Type 2 Diabetes MellitusPhase 3NCT01392677

Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea

A Phase 3 study testing dapagliflozin in people with Type 2 Diabetes Mellitus and High HbA1c Level, run by AstraZeneca at 42 sites in 6 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

This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus, High HbA1c Level, Inadequate Glycaemic Control
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: 311 participants
Where: 42 sitesin 6 countries
Study dates: Oct 2011to Aug 2013
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

Type 2 diabetes mellitus
Men or women age ≥ 18 years old
Stable dose combination of metformin and sulfonylurea
HbA1c ≥7.7% and ≤11.0%

Who cannot join

Type 1 diabetes mellitus or diabetes insipidus
Recent cardiovascular events
Kidney or urological disorders
Hepatic disorders

Trial locations and contacts

42 sites in 6 countries.

Country

City, postcode or hospital

42 sites in 6 countries

Canada12 sites

Research Site
Brampton, Ontario
Research Site
Edmonton, Alberta
Research Site
Etobicoke, Ontario
Research Site
Halifax, Nova Scotia
Research Site
Kensington, Prince Edward Island
Research Site
Laval, Quebec
Research Site
Markham, Ontario
Research Site
Québec, Quebec
Research Site
Smiths Falls, Ontario
Research Site
St. John's, Newfoundland and Labrador
Research Site
Sydney Mines, Nova Scotia
Research Site
Winnipeg, Manitoba

Other trials in Canada

Spain8 sites

Research Site
A Coruña, Galicia
Research Site
A Coruña
Research Site
Barcelona, Catalonia
Research Site
Barcelona
Research Site
Oviedo, Principality of Asturias
Research Site
Oviedo
Research Site
Santa Coloma de Gramanet (bcn), Catalu?a
Research Site
Santa Coloma de Gramenet (bcn)

Other trials in Spain

Czechia6 sites

Research Site
Beroun
Research Site
České Budějovice
Research Site
Jílové u Prahy
Research Site
Prague
Research Site
Semily
Research Site
Vyškov

Other trials in Czechia

Germany6 sites

Research Site
Aßlar
Research Site
Berlin
Research Site
Dresden
Research Site
Falkensee
Research Site
Neuwied
Research Site
Pirna

Other trials in Germany

Poland6 sites

Research Site
Kielce
Research Site
Lodz
Research Site
Lublin
Research Site
Poznan
Research Site
Warsaw
Research Site
Zgierz

Other trials in Poland

Slovakia4 sites

Research Site
Banská Bystrica
Research Site
Košice
Research Site
Považská Bystrica
Research Site
Rimavská Sobota

Other trials in Slovakia

About this study

Official title: A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study With a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg Once Daily in Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background Combination of Metformin and Sulfonylurea

Conditions: Type 2 Diabetes Mellitus, High HbA1c Level, Inadequate Glycaemic Control
Being tested: dapagliflozin, placebo
Keywords: dapagliflozin, diabetes, hyperglycaemia
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus, Hyperglycemia

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 28- week extension period
placeboDrug
matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period

Study groups in NCT01392677
Study group	Role	What they receive
Dapagliflozin 10 mg tablet	Experimental	Not described Receives: Drug: dapagliflozin
matching placebo tablet	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

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

Adjusted Mean Change From Baseline in HbA1c Levels
To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea.
Measured: Baseline to week 24

Secondary outcomes (4)

Adjusted Mean Change From Baseline in FPG
To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo
Measured: Baseline to week 24
Adjusted Mean Change From Baseline in Total Body Weight
To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo
Measured: Baseline to week 24
Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF)
To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, at week 24 (LOCF) between dapagliflozin and placebo
Measured: Baseline to week 24
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure
To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo
Measured: Baseline to week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Aug 2013

First posted12 Jul 2011 (estimated)
Study startOct 2011
Primary completionJan 2013
Study completionAug 2013

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 (1)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: 311 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01392677
Sponsor's protocol ID: D1693C00005
Status last verified: Feb 2014
First submitted: 11 Jul 2011
Last updated: 12 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Matthaei S, Bowering K, Rohwedder K, Grohl A, Parikh S; Study 05 Group. Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial. Diabetes Care. 2015 Mar;38(3):365-72. doi: 10.2337/dc14-0666. Epub 2015 Jan 15.
PubMed 25592197

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 12 Mar 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, International Phase III Study With a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg Once Daily in Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background Combination of Metformin and Sulfonylurea
ClinicalTrials.gov ID: NCT01392677
Acronym / sponsor ID: D1693C00005
Conditions: Type 2 Diabetes Mellitus, High HbA1c Level, Inadequate Glycaemic Control
Keywords: dapagliflozin, diabetes, hyperglycaemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 311 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Oct 2011
Primary completion: Jan 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 12 Jul 2011 (estimated)
Results: Posted 27 Dec 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
Dapagliflozin 10 mg tablet	Experimental	Drug: dapagliflozin
matching placebo tablet	Placebo comparator	Drug: placebo

Who may qualify

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

Key inclusion criteria (4 listed)

Type 2 diabetes mellitus
Men or women age ≥ 18 years old
Stable dose combination of metformin and sulfonylurea
HbA1c ≥7.7% and ≤11.0%

Key exclusion criteria (4 listed)

Type 1 diabetes mellitus or diabetes insipidus
Recent cardiovascular events
Kidney or urological disorders
Hepatic disorders

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 28- week extension period	Drug	Dapagliflozin 10 mg tablet
placebomatching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period	Drug	matching placebo tablet

Primary outcome

Adjusted Mean Change From Baseline in HbA1c Levels
Time frame: Baseline to week 24
To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea.

4 secondary outcomes

Adjusted Mean Change From Baseline in FPG
Time frame: Baseline to week 24
Adjusted Mean Change From Baseline in Total Body Weight
Time frame: Baseline to week 24
Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF)
Time frame: Baseline to week 24
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure
Time frame: Baseline to week 8

Results and safety

Results posted to the registry on 27 Dec 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 Plus Metformin Plus Sulfonylurea	109	101
Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea	109	101

Primary outcome: Adjusted Mean Change From Baseline in HbA1c Levels

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

Measure	Placebo Plus Metformin Plus Sulfonylurea n = 108	Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea n = 108
Value	-0.17 (-0.31 to -0.02)	-0.86 (-1.00 to -0.72)

Placebo Plus Metformin Plus Sulfonylurea vs Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea: Mean Difference (Final Values): -0.69 (95% CI -0.89 to -0.49), p <0.0001, Mixed Models Analysis

Population analysed: Full Analysis Set, participants with non-missing baseline and week 24 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
Placebo Plus Metformin Plus Sulfonylurea	6 of 109 (5.5%)	7 of 109 (6.4%)	Not reported
Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea	1 of 109 (0.9%)	5 of 109 (4.6%)	Not reported

Limitations and caveats (from the sponsor): For participants who did not complete 8 and/or 24 weeks, respectively, last observation carried forward (LOCF) was used for analyses of secondary endpoints. All endpoints were evaluated by excluding data after rescue.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25592197Matthaei S, Bowering K, Rohwedder K, Grohl A, Parikh S; Study 05 Group. Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial. Diabetes Care. 2015 Mar;38(3):365-72. doi: 10.2337/dc14-0666. Epub 2015 Jan 15.
D1693C00005.pdfLink provided by the sponsor.

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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.

Eva Johnsson, PhD, Medical Science Director study director

AstraZeneca R&D, Global Medicines Development CVGI, SE-431 83 Mölndal, Sweden

Stephan Matthaei, Prof.Dr.med principal investigator

Diabetes-Zentrum Quakenbruck

42 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 Mellitus and High HbA1c Level, run by AstraZeneca at 42 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 4 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 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in Canada, Spain, Czechia, Germany, Poland 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 27 Dec 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 From Baseline 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 NCT01392677, which also lists 1 linked publication.

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 12 Mar 2014.