| Outcome Measures: |
Primary: Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1, 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., Baseline to Week 24 (end of Short-term Period)|Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) (Last Observation Carried Forward [LOCF]): Group 2, 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., Baseline to Week 24 (end of Short-term Period) | Secondary: Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 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 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., Baseline to Week 24 (end of Short-term Period)|Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 2, 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., Baseline to Week 24 (end of Short-term Period)|Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 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. 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., From Baseline to Week 24 (end of Short-term Period)|Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 2, 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., From Baseline to Week 24 (end of Short-term Period)|Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 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., Baseline to Week 1 (end of Short-term Period)|Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 2, 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., Baseline to Week 1|Adjusted 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 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., Baseline to Week 24 (end of Short-term Period)|Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) in Patients With Baseline HbA1c ≥9.0% (Last Observation Carried Forward [LOCF]), 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., Baseline to Week 24 (end of Short-term Period)|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]), 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., Baseline to Week 24 (end of Short-term Period)|Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF]), 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., Baseline to Week 24 (end of Short-term Period)|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), 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., Baseline to Week 24 (end of Short-term Period)|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), 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., Day 1 to Week 102 (end of Long-term Period) + 30 days|Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods), 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., Baseline to Week 102 (end of Long-term Period)|Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods), 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., Day 1 to Week 102 (end of Long-term Period)|Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF]), 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., Baseline to Week 24 (end of Short-term Period)
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| Locations: |
43rd Medical Associates, P.C., Phoenix, Arizona, 85051, United States|Clin Res Advantage, Inc/East Valley Family Physicians, Plc, Tempe, Arizona, 85282, United States|Clinical Research Advantage, Inc, Tempe, Arizona, 85282, United States|Valley Research, Fresno, California, 93720, United States|Cherlin, Richard, Los Gatos, California, 95032, United States|Ritchken & First M.D.'S, San Diego, California, 92117, United States|Torrance Clinical Research, Torrance, California, 90717, United States|Aurora Family Medicine Center, P.C., Aurora, Colorado, 80012, United States|Expresscare Clinical Research, Colorado Springs, Colorado, 80909, United States|Center For Internal Medicine, Denver, Colorado, 80209, United States|Denver Internal Medicine Group, Denver, Colorado, 80209, United States|Central Florida Clinical Trials, Altamonte Springs, Florida, 32701, United States|Family Care Associates, Chipley, Florida, 32428, United States|Westside Center For Clinical Research, Jacksonville, Florida, 32205, United States|Panhandle Family Care Associates, Marianna, Florida, 32446, United States|Louisiana Heart Center, Slidell, Louisiana, 70458, United States|Jackson, Danny W., Rolling Fork, Mississippi, 39159, United States|Woodlake Research, Chesterfield, Missouri, 63017, United States|Nevada Alliance Against Diabetes, Las Vegas, Nevada, 89101, United States|Slocum-Dickson Medical Group, Pllc, New Hartford, New York, 13413, United States|Internist Associates Of Central New York, P. C., Syracuse, New York, 13210, United States|Southgate Medical Group, West Seneca, New York, 14224, United States|Providence Health Partners, Dayton, Ohio, 45439, United States|Newark Physician Associates, Newark, Ohio, 43055, United States|Physician Research, Inc., Zanesville, Ohio, 43701, United States|Gilbert Medical Research, Llc, Bethany, Oklahoma, 73008, United States|Integris Family Care Yukon, Yukon, Oklahoma, 73109, United States|Banksville Medical, Pc, Pittsburgh, Pennsylvania, 15216, United States|Southeastern Research Associates, Inc., Taylors, South Carolina, 29687, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|Village Family Practice, Houston, Texas, 77024, United States|Abbott Clinical Research Group, Inc., San Antonio, Texas, 78224, United States|Sam Clinical Research Center, San Antonio, Texas, 78229, United States|Taylor/Wade Medical, Bountiful, Utah, 84010, United States|Optimum Clinical Research, Inc., Salt Lake City, Utah, 84102, United States|J. Lewis Research, Inc, Salt Lake City, Utah, 84121, United States|Tidewater Integrated Medical Research, Virginia Beach, Virginia, 23454, United States|William L. Gray, Md, Spokane, Washington, 99216, United States|Local Institution, Calgary, Alberta, T2R 0X7, Canada|Local Institution, Kelowna, British Columbia, V1Y 2H4, Canada|Local Institution, Winnipeg, Manitoba, R3E 3P4, Canada|Local Institution, Bathurst, New Brunswick, E2A 4X7, Canada|Local Institution, Moncton, New Brunswick, E1G 1A7, Canada|Local Institution, Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada|Local Institution, St-John, Newfoundland and Labrador, A1E 2E2, Canada|Local Institution, St. John'S, Newfoundland and Labrador, A1A 3R5, Canada|Local Institution, Oakville, Ontario, L6H 3P1, Canada|Local Institution, Sarnia, Ontario, N7T 4X3, Canada|Local Institution, Thornhill, Ontario, L4J 8L7, Canada|Local Institution, Toronto, Ontario, M4R 2G4, Canada|Local Institution, Toronto, Ontario, M9W 4L6, Canada|Local Institution, Charlottetown, Prince Edward Island, C1A 5Y9, Canada|Local Institution, Drummondville, Quebec, J2B 7T1, Canada|Local Institution, Granby, Quebec, J2G 8Z9, Canada|Local Institution, L'Ancienne Lorette, Quebec, G2E 2X1, Canada|Local Institution, Mirabel, Quebec, J7J 2K8, Canada|Local Institution, St-Leonard, Quebec, H1S 3A9, Canada|Local Institution, Saskatoon, Saskatchewan, S7K 3H3, Canada|Local Institution, Saskatoon, Saskatchewan, S7K 7H9, Canada|Local Institution, Tijuana, Baja California, 22320, Mexico|Local Institution, Guadalajara, Distrito Federal, 44670, Mexico|Local Institution, Mexico, D. F., Distrito Federal, 06726, Mexico|Local Institution, Guadalajara, Jalisco, 44100, Mexico|Local Institution, Guadalajara, Jalisco, 44600, Mexico|Local Institution, Guadalajara, Jalisco, 44680, Mexico|Local Institution, Morelia, Michioacan, 58070, Mexico|Local Institution, Monterrey, Nuevo Leon, 64060, Mexico|Local Institution, Monterrrey, Nuevo Leon, 64700, Mexico|Local Institution, Merida, Yucatan, 97070, Mexico|Local Institution, Aguascalientes, 20230, Mexico|Local Institution, Durango, 34000, Mexico|Local Institution, Kursk, 305035, Russian Federation|Local Institution, Moscow, 115093, Russian Federation|Local Institution, Saint-Petersburg, 191015, Russian Federation|Local Institution, Smolensk, 214019, Russian Federation|Local Institution, St. Petersburg, 195257, Russian Federation|Local Institution, St.Petersburg, 195112, Russian Federation|Local Institution, Yaroslaval, 150003, Russian Federation
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