| Outcome Measures: |
Primary: Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF]), Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use, Baseline to Week 24 | Secondary: Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT), An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal, Baseline to Week 24|Change From Baseline in 120-minute PPG Values During an MTT, An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal., Baseline to Week 24|Change From Baseline in Fasting Plasma Glucose Values, Baseline to Week 24|Percentage of Participants Achieving a Therapeutic Glycemic Response, Therapeutic glycemic response is defined as an A1C\<7%. Significance was not interpreted with a p value., Baseline to Week 24|Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF), Based on information recorded in the participant's daily diary. The MTDDI was calculated at every visit using the values patients recorded since the last regularly scheduled visit (minimum of 80% of days with a value). At every visit, the MTDDI was compared with the participant's baseline MTDDI (measured during a 4-week lead-in period) to identify any changes in insulin use at that visit compared with insulin use at baseline., Baseline to Week 24 | Other: Number of Participants With Abnormal Changes From Baseline in Electrocardiogram (ECG) Results, ECG abnormalities included those in nonspecific "other" categories (Other nonspecific ST/T, Other intraventricular conduction defect, Other, and Other rhythm abnormalities)and nonspecific findings, such as sinus bradycardia, sinus arrythmia, sinus tachycardia, poor R-wave progression, and ventricular premature contractions., Baseline to Week 52|Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF), Absolute lymphocyte count=value\*10\^3 c/uL, Baseline and Weeks 24 and 52|Number of Participants With at Least 1 Adverse Event (AE), at Least 1 Treatment-related AE, Death as Outcome, at Least 1 Serious Adverse Event (SAE), at Least 1 Treatment-related SAE, Discontinuations Due to SAEs, and Discontinuations Due to AEs, An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment., Baseline to Week 52, continuously|Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings, Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52|Mean Changes From Baseline in Heart Rate, Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52|Shift in Platelet Counts From Baseline to Selected Visits (LOCF), Platelet count=value\*10\^9 c/L, Baseline and Weeks 24 and 52|Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period, Marked abnormality=a laboratory value lying outside the predefined criteria and more extreme (farther from the limit)on-treatment than at baseline. ULN=upper limit of normal; LLN=lower limit of normal; prx=pre-RX=pretreatment. Criteria 1: if prx=0 use \>=2, if prx=0.5 or 1 use \>=3, if prx=2 use 4., Baseline and during and up to 14 days after last dose of study drug (in Week 52)|Percentage of Participants With Reported and Confirmed Hypoglycemia, Confirmed hypoglycemia=fingerstick glucose measurement of ≤50 mg/dL with associated symptoms/, Baseline to Week 52
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| Locations: |
Clinical Research Advantage, Inc, Tempe, Arizona, 85282, United States|Valley Research, Fresno, California, 93720, United States|Torrance-Lomita Medical Center, Lomita, California, 90717, United States|Diabetes Medical Center Of California, Northridge, California, 91325, United States|Ritchken & First M.D.'S, San Diego, California, 92117, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|Central Florida Clinical Trials, Inc., Altamonte Springs, Florida, 32701, United States|Family Care Associates Of Nw Florida, Chipley, Florida, 32428, United States|Panhandle Family Care Assoc. & Coastal Palms Res. Grp Inc., Marianna, Florida, 32446, United States|Endocrine Research Solutions, Inc., Roswell, Georgia, 30076, United States|Danny W. Jackson P.A., Rolling Fork, Mississippi, 39159, United States|Southgate Medical Group, West Seneca, New York, 14224, United States|Southeastern Research Associates, Inc., Taylors, South Carolina, 29687, United States|Texas Center For Drug Development, Houston, Texas, 77081, United States|Dgd Research, Inc., San Antonio, Texas, 78229, United States|Aurora Advanced Healthcare, Milwaukee, Wisconsin, 53209, United States|Local Institution, Calgary, Alberta, T3B 0M3, Canada|Local Institution, Vancouver, British Columbia, V6E 1M7, Canada|Local Institution, Bathurst, New Brunswick, E2A 4X7, Canada|Local Institution, London, Ontario, N6A 4V2, Canada|Local Institution, Charlottetown, Prince Edward Island, C1A 5Y9, Canada|Local Institution, Gatineau, Quebec, J8V 2P5, Canada|Local Institution, Laval, Quebec, H7T 2P5, Canada|Local Institution, Sherbrooke, Quebec, J1G 5K2, Canada|Local Institution, Regina, Saskatchewan, S4P 0W5, Canada|Local Institution, Besancon Cedex, 25030, France|Local Institution, Montpellier Cedex 5, 34295, France|Local Institution, Nantes, 44093, France|Local Institution, Valenciennes, 59300, France|Local Institution, Balatonfured, 8230, Hungary|Local Institution, Budapest, 1041, Hungary|Local Institution, Budapest, 1083, Hungary|Local Institution, Budapest, 1212, Hungary|Local Institution, Szentes, 6600, Hungary|Local Institution, Zalaegerszeg-Pozva, 8900, Hungary|Local Institution, Indore, Madhya Pradesh, 452001, India|Local Institution, Hariyana, 132001, India|Local Institution, Mumbai, 400007, India|Local Institution, Pune, 411 030, India|Local Institution, Pune, 411011, India|Local Institution, Pune, 411037, India|Local Institution, Vellore, 632004, India|Local Institution, Ciudad De Mexico, Distrito Federal, 14000, Mexico|Local Institution, Zapopan, Jal., Jalisco, 45150, Mexico|Local Institution, Monterrey, Nuevo Leon, 64060, Mexico|Local Institution, Monterrey, Nuevo Leon, 64240, Mexico|Local Institution, Monterrey, Nuevo Leon, 64710, Mexico|Local Institution, Monterrrey, Nuevo Leon, 64700, Mexico|Local Institution, Aguascalientes, 20127, Mexico|Local Institution, Aguascalientes, 20230, Mexico|Local Institution, Mexico City, 06700, Mexico|Local Institution, Veracruz, 91700, Mexico|Local Institution, Elblag, 82-300, Poland|Local Institution, Gdansk, 80-286, Poland|Local Institution, Krakow, 30-510, Poland|Local Institution, Lodz, 90-153, Poland|Local Institution, Lublin, 20-950, Poland|Local Institution, Sopot, 81-756, Poland|Local Institution, Szczecin, 71-455, Poland|Local Institution, Wroclaw, 50-088, Poland|Local Institution, Zabrze, 41-800, Poland|Local Institution, Kursk, 305035, Russian Federation|Local Institution, Saint-Petersburg, 191015, Russian Federation|Local Institution, Saratov, 410031, Russian Federation|Local Institution, Smolensk, 214018, Russian Federation|Local Institution, St Petersburg, 198013, Russian Federation|Local Institution, St. Petersburg, 194156, Russian Federation|Local Institution, St. Petersburg, 195257, Russian Federation|Local Institution, St.Petersburg, 197022, Russian Federation|Local Institution, Yaroslaval, 150062, Russian Federation|Local Institution, Parktown, Gauteng, 2193, South Africa|Local Institution, Durban, Kwa Zulu Natal, 4001, South Africa|Local Institution, Umhlanga Rocks, Kwa Zulu Natal, 4319, South Africa|Local Institution, Goodwood, Western Cape, 7460, South Africa|Local Institution, Tygerberg, Western Cape, 7505, South Africa|Local Institution, Middlesborough, Cleveland, TS4 3BW, United Kingdom|Local Institution, Salford, Greater Manchester, M6 8HD, United Kingdom|Local Institution, Newcastle Upon Tyne, Tyne And Wear, NE4 6BE, United Kingdom|Local Institution, Birmingham, West Midlands, B9 5SS, United Kingdom|Local Institution, Sheffield, Yorkshire, S5 7AU, United Kingdom
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