Type 2 DiabetesPhase 3NCT00528879

A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

A Phase 3 study testing Dapagliflozin and Metformin in people with Type 2 Diabetes, run by AstraZeneca at 75 sites in 5 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 whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone. The safety of this treatment will also be studied. 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 915 participants
Where: 75 sitesin 5 countries
Study dates: Sep 2007to May 2010
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 and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic control
Participants who have been receiving metformin at a total daily dose ≥1500 mg per day for at least 8 weeks
C-peptide ≥1.0 ng/mL
Body mass index ≤45.0 kg/m^2
Serum creatinine level <1.50 mg/dL for men or <1.40 mg/dL for women.

Who cannot join

Aspartate aminotransferase and/or alanine aminotransferase level >3.0 times the upper limit of normal
Serum total bilirubin level >2 mg/dL
Creatinine kinase level >3 times upper limit of normal
Symptoms of severely uncontrolled diabetes
Serum creatinine level ≥1.50 mg/dL for men or ≥1.40 mg/dL for women
Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, endocrine, psychiatric, or rheumatic diseases

Trial locations and contacts

75 sites in 5 countries.

Country

City, postcode or hospital

75 sites in 5 countries

United States28 sites

Central Florida Clinical Trials, Inc.
Altamonte Springs, Florida, 32701
Cumberland Valley Endocrinology Center, Llc
Carlisle, Pennsylvania, 17013
Woodlake Research
Chesterfield, Missouri, 63017
Family Care Associates Of Nw Florida
Chipley, Florida, 32428
Express Care Clinical Res
Colorado Springs, Colorado, 80909
Denver Internal Medicine
Denver, Colorado, 80209
Medical Group Of Encino
Encino, California, 91436
Valley Research
Fresno, California, 93720
New West Physicians
Golden, Colorado, 80401
Texas Center For Drug Development, P.A.
Houston, Texas, 77081
Nevada Alliance Against Diabetes
Las Vegas, Nevada, 89101
Randall Shue, D.O.
Los Angeles, California, 90023
Health Partners Research Foundation
Minneapolis, Minnesota, 56440
Diabetes & Endocrinology Consultants, Pc
Morehead City, North Carolina, 28557
Newark Physician Associates
Newark, Ohio, 43055
Diabetes Medical Center Of California
Northridge, California, 91325
Integris Family Care S. Penn
Oklahoma City, Oklahoma, 73159
Banksville Medical Pc
Pittsburgh, Pennsylvania, 15216
Optimum Clinical Research
Salt Lake City, Utah, 84102
Diabetes & Glandular Disease Research Associates, Inc.
San Antonio, Texas, 78229
S.A.M. Clinical Research Center
San Antonio, Texas, 78229
Ritchken & First M.D.'S
San Diego, California, 92117
Office Of Dr. Gray
Spokane, Washington, 99216
Encompass Clinical Research
Spring Valley, California, 91978
Palmetto Clinical Research
Summerville, South Carolina, 29485
Southeastern Research Assoc
Taylors, South Carolina, 29687
Clinical Research Advantage / Desert Clinical Res, Llc
Tempe, Arizona, 85282
Raikhel, Marina
Torrance, California, 90505

Other trials in United States

Canada18 sites

Local Institution
Bathurst, New Brunswick, E2A 4X7
Local Institution
Calgary, Alberta, T2R 0X7
Local Institution
Charlottetown, Prince Edward Island, C1A 5Y9
Local Institution
Drummondville, Quebec, J2B 7T1
Local Institution
Granby, Quebec, J2G 8Z9
Local Institution
Kelowna, British Columbia, V1Y 2H4
Local Institution
L'Ancienne-Lorette, Quebec, G2E 2X1
Local Institution
Mirabel, Quebec, J7J 2K8
Local Institution
Mount Pearl, Newfoundland and Labrador, A1N 1W7
Local Institution
Saint-Léonard, Quebec, H1S 3A9
Local Institution
Sarnia, Ontario, N7T 4X3
Local Institution
Saskatoon, Saskatchewan, S7K 3H3
Local Institution
Saskatoon, Saskatchewan, S7K 7H9
Local Institution
St. John's, Newfoundland and Labrador, A1E 2E2
Local Institution
Thornhill, Ontario, L4J 8L7
Local Institution
Toronto, Ontario, M4R 2G4
Local Institution
Toronto, Ontario, M9W 4L6
Local Institution
Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Argentina11 sites

Local Institution
Buenos Aires, Buenos Aires, 1431
Local Institution
Capital Federal, Buenos Aires, 1034
Local Institution
Capital Federal, Buenos Aires, 1429
Local Institution
Capital Federal, Buenos Aires, C1056ABJ
Local Institution
Capital Federal, Buenos Aires, C1425AGC
Local Institution
Ciudad Auton, Buenos Aires, C1408INH
Local Institution
Ciudad Auton., Buenos Aires, C1505CWB
Local Institution
Córdoba, Córdoba Province, 5000
Local Institution
Mar del Plata, Buenos Aires, 7600
Local Institution
Villa Carlos Paz, Córdoba Province, 5152
Local Institution
Zárate, Buenos Aires, 2800

Other trials in Argentina

Mexico10 sites

Local Institution
Df, Mexico City, 11800
Local Institution
Durango, Durango, 64710
Local Institution
Guadalajara, Jalisco, 44650
Local Institution
Guadalajara, Jalisco, 44670
Local Institution
Guadalajara, Mexico City, 44670
Local Institution
Monterrey, Nuevo León, 64460
Local Institution
Monterrey, Nuevo León, 64710
Local Institution
Monterrrey, Nuevo León, 64700
Local Institution
Tampico, Tamaulipas, 89109
Local Institution
Zapopan, Mexico City, 45150

Other trials in Mexico

Brazil8 sites

Local Institution
Belém, Pará, 66073
Local Institution
Caxias do Sul, Rio Grande do Sul, 95070
Local Institution
Fortaleza, Ceará, 60021
Local Institution
Itajubá, Minas Gerais, 37502
Local Institution
Marília, São Paulo, 17519
Local Institution
Porto Alegre, Rio Grande do Sul, 90020090
Local Institution
Porto Alegre, Rio Grande do Sul, 90035
Local Institution
Rio de Janeiro, Rio de Janeiro, 20211

Other trials in Brazil

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 in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

Conditions: Type 2 Diabetes
Being tested: Dapagliflozin, Placebo, Metformin
Keywords: Diabetes Mellitus, Type 2, Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases, Metformin, Hypoglycemic Agents, Pharmacologic Actions, Physiological Effects of Drugs
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases

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 administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
PlaceboDrug
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
MetforminDrug
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks

Study groups in NCT00528879
Study group	Role	What they receive
Placebo + Metformin	Placebo comparator	Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks Receives: Drug: Placebo; Drug: Metformin
Dapagliflozin, 2.5 mg + Metformin	Experimental	Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks Receives: Drug: Dapagliflozin; Drug: Metformin
Dapagliflozin, 5 mg + Metformin	Experimental	Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks Receives: Drug: Dapagliflozin; Drug: Metformin
Dapagliflozin, 10 mg + Metformin	Experimental	Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks Receives: Drug: Dapagliflozin; Drug: Placebo; Drug: Metformin

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 (8)

Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. 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.
Measured: From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight 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
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.
Measured: From Baseline to Week 24
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF])
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized participants who received treatment and had a baseline HbA1c > 9.0%. Data after rescue medication were 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.
Measured: From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (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 Hemoglobin A1c (HbA1c) in Participants 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 for baseline HbA1c. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication were 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.
Measured: From Baseline to Week 24
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF])
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured 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.
Measured: From Baseline to Week 1
Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% 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. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
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.

Sep 2007May 2010

First posted12 Sep 2007 (estimated)
Study startSep 2007
Primary completionNov 2008
Study completionMay 2010

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 (7)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: 915 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00528879
Sponsor's protocol ID: MB102-014 LT
Other IDs: MB102-014
Status last verified: Sep 2015
First submitted: 11 Sep 2007
Last updated: 20 Oct 2015
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
Shah M, Stolbov L, Yakovleva T, Tang W, Sokolov V, Penland RC, Boulton D, Parkinson J. A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):991-1000. doi: 10.1111/dom.14305. Epub 2021 Jan 25.
PubMed 33368935
Bailey CJ, Del Prato S, Wei C, Reyner D, Saraiva G. Durability of glycaemic control with dapagliflozin, an SGLT2 inhibitor, compared with saxagliptin, a DPP4 inhibitor, in patients with inadequately controlled type 2 diabetes. Diabetes Obes Metab. 2019 Nov;21(11):2564-2569. doi: 10.1111/dom.13841. Epub 2019 Aug 26.
PubMed 31364269
Mellander A, Billger M, Johnsson E, Traff AK, Yoshida S, Johnsson K. Hypersensitivity Events, Including Potentially Hypersensitivity-Related Skin Events, with Dapagliflozin in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis. Clin Drug Investig. 2016 Nov;36(11):925-933. doi: 10.1007/s40261-016-0438-3.
PubMed 27461213
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
Bailey CJ, Gross JL, Hennicken D, Iqbal N, Mansfield TA, List JF. Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled 102-week trial. BMC Med. 2013 Feb 20;11:43. doi: 10.1186/1741-7015-11-43.
PubMed 23425012
Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Jun 26;375(9733):2223-33. doi: 10.1016/S0140-6736(10)60407-2.
PubMed 20609968

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

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2015. 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 in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
ClinicalTrials.gov ID: NCT00528879
Acronym / sponsor ID: MB102-014 LT
Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus, Type 2, Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases, Metformin, Hypoglycemic Agents, Pharmacologic Actions
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 915 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Sep 2007
Primary completion: Nov 2008 (actual)
Study completion: May 2010 (actual)
First posted: 12 Sep 2007 (estimated)
Results: Posted 2 May 2014

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: 4

Arm	Type	Receives
Placebo + Metformin	Placebo comparator	Drug: Placebo, Drug: MetforminParticipants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Dapagliflozin, 2.5 mg + Metformin	Experimental	Drug: Dapagliflozin, Drug: MetforminParticipants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Dapagliflozin, 5 mg + Metformin	Experimental	Drug: Dapagliflozin, Drug: MetforminParticipants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Dapagliflozin, 10 mg + Metformin	Experimental	Drug: Dapagliflozin, Drug: Placebo, Drug: MetforminParticipants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

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 and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic control
Participants who have been receiving metformin at a total daily dose ≥1500 mg per day for at least 8 weeks
C-peptide ≥1.0 ng/mL
Body mass index ≤45.0 kg/m^2
Serum creatinine level <1.50 mg/dL for men or <1.40 mg/dL for women.

Key exclusion criteria (6 listed)

Aspartate aminotransferase and/or alanine aminotransferase level >3.0 times the upper limit of normal
Serum total bilirubin level >2 mg/dL
Creatinine kinase level >3 times upper limit of normal
Symptoms of severely uncontrolled diabetes
Serum creatinine level ≥1.50 mg/dL for men or ≥1.40 mg/dL for women

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 administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks	Drug	Dapagliflozin, 10 mg + Metformin, Dapagliflozin, 2.5 mg + Metformin, Dapagliflozin, 5 mg + Metformin
PlaceboDapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks	Drug	Dapagliflozin, 10 mg + Metformin, Placebo + Metformin
MetforminOpen-label metformin administered as ≥1500 mg per day for up to 102 weeks	Drug	Dapagliflozin, 10 mg + Metformin, Dapagliflozin, 2.5 mg + Metformin, Dapagliflozin, 5 mg + Metformin, Placebo + Metformin

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.

8 secondary outcomes

Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight 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 Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline to Week 24
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants 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
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline to Week 1
Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% at Week 24 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline to Week 24

Results and safety

Results posted to the registry on 2 May 2014, 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 + Metformin	137	115
Dapagliflozin, 2.5 mg + Metformin	137	120
Dapagliflozin, 5 mg + Metformin	137	122
Dapagliflozin, 10 mg + Metformin	135	119

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: Percent

Measure	Placebo + Metformin n = 134	Dapagliflozin, 2.5 mg + Metformin n = 135	Dapagliflozin, 5 mg + Metformin n = 133	Dapagliflozin, 10 mg + Metformin n = 132
Value	-0.30 (0.0718)	-0.67 (0.0715)	-0.70 (0.0722)	-0.84 (0.0724)

Placebo + Metformin vs Dapagliflozin, 2.5 mg + Metformin: Mean Difference (Final Values): -0.38, p = 0.0002, ANCOVA
Placebo + Metformin vs Dapagliflozin, 5 mg + Metformin: Mean Difference (Final Values): -0.41, p <0.0001, ANCOVA
Placebo + Metformin vs Dapagliflozin, 10 mg + Metformin: Mean Difference (Final Values): -0.54, p <0.0001, ANCOVA

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

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo + Metformin	14 of 137 (10.2%)	84 of 137 (61.3%)	Not reported
Dapagliflozin, 2.5 mg + Metformin	15 of 137 (10.9%)	87 of 137 (63.5%)	Not reported
Dapagliflozin, 5.0 mg + Metformin	9 of 137 (6.6%)	77 of 137 (56.2%)	Not reported
Dapagliflozin, 10 mg + Metformin	14 of 135 (10.4%)	83 of 135 (61.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
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.
Derived from this study: PubMed 33368935Shah M, Stolbov L, Yakovleva T, Tang W, Sokolov V, Penland RC, Boulton D, Parkinson J. A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):991-1000. doi: 10.1111/dom.14305. Epub 2021 Jan 25.
Derived from this study: PubMed 31364269Bailey CJ, Del Prato S, Wei C, Reyner D, Saraiva G. Durability of glycaemic control with dapagliflozin, an SGLT2 inhibitor, compared with saxagliptin, a DPP4 inhibitor, in patients with inadequately controlled type 2 diabetes. Diabetes Obes Metab. 2019 Nov;21(11):2564-2569. doi: 10.1111/dom.13841. Epub 2019 Aug 26.
Derived from this study: PubMed 27461213Mellander A, Billger M, Johnsson E, Traff AK, Yoshida S, Johnsson K. Hypersensitivity Events, Including Potentially Hypersensitivity-Related Skin Events, with Dapagliflozin in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis. Clin Drug Investig. 2016 Nov;36(11):925-933. doi: 10.1007/s40261-016-0438-3.
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.
Derived from this study: PubMed 23425012Bailey CJ, Gross JL, Hennicken D, Iqbal N, Mansfield TA, List JF. Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled 102-week trial. BMC Med. 2013 Feb 20;11:43. doi: 10.1186/1741-7015-11-43.
Derived from this study: PubMed 20609968Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Jun 26;375(9733):2223-33. doi: 10.1016/S0140-6736(10)60407-2.

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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

75 sites in 5 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 75 sites in 5 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 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 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in United States, Canada, Argentina, Mexico, Brazil. 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 2 May 2014). 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 NCT00528879, which also lists 7 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 20 Oct 2015.