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

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: NCT00528372

Recruitment Status : Completed

First Posted : September 12, 2007

Results First Posted : May 14, 2014

Last Update Posted : October 20, 2015

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Bristol-Myers Squibb

Information provided by (Responsible Party):

AstraZeneca

Study Description

Brief Summary:

The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes who have never been treated with medication or have been taking medication for less than 24 weeks since their original diabetes diagnosis. The safety of this treatment will also be studied.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes	Drug: Dapagliflozin Drug: Dapagliflozin placebo Drug: Metformin	Phase 3

Detailed Description:

All eligible participants will receive single-blind placebo medication during the 2-week lead-in period. All participants may receive additional open-label treatment with metformin, 500-2000 mg, as needed for rescue, based on protocol specific criteria.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1067 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
Study Start Date :	September 2007
Actual Primary Completion Date :	February 2009
Actual Study Completion Date :	July 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Type 2 diabetes

Drug Information available for: Dapagliflozin Dapagliflozin propanediol

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group 1: Dapagliflozin, 2.5 mg AM Participants with hemoglobin A1c (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks.	Drug: Dapagliflozin Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks Other Name: BMS-512148 Drug: Metformin Other Name: Tablets, 500-2000 mg, orally as needed in any arm for rescue, based on protocol specific criteria
Experimental: Group 1: Dapagliflozin, 10 mg AM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks.	Drug: Dapagliflozin Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks Other Name: BMS-512148 Drug: Metformin Other Name: Tablets, 500-2000 mg, orally as needed in any arm for rescue, based on protocol specific criteria
Experimental: Group 1: Dapagliflozin 2.5 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks.	Drug: Dapagliflozin Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks Other Name: BMS-512148 Drug: Metformin Other Name: Tablets, 500-2000 mg, orally as needed in any arm for rescue, based on protocol specific criteria
Experimental: Group 1: Dapagliflozin, 5 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks.	Drug: Dapagliflozin Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks Other Name: BMS-512148 Drug: Metformin Other Name: Tablets, 500-2000 mg, orally as needed in any arm for rescue, based on protocol specific criteria
Experimental: Group 1: Dapagliflozin, 10 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks.	Drug: Dapagliflozin Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks Other Name: BMS-512148 Drug: Metformin Other Name: Tablets, 500-2000 mg, orally as needed in any arm for rescue, based on protocol specific criteria
Experimental: Group 2: Dapagliflozin, 5 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks.	Drug: Dapagliflozin Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks Other Name: BMS-512148 Drug: Metformin Other Name: Tablets, 500-2000 mg, orally as needed in any arm for rescue, based on protocol specific criteria
Experimental: Group 2: Dapagliflozin, 10 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks.	Drug: Dapagliflozin Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks Other Name: BMS-512148 Drug: Metformin Other Name: Tablets, 500-2000 mg, orally as needed in any arm for rescue, based on protocol specific criteria
Experimental: Group 1: Dapagliflozin placebo AM & PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks.	Drug: Dapagliflozin placebo Tablets, oral, 0 mg, once daily in the morning or evening for up to 102 weeks Drug: Metformin Other Name: Tablets, 500-2000 mg, orally as needed in any arm for rescue, based on protocol specific criteria
Experimental: Group 1: Dapaglifozon, 5 mg AM Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks.	Drug: Dapagliflozin Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks Other Name: BMS-512148 Drug: Metformin Other Name: Tablets, 500-2000 mg, orally as needed in any arm for rescue, based on protocol specific criteria

Outcome Measures

Primary Outcome Measures :

Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1 [ Time Frame: Baseline to Week 24 (end of Short-term Period) ]
HbA1c was measured 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. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Evening dosing groups were summarized as exploratory endpoints.
Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) (Last Observation Carried Forward [LOCF]): Group 2 [ Time Frame: Baseline to Week 24 (end of Short-term Period) ]
HbA1c was measured 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. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.

Secondary Outcome Measures :

Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 1 [ Time Frame: Baseline to Week 24 (end of Short-term Period) ]
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized in secondary efficacy analyses. 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. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint.
Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 2 [ Time Frame: Baseline to Week 24 (end of Short-term Period) ]
Group 2 was an exploratory group, included to obtain initial efficacy and safety data. No comparator arm was included. Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. 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. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint.
Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 1 [ Time Frame: From Baseline to Week 24 (end of Short-term Period) ]
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. 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.
Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 2 [ Time Frame: From Baseline to Week 24 (end of Short-term Period) ]
Secondary endpoints were tested using a 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.Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 1 [ Time Frame: Baseline to Week 1 (end of Short-term Period) ]
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. 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.
Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 2 [ Time Frame: Baseline to Week 1 ]
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. 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.
Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1c] <7.0%) at Week 24 (Last Observation Carried Forward [LOCF]) [ Time Frame: Baseline to Week 24 (end of Short-term Period) ]
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.
Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) in Patients With Baseline HbA1c ≥9.0% (Last Observation Carried Forward [LOCF]) [ Time Frame: Baseline to Week 24 (end of Short-term Period) ]
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. HbA1c was measured as % of hemoglobin by a central laboratory. The population included randomized patients who received treatment and had 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 double-blind study drug. In cases where time of the first dose or 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 drug. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered exploratory, included to obtain initial data. No comparator arm was included. Thus, only key safety and efficacy analyses were performed in Group 2.
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF]) [ Time Frame: Baseline to Week 24 (end of Short-term Period) ]
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. 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. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.
Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF]) [ Time Frame: Baseline to Week 24 (end of Short-term Period) ]
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.
Adjusted Mean Change From Baseline to Week 24 in Total Body Weight in Patients With Baseline Body Mass Index ≥27 kg/m^2 (Last Observation Carried Forward) [ Time Frame: Baseline to Week 24 (end of Short-term Period) ]
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. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.
Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods) [ Time Frame: Day 1 to Week 102 (end of Long-term Period) + 30 days ]
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. Related=having certain, probable, possible, or missing relationship to study drug. Includes non-SAEs and hypoglycemia with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 4 days. Includes SAEs with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 30 days.
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods) [ Time Frame: Baseline to Week 102 (end of Long-term Period) ]
Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue were also included. ULN=upper limit of normal; preRX=pretreatment. Phosphorus, inorganic (high) defined as >=5.6 mg/dL for ages 17-65 years or >=5.1 mg/dL for ages >=66.
Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods) [ Time Frame: Day 1 to Week 102 (end of Long-term Period) ]
Data after rescue was included. AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.
Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF]) [ Time Frame: Baseline to Week 24 (end of Short-term Period) ]
12-Lead ECGs were performed at entry into lead-in period Day -7 visit and Week 24/end of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter, and data after rescue were included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.

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

Key Inclusion Criteria

Males and females, aged 18 to 77 years
Type 2 diabetes with inadequate glycemic control, defined as: Group 1, hemoglobin A1c (HbA1c) ≥7% and ≤10%; Group 2, HbA1c ≥10.1% and ≤12.0%
Drug naive, defined as never having received prescription medications for diabetes, having received prescription medications for diabetes for <24 weeks since the original diagnosis
C-peptide ≥1.0 ng/mL at enrollment
Body Mass Index ≤ 45.0 kg/m^2 at enrollment

Key Exclusion Criteria

Urine albumin:creatinine ratio >1,800 mg/g
Aspartate aminotransferase >3*upper limit of normal (ULN)
Alanine aminotransferase >3*ULN
Serum total bilirubin >2*ULN
Serum creatinine ≥1.5 mg/dL for men; ≥1.4 mg/dLfor women
Calcium value outside of the central laboratory normal reference range
Positive hepatitis B surface antigen
Positive anti-hepatitis C virus antibody
Hemoglobin ≤11 g/dL for men; hemoglobin ≤10 g/dL for women
Creatine kinase >3*ULN
Abnormal free T4 values
History of diabetes insipidus
Symptoms of poorly controlled diabetes, including marked polyuria and polydipsia with greater than 10% weight loss in the 3 months prior to enrollment
History of diabetic ketoacidosis or hyperosmolar nonketotic coma
Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg
Any of the following within 6 months of enrollment: Myocardial infarction, cardiac surgery or revascularization, unstable angina, unstable congestive heart failure (CHF), CHF New York Heart Association Class III or IV status, transient ischemic attack or significant cerebrovascular disease, unstable or previously undiagnosed arrhythmia
History of unstable or rapidly progressing renal disease
Conditions of congenital renal glucosuria
Significant hepatic disease, including chronic active hepatitis and/or severe hepatic insufficiency
Documented history of hepatotoxicity with any medication
Documented history of severe hepatobiliary disease
History of hemoglobinopathy, with the exception of sickle cell trait, thalassemia minor, or chronic or recurrent hemolysis
Donation of blood or blood products to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of >400 mL of blood during the 6 weeks prior to enrollment
Malignancy (with the exception of treated basal cell or treated squamous cell carcinoma) within 5 years of enrollment visit
Known immunocompromised status, including individuals who had undergone organ transplantation or who had positive HIV results
Administration of any antidiabetic therapy for more than 14 days (consecutive or not) during the 12 weeks prior to enrollment
Administration of any antidiabetic therapy, other than any previously specified, at any dose, at any time during the 4 weeks prior to enrollment
Replacement or chronic systemic corticosteroid therapy, defined as any dose of systemic corticosteroid taken for >4 weeks within 3 months prior to enrollment
History of bariatric surgery or lap-band procedure
Administration of sibutramine, phentermine, orlistat, rimonabant, benzphetamine, diethylpropion, methamphetamine, and/or phendimetrazine, within 30 days of enrollment

Contacts and Locations

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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): NCT00528372

Locations

Show 78 study locations

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United States, Arizona
43rd Medical Associates, P.C.
Phoenix, Arizona, United States, 85051
Clin Res Advantage, Inc/East Valley Family Physicians, Plc
Tempe, Arizona, United States, 85282
Clinical Research Advantage, Inc
Tempe, Arizona, United States, 85282
United States, California
Valley Research
Fresno, California, United States, 93720
Cherlin, Richard
Los Gatos, California, United States, 95032
Ritchken & First M.D.'S
San Diego, California, United States, 92117
Torrance Clinical Research
Torrance, California, United States, 90717
United States, Colorado
Aurora Family Medicine Center, P.C.
Aurora, Colorado, United States, 80012
Expresscare Clinical Research
Colorado Springs, Colorado, United States, 80909
Center For Internal Medicine
Denver, Colorado, United States, 80209
Denver Internal Medicine Group
Denver, Colorado, United States, 80209
United States, Florida
Central Florida Clinical Trials
Altamonte Springs, Florida, United States, 32701
Family Care Associates
Chipley, Florida, United States, 32428
Westside Center For Clinical Research
Jacksonville, Florida, United States, 32205
Panhandle Family Care Associates
Marianna, Florida, United States, 32446
United States, Louisiana
Louisiana Heart Center
Slidell, Louisiana, United States, 70458
United States, Mississippi
Jackson, Danny W.
Rolling Fork, Mississippi, United States, 39159
United States, Missouri
Woodlake Research
Chesterfield, Missouri, United States, 63017
United States, Nevada
Nevada Alliance Against Diabetes
Las Vegas, Nevada, United States, 89101
United States, New York
Slocum-Dickson Medical Group, Pllc
New Hartford, New York, United States, 13413
Internist Associates Of Central New York, P. C.
Syracuse, New York, United States, 13210
Southgate Medical Group
West Seneca, New York, United States, 14224
United States, Ohio
Providence Health Partners
Dayton, Ohio, United States, 45439
Newark Physician Associates
Newark, Ohio, United States, 43055
Physician Research, Inc.
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Gilbert Medical Research, Llc
Bethany, Oklahoma, United States, 73008
Integris Family Care Yukon
Yukon, Oklahoma, United States, 73109
United States, Pennsylvania
Banksville Medical, Pc
Pittsburgh, Pennsylvania, United States, 15216
United States, South Carolina
Southeastern Research Associates, Inc.
Taylors, South Carolina, United States, 29687
United States, Tennessee
Holston Medical Group
Kingsport, Tennessee, United States, 37660
United States, Texas
Village Family Practice
Houston, Texas, United States, 77024
Abbott Clinical Research Group, Inc.
San Antonio, Texas, United States, 78224
Sam Clinical Research Center
San Antonio, Texas, United States, 78229
United States, Utah
Taylor/Wade Medical
Bountiful, Utah, United States, 84010
Optimum Clinical Research, Inc.
Salt Lake City, Utah, United States, 84102
J. Lewis Research, Inc
Salt Lake City, Utah, United States, 84121
United States, Virginia
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States, 23454
United States, Washington
William L. Gray, Md
Spokane, Washington, United States, 99216
Canada, Alberta
Local Institution
Calgary, Alberta, Canada, T2R 0X7
Canada, British Columbia
Local Institution
Kelowna, British Columbia, Canada, V1Y 2H4
Canada, Manitoba
Local Institution
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, New Brunswick
Local Institution
Bathurst, New Brunswick, Canada, E2A 4X7
Local Institution
Moncton, New Brunswick, Canada, E1G 1A7
Canada, Newfoundland and Labrador
Local Institution
Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
Local Institution
St-John, Newfoundland and Labrador, Canada, A1E 2E2
Local Institution
St. John'S, Newfoundland and Labrador, Canada, A1A 3R5
Canada, Ontario
Local Institution
Oakville, Ontario, Canada, L6H 3P1
Local Institution
Sarnia, Ontario, Canada, N7T 4X3
Local Institution
Thornhill, Ontario, Canada, L4J 8L7
Local Institution
Toronto, Ontario, Canada, M4R 2G4
Local Institution
Toronto, Ontario, Canada, M9W 4L6
Canada, Prince Edward Island
Local Institution
Charlottetown, Prince Edward Island, Canada, C1A 5Y9
Canada, Quebec
Local Institution
Drummondville, Quebec, Canada, J2B 7T1
Local Institution
Granby, Quebec, Canada, J2G 8Z9
Local Institution
L'Ancienne Lorette, Quebec, Canada, G2E 2X1
Local Institution
Mirabel, Quebec, Canada, J7J 2K8
Local Institution
St-Leonard, Quebec, Canada, H1S 3A9
Canada, Saskatchewan
Local Institution
Saskatoon, Saskatchewan, Canada, S7K 3H3
Local Institution
Saskatoon, Saskatchewan, Canada, S7K 7H9
Mexico
Local Institution
Tijuana, Baja California, Mexico, 22320
Local Institution
Guadalajara, Distrito Federal, Mexico, 44670
Local Institution
Mexico, D. F., Distrito Federal, Mexico, 06726
Local Institution
Guadalajara, Jalisco, Mexico, 44100
Local Institution
Guadalajara, Jalisco, Mexico, 44600
Local Institution
Guadalajara, Jalisco, Mexico, 44680
Local Institution
Morelia, Michioacan, Mexico, 58070
Local Institution
Monterrey, Nuevo Leon, Mexico, 64060
Local Institution
Monterrrey, Nuevo Leon, Mexico, 64700
Local Institution
Merida, Yucatan, Mexico, 97070
Local Institution
Aguascalientes, Mexico, 20230
Local Institution
Durango, Mexico, 34000
Russian Federation
Local Institution
Kursk, Russian Federation, 305035
Local Institution
Moscow, Russian Federation, 115093
Local Institution
Saint-Petersburg, Russian Federation, 191015
Local Institution
Smolensk, Russian Federation, 214019
Local Institution
St. Petersburg, Russian Federation, 195257
Local Institution
St.Petersburg, Russian Federation, 195112
Local Institution
Yaroslaval, Russian Federation, 150003

Sponsors and Collaborators

AstraZeneca

Bristol-Myers Squibb

Investigators

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Study Director:	Anna Maria Langkilde	AstraZeneca

More Information

Additional Information:

MB102013_Clinical_Study_Protocol This link exits the ClinicalTrials.gov site

Publications of Results:

Ferrannini E, Ramos SJ, Salsali A, Tang W, List JF. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care. 2010 Oct;33(10):2217-24. doi: 10.2337/dc10-0612. Epub 2010 Jun 21.

Bailey CJ, Morales Villegas EC, Woo V, Tang W, Ptaszynska A, List JF. Efficacy and safety of dapagliflozin monotherapy in people with Type 2 diabetes: a randomized double-blind placebo-controlled 102-week trial. Diabet Med. 2015 Apr;32(4):531-41. doi: 10.1111/dme.12624. Epub 2014 Nov 22.

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

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.

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:	NCT00528372
Other Study ID Numbers:	MB102-013 LT
First Posted:	September 12, 2007 Key Record Dates
Results First Posted:	May 14, 2014
Last Update Posted:	October 20, 2015
Last Verified:	September 2015

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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