| Outcome Measures: |
Primary: 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: Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (LOCF) - Randomized, Treated Participants, 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., Week 24|Percent Adjusted for Baseline HbA1c of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized, Treated Participants, 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., Week 24|Adjusted Mean Change From Baseline in HbA1C at Week 24 (LOCF) in Participants Whose Baseline HbA1C Category ≥9.0%, 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., Week 24|The Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized, Treated Participants, 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., 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, 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., Day 1 of Double Blind Period to end of Week 24 Plus 30 days|Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants, 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., Baseline to last dose plus 4 days in 12 Week Double Blind Period|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24 - Treated Participants, 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., Week 24|Mean Change From Baseline in Seated Heart Rate at Week 24 - Randomized, Treated Participants, 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., Week 24|Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Randomized, Treated Participants, 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., Week 24|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, 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), Baseline to Week 24/end of treatment plus 4 days|Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants, 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., Baseline to Week 24/end of treatment plus 30 days
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| Locations: |
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., W 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, E. 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, Haryana, 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, Tamilnadu, 600020, India|Local Institution, Ghaziabad, Uttar Pradesh, 201002, India|Local Institution, Jaipur, 302001, India|Local Institution, Bucheon, Gyeonggi-Do, 420-717, Korea, Republic of|Local Institution, Goyang-Si, Gyeonggi-Do, 410773, Korea, Republic of|Local Institution, Guri-Si, Gyeonggi-Do, 471-701, Korea, Republic of|Local Institution, Sungnam, Gyeonggi-Do, 463-070, Korea, Republic of|Local Institution, Daegu, 700-721, Korea, Republic of|Local Institution, Incheon, 405-760, Korea, Republic of|Local Institution, Seoul, 137040, Korea, Republic of|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 Leon, 64000, Mexico|Local Institution, Monterrey, Nuevo Leon, 64460, Mexico|Local Institution, Merida, Yucatan, 97070, Mexico|Local Institution, Aguascalientes, 20230, Mexico|Local Institution, Durango, 34000, Mexico|Local Institution, Veracruz, CP 91910, 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, Russian Federation|Local Institution, Kemerovo, 650029, Russian Federation|Local Institution, Krasnoyarsk, 660022, Russian Federation|Local Institution, Moscov, 119048, Russian Federation|Local Institution, Moscow, 105229, Russian Federation|Local Institution, Moscow, 125299, Russian Federation|Local Institution, Moscow, 140091, Russian Federation|Local Institution, Nizhniy Novgorod, 603018, Russian Federation|Local Institution, Nizhniy Novgorod, 603126, Russian Federation|Local Institution, Novosibirsk, 630091, Russian Federation|Local Institution, Novosibirsk, 630117, Russian Federation|Local Institution, Saint Petersburg, 194044, Russian Federation|Local Institution, Saint-Petersburg, 190068, Russian Federation|Local Institution, Samara, 443067, Russian Federation|Local Institution, Saratov, 410028, Russian Federation|Local Institution, Smolensk, 214018, Russian Federation|Local Institution, St. Petersburg, 191015, Russian Federation|Local Institution, St. Petersburg, 193312, Russian Federation|Local Institution, St.Petersburg, 191186, Russian Federation|Local Institution, Tyumen, 625023, Russian Federation|Local Institution, Vladimir, 600023, Russian Federation|Local Institution, Volgograd, 400001, Russian Federation|Local Institution, Voronezh, 394018, Russian Federation|Local Institution, Yaroslavl, 150003, Russian Federation|Local Institution, Yaroslavl, 150023, Russian Federation
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