbA1c ≥8% achieved with dapagliflozin versus placebo from baseline to week 24.
Measured: Baseline to Week 24
Adjusted Mean Change in Fasting Plasma Glucose (FPG)
To compare the change in FPG achieved with dapagliflozin versus placebo from baseline to week 24.
Measured: Baseline to Week 24
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg
To compare the change in seated systolic blood pressure (SBP) in participants with baseline seated SBP >=130 achieved with dapagliflozin versus placebo from baseline to week 8.
Measured: Baseline to Week 8
Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise
To compare the change in 2-hour post liquid meal glucose rise achieved with dapagliflozin versus placebo from baseline to week 24.
Measured: Baseline to Week 24
Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline
To compare the proportion of participants achieving a therapeutic glycaemic response, defined as a reduction in HbA1c of ≥0.7% compared to baseline, with dapagliflozin versus placebo at week 24. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.
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.

Oct 2009Sep 2011

First posted25 Sep 2009 (estimated)
Study startOct 2009
Primary completionMar 2011
Study completionSep 2011

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 DiabetesStudies 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: 833 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00984867
Sponsor's protocol ID: D1690C00010
Status last verified: Jun 2014
First submitted: 23 Sep 2009
Last updated: 13 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Jabbour SA, Hardy E, Sugg J, Parikh S; Study 10 Group. Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study. Diabetes Care. 2014;37(3):740-50. doi: 10.2337/dc13-0467. Epub 2013 Oct 21.
PubMed 24144654
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

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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Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
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A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
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Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study With 24 Week Extension to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg/Day in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on a DPP-4 Inhibitor Sitagliptin+/-Metformin
ClinicalTrials.gov ID: NCT00984867
Acronym / sponsor ID: D1690C00010
Conditions: Type 2 Diabetes
Keywords: Dapagliflozin DPP IV inhibitor add on study, Inadequate control
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 833 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Oct 2009
Primary completion: Mar 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 25 Sep 2009 (estimated)
Results: Posted 14 Oct 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	Active comparator	Drug: DapagliflozinDapagliflozin 10 mg tablet
2	Placebo comparator	Drug: PlaceboMatching placebo tablet

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with type 2 diabetes
Patients who are not receiving treatment , or those who currently receive metformin, sitagliptin or vildagliptin or the combination of these
Patients will be screened by a blood test and only those who need additional therapy can be enrolled

Key exclusion criteria (3 listed)

Patients with type 1 diabetes
Patients with very poorly controlled diabetes
Any clinically significant illness, which in the judgement of the investigator would compromise the patient's safety or successful participation in the clinical 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, 48 weeks	Drug	1
PlaceboMatching placebo tablet	Drug	2

Primary outcome

Adjusted Mean Change in HbA1c Levels
Time frame: Baseline to Week 24
To compare the change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin.

6 secondary outcomes

Adjusted Mean Change in Body Weight
Time frame: Baseline to Week 24
Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8%
Time frame: Baseline to Week 24
Adjusted Mean Change in Fasting Plasma Glucose (FPG)
Time frame: Baseline to Week 24
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg
Time frame: Baseline to Week 8
Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise
Time frame: Baseline to Week 24
Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline
Time frame: Baseline to Week 24

Results and safety

Results posted to the registry on 14 Oct 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
Placebo	226	203
Dapagliflozin	225	208

Primary outcome: Adjusted Mean Change in HbA1c Levels

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

Measure	Placebo n = 223	Dapagliflozin n = 223
Value	0.04 (0.0509)	-0.45 (0.0509)

Placebo vs Dapagliflozin: Mean Difference (Final Values): -0.48 (95% CI -0.62 to -0.34), p <0.0001, ANCOVA

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

6 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
Placebo	9 of 226 (4%)	14 of 226 (6.2%)	Not reported
Dapagliflozin	10 of 225 (4.4%)	9 of 225 (4%)	Not reported

Limitations and caveats (from the sponsor): For participants who did not complete 8 and/or 24 weeks, respectively, LOCF was used. All endpoints were evaluated by excluding data after rescue with the exception of systolic blood pressure which was evaluated regardless of rescue medication.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24144654Jabbour SA, Hardy E, Sugg J, Parikh S; Study 10 Group. Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study. Diabetes Care. 2014;37(3):740-50. doi: 10.2337/dc13-0467. Epub 2013 Oct 21.
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.
D1690C00010\_Clinical\_Study\_Report\_SynopsisLink provided by the sponsor.
D1690C00010\_Revised\_CSP1\_and\_Amdt\_1\_Priv\_RedactedLink provided by the sponsor.

Related trials for Type 2 Diabetes

Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
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Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
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Active, not recruitingPhase 1/2
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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.

Serge Jabbour, MD principal investigator

Thomas Jefferson University, Philadelphia

88 sites in 6 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, run by AstraZeneca at 88 sites in 6 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 13 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, Poland, United Kingdom, Argentina, Germany and 1 more country. 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 14 Oct 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). 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 NCT00984867, 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 13 Jun 2014.