| Outcome Measures: |
Primary: Change From Baseline in HbA1c at Week 80, Blood was taken for serum HbA1c measurements. Change from baseline was calculated as the Week 80 value minus the baseline value. Last observation carried forward (LOCF) was not used for this analysis., Baseline and Week 80 | Secondary: Mean Change From Baseline in HbA1c at Week 80, Blood was taken for serum Hb1AC measurements. Change from baseline was calculated as the Week 80 value minus the baseline value, with LOCF from Week 32 for withdrawn participants or missing values., Baseline and Week 80|Number of Participants Achieving HbA1c <=6.5% and <7% at Week 80, Blood was taken for serum Hb1AC measurements. Hb1AC responders were described as participants having achieved Hb1AC \<=6% and \<7% at Week 80 with LOCF from Week 32., Week 80|Change in Fasting Plasma Glucose (FPG) From Baseline at Week 80, Blood was taken for serum FPG measurements. Change from baseline was calculated as the Week 80 value minus the baseline value., Baseline and Week 80|Change From Baseline in FPG at Week 80, Blood was taken for serum FPG measurements. Change from baseline was calculated as the Week 80 value minus the baseline value with LOCF from Week 32 for withdrawn participants or missing values., Baseline and Week 80|Number of Participants Achieving FPG <=6 mmol/L (110 mg/dL) and <=7 mmol/L (126 mg/dL) at Week 80, Blood was taken for serum FPG measurements. FPG responders were described as participants having achieved FPG \<=6 mmol/L (110 mg/dL) and \<7 mmol/L (126 mg/dL) Hb1AC at Week 80 with LOCF from Week 32., Week 80|Number of Participants Achieving Treatment Failure, Treatment failure was defined as an HbA1c level \>= 7% after Week 32 or withdrawal due to insufficient therapeutic effect (ITE) at any time., Randomization to treatment failure (up to Week 80)|Percent Change From Baseline in Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Triglycerides at Week 80, Blood was taken for measurement of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. Percent change from baseline at Week 80 was based on log transformed data. Geometric mean, GM; standard error, SE. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest., Baseline and Week 80|Percent Change From Baseline in Adiponectin at Week 80 (United States [US] and Mexico Subset of Participants ), Blood was taken for measurement of adiponectin. Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only., Baseline and Week 80|Percent Change From Baseline in C-reactive Protein (CRP) at Week 80 (US and Mexico Subset of Participants), Blood was taken for measurement of CRP. Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only., Baseline and Week 80|Percent Change in Free Fatty Acids (FFA) From Baseline at Week 80 (US and Mexico Subset of Participants)., Blood was taken for measurement of FFA. Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only., Baseline and Week 80|Change in Fasting Insulin From Baseline at Week 80 (US and Mexico Subset of Participants), Blood was taken for fasting insulin measurements. Change from baseline was calculated as the Week 80 value minus the baseline value, with LOCF from Week 32 for withdrawn participants or missing values. This outcome measure was analyzed for a subset of participants in the US and Mexico only., Baseline and Week 80|Change in C-peptide From Baseline at Week 80 (US and Mexico Subset of Participants), Blood was taken for C-peptide measurements. Change from baseline was calculated as the Week 80 value minus the baseline value with LOCF from Week 32 for withdrawn participants or missing values. This outcome measure was analyzed for a subset of participants in the US and Mexico only., Baseline and Week 80|Percent Change From Baseline in in HOMA-S and HOMA-B to Week 80 (US and Mexico Subset of Participants), Blood was taken for measurement of homeostasis model assessment for insulin sensitivity (HOMA-S) and beta-cell function (HOMA-B). Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only. GM, geometric mean; SE, standard error., Baseline and Week 80|Slope of Delta-cell Function as Estimated by the Ratio deltaI/deltaG, The ratio Delta I/Delta G is calculated based on the oral glucose tolerance test (OGTT), where Delta I = (30 minute immunoreactive insulin minus 0 minute immunoreactive insulin) and Delta G = (30 minute plasma glucose minus 0 minute plasma glucose). The 0 minute values are fasting insulin and glucose; the 30 minute values are taken 30 minutes after the oral glucose challenge. This outcome measure was analyzed for a subset of participants in the US and Mexico only., Baseline and Week 80|Number of Participants at Final Dose Level, Baseline to Week 80 or withdrawal|Percent Change From Baseline in Lumbar Spine Bone Mass Density (BMD) at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants), BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100%. This outcome measure was analyzed for a subset of participants in the bone study only., Baseline and Weeks 20, 56, and 80|Percent Change From Baseline in Total Hip BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants), BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only., Baseline and Weeks 20, 56, and 80|Percent Change From Baseline in Trochanter BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants), BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only., Baseline and Weeks 20, 56, and 80|Percent Change From Baseline in Femoral Neck BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants), BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only., Baseline and Weeks 20, 56, and 80|Percent Change From Baseline in Distal Radius BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants), BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only., Baseline and Weeks 20, 56, and 80|Percent Change From Baseline in Total Body BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants), BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only., Baseline and Weeks 20, 56, and 80|Percent Change From Baseline in Serum Calcium at Weeks 12, 32, 56, and 80, Blood was taken for measurement of serum calcium. Percent change from baseline was based on log transformed data. Geometric mean, GM; standard error, SE. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest., Baseline and Weeks 12, 32, 56, and 80|Percent Change From Baseline in Intact Parathyroid Hormone at Week 80, Blood was taken for measurement of intact parathyroid hormone. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest., Baseline and Week 80|Percent Change From Baseline in 25-hydroxy Vitamin D at Week 80, Blood was taken for measurement of 25-hydroxy vitamin D. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest., Baseline and Week 80|Percent Change From Baseline in Estradiol at Weeks 20, 56, and 80, Blood was taken for measurement of estradiol. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of female participants in the bone study only. n is the number of evaluable participants, which is the number of female participants with a value at baseline and at the specified visit for the parameter of interest., Baseline and Weeks 20, 56, and 80|Percent Change From Baseline in C-terminal Telopeptide (CTX) at Weeks 20, 56, and 80, Blood was taken for measurement of CTX. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest., Baseline and Weeks 20, 56, and 80|Percent Change From Baseline in Procollagen Type-1 N-propeptide (P1NP) at Weeks 20, 56, and 80, Blood was taken for measurement of P1NP. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest., Baseline and Weeks 20, 56, and 80|Percent Change From Baseline in Bone Alkaline Phosphatase (BSAP) at Weeks 20, 56, and 80, Blood was taken for measurement of BSAP. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest., Baseline and Weeks 20, 56, and 80
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| Locations: |
GSK Investigational Site, Tuscaloosa, Alabama, 35406, United States|GSK Investigational Site, Gilbert, Arizona, 85296, United States|GSK Investigational Site, Glendale, Arizona, 85308, United States|GSK Investigational Site, Phoenix, Arizona, 85020, United States|GSK Investigational Site, Tucson, Arizona, 85712, United States|GSK Investigational Site, Tucson, Arizona, 85745, United States|GSK Investigational Site, Alhambra, California, 91801, United States|GSK Investigational Site, Artesia, California, 90701, United States|GSK Investigational Site, Greenbrae, California, 94904, United States|GSK Investigational Site, Roseville, California, 95661, United States|GSK Investigational Site, Sacramento, California, 95825, United States|GSK Investigational Site, Wheat Ridge, Colorado, 80033, United States|GSK Investigational Site, Hialeah, Florida, 33013, United States|GSK Investigational Site, Ocala, Florida, 34471, United States|GSK Investigational Site, Kahului, Hawaii, 96732, United States|GSK Investigational Site, Peoria, Illinois, 61615, United States|GSK Investigational Site, Avon, Indiana, 46123, United States|GSK Investigational Site, Evansville, Indiana, 47710, United States|GSK Investigational Site, Evansville, Indiana, 47712, United States|GSK Investigational Site, Indianapolis, Indiana, 46254, United States|GSK Investigational Site, Waterloo, Iowa, 50702, United States|GSK Investigational Site, Slidell, Louisiana, 70461, United States|GSK Investigational Site, Sunset, Louisiana, 70584, United States|GSK Investigational Site, Elkridge, Maryland, 21075, United States|GSK Investigational Site, Chaska, Minnesota, 55318, United States|GSK Investigational Site, Minneapolis, Minnesota, 55407-3799, United States|GSK Investigational Site, Excelsior Springs, Missouri, 64024, United States|GSK Investigational Site, St. Louis, Missouri, 63110, United States|GSK Investigational Site, St. Louis, Missouri, 63128, United States|GSK Investigational Site, St. Peters, Missouri, 63376, United States|GSK Investigational Site, Billings, Montana, 59102, United States|GSK Investigational Site, Las Vegas, Nevada, 89016, United States|GSK Investigational Site, Pahrump, Nevada, 89048, United States|GSK Investigational Site, Hamilton, New Jersey, 08690, United States|GSK Investigational Site, Albuquerque, New Mexico, 87102, United States|GSK Investigational Site, East Syracuse, New York, 13057, United States|GSK Investigational Site, Flushing, New York, 11355, United States|GSK Investigational Site, Kingston, New York, 12401, United States|GSK Investigational Site, Huntersville, North Carolina, 28078, United States|GSK Investigational Site, Canal Fulton, Ohio, 44614, United States|GSK Investigational Site, Canton, Ohio, 44718, United States|GSK Investigational Site, Cleveland, Ohio, 44195, United States|GSK Investigational Site, Columbus, Ohio, 43210, United States|GSK Investigational Site, Kettering, Ohio, 45429, United States|GSK Investigational Site, Mogadore, Ohio, 44260, United States|GSK Investigational Site, Wandsworth, Ohio, 44281, United States|GSK Investigational Site, Oregon City, Oregon, 97045, United States|GSK Investigational Site, Beaver, Pennsylvania, 15009, United States|GSK Investigational Site, Clairton, Pennsylvania, 15205, United States|GSK Investigational Site, Coatsville, Pennsylvania, 19320, United States|GSK Investigational Site, Erie, Pennsylvania, 16508, United States|GSK Investigational Site, Sewickley, Pennsylvania, 15143, United States|GSK Investigational Site, West Chester, Pennsylvania, 19382, United States|GSK Investigational Site, Clinton, South Carolina, 29325, United States|GSK Investigational Site, Columbia, South Carolina, 29201, United States|GSK Investigational Site, Pelzer, South Carolina, 29669, United States|GSK Investigational Site, Kingsport, Tennessee, 37660, United States|GSK Investigational Site, Corpus Christi, Texas, 78404, United States|GSK Investigational Site, Dallas, Texas, 75235, United States|GSK Investigational Site, Georgetown, Texas, 78626, United States|GSK Investigational Site, South Burlington, Vermont, 05403, United States|GSK Investigational Site, Burke, Virginia, 22015, United States|GSK Investigational Site, Manassas, Virginia, 20110, United States|GSK Investigational Site, Salem, Virginia, 24153, United States|GSK Investigational Site, Gig Harbor, Washington, 98335, United States|GSK Investigational Site, Graham, Washington, 98338, United States|GSK Investigational Site, Olympia, Washington, 98506, United States|GSK Investigational Site, Tacoma, Washington, 98405, United States|GSK Investigational Site, Vancouver, Washington, 98664, United States|GSK Investigational Site, Wenatchee, Washington, 98801, United States|GSK Investigational Site, Wauwatosa, Wisconsin, 53228, United States|GSK Investigational Site, Buenos Aries, Buenos Aires, C1425AWC, Argentina|GSK Investigational Site, Capital Federal, Buenos Aires, C1416DRJ, Argentina|GSK Investigational Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, B1704ETD, Argentina|GSK Investigational Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, C1155ADP, Argentina|GSK Investigational Site, Cordoba, Córdova, 5000, Argentina|GSK Investigational Site, Buenos Aires, 1425, Argentina|GSK Investigational Site, Ciudad Autónoma de Buenos Aires, C1117ABH, Argentina|GSK Investigational Site, Mendoza, 5500, Argentina|GSK Investigational Site, Fortaleza, Ceará, 60120-021, Brazil|GSK Investigational Site, Goiânia, Goiás, 74110-010, Brazil|GSK Investigational Site, Porto Alegre, Rio Grande Do Sul, 90035-170, Brazil|GSK Investigational Site, Campinas, São Paulo, 13073-350, Brazil|GSK Investigational Site, Brasília, 71625-009, Brazil|GSK Investigational Site, São Paulo, 01323-001, Brazil|GSK Investigational Site, Coquitlam, British Columbia, V3K 3P4, Canada|GSK Investigational Site, Bathurst, New Brunswick, E2A 4X7, Canada|GSK Investigational Site, Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada|GSK Investigational Site, St. John's, Newfoundland and Labrador, A1E 2C2, Canada|GSK Investigational Site, Brampton, Ontario, L6T 3T1, Canada|GSK Investigational Site, Smiths Falls, Ontario, K7A 4W8, Canada|GSK Investigational Site, Toronto, Ontario, M9W 4L6, Canada|GSK Investigational Site, Gatineau, Quebec, J8Y 6S8, Canada|GSK Investigational Site, Sherbrooke, Quebec, J1H 4J6, Canada|GSK Investigational Site, Gwangju, 501-757, Korea, Republic of|GSK Investigational Site, Seoul, 110-749, Korea, Republic of|GSK Investigational Site, Seoul, 139-872, Korea, Republic of|GSK Investigational Site, Seoul, 152-703, Korea, Republic of|GSK Investigational Site, Suwon, Kyonggi-do, 443-721, Korea, Republic of|GSK Investigational Site, Uijeongbu-si, Kyonggi-do, 480-130, Korea, Republic of|GSK Investigational Site, Tijuana, Baja California Norte, 22320, Mexico|GSK Investigational Site, Pachuca, Hidalgo, 42039, Mexico|GSK Investigational Site, Monterrey, Nuevo León, 64460, Mexico|GSK Investigational Site, Durango, 34070, Mexico|GSK Investigational Site, Karachi, 74800, Pakistan|GSK Investigational Site, Lahore, 54000, Pakistan|GSK Investigational Site, Cebu City, 6000, Philippines|GSK Investigational Site, Manila, 1000, Philippines|GSK Investigational Site, Manila, 1008, Philippines|GSK Investigational Site, Marikina City, 1810, Philippines|GSK Investigational Site, Quezon City, 1108, Philippines|GSK Investigational Site, Changhua, 500, Taiwan|GSK Investigational Site, Kaohsiung, 833, Taiwan|GSK Investigational Site, Taichung, 404, Taiwan|GSK Investigational Site, Taipei, 114, Taiwan|GSK Investigational Site, Taoyuan Hsien, 333, Taiwan
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