DiabetesPhase 3NCT02096705
Phase III Insulin Add-On Asia Regional Program - ST
A Phase 3 study testing Dapagliflozin in people with Diabetes, run by AstraZeneca at 29 sites in 3 countries.
Trial summary
The purpose is to determine if after 24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- 477 participants
- Where
- 29 sitesin 3 countries
- Study dates
- 31 Mar 2014to 28 Jan 2016
- 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
- Subjects must have type 2 diabetes with inadequate glycemic control, defined as HbA1c ≥ 7.5% and ≤ 11.0% obtained at screening visit
- Subjects must be taking a stable mean dose of ≥ 20 IU injectable insulin daily for at least 8 weeks prior to enrollment
- HbA1c ≥ 7.5 and ≤ 10.5% at Day -14
Who cannot join
- Treatment with more than two oral antidiabetic (OAD) agents within 6 weeks of Enrollment
- History of diabetic ketoacidosis of hyperosmolar nonketotic coma
- Clinically diagnosed Type 1 diabetes mellitus
- Congestive heart failure defined as New York Heart Association (NYHA) stage III and IV
- Severe uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or diastolic blood pressure (DBP) ≥ 110 mmHg
- History of unstable or rapidly progressing renal disease
- History of severe hepatobiliary disease
- Mallingancy within 5 years of the screening/enrollment visit
Trial locations and contacts
29 sites in 3 countries.
29 sites in 3 countries
China22 sites
Local Institution
Beijing, Beijing Municipality, 100029
Local Institution
Beijing, Beijing Municipality, 100700
Local Institution
Beijing, Beijing Municipality, 100730
Local Institution
Beijing, 100039
Local Institution
Changchun, Jilin, 130041
Local Institution
Changsha, Hunan, 410000
Local Institution
Changsha, Hunan, 410008
Local Institution
Chengdu, Sichuan, 610072
Local Institution
Chongqing, Sichuan, 400010
Local Institution
Guangzhou, Guangdong, 510080
Local Institution
Guangzhou, Guangdong, 510120
Local Institution
Haerbin, Heilongjiang, 150001
Local Institution
Nanjing, Jiangsu, 210012
Local Institution
Shanghai, Shanghai Municipality, 200040
Local Institution
Shanghai, Shanghai Municipality, 200072
Local Institution
Shanghai, Shanghai Municipality, 200080
Local Institution
Shanghai, Shanghai Municipality, 200092
Local Institution
Suzhou, Jiangsu, 215004
Local Institution
Tianjin
Local Institution
Wuxi, Jiangsu, 214023
Local Institution
Xi’an, Shanxi, 710032
Local Institution
Xi’an, Shanxi, 710061
South Korea5 sites
Local Institution
Busan, 49241
Local Institution
Daegu, 42415
Local Institution
Daejeon, 35233
Local Institution
Seoul, 06351
Local Institution
Seoul, 134-727
Singapore2 sites
Local Institution
Singapore, 169856
Local Institution
Singapore, 529889
About this study
Official title: A 24-week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate Efficacy and Safety of Dapagliflozin Added to Therapy of Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin
The purpose is to determine if after 24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes.
- Conditions
- Diabetes
- Being tested
- Dapagliflozin, Dapagliflozin Placebo
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called BMS-512148
Tablet
Dapagliflozin PlaceboDrug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Dapagliflozin | Experimental | Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin Receives: Drug: Dapagliflozin |
| Group 2: Dapagliflozin Placebo | Placebo comparator | Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin Receives: Drug: Dapagliflozin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted Mean Change in HbA1c From Baseline to Week 24
The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm.
Measured: Baseline (Day 1) and 24 weeks
Secondary outcomes (3)
Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24
The adjusted mean change from baseline to 24 weeks in Fasting Plasma Glucose (FPG) was reported for each arm in milligrams per deciliter (mg/dL).
Measured: Baseline (Day 1) and 24 weeks
Adjusted Mean Change in Body Weight From Baseline to Week 24
Adjusted mean change in body weight from baseline to week 24 was reported for each arm in kilograms (kg).
Measured: Baseline (Day 1) and 24 weeks
Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24
The adjusted mean change in absolute calculated mean Total Daily Dose of Insulin (TDDI) from baseline to week 24 was reported for each arm in International Units (IU).
Measured: Baseline (Day 1) and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study start31 Mar 2014
- Primary completion28 Jan 2016
- Study completion28 Jan 2016
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 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
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096705
- Sponsor's protocol ID
- MB102-137
- Status last verified
- Jul 2017
- First submitted
- 24 Mar 2014
- Last updated
- 9 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate Efficacy and Safety of Dapagliflozin Added to Therapy of Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin
- ClinicalTrials.gov ID
- NCT02096705
- Acronym / sponsor ID
- MB102-137
- Conditions
- Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- 31 Mar 2014 (actual)
- Primary completion
- 28 Jan 2016 (actual)
- Study completion
- 28 Jan 2016 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Posted 6 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to determine if after 24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes.
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 |
|---|---|---|
| Group 1: Dapagliflozin | Experimental | Drug: DapagliflozinDapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin |
| Group 2: Dapagliflozin Placebo | Placebo comparator | Drug: Dapagliflozin PlaceboDapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must have type 2 diabetes with inadequate glycemic control, defined as HbA1c ≥ 7.5% and ≤ 11.0% obtained at screening visit
- Subjects must be taking a stable mean dose of ≥ 20 IU injectable insulin daily for at least 8 weeks prior to enrollment
- HbA1c ≥ 7.5 and ≤ 10.5% at Day -14
Key exclusion criteria (8 listed)
- Treatment with more than two oral antidiabetic (OAD) agents within 6 weeks of Enrollment
- History of diabetic ketoacidosis of hyperosmolar nonketotic coma
- Clinically diagnosed Type 1 diabetes mellitus
- Congestive heart failure defined as New York Heart Association (NYHA) stage III and IV
- Severe uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or diastolic blood pressure (DBP) ≥ 110 mmHg
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 |
|---|---|---|
| DapagliflozinAlso: BMS-512148Tablet | Drug | Group 1: Dapagliflozin |
| Dapagliflozin PlaceboTablet | Drug | Group 2: Dapagliflozin Placebo |
Primary outcome
Adjusted Mean Change in HbA1c From Baseline to Week 24
Time frame: Baseline (Day 1) and 24 weeks
The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm.
3 secondary outcomes
Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24
Time frame: Baseline (Day 1) and 24 weeks
Adjusted Mean Change in Body Weight From Baseline to Week 24
Time frame: Baseline (Day 1) and 24 weeks
Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24
Time frame: Baseline (Day 1) and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 3 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 Diabetes, run by AstraZeneca at 29 sites in 3 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 8 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 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in China, South Korea, Singapore. 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 6 Mar 2017). 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 From Baseline to Week 24 (time frame: Baseline (Day 1) and 24 weeks). 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 NCT02096705, 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 9 Aug 2017; AzTrials last refreshed its copy on 30 Oct 2026.