Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes
A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg in Combination With Metformin as Initial Therapy as Compared With Dapagliflozin 10 mg Monotherapy and Metformin Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
2 other identifiers
interventional
1,093
6 countries
123
Brief Summary
The primary purpose of this study is to compare the change from baseline in hemoglobin A1C achieved with dapagliflozin 10 mg in combination with metformin XR as compared with metformin XR monotherapy and compared with Dapagliflozin monotherapy, after 24 weeks of oral administration of double-blind treatment. The safety of treatment with dapagliflozin will also be assessed in this study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Apr 2009
Shorter than P25 for phase_3 type-2-diabetes-mellitus
123 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2009
CompletedFirst Posted
Study publicly available on registry
March 11, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
March 20, 2014
CompletedJuly 7, 2016
May 1, 2016
1.1 years
March 10, 2009
February 4, 2014
May 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 (Last Observation Carried Forward) - Randomized Treated Participants
Adjusted mean change in HbA1c from baseline at Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, ie, last observation carried forward (LOCF) was determined. 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.
Week 24
Secondary Outcomes (11)
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (LOCF) - Randomized, Treated Participants
Week 24
Percent Adjusted for Baseline HbA1c of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized, Treated Participants
Week 24
Adjusted Mean Change From Baseline in HbA1C at Week 24 (LOCF) in Participants Whose Baseline HbA1C Category ≥9.0%
Week 24
The Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized, Treated Participants
Week 24
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants
Day 1 of Double Blind Period to end of Week 24 Plus 30 days
- +6 more secondary outcomes
Study Arms (3)
Dapagliflozin + Metformin XR
EXPERIMENTALDapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
Dapagliflozin + Placebo
EXPERIMENTALDapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks. Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.
Metformin XR + Placebo
ACTIVE COMPARATORMetformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
Interventions
Tablets, Oral, 10 mg, once daily, 24 weeks
Tablets, Oral, up to 2000 mg, once daily, 24 weeks
Eligibility Criteria
You may qualify if:
- Treatment naive males and females, \>= 18 years old and
- \<= 77 years old, with type 2 diabetes mellitus
- Subjects must have central laboratory pre-randomization hemoglobin A1C \>= 7.5 and \<= 12.0%
- C-peptide \>= 1.0 ng/mL (0.34 nmol/L)
- Body Mass Index \<= 45 kg/m2
- Must be able to perform self monitoring of blood glucose
You may not qualify if:
- aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>3X\*upper limit of normal (ULN)
- Serum Total bilirubin \>2 mg/dL (34.2 µmol/L)
- Creatinine kinase \>3\*ULN
- Serum creatinine \>= 1.50 mg/dL (133 µmol/L) for male subjects, \>= 1.40 mg/dL (124 µmol/L) for female subjects
- Calcium value outside of the central laboratory normal reference range
- Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
- Urine albumin:creatinine ratio (UACR) \>1800 mg/g (203.4 mg/mmol Cr)
- Severe uncontrolled hypertension defined as systolic blood pressure (SBP) \>=180 mmHg and/or diastolic blood pressure (DBP) \>=110 mmHg
- Hemoglobin \>=11.0 g/dL (110 g/L) for men; hemoglobin \>=10.0 g/dL (100 g/L) for women
- Positive for hepatitis B surface antigen
- Positive for anti-hepatitis C virus antibody
- History of diabetes insipidus
- History of diabetic ketoacidosis or hyperosmolar nonketotic coma
- Symptoms of poorly controlled diabetes that would preclude participation in this trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (123)
International Institute Of Clinical Research
Ozark, Alabama, 36360, United States
Clinical Research Advantage, Inc./Mesa Family Med Ctr, Pc
Tempe, Arizona, 85282, United States
Clinical Research Advantage, Inc.
Tempe, Arizona, 85282, United States
John Muir Physician Network Clinical Research Center
Concord, California, 94520, United States
Encompass Clinical Research-North Coast
Encinitas, California, 92024, United States
Southland Clinical Research Center, Inc.
Fountain Valley, California, 92708, United States
Valley Research
Fresno, California, 93720, United States
Del Rosario Medical Clinic, Inc.
Huntington Park, California, 90255, United States
Irvine Center For Clinical Research, Inc.
Irvine, California, 92618, United States
Pacific Sleep Medicine Services (Avastra Clinical Trials)
Redlands, California, 92373, United States
Orange County Research Center
Tustin, California, 92780, United States
Lynn Institute Of The Rockies
Colorado Springs, Colorado, 80907, United States
Radiant Research, Inc.
Denver, Colorado, 80239, United States
Clinical Therapeutics Corporation
Coral Gables, Florida, 33134, United States
Nextphase Clinical Trials, Inc.
Miami, Florida, 33145, United States
Baptist Diabetes Associates
Miami, Florida, 33156, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401, United States
Lake Hartwell Family Medicine
Hartwell, Georgia, 30643, United States
Middle Georgia Drug Study Center, Llc
Perry, Georgia, 31069, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
Provident Clinical Research
Addison, Illinois, 60101, United States
Cedar Crosse Research Center
Chicago, Illinois, 60607, United States
Deerbrook Medical Associates
Vernon Hills, Illinois, 60061, United States
Physicians Research Group
Indianapolis, Indiana, 46250, United States
Borgess Research Institute
Kalamazoo, Michigan, 49048, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654, United States
Clinilabs, Inc.
New York, New York, 10019, United States
Metrolina Medical Research
Charlotte, North Carolina, 28209, United States
Pharmquest
Greensboro, North Carolina, 27408, United States
Crescent Medical Research
Salisbury, North Carolina, 28144, United States
Community Health Care, Inc.
Canal Fulton, Ohio, 44614, United States
Holzer Clinic, Inc
Gallipolis, Ohio, 45631, United States
Wells Institute For Health Awareness
Kettering, Ohio, 45429, United States
Newark Physician Associates
Newark, Ohio, 43055, United States
Daniel G. Williams, Md
Perrysburg, Ohio, 43551, United States
Physician Research, Inc.
Zanesville, Ohio, 43701, United States
Gilbert Medical Research, Llc
Bethany, Oklahoma, 73008, United States
Tulsa Clinical Research, Llc
Tulsa, Oklahoma, 74104, United States
Integris Family Care Yukon
Yukon, Oklahoma, 73099, United States
Williamette Valley Clinical Studies
Eugene, Oregon, 97404, United States
Dingmans Medical
Dingmans Ferry, Pennsylvania, 18328, United States
Integrated Medical Group Pc/Fleetwood Clinical Research
Fleetwood, Pennsylvania, 19522, United States
Wellmon Family Practice
Shippensburg, Pennsylvania, 17257, United States
Safe Harbor Clinical Research
East Providence, Rhode Island, 02914, United States
Southeastern Research Associates, Inc.
Greenville, South Carolina, 29605, United States
Holston Medical Group
Bristol, Tennessee, 37620, United States
Parkway Medical Group
Fayetteville, Tennessee, 37334, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Southwind Medical Specialists
Memphis, Tennessee, 38125, United States
Dallas Diabetes & Endocrine Center
Dallas, Texas, 75230, United States
Endocrine Associates
Houston, Texas, 77004, United States
Village Family Practice
Houston, Texas, 77024, United States
Juno Research, Llc.
Houston, Texas, 77036, United States
Non-Invasive Cardiovascular, Pa
Houston, Texas, 77074, United States
Excel Clinical Research
Houston, Texas, 77081, United States
Texas Center For Drug Development
Houston, Texas, 77081, United States
Midland Clinical Research Center
Midland, Texas, 79707, United States
Hill Country Medical Associates
New Braunfels, Texas, 78130, United States
Covenant Clinical Research, Pa
San Antonio, Texas, 78229, United States
S.A.M. Clinical Research Center
San Antonio, Texas, 78229, United States
Avastra Clinical Trials
Midvale, Utah, 84047, United States
Seven Corners Medical Center
Falls Church, Virginia, 22044, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Local Institution
Hyderabad, Andhra Pradesh, 500034, India
Local Institution
Aminjikarai, Chennai, 600029, India
Local Institution
Haryāna, Karnal, 132001, India
Local Institution
Bangalore, Karnataka, 560054, India
Local Institution
Indore, Madhya Pradesh, 452010, India
Local Institution
Nagpur, Maharashtra, 440010, India
Local Institution
Nagpur, Maharashtra, 440012, India
Local Institution
Chennai, Tamil Nadu, 600020, India
Local Institution
Ghaziabad, Uttar Pradesh, 201002, India
Local Institution
Jaipur, 302001, India
Local Institution
Aguascalientes, Aguascalientes, 20230, Mexico
Local Institution
Durango, Durango, 34000, Mexico
Local Institution
Guadalajara, Jalisco, 44100, Mexico
Local Institution
Guadalajara, Jalisco, CP 44650, Mexico
Local Institution
Guadalajara, Jalisco, CP 44670, Mexico
Local Institution
Morelia, Michioacan, 58070, Mexico
Local Institution
Cuernavaca, Morelos, 62448, Mexico
Local Institution
Monterrey, Nuevo León, 64000, Mexico
Local Institution
Monterrey, Nuevo León, 64460, Mexico
Local Institution
Veracruz, Veracruz, CP 91910, Mexico
Local Institution
Mérida, Yucatán, 97070, Mexico
Local Institution
Fajardo, 00738, Puerto Rico
Local Institution
Ponce, 00716, Puerto Rico
Local Institution
Ponce, 00717, Puerto Rico
Local Institution
San Juan, 00909, Puerto Rico
Local Institution
San Juan, 00920, Puerto Rico
Local Institution
San Juan, 00926, Puerto Rico
Local Institution
Ekaterinaburg, 620043, Russia
Local Institution
Kemerovo, 650029, Russia
Local Institution
Krasnoyarsk, 660022, Russia
Local Institution
Moscov, 119048, Russia
Local Institution
Moscow, 105229, Russia
Local Institution
Moscow, 125299, Russia
Local Institution
Moscow, 140091, Russia
Local Institution
Nizhny Novgorod, 603018, Russia
Local Institution
Nizhny Novgorod, 603126, Russia
Local Institution
Novosibirsk, 630091, Russia
Local Institution
Novosibirsk, 630117, Russia
Local Institution
Saint Petersburg, 190068, Russia
Local Institution
Saint Petersburg, 191015, Russia
Local Institution
Saint Petersburg, 191186, Russia
Local Institution
Saint Petersburg, 193312, Russia
Local Institution
Saint Petersburg, 194044, Russia
Local Institution
Samara, 443067, Russia
Local Institution
Saratov, 410028, Russia
Local Institution
Smolensk, 214018, Russia
Local Institution
Tyumen, 625023, Russia
Local Institution
Vladimir, 600023, Russia
Local Institution
Volgograd, 400001, Russia
Local Institution
Voronezh, 394018, Russia
Local Institution
Yaroslavl, 150003, Russia
Local Institution
Yaroslavl, 150023, Russia
Local Institution
Bucheon-si, Gyeonggi-do, 420-717, South Korea
Local Institution
Goyang-si, Gyeonggi-do, 410773, South Korea
Local Institution
Guri-si, Gyeonggi-do, 471-701, South Korea
Local Institution
Sungnam, Gyeonggi-do, 463-070, South Korea
Local Institution
Daegu, 700-721, South Korea
Local Institution
Incheon, 405-760, South Korea
Local Institution
Seoul, 137040, South Korea
Related Publications (1)
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.
PMID: 26894924DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- AstraZeneca
- Organization
- Clinical Trial Transparency
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2009
First Posted
March 11, 2009
Study Start
April 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
July 7, 2016
Results First Posted
March 20, 2014
Record last verified: 2016-05