| Outcome Measures: |
Primary: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12, Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the three-month average glucose concentration in the blood. Target HbA1c for Type 2 diabetics was less than 7% at the time of this trial. Negative scores show improvement from baseline., Baseline, Week 12 | Secondary: Change From Baseline in Total Cholesterol (TC) at Week 12, 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, Week 12|Change From Baseline in LDL-C at Week 12, LDL-C is known as the "bad" cholesterol, so a lower score (negative change) means improvement., Baseline, Week 12|Change From Baseline in HDL-C at Week 12, HDL-C is known as the "good" cholesterol, so a higher score (positive change) means improvement., Baseline, Week 12|Change From Baseline in Non-HDL-C at Week 12, Non-HDL-C is the measure of "bad" cholesterol in the blood, including triglycerides and LDL-C, so a negative change means improvement. The equation for Non-HDL-C = LDL-C + (triglycerides/5)., Baseline, Week 12|Change From Baseline in Triglycerides at Week 12, Triglycerides are a type of fat found in the blood. The body uses them for energy. Some triglycerides are needed for good health. But high triglycerides might raise the risk of heart disease. Since Type 2 diabetics tend to have high triglycerides, a negative change means improvement., Baseline, Week 12|Change From Baseline in Area-Under-the Curve 0-3 Hours (AUC0-3h) of Plasma Glucose (PG) in Response to the Mixed Meal Tolerance Test (MMTT) at Week 4, The MMTT requires a participant to drink a "mixed meal," such as Boost or Ensure, that contains protein, carbohydrates, and fat. The goal of the test is to find out how much insulin the pancreas makes in response to food by measuring the level of glucose in the blood. The lower the level of glucose in the blood during the first three hours after the test (AUC0-3h), the more insulin the body has made in response to the test. This would mean a negative change shows improvement., Baseline, Week 4|Change From Baseline in AUC0-3h of PG in Response to the MMTT at Week 12, The MMTT requires a participant to drink a "mixed meal," such as Boost or Ensure, that contains protein, carbohydrates, and fat. The goal of the test is to find out how much insulin the pancreas makes in response to food by measuring the level of glucose in the blood. The lower the level of glucose in the blood during the first three hours after the test (AUC0-3h), the more insulin the body has made in response to the test. This would mean a negative change shows improvement., Baseline, Week 12|Change From Baseline in Maximum Concentration (Cmax) of PG in Response to MMTT at Week 4, Cmax measures the highest amount of glucose in the blood, so a negative change means improvement., Baseline, Week 4|Change From Baseline in Cmax of PG in Response to MMTT at Week 12, Cmax measures the highest amount of glucose in the blood, so a negative change means improvement., Baseline, Week 12|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 2, Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement., Baseline, Week 2|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement., Baseline, Week 4|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 8, Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement., Baseline, Week 8|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12, Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement., Baseline, Week 12|Count of Participants With HbA1c Less Than 7.0% at Week 12, HbA1C less than 7% is the success goal for many Type 2 diabetics., Week 12
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| Locations: |
Birmingham, Alabama, 35216, United States|Litchfield Park, Arizona, 85340, United States|Tempe, Arizona, 85282, United States|Anaheim, California, 92801, United States|Chino, California, 91710, United States|Chula Vista, California, 91911, United States|Fresno, California, 93720, United States|Gold River, California, 95670, United States|Greenbrae, California, 94904, United States|San Diego, California, 92103, United States|Colorado Springs, Colorado, 80920, United States|Lakewood, Colorado, 80227, United States|Hallandale Beach, Florida, 33009, United States|Miami, Florida, 33126, United States|Miami, Florida, 33135, United States|Pembroke Pines, Florida, 33026, United States|West Palm Beach, Florida, 33409, United States|Atlanta, Georgia, 30331, United States|Boise, Idaho, 83704, United States|Avon, Indiana, 46123, United States|Evansville, Indiana, 47725, United States|Franklin, Indiana, 46131, United States|Greenfield, Indiana, 46140, United States|Council Bluffs, Iowa, 51503, United States|Troy, Michigan, 48098, United States|Edina, Minnesota, 55435, United States|Washington, Missouri, 63090, United States|Omaha, Nebraska, 68114, United States|Mooresville, North Carolina, 28117, United States|Morgantown, North Carolina, 28655, United States|Winston-Salem, North Carolina, 27103, United States|Columbus, Ohio, 43213, United States|Medford, Oregon, 97504, United States|Charleston, South Carolina, 29407, United States|Charleston, South Carolina, 29425, United States|Greer, South Carolina, 29651, United States|Mount Pleasant, South Carolina, 29464, United States|Spartanburg, South Carolina, 29303, United States|Austin, Texas, 78705, United States|Dallas, Texas, 75231, United States|Houston, Texas, 77036, United States|Plano, Texas, 75024, United States|San Antonio, Texas, 78228, United States|San Antonio, Texas, 78229, United States|Salt Lake City, Utah, 84102, United States|Salt Lake City, Utah, 84121, United States|South Jordan, Utah, 84095, United States|Burke, Virginia, 22015, United States|Victoria, British Columbia, V8V 4A1, Canada|Brampton, Ontario, L6T 0G1, Canada|London, Ontario, N5W 6A2, Canada|Newmarket, Ontario, L3Y 5GB, Canada|Toronto, Ontario, M9V 4B4, Canada|Toronto, Ontario, M9W 4L6, Canada|Mirabel, Quebec, J7J 2K8, Canada|Montreal, Quebec, H4N 2W2, Canada|Sherbrooke, Quebec, J1H 1Z1, Canada|Quebec, G1W 4R4, Canada
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