Type 2 DiabetesPhase 3NCT00643851

An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets

A Phase 3 study testing Dapagliflozin and Metformin XR in people with Type 2 Diabetes, run by AstraZeneca at 99 sites in 7 countries.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this clinical research study is to learn if initiating treatment with BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes, when compared to initial treatment with… Read more about this study

Who is it for?: Ages 18 to 77 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Dapagliflozin and Metformin XR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 994 participants
Where: 99 sitesin 7 countries
Study dates: Jun 2008to Aug 2009
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 to 77 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males \& females, 18-77 years old inclusive, with type 2 diabetes and with inadequate glycemic control
Drug naive or treated with anti-diabetic medication for < 24 weeks since original diagnosis
C-peptide ≥ 1.0 ng/mL
Body Mass Index ≤ 45.0 kg/m
Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women

Who cannot join

AST and/or ALT >3.0 times the upper limit of normal (ULN)
Serum total bilirubin > 2.0 mg/dL
Creatine kinase > 3X the upper limit of normal (ULN)
Symptoms of severely uncontrolled diabetes
Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric or rheumatic diseases

Trial locations and contacts

99 sites in 7 countries.

Country

City, postcode or hospital

99 sites in 7 countries

United States44 sites

Central Florida Clinical Trials, Inc.
Altamonte Springs, Florida, 32701
Gilbert Medical Research, Llc
Bethany, Oklahoma, 73008
Greystone Medical Research, Llc
Birmingham, Alabama, 35242
Community Health Care, Inc.
Canal Fulton, Ohio, 44614
Metrolina Medical Research
Charlotte, North Carolina, 28209
Mercy Medical Group/Dba Woodlake Research
Chesterfield, Missouri, 63017
Cedar Crosse Research Center
Chicago, Illinois, 60607
John Muir Physician Network Clinical Research Center
Concord, California, 94520
Clinical Therapeutics Corporation
Coral Gables, Florida, 33134
Safe Harbor Clinical Research
East Providence, Rhode Island, 02914
Willamette Valley Clinical Studies
Eugene, Oregon, 97404
Middle Tennessee Clinical Research
Fayetteville, Tennessee, 37334
Commonwealth Primary Care, Pc / Fleetwood Clinical Research
Fleetwood, Pennsylvania, 19522
Southland Clinical Research Center, Inc.
Fountain Valley, California, 92708
Valley Research
Fresno, California, 93720
Florida Research Network, Llc
Gainesville, Florida, 32605
Southeastern Research Associates, Inc.
Greenville, South Carolina, 29605
Winston Technology Research, Llc
Haleyville, Alabama, 35565
Endocrine Associates
Houston, Texas, 77004
Village Family Practice
Houston, Texas, 77024
Non-Invasive Cardiovascular, Pa
Houston, Texas, 77074
Excel Clinical Research, Llc
Houston, Texas, 77081
Texas Center For Drug Development
Houston, Texas, 77081
Wells Institute For Health Awareness
Kettering, Ohio, 45429
Holston Medical Group
Kingsport, Tennessee, 37660
Hudson Valley Clinical Research Center
Kingston, New York, 12401
Fpa Clinical Research
Kissimmee, Florida, 34741
Nextphase Clinical Trials, Inc.
Miami, Florida, 33145
Inst. Of Clin. Research At The Diabetes Cntr. Of The Sw
Midland, Texas, 79705
Hill Country Medical Associates
New Braunfels, Texas, 78130
Newark Physician Associates
Newark, Ohio, 43055
Integris Family Care South Penn
Oklahoma City, Oklahoma, 73159
Southwest Clinical Research Center, Llc
Pearland, Texas, 77584
Middle Georgia Drug Study Center, Llc
Perry, Georgia, 31069
Jackson Clinic
Rolling Fork, Mississippi, 39159
Crescent Medical Research
Salisbury, North Carolina, 28144
Covenant Clinical Research, Pa
San Antonio, Texas, 78229
S.A.M. Clinical Research Center
San Antonio, Texas, 78229
Biomedical Research Associates, Llc
Shippensburg, Pennsylvania, 17257
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Clinical Research Advantage, Inc.
Tempe, Arizona, 85282
Deerbrook Medical Associates
Vernon Hills, Illinois, 60061
Integris Family Care Yukon
Yukon, Oklahoma, 73099
Physician Research, Inc.
Zanesville, Ohio, 43701

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About this study

Official title: A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin as Initial Therapy as Compared With Dapagliflozin Monotherapy and Metformin Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

Conditions: Type 2 Diabetes
Being tested: Dapagliflozin, Metformin XR
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, Once daily, 24 weeks
Metformin XRDrug
Tablets, Oral, Once daily, 24 weeks

Study groups in NCT00643851
Study group	Role	What they receive
Arm 1	Experimental	Dapagliflozin (5 mg) + Metformin XR (up to 2000 mg) Receives: Drug: Dapagliflozin; Drug: Metformin XR
Arm 2	Experimental	Dapagliflozin (5 mg) Receives: Drug: Dapagliflozin
Arm 3	Active comparator	Metformin XR (500 mg up to 2000 mg) Receives: Drug: Metformin XR

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 (5)

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, 3, 4, 6, 8, 12, 16, 20, and 24 in 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 estimated by modified logistic regression model.
Measured: From Baseline to Week 24
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) in Subjects With Baseline HbA1c ≥ 9% 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
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, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.
Measured: From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight (kg) in Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 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, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.
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 2008Aug 2009

First posted26 Mar 2008 (estimated)
Study startJun 2008
Primary completionAug 2009
Study completionAug 2009

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 994 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00643851
Sponsor's protocol ID: MB102-021
Status last verified: Jan 2023
First submitted: 20 Mar 2008
Last updated: 30 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Henry RR, Murray AV, Marmolejo MH, Hennicken D, Ptaszynska A, List JF. Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. Int J Clin Pract. 2012 May;66(5):446-56. doi: 10.1111/j.1742-1241.2012.02911.x. Epub 2012 Mar 13.
PubMed 22413962
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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Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin as Initial Therapy as Compared With Dapagliflozin Monotherapy and Metformin Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
ClinicalTrials.gov ID: NCT00643851
Acronym / sponsor ID: MB102-021
Conditions: Type 2 Diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 994 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Jun 2008
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 26 Mar 2008 (estimated)
Results: Posted 23 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: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Arm 1	Experimental	Drug: Dapagliflozin, Drug: Metformin XRDapagliflozin (5 mg) + Metformin XR (up to 2000 mg)
Arm 2	Experimental	Drug: DapagliflozinDapagliflozin (5 mg)
Arm 3	Active comparator	Drug: Metformin XRMetformin XR (500 mg up to 2000 mg)

Who may qualify

Ages: 18 to 77 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Males \& females, 18-77 years old inclusive, with type 2 diabetes and with inadequate glycemic control
Drug naive or treated with anti-diabetic medication for < 24 weeks since original diagnosis
C-peptide ≥ 1.0 ng/mL
Body Mass Index ≤ 45.0 kg/m
Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women

Key exclusion criteria (5 listed)

AST and/or ALT >3.0 times the upper limit of normal (ULN)
Serum total bilirubin > 2.0 mg/dL
Creatine kinase > 3X the upper limit of normal (ULN)
Symptoms of severely uncontrolled diabetes
Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric or rheumatic diseases

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, Once daily, 24 weeks	Drug	Arm 1, Arm 2
Metformin XRTablets, Oral, Once daily, 24 weeks	Drug	Arm 1, Arm 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.

5 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
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
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) in Subjects With Baseline HbA1c ≥ 9% 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
Adjusted Mean Change From Baseline in Total Body Weight (kg) in Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline to Week 24

Results and safety

Results posted to the registry on 23 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
Dapagliflozin 5 mg + Metformin XR	194	177
Dapagliflozin 5 mg	203	170
Metformin XR	201	171

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	Dapagliflozin 5 mg + Metformin XR n = 185	Dapagliflozin 5 mg n = 196	Metformin XR n = 195
Value	-2.05 (0.0892)	-1.19 (0.0866)	-1.35 (0.0868)

Dapagliflozin 5 mg + Metformin XR vs Dapagliflozin 5 mg: Mean Difference (Final Values): -0.86 (95% CI -1.11 to -0.62), p <0.0001, ANCOVA
Dapagliflozin 5 mg + Metformin XR vs Metformin XR: Mean Difference (Final Values): -0.70 (95% CI -0.94 to -0.45), p <0.0001, ANCOVA

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

5 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
Dapagliflozin 5 mg + Metformin XR	6 of 194 (3.1%)	48 of 194 (24.7%)	Not reported
Dapagliflozin 5 mg	9 of 203 (4.4%)	32 of 203 (15.8%)	Not reported
Metformin XR	7 of 201 (3.5%)	40 of 201 (19.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22413962Henry RR, Murray AV, Marmolejo MH, Hennicken D, Ptaszynska A, List JF. Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. Int J Clin Pract. 2012 May;66(5):446-56. doi: 10.1111/j.1742-1241.2012.02911.x. Epub 2012 Mar 13.
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.

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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

99 sites in 7 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 XR in people with Type 2 Diabetes, run by AstraZeneca at 99 sites in 7 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 5 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 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, Russia, Mexico, Ukraine, South Korea and 2 more countries. 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 23 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 NCT00643851, 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 30 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.