| Outcome Measures: |
Primary: Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c), The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound)., Baseline and Week 26 | Secondary: Change From Baseline in HbA1c Over Time, The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at 4 week intervals during the study. Least Squares Means were from an Analysis of Covariance (ANCOVA) model with treatment and geographic region as class variables and baseline HbA1c as a covariate., Baseline and Weeks 4, 8, 12, 16 and 20.|Change From Baseline in Fasting Plasma Glucose Over Time, The change from Baseline in fasting plasma glucose was assessed at weeks 1, 2, 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline plasma glucose as a covariate., Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.|Percentage of Participants With Marked Hyperglycemia, Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL. Study week windows are defined to place hyperglycemia into visit categories., Weeks 1, 2, 4, 8, 12, 16, 20 and 26.|Percentage of Participants Meeting Rescue Criteria, Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days after the first sample and analyzed by the central laboratory: 1. After more than 4 weeks of treatment but prior to the Week 8 Visit: a single fasting plasma glucose ≥310 mg/dL (≥17.5 mmol/L); 2. From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose ≥275 mg/dL (≥15.27 mmol/L); 3. From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% and ≤0.5% reduction in HbA1c as compared with the Baseline HbA1c., Weeks 4, 8, 12, 16, 20 and 26.|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5%, Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤6.5%., Week 26|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0%, Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤ 7%., Week 26|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.5%, Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤ 7.5%., Week 26|Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 0.5%, Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 0.5%., Baseline and Week 26|Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.0%, Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 1%., Baseline and Week 26|Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.5%., Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 1.5%., Baseline and Week 26|Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 2.0%, Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 2.0%., Baseline and Week 26|Change From Baseline in Fasting Proinsulin, Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline proinsulin as a covariate., Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Change From Baseline in Insulin, The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline insulin as a covariate., Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Change From Baseline in Proinsulin/Insulin Ratio, The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL) at weeks 4, 8, 12, 16, 20 and 26 relative to the Baseline value. Least squares means were from an ANCOVA model with treatment and geographic region as class variables and Baseline proinsulin/insulin ratio as a covariate., Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Change From Baseline in C-peptide Levels, C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline C-peptide as a covariate., Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance, The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR = fasting plasma insulin (µIU/mL) \* fasting plasma glucose (mmol/L) / 22.5 A higher number indicates a greater degree of insulin resistance. The change from Baseline in HOMA IR was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HOMA IR as a covariate., Baseline and Weeks 12 and 26.|Change From Baseline in Homeostatic Model Assessment Beta Cell Function, The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population. HOMA %B = 20 \* insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5 The change from Baseline in the homeostasis model assessment of beta cell function was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HOMA beta cell function as a covariate., Baseline and Weeks 12 and 26.|Change From Baseline in Body Weight, Change from Baseline in body weight was assessed at Weeks 8, 12, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and Baseline weight as a covariate., Baseline and Weeks 8, 12, 20 and 26.|Change From Baseline in Total Cholesterol Level, Change from Baseline in total cholesterol level was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline total cholesterol as a covariate., Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Change From Baseline in Low-Density Lipoprotein Cholesterol, Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline LDL cholesterol as a covariate., Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Change From Baseline in High-Density Lipoprotein Cholesterol, Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HDL cholesterol as a covariate., Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Change From Baseline in Triglyceride Levels, Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline triglycerides as a covariate., Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Change From Baseline in Free Fatty Acids, Change from Baseline in free fatty acids (FFA) was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline free fatty acid as a covariate., Baseline and Weeks 12 and 26.|Change From Baseline in Plasminogen Activator Inhibitor-1, Change from Baseline in plasminogen activator inhibitor-1 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline plasminogen activator inhibitor-1 as a covariate., Baseline and Weeks 12 and 26.|Change From Baseline in High-sensitivity C-Reactive Protein, Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline hsCRP as a covariate., Baseline and Weeks 12 and 26.|Change From Baseline in Adiponectin, Change from Baseline in adiponectin was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline adiponectin as a covariate., Baseline and Weeks 12 and 26.|Change From Baseline in Apolipoprotein A1, Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and Baseline apolipoprotein A1 as a covariate., Baseline and Weeks 12 and 26.|Change From Baseline in Apolipoprotein A2, Change from Baseline in apolipoprotein A2 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein A2 as a covariate., Baseline and Weeks 12 and 26.|Change From Baseline in Apolipoprotein B, Change from Baseline in apolipoprotein B was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein B as a covariate., Baseline and Weeks 12 and 26.|Change From Baseline in Apolipoprotein C-III, Change from Baseline in apolipoprotein C-III was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein C-III as a covariate., Baseline and Weeks 12 and 26.|Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides, Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline NMR total triglycerides as a covariate., Baseline and Weeks 12 and 26.|Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles, The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL/chylomicron particles as a covariate., Baseline and Weeks 12 and 26.|Change From Baseline in VLDL / Chylomicron Triglycerides, The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL/chylomicron triglycerides as a covariate., Baseline and Weeks 12 and 26.|Change From Baseline in VLDL Particles, The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL particles as a covariate., Baseline and Weeks 12 and 26.|Change From Baseline in Mean VLDL Particle Size, Change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean VLDL particle size as a covariate., Baseline and Weeks 12 and 26.|Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles, The change from Baseline in levels of IDL particles was assessed by NMR fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline IDL particles as a covariate., Baseline and Weeks 12 and 26.|Change From Baseline in Low Density Lipoprotein (LDL) Particles, The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline LDL particles as a covariate., Baseline and Weeks 12 and 26.|Change From Baseline in Mean LDL Particle Size, Change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean LDL particle size as a covariate., Baseline and Weeks 12 and 26.|Change From Baseline in High Density Lipoprotein (HDL) Particles, The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HDL particles as a covariate., Baseline and Weeks 12 and 26.|Change From Baseline in Mean HDL Particle Size, Change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean HDL particle size as a covariate., Baseline and Weeks 12 and 26.
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Columbiana, Alabama, United States|Hueytown, Alabama, United States|Huntsville, Alabama, United States|Northport, Alabama, United States|Tucson, Arizona, United States|Jonesboro, Arkansas, United States|Little Rock, Arkansas, United States|Searcy, Arkansas, United States|Foothill Ranch, California, United States|Irvine, California, United States|Northridge, California, United States|San Diego, California, United States|San Mateo, California, United States|Santa Monica, California, United States|Jacksonville, Florida, United States|Melbourne, Florida, United States|Miami, Florida, United States|Port Charlotte, Florida, United States|Sebastian, Florida, United States|South Miami, Florida, United States|Winter Haven, Florida, United States|Augusta, Georgia, United States|Barnesville, Georgia, United States|Columbus, Georgia, United States|Savannah, Georgia, United States|Chicago, Illinois, United States|Libertyville, Illinois, United States|South Bend, Indiana, United States|Bossier City, Louisiana, United States|Elkton, Maryland, United States|Prince Frederick, Maryland, United States|Towson, Maryland, United States|North Dartmouth, Massachusetts, United States|Bay City, Michigan, United States|Benzonia, Michigan, United States|Portage, Michigan, United States|St Clair Shores, Michigan, United States|Picayune, Mississippi, United States|St Louis, Missouri, United States|Billings, Montana, United States|Las Vegas, Nevada, United States|Elizabeth, New Jersey, United States|Hamilton, New Jersey, United States|Cicero, New York, United States|Charlotte, North Carolina, United States|Mooresville, North Carolina, United States|Northeast, North Dakota, United States|Franklin, Ohio, United States|Ashland, Oregon, United States|Altoona, Pennsylvania, United States|Fleetwood, Pennsylvania, United States|Harleysville, Pennsylvania, United States|Havertown, Pennsylvania, United States|Norristown, Pennsylvania, United States|Northern Cambria, Pennsylvania, United States|Penndel, Pennsylvania, United States|Philadelphia, Pennsylvania, United States|Charleston, South Carolina, United States|Florence, South Carolina, United States|Orangeburg, South Carolina, United States|Taylors, South Carolina, United States|Williamston, South Carolina, United States|Morristown, Tennessee, United States|Arlington, Texas, United States|Colleyville, Texas, United States|Conroe, Texas, United States|Corpus Christi, Texas, United States|Dallas, Texas, United States|Euless, Texas, United States|Fort Worth, Texas, United States|Garland, Texas, United States|Houston, Texas, United States|Katy, Texas, United States|San Antonio, Texas, United States|Seguin, Texas, United States|Sugarland, Texas, United States|Tomball, Texas, United States|Ogden, Utah, United States|Arlington, Virginia, United States|Norfolk, Virginia, United States|Richmond, Virginia, United States|Lewisburg, West Virginia, United States|Milwaukee, Wisconsin, United States|Cap. Fed., Buenos Aires, Argentina|Chacabuco, Buenos Aires, Argentina|La Plata, Buenos Aires, Argentina|Mar del Plata, Buenos Aires, Argentina|Morón, Buenos Aires, Argentina|Córdoba, Argentina|Kingswood, New South Wales, Australia|Fitzroy, Victoria, Australia|Frankston, Victoria, Australia|Fortaleza, CE, Brazil|Goiás, GO, Brazil|Belém, PA, Brazil|Curitiba, PR, Brazil|Maringá, RP, Brazil|Marília, SP, Brazil|Mogi das Cruzes, SP, Brazil|Pleven, Bulgaria|Santiago, Chile|Slavonski Brod, Croatia|Pärnu, Estonia|Guatemala, Guatemala|Budapest, Hungary|Eger, Hungary|Gyula, Hungary|Mako, Hungary|Nyiregyhaza, Hungary|Pecs, Hungary|Hyderabad, Andhra Pradesh, India|Bangalore, Karnataka, India|Aurangabad, Maharashtra, India|Mumbai, Maharashtra, India|Nagpur, Maharashtra, India|Chennai, Tamil Nadu, India|Hadera, Israel|Haifa, Israel|Holon, Israel|Jaffa Tel Aviv, Israel|Jerusalem, Israel|Nahariya, Israel|Riga, Latvia|Kaunas, Lithuania|Kedainiai, Lithuania|Aguascalientes, Mexico|Mexico City, Mexico|Monterrey, Mexico|Christchurch, New Zealand|Hamilton, New Zealand|Bialystok, Poland|Bytom, Poland|Gdansk, Poland|Gniewkowo, Poland|Kamieniec Zabkowicki, Poland|Krakow, Poland|Leczyca, Poland|Brasov, Romania|Bucharest, Romania|Galati, Romania|Ekaterinburg, Russian Federation|Kazan, Russian Federation|Moscow, Russian Federation|Belgrade, Serbia|Kragujevac, Serbia|Nis, Serbia|Interna klinika II, Nitra, Slovakia|Banska Bysterica, Slovakia|Lucenec, Slovakia|Riverside, Slovakia|Sahy, Slovakia|Port Elizabeth, Eastern Cape, South Africa|Johannesburg, Gauteng, South Africa|Durban, Kwa-Zulu Natal, South Africa|East Lynne, Pretoria, South Africa|Bellville, Western Province, South Africa|Cape Town, Western Province, South Africa|Dnipropetrovsk, Ukraine|Kharkiv, Ukraine|Lviv, Ukraine|Odesa, Ukraine
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