Type2 DiabetesPhase 3NCT01294436
Evaluate Safety as Mono or Combination Therapies With Anti-diabetes Mellitus Drugs in Japanese Subjects With Type 2 Diabetes Mellitus
A Phase 3 study testing Dapagliflozin in people with Type2 Diabetes and High Blood Sugar, run by AstraZeneca at 38 sites in Japan.
Trial summary
This is a long term, single arm, open label study to evaluate the safety and efficacy of dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on diet and exercise or on other anti-diabetic… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type2 Diabetes, High Blood Sugar
- What is being tested?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 728 participants
- Where
- 38 sitesJapan
- Study dates
- Feb 2011to Sep 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 type2 DM ; ≥6.5% and ≤10% at 1 week before treatment started
Who cannot join
- Type 1 diabetes mellitus,
- FPG >240 mg/dL before treatment started
- 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
38 sites in 1 country.
38 sites in 1 country
Japan38 sites
Research Site
Aki-gun, Hiroshima
Research Site
Annaka, Gunma
Research Site
Atami, Shizuoka
Research Site
Chiyoda City, Tokyo
Research Site
Chūō, Tokyo
Research Site
Fukuoka, Fukuoka
Research Site
Hirosaki, Aomori
Research Site
Hiroshima, Hiroshima
Research Site
Itoshima, Fukuoka
Research Site
Kamakura, Kanagawa
Research Site
Kawasaki, Kanagawa
Research Site
Kochi, Kochi
Research Site
Komatsushimachō, Tokushima
Research Site
Matsumoto, Nagano
Research Site
Mitaka, Tokyo
Research Site
Nagoya, Aichi-ken
Research Site
Niihama, Ehime
Research Site
Osaka, Osaka
Research Site
Ōta, Gunma
Research Site
Ōta-ku, Tokyo
Research Site
Ōtsu, Shiga
Research Site
Owariasahi, Aichi-ken
Research Site
Sanuki, Kagawa-ken
Research Site
Sapporo, Hokkaido
Research Site
Sendai, Miyagi
Research Site
Shibuya City, Tokyo
Research Site
Shinjuku, Tokyo
Research Site
Shizuoka, Shizuoka
Research Site
Suita, Osaka
Research Site
Taitō City, Tokyo
Research Site
Takamatsu, Kagawa-ken
Research Site
Takaoka, Toyama
Research Site
Toyama, Toyama
Research Site
Toyohashi, Aichi-ken
Research Site
Ube, Yamaguchi
Research Site
Yokohama, Kanagawa
Research Site
Yukuhashi, Fukuoka
Research Site
Zushi, Kanagawa
About this study
Official title: A Long Term Open Label Study to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy or Combination Therapies With Anti-diabetic Drugs in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
This is a long term, single arm, open label study to evaluate the safety and efficacy of dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on diet and exercise or on other anti-diabetic treatment will be included in this study.
- Conditions
- Type2 Diabetes, High Blood Sugar
- Being tested
- Dapagliflozin
- Keywords
- Phase3, Clinical trial, Type 2 Diabetes Mellitus
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Oral Dose 5 or 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Open label treatment | Experimental | Not described Receives: Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Adverse Events
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to adverse events
Measured: Long-term treatment up to 52 weeks
Proportion of Participants With Serious Adverse Events
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to serious adverse events
Measured: Long-term treatment up to 52 weeks
Proportion of Participants With At Least One Episode of Hypoglycemia
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to occurrence of hypoglycemia
Measured: Long-term treatment up to 52 weeks
Mean Change in Hematocrit
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in hematocrit
Measured: Baseline to Week 52
Mean Change in Alanine Aminotransferase (ALT)
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in alanine aminotransferase
Measured: Baseline to Week 52
Mean Change in Aspartate Aminotransferase (AST)
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in aspartate aminotransferase
Measured: Baseline to Week 52
Mean Change in Blood Urea Nitrogen (BUN)
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood urea nitrogen
Measured: Baseline to Week 52
Mean Change in Magnesium
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in magnesium (1 mEq/L equivalent to 0.50 mmol/L)
Measured: Baseline to Week 52
Mean Change in Serum Uric Acid
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in serum uric acid
Measured: Baseline to Week 52
Mean Change in Seated Heart Rate
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in pulse
Measured: Baseline to Week 52
Mean Change in Seated Diastolic Blood Pressure
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure
Measured: Baseline to Week 52
Mean Change in Seated Systolic Blood Pressure
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionSep 2012
- Study completionSep 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.
- Other trials for Type2 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 728 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Dr Jisin Yang, MD, Study director, AstraZeneca KK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294436
- Sponsor's protocol ID
- D1692C00012
- Status last verified
- Nov 2013
- First submitted
- 10 Feb 2011
- Last updated
- 17 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long Term Open Label Study to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy or Combination Therapies With Anti-diabetic Drugs in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
- ClinicalTrials.gov ID
- NCT01294436
- Acronym / sponsor ID
- D1692C00012
- Conditions
- Type2 Diabetes, High Blood Sugar
- Keywords
- Phase3, Clinical trial, Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 728 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Feb 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Posted 16 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a long term, single arm, open label study to evaluate the safety and efficacy of dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on diet and exercise or on other anti-diabetic treatment will be included in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label treatment | Experimental | Drug: Dapagliflozin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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 type2 DM ; ≥6.5% and ≤10% at 1 week before treatment started
Key exclusion criteria (5 listed)
- Type 1 diabetes mellitus,
- FPG >240 mg/dL before treatment started
- 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 |
|---|---|---|
| DapagliflozinOral Dose 5 or 10 mg | Drug | Open label treatment |
Primary outcome
Proportion of Participants With Adverse Events
Time frame: Long-term treatment up to 52 weeks
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to adverse events
Proportion of Participants With Serious Adverse Events
Time frame: Long-term treatment up to 52 weeks
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to serious adverse events
Proportion of Participants With At Least One Episode of Hypoglycemia
Time frame: Long-term treatment up to 52 weeks
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to occurrence of hypoglycemia
Mean Change in Hematocrit
Time frame: Baseline to Week 52
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in hematocrit
Mean Change in Alanine Aminotransferase (ALT)
Time frame: Baseline to Week 52
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in alanine aminotransferase
Mean Change in Aspartate Aminotransferase (AST)
Time frame: Baseline to Week 52
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in aspartate aminotransferase
Mean Change in Blood Urea Nitrogen (BUN)
Time frame: Baseline to Week 52
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood urea nitrogen
Mean Change in Magnesium
Time frame: Baseline to Week 52
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in magnesium (1 mEq/L equivalent to 0.50 mmol/L)
Mean Change in Serum Uric Acid
Time frame: Baseline to Week 52
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in serum uric acid
Mean Change in Seated Heart Rate
Time frame: Baseline to Week 52
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in pulse
Mean Change in Seated Diastolic Blood Pressure
Time frame: Baseline to Week 52
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure
Mean Change in Seated Systolic Blood Pressure
Time frame: Baseline to Week 52
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Jisin Yang, MD study director
AstraZeneca KK
38 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 Type2 Diabetes and High Blood Sugar, run by AstraZeneca at 38 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 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 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 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. 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 16 Sep 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?
Proportion of Participants With Adverse Events (time frame: Long-term treatment up to 52 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2013; AzTrials last refreshed its copy on 7 Nov 2026.