Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00859898

Recruitment Status : Completed

First Posted : March 11, 2009

Results First Posted : March 20, 2014

Last Update Posted : July 7, 2016

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Bristol-Myers Squibb

Information provided by (Responsible Party):

AstraZeneca

Study Description

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

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Drug: Dapagliflozin Drug: Metformin XR Drug: dapagliflozin matching Placebo Drug: metformin HCl Modified Release matching Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1093 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	April 2009
Actual Primary Completion Date :	May 2010
Actual Study Completion Date :	May 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Type 2 diabetes

Drug Information available for: Metformin Metformin hydrochloride Dapagliflozin Dapagliflozin propanediol

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dapagliflozin + Metformin XR Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks	Drug: Dapagliflozin Tablets, Oral, 10 mg, once daily, 24 weeks Other Name: Farxiga™ Drug: Metformin XR Tablets, Oral, up to 2000 mg, once daily, 24 weeks Other Name: Glucophage®
Experimental: Dapagliflozin + Placebo Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks. Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.	Drug: Dapagliflozin Tablets, Oral, 10 mg, once daily, 24 weeks Other Name: Farxiga™ Drug: metformin HCl Modified Release matching Placebo Tablets
Active Comparator: Metformin XR + Placebo Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks	Drug: Metformin XR Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks Other Name: Glucophage® Drug: dapagliflozin matching Placebo Tablets

Outcome Measures

Primary Outcome Measures :

Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 (Last Observation Carried Forward) - Randomized Treated Participants [ Time Frame: Week 24 ]
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.

Secondary Outcome Measures :

Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (LOCF) - Randomized, Treated Participants [ Time Frame: Week 24 ]
Data after rescue medication was excluded from this analysis. FPG 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 of the Double-Blind Period.
Percent Adjusted for Baseline HbA1c of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized, Treated Participants [ Time Frame: Week 24 ]
Therapeutic glycemic response was defined as HbA1c less than 7.0%. n=Number of participants with HBA1c less than (<) 7 % at Week 24, last observation carried forward (LOCF) while N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values. Percent=n/N and was adjusted for Baseline HbA1c. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
Adjusted Mean Change From Baseline in HbA1C at Week 24 (LOCF) in Participants Whose Baseline HbA1C Category ≥9.0% [ Time Frame: Week 24 ]
HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized, treated participants whose Baseline HbA1c was greater than, equal to (>=) 9.0%. 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.
The Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized, Treated Participants [ Time Frame: Week 24 ]
Adjusted mean change from baseline in total body weight at Week 24 (or the last post-baseline 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 was measured in kilograms (kg). 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.
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 [ Time Frame: Day 1 of Double Blind Period to end of Week 24 Plus 30 days ]
Medical Dictionary for Regulatory Activities (MedDRA), version 12.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Events captured from baseline to last dose plus 4 days for AEs, plus 30 days for SAEs during the Double Blind 12 Week Period. Data after rescue included.
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants [ Time Frame: Baseline to last dose plus 4 days in 12 Week Double Blind Period ]
Participants with AEs of hypoglycemia, cardiac/vascular disorders, renal impairment or failure, volume depletion (hypotension/dehydration/hypovolemia), fractures, urinary stones, and other reports suggestive of genital infection or urinary tract infection (UTI) were summarized using MedDRA version 13.0. Data after rescue included for all special AEs except hypoglycemia (excluded data after rescue). Major hypoglycemic episode: symptomatic requiring 3rd party assistance due to severe impairment in consciousness or behavior with a glucose value < 54 mg/dL and prompt recovery after glucose/glucagon; Minor: either symptomatic with glucose measurement < 63 mg/dL, regardless of need for 3rd party assistance, or asymptomatic with glucose < 63 mg/dL that does not qualify as major; Other: suggestive but not meeting criteria for major or minor.
Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24 - Treated Participants [ Time Frame: Week 24 ]
Measurements were taken 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. Blood pressure values were obtained: after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Systolic and Diastolic pressures were measured in millimeters of mercury (mmHg). Data after rescue were also included. 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.
Mean Change From Baseline in Seated Heart Rate at Week 24 - Randomized, Treated Participants [ Time Frame: Week 24 ]
Measurements were taken 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. Heart rate values were obtained: after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently throughout the study. Heart rate was measured in beats per minute (bpm). Data after rescue were also included. 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.
Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Randomized, Treated Participants [ Time Frame: Week 24 ]
12-Lead electrocardiograms (ECGs) were performed at entry into Lead-In Period Day -7 visit and Week 24/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator. Baseline (BL) was Day -7 for this parameter. Data after rescue included.
Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants [ Time Frame: Baseline to Week 24/end of treatment plus 4 days ]
Laboratory samples: Qualification and Lead-In Periods, Day 1, Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of Double-Blind Period. Baseline (BL)=last assessment prior to start of first dose of double-blind study medication. Data after rescue included. Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); Units per liter (U/L), blood urea nitrogen (BUN). Marked abnormality Low (High) defined: hemoglobin <6 (>18 females or >20 males) g/dL; hematocrit <20% ( >55% females or >60% males); creatinine (>=1.5*preRX, >=2.5 mg/dL); glucose <54 (>350) mg/dL; creatine kinase (>5*ULN);calcium <7.5 (>=1 mg/dL from ULN and >= 0.5mg/dL from PreRX); sodium <130 or < 120 male/female (>150 mEq/L; potassium <=2.5 (>=6.0) mEq/L; bicarbonate <= 13 mEq/L; inorganic phosphorus: <=1.8 if age 17-65 or <=2.1 if age >=66, (>=5.6 if age 17-65 or >=5.1) mg/dL if age >=66; albumin <=2 (>6) g/dL; urine albumin(alb) / creatinine (creat) ratio (>1800 mg/g)
Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants [ Time Frame: Baseline to Week 24/end of treatment plus 30 days ]
Safety laboratory measurements were obtained during the Qualification and Lead-In Periods and on Day 1 of the Double-Blind Period and at Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24. BL was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from BL up to and including the last day of treatment plus 30 days. Liver function abnormality criteria: FDA Guidance for Industry: Premarketing Clinical Evaluation (July 2009). Data after rescue was also included. Abbreviations: Pretreatment (PreRX), upper limit of normal (ULN); greater than (>) less than (<); Units per liter (U/L), alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). Marked abnormality Low (High) defined: ALP, AST and ALT (>3*ULN); bilirubin (>2*ULN if PreRX <= ULN; >3*ULN if PreRX > ULN); AST or ALT plus (+) bilirubin elevation: AST or ALT >3*ULN and bilirubin >1.5*ULN within 14 days on or after ALT elevation.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 77 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00859898

Locations

Show 123 study locations

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United States, Alabama
International Institute Of Clinical Research
Ozark, Alabama, United States, 36360
United States, Arizona
Clinical Research Advantage, Inc./Mesa Family Med Ctr, Pc
Tempe, Arizona, United States, 85282
Clinical Research Advantage, Inc.
Tempe, Arizona, United States, 85282
United States, California
John Muir Physician Network Clinical Research Center
Concord, California, United States, 94520
Encompass Clinical Research-North Coast
Encinitas, California, United States, 92024
Southland Clinical Research Center, Inc.
Fountain Valley, California, United States, 92708
Valley Research
Fresno, California, United States, 93720
Del Rosario Medical Clinic, Inc.
Huntington Park, California, United States, 90255
Irvine Center For Clinical Research, Inc.
Irvine, California, United States, 92618
Pacific Sleep Medicine Services (Avastra Clinical Trials)
Redlands, California, United States, 92373
Orange County Research Center
Tustin, California, United States, 92780
United States, Colorado
Lynn Institute Of The Rockies
Colorado Springs, Colorado, United States, 80907
Radiant Research, Inc.
Denver, Colorado, United States, 80239
United States, Florida
Clinical Therapeutics Corporation
Coral Gables, Florida, United States, 33134
Nextphase Clinical Trials, Inc.
Miami, Florida, United States, 33145
Baptist Diabetes Associates
Miami, Florida, United States, 33156
Metabolic Research Institute, Inc.
W Palm Beach, Florida, United States, 33401
United States, Georgia
Lake Hartwell Family Medicine
Hartwell, Georgia, United States, 30643
Middle Georgia Drug Study Center, Llc
Perry, Georgia, United States, 31069
United States, Idaho
Northwest Clinical Trials
Boise, Idaho, United States, 83704
United States, Illinois
Provident Clinical Research
Addison, Illinois, United States, 60101
Cedar Crosse Research Center
Chicago, Illinois, United States, 60607
Deerbrook Medical Associates
Vernon Hills, Illinois, United States, 60061
United States, Indiana
Physicians Research Group
Indianapolis, Indiana, United States, 46250
United States, Michigan
Borgess Research Institute
Kalamazoo, Michigan, United States, 49048
United States, Mississippi
Olive Branch Family Medical Center
Olive Branch, Mississippi, United States, 38654
United States, New York
Clinilabs, Inc.
New York, New York, United States, 10019
United States, North Carolina
Metrolina Medical Research
Charlotte, North Carolina, United States, 28209
Pharmquest
Greensboro, North Carolina, United States, 27408
Crescent Medical Research
Salisbury, North Carolina, United States, 28144
United States, Ohio
Community Health Care, Inc.
Canal Fulton, Ohio, United States, 44614
Holzer Clinic, Inc
Gallipolis, Ohio, United States, 45631
Wells Institute For Health Awareness
Kettering, Ohio, United States, 45429
Newark Physician Associates
Newark, Ohio, United States, 43055
Daniel G. Williams, Md
Perrysburg, Ohio, United States, 43551
Physician Research, Inc.
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Gilbert Medical Research, Llc
Bethany, Oklahoma, United States, 73008
Tulsa Clinical Research, Llc
Tulsa, Oklahoma, United States, 74104
Integris Family Care Yukon
Yukon, Oklahoma, United States, 73099
United States, Oregon
Williamette Valley Clinical Studies
Eugene, Oregon, United States, 97404
United States, Pennsylvania
Dingmans Medical
Dingmans Ferry, Pennsylvania, United States, 18328
Integrated Medical Group Pc/Fleetwood Clinical Research
Fleetwood, Pennsylvania, United States, 19522
Wellmon Family Practice
Shippensburg, Pennsylvania, United States, 17257
United States, Rhode Island
Safe Harbor Clinical Research
E. Providence, Rhode Island, United States, 02914
United States, South Carolina
Southeastern Research Associates, Inc.
Greenville, South Carolina, United States, 29605
United States, Tennessee
Holston Medical Group
Bristol, Tennessee, United States, 37620
Parkway Medical Group
Fayetteville, Tennessee, United States, 37334
Holston Medical Group
Kingsport, Tennessee, United States, 37660
Southwind Medical Specialists
Memphis, Tennessee, United States, 38125
United States, Texas
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States, 75230
Endocrine Associates
Houston, Texas, United States, 77004
Village Family Practice
Houston, Texas, United States, 77024
Juno Research, Llc.
Houston, Texas, United States, 77036
Non-Invasive Cardiovascular, Pa
Houston, Texas, United States, 77074
Excel Clinical Research
Houston, Texas, United States, 77081
Texas Center For Drug Development
Houston, Texas, United States, 77081
Midland Clinical Research Center
Midland, Texas, United States, 79707
Hill Country Medical Associates
New Braunfels, Texas, United States, 78130
Covenant Clinical Research, Pa
San Antonio, Texas, United States, 78229
S.A.M. Clinical Research Center
San Antonio, Texas, United States, 78229
United States, Utah
Avastra Clinical Trials
Midvale, Utah, United States, 84047
United States, Virginia
Seven Corners Medical Center
Falls Church, Virginia, United States, 22044
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States, 23454
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
India
Local Institution
Hyderabad, Andhra Pradesh, India, 500034
Local Institution
Aminjikarai, Chennai, India, 600029
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Haryana, Karnal, India, 132001
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Bangalore, Karnataka, India, 560054
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Indore, Madhya Pradesh, India, 452010
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Nagpur, Maharashtra, India, 440010
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Nagpur, Maharashtra, India, 440012
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Chennai, Tamilnadu, India, 600020
Local Institution
Ghaziabad, Uttar Pradesh, India, 201002
Local Institution
Jaipur, India, 302001
Korea, Republic of
Local Institution
Bucheon, Gyeonggi-Do, Korea, Republic of, 420-717
Local Institution
Goyang-Si, Gyeonggi-Do, Korea, Republic of, 410773
Local Institution
Guri-Si, Gyeonggi-Do, Korea, Republic of, 471-701
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Sungnam, Gyeonggi-Do, Korea, Republic of, 463-070
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Daegu, Korea, Republic of, 700-721
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Incheon, Korea, Republic of, 405-760
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Seoul, Korea, Republic of, 137040
Mexico
Local Institution
Guadalajara, Jalisco, Mexico, 44100
Local Institution
Guadalajara, Jalisco, Mexico, CP 44650
Local Institution
Guadalajara, Jalisco, Mexico, CP 44670
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Morelia, Michioacan, Mexico, 58070
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Cuernavaca, Morelos, Mexico, 62448
Local Institution
Monterrey, Nuevo Leon, Mexico, 64000
Local Institution
Monterrey, Nuevo Leon, Mexico, 64460
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Merida, Yucatan, Mexico, 97070
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Aguascalientes, Mexico, 20230
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Durango, Mexico, 34000
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Veracruz, Mexico, CP 91910
Puerto Rico
Local Institution
Fajardo, Puerto Rico, 00738
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Ponce, Puerto Rico, 00716
Local Institution
Ponce, Puerto Rico, 00717
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San Juan, Puerto Rico, 00909
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San Juan, Puerto Rico, 00920
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San Juan, Puerto Rico, 00926
Russian Federation
Local Institution
Ekaterinaburg, Russian Federation, 620043
Local Institution
Kemerovo, Russian Federation, 650029
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Krasnoyarsk, Russian Federation, 660022
Local Institution
Moscov, Russian Federation, 119048
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Moscow, Russian Federation, 105229
Local Institution
Moscow, Russian Federation, 125299
Local Institution
Moscow, Russian Federation, 140091
Local Institution
Nizhniy Novgorod, Russian Federation, 603018
Local Institution
Nizhniy Novgorod, Russian Federation, 603126
Local Institution
Novosibirsk, Russian Federation, 630091
Local Institution
Novosibirsk, Russian Federation, 630117
Local Institution
Saint Petersburg, Russian Federation, 194044
Local Institution
Saint-Petersburg, Russian Federation, 190068
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Samara, Russian Federation, 443067
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Saratov, Russian Federation, 410028
Local Institution
Smolensk, Russian Federation, 214018
Local Institution
St. Petersburg, Russian Federation, 191015
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St. Petersburg, Russian Federation, 193312
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St.Petersburg, Russian Federation, 191186
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Tyumen, Russian Federation, 625023
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Vladimir, Russian Federation, 600023
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Volgograd, Russian Federation, 400001
Local Institution
Voronezh, Russian Federation, 394018
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Yaroslavl, Russian Federation, 150003
Local Institution
Yaroslavl, Russian Federation, 150023

Sponsors and Collaborators

AstraZeneca

Bristol-Myers Squibb

Investigators

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Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00859898
Other Study ID Numbers:	MB102-034 Eudract #: 2008-007548-33
First Posted:	March 11, 2009 Key Record Dates
Results First Posted:	March 20, 2014
Last Update Posted:	July 7, 2016
Last Verified:	May 2016

Keywords provided by AstraZeneca:


Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases	Metformin Dapagliflozin Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs

Additional relevant MeSH terms:

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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Metformin	Dapagliflozin Hypoglycemic Agents Physiological Effects of Drugs Sodium-Glucose Transporter 2 Inhibitors Molecular Mechanisms of Pharmacological Action

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