Type 2 DiabetesPhase 3NCT01294423

Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus

A Phase 3 study testing Dapagliflozin in people with Type 2 Diabetes and High Blood Sugar, run by AstraZeneca at 26 sites in Japan.

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 is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who have inadequate glycemic control with diet and exercise. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Type 2 Diabetes, High Blood Sugar
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: 261 participants
Where: 26 sitesJapan
Study dates: Feb 2011to Mar 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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of informed consent prior to any study specific procedures
Men or women age ≥20 years old (Either gender needs to be 40% or higher of total number of treated subjects)diagnosed with type 2 DM ; ≥6.5% and ≤10% at 1 week before randomization

Who cannot join

Type 1 diabetes mellitus
FPG >240 mg/dL before randomization
Subjects who have history of unstable or rapidly progressing renal disease
Subjects who have severe hepatic insufficiency and/or significant abnormal liver function
Significant cardiovascular history

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

Japan26 sites

Research Site
Chitose-shi, Hokkaido
Research Site
Chūō, Tokyo
Research Site
Chuo-ku, Tokyo
Research Site
Ebina-shi, Kanagawa
Research Site
Fukuoka, Fukuoka
Research Site
Hakusan-shi, Ishikawa-ken
Research Site
Hiroshima, Hiroshima
Research Site
Kamakura-shi, Kanagawa
Research Site
Matsumoto-shi, Nagano
Research Site
Meguro-ku,, Tokyo
Research Site
Noda, Chiba
Research Site
Okayama, Okayama-ken
Research Site
Osaka, Osaka
Research Site
Ōta-ku, Tokyo
Research Site
Ōtsu, Shiga
Research Site
Sanuki-shi, Kagawa-ken
Research Site
Sapporo, Hokkaido
Research Site
Sendai, Miyagi
Research Site
Shizuoka, Shizuoka
Research Site
Suita, Osaka
Research Site
Takamatsu, Kagawa-ken
Research Site
Takaoka-shi, Toyama
Research Site
Takasago-shi, Hyōgo
Research Site
Tokyo, Tokyo
Research Site
Toyama, Toyama
Research Site
Yukuhashi, Fukuoka

Other trials in Japan

About this study

Official title: A 24-week Randomised, Double-blind, Parallel-group, Multi-centre, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

Conditions: Type 2 Diabetes, High Blood Sugar
Being tested: Dapagliflozin, Placebo
Keywords: Phase3, Clinical trial, Type2 Diabetes Mellitus
Medical subject headings: Diabetes Mellitus, Type 2, Hyperglycemia

What participants receive

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

DapagliflozinDrug
Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
DapagliflozinDrug
Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
PlaceboDrug
Matching placebo for Dapagliflozin 5mg/10mg oral dose

Study groups in NCT01294423
Study group	Role	What they receive
1	Experimental	Dapagliflozin 5 mg Receives: Drug: Dapagliflozin
2	Experimental	Dapagliflozin 10 mg Receives: Drug: Dapagliflozin
3	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 in HbA1c Levels
To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.
Measured: From Baseline to Week 24

Secondary outcomes (2)

Adjusted Mean Change in Fasting Plasma Glucose (FPG)
To compare the change from baseline in fasting plasma glucose (FPG) achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.
Measured: From Baseline to Week 24
Adjusted Mean Change in Body Weight
To compare the change from baseline in total body weight achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.
Measured: From 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 2011Mar 2012

First posted11 Feb 2011 (estimated)
Study startFeb 2011
Primary completionMar 2012
Study completionMar 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 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: 261 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01294423
Sponsor's protocol ID: D1692C00006
Status last verified: Jul 2014
First submitted: 10 Feb 2011
Last updated: 24 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kaku K, Kiyosue A, Inoue S, Ueda N, Tokudome T, Yang J, Langkilde AM. Efficacy and safety of dapagliflozin monotherapy in Japanese patients with type 2 diabetes inadequately controlled by diet and exercise. Diabetes Obes Metab. 2014 Nov;16(11):1102-10. doi: 10.1111/dom.12325. Epub 2014 Jul 8.
PubMed 24909293
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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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 24-week Randomised, Double-blind, Parallel-group, Multi-centre, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
ClinicalTrials.gov ID: NCT01294423
Acronym / sponsor ID: D1692C00006
Conditions: Type 2 Diabetes, High Blood Sugar
Keywords: Phase3, Clinical trial, Type2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 261 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Feb 2011
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 11 Feb 2011 (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: 3

Arm	Type	Receives
1	Experimental	Drug: DapagliflozinDapagliflozin 5 mg
2	Experimental	Drug: DapagliflozinDapagliflozin 10 mg
3	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Provision of informed consent prior to any study specific procedures
Men or women age ≥20 years old (Either gender needs to be 40% or higher of total number of treated subjects)diagnosed with type 2 DM ; ≥6.5% and ≤10% at 1 week before randomization

Key exclusion criteria (5 listed)

Type 1 diabetes mellitus
FPG >240 mg/dL before randomization
Subjects who have history of unstable or rapidly progressing renal disease
Subjects who have severe hepatic insufficiency and/or significant abnormal liver function
Significant cardiovascular 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
DapagliflozinDapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose	Drug	1
DapagliflozinDapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose	Drug	2
PlaceboMatching placebo for Dapagliflozin 5mg/10mg oral dose	Drug	3

Primary outcome

Adjusted Mean Change in HbA1c Levels
Time frame: From Baseline to Week 24
To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.

2 secondary outcomes

Adjusted Mean Change in Fasting Plasma Glucose (FPG)
Time frame: From Baseline to Week 24
Adjusted Mean Change in Body Weight
Time frame: From 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
Dapagliflozin 5 mg	86	81
Dapagliflozin 10 mg	88	79
Placebo	87	79

Primary outcome: Adjusted Mean Change in HbA1c Levels

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

Measure	Dapagliflozin 5 mg n = 86	Dapagliflozin 10 mg n = 87	Placebo n = 86
Value	-0.41 (-0.53 to -0.29)	-0.45 (-0.57 to -0.33)	-0.06 (-0.18 to 0.06)

Dapagliflozin 5 mg vs Placebo: Mean Difference (Final Values): -0.35 (95% CI -0.52 to -0.18), p <0.0001, ANCOVA
Dapagliflozin 10 mg vs Placebo: Mean Difference (Final Values): -0.39 (95% CI -0.56 to -0.23), p <0.0001, ANCOVA

Population analysed: Full Analysis Set, participants with non-missing baseline and Week 24 (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 24-week double-blind treatment period plus 4/30 days or up to follow-up visit if earlier.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dapagliflozin 5 mg	0 of 86 (0%)	11 of 86 (12.8%)	Not reported
Dapagliflozin 10 mg	1 of 88 (1.1%)	15 of 88 (17%)	Not reported
Placebo	1 of 87 (1.1%)	14 of 87 (16.1%)	Not reported

Limitations and caveats (from the sponsor): For participants who did not complete 24 weeks LOCF (last observation carried forward) was used. Only values prior to rescue medication were used for outcome measures except for total body weight which was evaluated regardless of rescue.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24909293Kaku K, Kiyosue A, Inoue S, Ueda N, Tokudome T, Yang J, Langkilde AM. Efficacy and safety of dapagliflozin monotherapy in Japanese patients with type 2 diabetes inadequately controlled by diet and exercise. Diabetes Obes Metab. 2014 Nov;16(11):1102-10. doi: 10.1111/dom.12325. Epub 2014 Jul 8.
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.
Related InfoLink provided by the sponsor.
CSR-D1692C00006.pdfLink provided by the sponsor.
D1692C00006\_Clinical\_Study\_Protocol\_and\_AmendmentLink 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.

Jisin Yang, MD study director

AstraZeneca KK

26 sites in 1 country: 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 and High Blood Sugar, run by AstraZeneca at 26 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 2 inclusion and 5 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 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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 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: From 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 NCT01294423, 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 24 Jul 2014.