Type 2 DiabetesPhase 3NCT01095653

A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

A Phase 3 study testing Dapagliflozin and Metformin in people with Type 2 Diabetes, run by AstraZeneca at 39 sites in 4 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

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can improve (decrease) blood glucose values in Asian patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: Dapagliflozin and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,179 participants
Where: 39 sitesin 4 countries
Study dates: Jun 2010to 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females, 18 years old, with type 2 diabetes and with inadequate glycemic control
Drug naive or treated with anti-diabetic medication for < 24 weeks
C-peptide ≥ 1.0 ng/mL
Body Mass Index ≤ 45.0 kg/m²

Who cannot join

AST and/or ALT > 3 times ULN
Serum total bilirubin > 2 mg/dL
Serum creatinine ≥ 1.50 mg/dL for men or ≥ 1.40 mg/dL for women
Creatine kinase ≥ 3 times ULN
Symptoms of severely uncontrolled diabetes
Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Trial locations and contacts

39 sites in 4 countries.

Country

City, postcode or hospital

39 sites in 4 countries

China25 sites

Local Institution
Beijing, Beijing Municipality, 100029
Local Institution
Beijing, Beijing Municipality, 100044
Local Institution
Beijing, Beijing Municipality, 100730
Local Institution
Beijing, Beijing Municipality, 100853
Local Institution
Beijing, 100034
Local Institution
Changchun, Jilin, 130041
Local Institution
Changsha, Hunan, 410000
Local Institution
Changsha, Hunan, 410008
Local Institution
Chengdu, Sichuan, 610072
Local Institution
Chongqing, Chongqing Municipality, 40016
Local Institution
Guanzhou, Guangdong, 510120
Local Institution
Hangzhou, Zhejiang, 310003
Local Institution
Hangzhou, Zhejiang, 310009
Local Institution
Hefei, Anhui, 230022
Local Institution
Nanjing, Jiangsu, 210008
Local Institution
Nanjing, Jiangsu, 210012
Local Institution
Shanghai, Shanghai Municipality, 200003
Local Institution
Shanghai, Shanghai Municipality, 200040
Local Institution
Shanghai, Shanghai Municipality, 200065
Local Institution
Shenyang, Liaoning, 110003
Local Institution
Tianjin, Tianjin Municipality, 300211
Local Institution
Wuhan, Hubei, 430022
Local Institution
Wuhan, 430030
Local Institution
Wuxi, Jiangsu, 214023
Local Institution
Xi'an, 710032

Other trials in China

South Korea5 sites

Local Institution
Busanjin-gu, 633-165
Local Institution
Guri-si, 471-701
Local Institution
Seoul, Nowon-GU, 139-711
Local Institution
Seoul, 120-752
Local Institution
Seoul, 137040

Other trials in South Korea

Taiwan5 sites

Local Institution
Taichung, 402
Local Institution
Taichung, 43303
Local Institution
Taipei, 110
Local Institution
Taipei, 235
Local Institution
Yung Kang City, 71044

Other trials in Taiwan

India4 sites

Local Institution
Bangalore, Karnataka, 560043
Local Institution
Bangalore, 560092
Local Institution
Indore, Madhya Pradesh, 452010
Local Institution
Jaipur, 302023

Other trials in India

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

Conditions: Type 2 Diabetes
Being tested: Dapagliflozin, Metformin, Dapagliflozin Placebo
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
Also called BMS-512148
Tablets, Oral, 5 mg, Once daily, 24 weeks
DapagliflozinDrug
Also called BMS-512148
Tablets, Oral, 10 mg, Once daily, 24 weeks
MetforminDrug
Also called Glucophage®
Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks
Dapagliflozin PlaceboDrug
Tablets, Oral, 0 mg, Once daily, 24 weeks

Study groups in NCT01095653
Study group	Role	What they receive
Group 1	Experimental	Not described Receives: Drug: Dapagliflozin; Drug: Metformin; Drug: Dapagliflozin Placebo
Group 2	Experimental	Not described Receives: Drug: Dapagliflozin; Drug: Metformin; Drug: Dapagliflozin Placebo
Group 3	Experimental	Not described Receives: Drug: Metformin; Drug: Dapagliflozin Placebo

What is being measured

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

Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])
HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.
Measured: From Baseline to Week 24

Secondary outcomes (4)

Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period.
Measured: From Baseline to Week 24
Adjusted Mean Change From Baseline in 2-hour Post Liquid Meal Glucose (PLMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Post Liquid Meal Glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PLMG measurements were obtained on Day 1 and week 24 in the double-blind period.
Measured: From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.
Measured: From Baseline to Week 24
Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants were estimated by modified logistic regression model.
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.

Jun 2010Mar 2012

First posted30 Mar 2010 (estimated)
Study startJun 2010
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.
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: 1,179 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01095653
Sponsor's protocol ID: MB102-054
Status last verified: Dec 2016
First submitted: 26 Mar 2010
Last updated: 6 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2017. 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 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
ClinicalTrials.gov ID: NCT01095653
Acronym / sponsor ID: MB102-054
Conditions: Type 2 Diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,179 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Astra Zeneca, Bristol-Myers Squibb
Study start: Jun 2010
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 30 Mar 2010 (estimated)
Results: Posted 6 Feb 2017

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
Group 1	Experimental	Drug: Dapagliflozin, Drug: Metformin, Drug: Dapagliflozin Placebo
Group 2	Experimental	Drug: Dapagliflozin, Drug: Metformin, Drug: Dapagliflozin Placebo
Group 3	Experimental	Drug: Metformin, Drug: Dapagliflozin 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)

Males and females, 18 years old, with type 2 diabetes and with inadequate glycemic control
Drug naive or treated with anti-diabetic medication for < 24 weeks
C-peptide ≥ 1.0 ng/mL
Body Mass Index ≤ 45.0 kg/m²

Key exclusion criteria (6 listed)

AST and/or ALT > 3 times ULN
Serum total bilirubin > 2 mg/dL
Serum creatinine ≥ 1.50 mg/dL for men or ≥ 1.40 mg/dL for women
Creatine kinase ≥ 3 times ULN
Symptoms of severely uncontrolled diabetes

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-512148Tablets, Oral, 5 mg, Once daily, 24 weeks	Drug	Group 1
DapagliflozinAlso: BMS-512148Tablets, Oral, 10 mg, Once daily, 24 weeks	Drug	Group 2
MetforminAlso: Glucophage®Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks	Drug	Group 1, Group 2, Group 3
Dapagliflozin PlaceboTablets, Oral, 0 mg, Once daily, 24 weeks	Drug	Group 1, Group 2, Group 3

Primary outcome

Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline to Week 24
HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.

4 secondary outcomes

Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline to Week 24
Adjusted Mean Change From Baseline in 2-hour Post Liquid Meal Glucose (PLMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline to Week 24
Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline to Week 24

Results and safety

Results posted to the registry on 6 Feb 2017, 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	132	113
Dapagliflozin 5 mg	128	113
Dapagliflozin 10 mg	133	117

Primary outcome: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])

Time frame: From Baseline to Week 24. Mean (Standard Error). Unit: % of hemoglobin

Measure	Placebo n = 127	Dapagliflozin 5 mg n = 122	Dapagliflozin 10 mg n = 127
Value	-0.29 (0.0681)	-1.04 (0.0695)	-1.11 (0.0680)

Placebo vs Dapagliflozin 5 mg: Mean Difference (Final Values): -0.75 (95% CI -0.94 to -0.56), p <0.0001, ANCOVA
Placebo vs Dapagliflozin 10 mg: Mean Difference (Final Values): -0.82 (95% CI -1.01 to -0.63), p <0.0001, ANCOVA

Population analysed: All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 132 (1.5%)	38 of 132 (28.8%)	Not reported
Dapagliflozin 5 mg	5 of 128 (3.9%)	28 of 128 (21.9%)	Not reported
Dapagliflozin 10 mg	4 of 133 (3%)	23 of 133 (17.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
PublicationLink 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.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

39 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin and Metformin in people with Type 2 Diabetes, run by AstraZeneca at 39 sites in 4 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 6 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 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in China, South Korea, Taiwan, India. 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 6 Feb 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 From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) (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 NCT01095653.

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 6 Feb 2017.