| Outcome Measures: |
Primary: Hemoglobin A1c at Baseline and Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, Percentage of hemoglobin A1c (HbA1c) levels are reported., Baseline up to week 26 post-dose|Change in Hemoglobin A1c From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, Percent change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement., Baseline up to 26 weeks post-dose | Secondary: Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, Normal fasting plasma glucose (FPG) levels are being reported. Normal FPG levels range from 70-110 mg/dL. Lower FPG values indicates better clinical outcome, ie. improvement in FPG., Baseline up to week 26 post-dose|Change in Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, The change in normal fasting plasma glucose (FPG) levels are being reported. A greater (negative) change from baseline indicates an improvement in FPG., Baseline up to 26 weeks post-dose|Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, Homeostasis Model Assessment index for Insulin Resistance (HOMA-IR) was calculated as: (fasting insulin concentration \[μU/mL\] x fasting glucose concentration \[mmol/L\])/22.5 Low HOMA-IR scores indicate high insulin sensitivity, whereas high HOMA-IR scores indicate low insulin sensitivity (insulin resistance). A normal HOMA-IR score is \<2.60, HOMA-IR scores 2.60-3.80 are considered "borderline high", and HOMA-IR scores \>3.80 are considered "high" and have correlations of insulin resistance. High HOMA-IR scores indicate worse outcome., Baseline up to week 26 post-dose|Change in Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, The change in the Homeostasis Model Assessment index for Insulin Resistance (HOMA-IR) was calculated as: (fasting insulin concentration \[μU/mL\] x fasting glucose concentration \[mmol/L\])/22.5 Low HOMA-IR scores indicate high insulin sensitivity, whereas high HOMA-IR scores indicate low insulin sensitivity (insulin resistance). A normal HOMA-IR score is \<2.60, HOMA-IR scores 2.60-3.80 are considered "borderline high", and HOMA-IR scores \>3.80 are considered "high" and have correlations of insulin resistance. A negative HOMA-IR score indicates an improvement in insulin sensitivity., Baseline up to 26 weeks post-dose|Total Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol., Baseline up to week 26 post-dose|Percent Change in Total Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol. Higher percent change in total cholesterol indicates better outcome, ie. improvement., Baseline up to 26 weeks post-dose|Total Triglycerides At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. Normal triglyceride levels are below 150 mg/dL., Baseline up to Week 26 post-dose|Percent Change in Total Triglycerides From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. A negative change means better outcome, ie. improvement., Baseline up to 26 weeks post-dose|Low-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, Low-density lipoprotein cholesterol (LDL-C), "bad" cholesterol, is a measure of the total amount of low-density lipoprotein cholesterol in the blood. Normal LDL levels are \<100 mg/dL., Baseline up to Week 26 post-dose|Percent Change in Low-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, Low-density lipoprotein cholesterol (LDL-C), "bad" cholesterol, is a measure of the total amount of low-density lipoprotein cholesterol in the blood. A higher percent change indicates improvement., Baseline up to 26 weeks post-dose|High-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, High-density lipoprotein cholesterol (HDL-C), "good" cholesterol, is a measure of the total amount of high-density lipoprotein cholesterol in the blood. Normal HDL levels are \>40 mg/dL., Baseline to Week 26 post-dose|Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, High-density lipoprotein cholesterol (HDL-C), "good" cholesterol, is a measure of the total amount of high-density lipoprotein cholesterol in the blood. A higher percent change indicates improvement., Baseline to 26 weeks post-dose|Apolipoprotein A-I At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, Apolipoprotein (Apo) A-I levels, a measure of the total amount of Apolipoprotein (Apo) A-I in the blood, are being reported. Normal Apo A-1 levels range from 120-140 mg/dL., Baseline to Week 26 post-dose|Percent Change in Apolipoprotein A-I From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, Apolipoprotein (Apo) A-I is a measure of the total amount of Apolipoprotein (Apo) A-I in the blood. Decreased ApoA-1 levels are associated with poor clinical outcome. A lower percent change in ApoA-1 levels indicates an improvement in clinical outcome., Baseline up to 26 weeks post-dose|Apolipoprotein B At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, Apolipoprotein (Apo) B, a measure of the total amount of Apo B in the blood, is being reported. Normal Apo B levels are \<100 mg/dL., Baseline to Week 26 post-dose|Percent Change in Apolipoprotein B From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, Apolipoprotein (Apo) B, a measure of the total amount of Apo B in the blood, is being reported. A greater (negative) percent change in ApoB levels indicated an improvement in clinical outcome., Baseline up to 26 weeks post-dose|Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, Percentage of hemoglobin A1c (HbA1c) levels are reported., Baseline up to Week 52 post-dose|Change in Hemoglobin A1c From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, Change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement., Baseline up to 52 weeks post-dose|Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, Normal fasting plasma glucose (FPG) levels are being reported. Normal FPG levels range from 70-110 mg/dL. Lower FPG values indicates better clinical outcome, ie. improvement in FPG., Baseline up to Week 52 post-dose|Change in Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, The change in normal fasting plasma glucose (FPG) levels are being reported. A greater (negative) change from baseline indicates an improvement in FPG., Baseline up to 52 weeks post-dose|Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus, Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of double-blind study medication, and ongoing AEs that started prior to the first dose of double-blind study medication and increased in severity on or after the first dose of double-blind study medication., Week -2 up to Week 52 post-dose
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| Locations: |
Anniston, Alabama, United States|Birmingham, Alabama, United States|Hoover, Alabama, United States|Muscle Shoals, Alabama, United States|Hot Springs, Arkansas, United States|Jonesboro, Arkansas, United States|Little Rock, Arkansas, United States|Buena Park, California, United States|Garden Grove, California, United States|Huntington Park, California, United States|Los Angeles, California, United States|Paramount, California, United States|Sacramento, California, United States|San Diego, California, United States|Walnut Creek, California, United States|West Covina, California, United States|West Hills, California, United States|Denver, Colorado, United States|Delray Beach, Florida, United States|Jacksonville, Florida, United States|Merritt Island, Florida, United States|Miami, Florida, United States|Pembroke Pines, Florida, United States|Tampa, Florida, United States|Honolulu, Hawaii, United States|Boise, Idaho, United States|Chicago, Illinois, United States|Evansville, Indiana, United States|Indianapolis, Indiana, United States|Wichita, Kansas, United States|Madisonville, Kentucky, United States|New Orleans, Louisiana, United States|Slidell, Louisiana, United States|Springfield, Massachusetts, United States|Portage, Michigan, United States|Southfield, Michigan, United States|Saint Louis, Missouri, United States|Voorhees, New Jersey, United States|Syracuse, New York, United States|Morehead City, North Carolina, United States|Salisbury, North Carolina, United States|Statesville, North Carolina, United States|Winston-Salem, North Carolina, United States|Cincinnati, Ohio, United States|Cleveland, Ohio, United States|Delaware, Ohio, United States|Lyndhurst, Ohio, United States|Marion, Ohio, United States|Oklahoma City, Oklahoma, United States|Tulsa, Oklahoma, United States|Portland, Oregon, United States|Beaver, Pennsylvania, United States|Philadelphia, Pennsylvania, United States|Charleston, South Carolina, United States|Columbia, South Carolina, United States|Cleveland, Tennessee, United States|Kingsport, Tennessee, United States|New Tazewell, Tennessee, United States|Carrollton, Texas, United States|Conroe, Texas, United States|Corpus Christi, Texas, United States|Dallas, Texas, United States|El Paso, Texas, United States|Garland, Texas, United States|Irving, Texas, United States|Midland, Texas, United States|San Antonio, Texas, United States|Richmond, Virginia, United States|Olympia, Washington, United States|Milwaukee, Wisconsin, United States|Loma Verde, Buenos Aires, Argentina|Zarate, Buenos Aires, Argentina|San Vicente, Cordoba, Argentina|Feldkirch, Austria|Graz, Austria|Wien, Austria|Santiago, Providencia, Chile|Santiago, Chile|Temuco, Chile|Horní Město, Czechia|Karlovy Vary, Czechia|Prague, Czechia|Praha, Czechia|Usti nad Labem, Czechia|Vysoký Les, Czechia|Zlin, Czechia|Znojmo, Czechia|Aschaffenburg, Germany|Augsburg, Germany|Bad Oeynhausen, Germany|Berlin, Germany|Bosenheim, Germany|Dortmund, Germany|Dresden, Germany|Friedrichsthal, Germany|Giessen, Germany|Halle, Germany|Hamburg, Germany|Kippenheim, Germany|Mainz, Germany|Rehlingen, Germany|Riesa, Germany|Saarbrucken, Germany|Saarlouis, Germany|Siegen, Germany|Wiesbaden, Germany|Balatonfured, Hungary|Bekescsaba, Hungary|Budapest, Hungary|Debrecen, Hungary|Eger, Hungary|Gyula, Hungary|Kaposvar, Hungary|Szentes, Hungary|Hyderabad, Andhra Pradesh, India|Vijayawada, Andhra Pradesh, India|Visakhapatnam, Andhra Pradesh, India|Vasanth Nagar, Bangalore, India|Mylapore, Chennai, India|Shastri Nagar, Ghaziabad, India|Ahmedabad, Gujarat, India|Gandhinagar, Gujarat, India|Karnal, Haryana, India|Sarwa C., Jaipur, India|Bangalore, Karnataka, India|Belgaum, Karnataka, India|Mangalore, Karnataka, India|Kochi, Kerala, India|Indore, Madhya Pradesh, India|Mumbai, Maharashtra, India|Dhantoli, Nagpur, India|Ramdaspeth, Nagpur, India|Jaipur, Rajasthan, India|Coimbatore, Tamil Nadu, India|Aligarh, Uttar Pradesh, India|Daugavpils, Latvia|Kuldiga, Latvia|Liepaja, Latvia|Riga, Latvia|Cuernavaca, Morelos, Mexico|Monterrey, Nuevo Leon, Mexico|Metepec, Toluca, Mexico|Merida, Yucatan, Mexico|Aguascalientes, Mexico|Durango, Mexico|Puebla, Mexico|La Victoria, Lima, Peru|Magdalena del Mar, Lima, Peru|San Juan de Miraflores, Lima, Peru|San Martin de Porres, Lima, Peru|Monterrico, Sucro Lima, Peru|Lima, Peru|Rio Piedras, Puerto Rico|San Juan, Puerto Rico|Villa Fontana, 00983, Puerto Rico|Arad, Romania|Brasov, Romania|Bucharest, Romania|Satu Mare, Romania|Targu Mures, Romania|Belgrade, Serbia|Kragujevac, Serbia|Nis, Serbia|Subotica, Serbia|Zemun, Serbia|Bratislava, Slovakia|Lucenec, Slovakia|Moldava nad Bodvou, Slovakia|Nove Mesto nad Vahom, Slovakia|Považská Bystrica, Slovakia|Zilina, Slovakia|Johannesburg, South Africa|Port Elizabeth, South Africa|Dnipropetrovs'k, Ukraine|Kharkov, Ukraine|Kiev, Ukraine|Lviv, Ukraine|Simferopol, Ukraine|Edmonton, London, United Kingdom|Sunbury, Middlesex, United Kingdom|Addlestone, Surrey, United Kingdom|Wakefield, West Yorks, United Kingdom|Swindon, Wiltshire, United Kingdom|Chippenham, United Kingdom
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