| Outcome Measures: |
Primary: Co-primary: Body Weight- Mean Percent Change, Baseline, 56 weeks|Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease, Baseline, 56 weeks | Secondary: Change in HbA1c Levels, Baseline, 56 weeks|Change in Fasting Triglycerides Levels, Using Log-transformed Data, Baseline, 56 weeks|Change in Fasting HDL Cholesterol Levels, Baseline, 56 weeks|Change in Fasting Blood Glucose Levels, Baseline, 56 weeks|Change in Waist Circumference, Baseline, 56 weeks|Body Weight- Proportion of Subjects With ≥10% Decrease, Baseline, 56 weeks|HbA1c- Proportion of Subjects With HbA1c <7% at Endpoint, Baseline, 56 weeks|Percent of Subjects Requiring Rescue Medications for Diabetes, Baseline, 56 weeks|Percent of Subjects With Dose Reduction in Oral Antidiabetes Medications, Baseline, 56 weeks|Percent of Subjects With Dose Increase in Oral Antidiabetes Medications, Baseline, 56 weeks|Change in HOMA-IR Levels, Using Log-transformed Data, HOMA-IR= Homeostasis Model Assessment-Insulin Resistance, Baseline, 56 weeks|Change in Fasting Insulin Levels, Using Log-transformed Data, Baseline, 56 weeks|HbA1c- Proportion of Subjects With HbA1c <6.5% at Endpoint, Baseline, 56 weeks|Change in IWQOL-Lite Total Scores, IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment, Baseline, 56 weeks|Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data, Baseline, 56 weeks|Percent of Subjects Discontinuing Due to Poor Glycemic Control, Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed. Odds ratio not calculated as there were no subjects in the NB32 group that discontinued due to poor glycemic control., Baseline, 56 weeks|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire, Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult, Baseline, 56 weeks|Change in Fasting LDL Cholesterol Levels, Baseline, 56 weeks|Change in Systolic Blood Pressure, Baseline, 56 weeks|Change in Diastolic Blood Pressure, Baseline, 56 weeks|Change in IDS-SR Total Scores, IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression., Baseline, 56 weeks|Change in Food Craving Inventory Sweets Subscale Score, The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome)., Baseline, 56 weeks|Change in Food Craving Inventory Carbohydrates Subscale Score, The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome)., Baseline, 56 weeks
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| Locations: |
SelfCenter, PC, Fairhope, Alabama, 36532, United States|Pivotal Research Centers, Peoria, Arizona, 85381, United States|HOPE Research Institute, Phoenix, Arizona, 85050, United States|HealthStar Research, Hot Springs, Arkansas, 71913, United States|Impact Clinical Trials, Beverly Hills, California, 90211, United States|Northern California Research, Carmichael, California, 98608, United States|Sierra Medical Research, Fresno, California, 93710, United States|Advance Clinical Research Institute, Orange, California, 92869, United States|Affiliated Research Institute, San Diego, California, 92108, United States|VA San Diego Healthcare System, San Diego, California, 92161, United States|Apex Research Institue, Santa Ana, California, 92705, United States|Chase Medical Research, LLC, Waterbury, Connecticut, 06708, United States|LCFP Inc., Fort Myers, Florida, 33907, United States|Miami Research Associates, Miami, Florida, 33143, United States|Suncoast Clinical Research, Palm Harbor, Florida, 34684, United States|University Clinical Research, Pembroke Pines, Florida, 33024, United States|CSRA Partners in Health, Inc, Augusta, Georgia, 30909, United States|East-West Medical Research Institute, Honolulu, Hawaii, 96814, United States|Deaconess Clinic, Evansville, Indiana, 47713, United States|Northwest Indiana Center for Clinical Research, Valparaiso, Indiana, 46383, United States|Central Kentucky Research Associates, Inc., Lexington, Kentucky, 40509, United States|L-Marc, Louisville, Kentucky, 40213, United States|Trover Center for Clinical Studies, Madisonville, Kentucky, 42431, United States|Pennington Biomedical Research Center, Baton Rouge, Louisiana, 70808, United States|Medical Research Institute, Slidell, Louisiana, 70458, United States|Health Trends Research, LLC, Baltimore, Maryland, 21209, United States|FutureCare Studies, Springfield, Massachusetts, 01103, United States|Twin Cities Clinical Research, Brooklyn Center, Minnesota, 55430, United States|The Center for Pharmaceutical Research, Kansas City, Missouri, 64114, United States|Mercy Health Research, St. Louis, Missouri, 63141, United States|Radiant Research, Inc., St. Louis, Missouri, 63141, United States|Center for Nutrition and Metabolic Diseases, Univ. of Nevada, Reno, Nevada, 89557, United States|Endocrinology & Diabetes Consultants, Dover, New Hampshire, 03820, United States|Lovelace Scientific Resources, Albuquerque, New Mexico, 87108, United States|Diabetes care and Information Center, Flushing, New York, 11365, United States|Central New York Clinical Research, Manlius, New York, 13104, United States|Rochester Clinical Research, Inc, Rochester, New York, 14609, United States|Metrolina Medical Research, Charlotte, North Carolina, 28209, United States|Rapid Medical Research, Inc., Cleveland, Ohio, 44122, United States|Central Ohio Nutrition Center, Inc., Columbus, Ohio, 43213, United States|Wells Institute for Health Awareness, Kettering, Ohio, 45429, United States|Your Diabetes Endocrine and Nutrition Group, Mentor, Ohio, 44060, United States|Mountain View Clinical Research, Greer, South Carolina, 29349, United States|Palmetto Medical Research, Mt. Pleasant, South Carolina, 29464, United States|ClinSearch, Chattanooga, Tennessee, 37404, United States|Clinical Research Associates, Inc., Nashville, Tennessee, 37203, United States|The Cooper Institute, Dallas, Texas, 75230, United States|Baylor Endocrine Center, Dallas, Texas, 75246, United States|Diabetes Center of the Southwest, Midland, Texas, 79705, United States|InVisions Consultants, LLC, San Antonio, Texas, 78217, United States|Diabetes & Glandular Disease Research Associates, Inc., San Antonio, Texas, 78229-4801, United States|Summit Research Network, Inc., Seattle, Washington, 98104, United States|Northside Internal Medicine, Spokane, Washington, 99208, United States
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