Type 2 Diabetes MellitusPhase 2NCT00972244

Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus Patients

A Phase 2 study testing Dapagliflozin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 20 sites in Japan.

Completed

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

Trial summary

The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of dapagliflozin to placebo when given in oral doses. Read more about this study

Who is it for?: Ages 18 to 79 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Dapagliflozin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 417 participants
Where: 20 sitesJapan
Study dates: Aug 2009to May 2010
Phase: Phase 2
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 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Japanese Subjects with type 2 diabetes mellitus.
Strictly/relatively treatment naïve Subjects with HbA1c ≥ 7.0% and ≤ 10%, or Subjects treated with single or two (less than half of the approved maximal dose for each) oral anti-hyperglycaemic agent with HbA1c ≤ 8%.
Provision of informed consent.

Who cannot join

Having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease.
The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

Japan20 sites

Research Site
Anjyo
Research Site
Bunkyō City
Research Site
Chūōku
Research Site
Daitō
Research Site
Kamagaya
Research Site
Kashiwara
Research Site
Matsuyama
Research Site
Nagoya
Research Site
Naka
Research Site
Nakano
Research Site
Nerima-ku
Research Site
Okinawa
Research Site
Osaka
Research Site
Sapporo
Research Site
Shibuya-ku
Research Site
Shinjyuku-ku
Research Site
Suita
Research Site
Uji
Research Site
Wakayama
Research Site
Yamato

Other trials in Japan

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Conditions: Type 2 Diabetes Mellitus
Being tested: Dapagliflozin, Placebo
Keywords: Type 2 diabetes mellitus, Japanese, phase 2, efficacy, safety, dapagliflozin
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
once daily, 12 weeks
PlaceboDrug
once daily, 12 weeks

Study groups in NCT00972244
Study group	Role	What they receive
1	Experimental	1mg dapagliflozin Receives: Drug: Dapagliflozin
2	Experimental	2.5mg dapagliflozin Receives: Drug: Dapagliflozin
3	Experimental	5mg dapagliflozin Receives: Drug: Dapagliflozin
4	Experimental	10mg dapagliflozin Receives: Drug: Dapagliflozin
5	Placebo comparator	Placebo 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
The primary efficacy endpoint is the absolute change in HbA1c from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.
Measured: Baseline to Week 12

Secondary outcomes (2)

Adjusted Mean Change in Fasting Plasma Glucose
Change in fasting plasma glucose from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.
Measured: Baseline to Week 12
Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
Proportion of participants achieving therapeutic glycemic response defined as glycosylated hemoglobin <7%, after 12 weeks of double-blind therapy
Measured: At Week 12

Timeline

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

Aug 2009May 2010

First posted4 Sep 2009 (estimated)
Study startAug 2009
Primary completionMay 2010
Study completionMay 2010

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 417 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00972244
Sponsor's protocol ID: D1692C00005
Status last verified: Aug 2013
First submitted: 31 Aug 2009
Last updated: 14 Oct 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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

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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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
ClinicalTrials.gov ID: NCT00972244
Acronym / sponsor ID: D1692C00005
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus, Japanese, phase 2, efficacy, safety, dapagliflozin
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 417 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Aug 2009
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 4 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: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
1	Experimental	Drug: Dapagliflozin1mg dapagliflozin
2	Experimental	Drug: Dapagliflozin2.5mg dapagliflozin
3	Experimental	Drug: Dapagliflozin5mg dapagliflozin
4	Experimental	Drug: Dapagliflozin10mg dapagliflozin
5	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Japanese Subjects with type 2 diabetes mellitus.
Strictly/relatively treatment naïve Subjects with HbA1c ≥ 7.0% and ≤ 10%, or Subjects treated with single or two (less than half of the approved maximal dose for each) oral anti-hyperglycaemic agent with HbA1c ≤ 8%.
Provision of informed consent.

Key exclusion criteria (2 listed)

Having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease.
The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.

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
Dapagliflozinonce daily, 12 weeks	Drug	1, 2, 3, 4
Placeboonce daily, 12 weeks	Drug	5

Primary outcome

Adjusted Mean Change in HbA1c Levels
Time frame: Baseline to Week 12
The primary efficacy endpoint is the absolute change in HbA1c from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.

2 secondary outcomes

Adjusted Mean Change in Fasting Plasma Glucose
Time frame: Baseline to Week 12
Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
Time frame: At Week 12

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
1mg Dapagliflozin	59	54
2.5mg Dapagliflozin	56	51
5mg Dapagliflozin	58	56
10mg Dapagliflozin	52	52
Placebo	54	45

Primary outcome: Adjusted Mean Change in HbA1c Levels

Time frame: Baseline to Week 12. Least squares mean (95% Confidence Interval). Unit: percent

Measure	1mg Dapagliflozin n = 59	2.5mg Dapagliflozin n = 54	5mg Dapagliflozin n = 58	10mg Dapagliflozin n = 52	Placebo n = 52
Value	-0.12 (-0.25 to 0.01)	-0.10 (-0.24 to 0.04)	-0.37 (-0.50 to -0.23)	-0.44 (-0.58 to -0.29)	0.35 (0.21 to 0.49)

1mg Dapagliflozin vs Placebo: Mean Difference (Final Values): -0.47 (95% CI -0.67 to -0.28), p <0.0001, ANCOVA
2.5mg Dapagliflozin vs Placebo: Mean Difference (Final Values): -0.45 (95% CI -0.65 to -0.26), p <0.0001, ANCOVA
5mg Dapagliflozin vs Placebo: Mean Difference (Final Values): -0.72 (95% CI -0.92 to -0.53), p <0.0001, ANCOVA

Population analysed: Full Analysis Set, participants with non-missing baseline and Week 12 (LOCF) values

2 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 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1mg Dapagliflozin	2 of 59 (3.4%)	14 of 59 (23.7%)	Not reported
2.5mg Dapagliflozin	1 of 56 (1.8%)	13 of 56 (23.2%)	Not reported
5mg Dapagliflozin	2 of 58 (3.4%)	14 of 58 (24.1%)	Not reported
10mg Dapagliflozin	1 of 52 (1.9%)	13 of 52 (25%)	Not reported
Placebo	0 of 54 (0%)	14 of 54 (25.9%)	Not reported

Limitations and caveats (from the sponsor): If an efficacy measurement was unavailable at the time point for analysis, last observation was carried forward (LOCF).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26894924Kohan 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.

Related trials for Type 2 Diabetes Mellitus

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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.

Parikh Shamik study director

AstraZeneca

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dapagliflozin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 20 sites in Japan.

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 2 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 14 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 20 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 12). 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 NCT00972244, 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 14 Oct 2013.