| Outcome Measures: |
Primary: Change in Glycated Haemoglobin (HbA1c), Measured in percentage (%)- points., From baseline (week 0) to end of treatment (week 40) | Secondary: Relative Change in Body Weight, Measured in percentage (%)., From baseline (week 0) to end of treatment (week 40)|Number of Participants Who Achieve Greater than or Equal to (≥) 10% Body Weight Reduction, Measured as count of participants., From baseline (week 0) to end of treatment (week 40)|Number of Participants Who Achieve ≥15% Body Weight Reduction, Measured as count of participants., From baseline (week 0) to end of treatment (week 40)|Number of Participants Who Achieve HbA1c Target Values of Less than (<) 7.0% (<53 millimole per mole [mmol/mol]), Measured as count of participants., At end of treatment (week 40)|Number of Participants Who Achieve HbA1c Target Values of Less than or Equal to (≤) 6.5% (≤48 mmol/mol), Measured as count of participants., At end of treatment (week 40)|Change in Fasting Plasma Glucose (FPG), Measured as millimole per liter (mmol/L)., From baseline (week 0) to end of treatment (week 40)|Change in Insulin Dose, Measured in units (u)., From baseline (week 0) to end of treatment (week 40)|Number of Participants Who Achieve Insulin Dose Equal to (=) 0 Units, Measured as count of participants., At end of treatment (week 40)|Change in 7-point Self-measured Plasma Glucose (SMPG) Profiles: Mean 7-point profile and Mean postprandial increment (over all meals), Measured in mmol/L., From baseline (week 0) to end of treatment (week 40)|Number of Participants Who Achieve ≥5% Body Weight Reduction, Measured as count of participants., From baseline (week 0) to end of treatment (week 40)|Number of Participants Who Achieve ≥20% Body Weight Reduction, Measured as count of participants., From baseline (week 0) to end of treatment (week 40)|Change in Waist Circumference, Measured in centimeter (cm)., From baseline (week 0) to end of treatment (week 40)|Change in Systolic Blood Pressure (SBP), Measured in millimeter of mercury (mmHg)., From baseline (week 0) to end of treatment (week 40)|Change in Diastolic Blood Pressure (DBP), Measured in mmHg., From baseline (week 0) to end of treatment (week 40)|Ratio to Baseline in High Sensitivity C-reactive Protein (hsCRP), Measured in ratio., From baseline (week 0) to end of treatment (week 40)|Ratio to Baseline in Lipids: Non-high Density Lipoprotein (Non-HDL) Cholesterol, Measured in ratio., From baseline (week 0) to end of treatment (week 40)|Ratio to Baseline in Lipids: Triglycerides, Measured in ratio., From baseline (week 0) to end of treatment (week 40)|Ratio to Baseline in Lipids: Low-Density Lipoprotein (LDL) Cholesterol, Measured in ratio., From baseline (week 0) to end of treatment (week 40)|Ratio to Baseline in Lipids: Very Low-Density Lipoprotein (VLDL) cholesterol, Measured in ratio., From baseline (week 0) to end of treatment (week 40)|Ratio to Baseline in Lipids: HDL Cholesterol, Measured in ratio., From baseline (week 0) to end of treatment (week 40)|Ratio to Baseline in Lipids: Total Cholesterol, Measured in ratio., From baseline (week 0) to end of treatment (week 40)|Ratio to Baseline in Lipids: Free Fatty Acids, Measured in ratio., From baseline (week 0) to end of treatment (week 40)|Change in Short Form-36 Version 2.0 Health Survey (SF-36v2): Vitality score, Measured as score points. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The vitality score range is from 25.6 to 69.1., From baseline (week 0) to end of treatment (week 40)|Change in SF-36v2: Physical Component Summary Score, Measured as score points. SF-36v2 Acute measures HRQoL. The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The score range for physical component summary is 6.1 to 79.7., From baseline (week 0) to end of treatment (week 40)|Change in SF-36v2: Mental Component Summary Core, Measured as score points. SF-36v2 Acute measures HRQoL. The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The score range for mental component summary score is -3.8 to 78.7., From baseline (week 0) to end of treatment (week 40)|Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Measured as score points. DTSQs measures treatment satisfaction and diabetes-specific quality of life. The measure consists of 8 items yielding 1 global score and 2 single item scores. Higher scores on the global score indicate greater satisfaction with treatment. Lower scores on the single-item scores indicate BG levels closer to the ideal, while higher scores indicate problems. Single-item scores (score range): Perceived frequency of hyperglycaemia (0-6), Perceived frequency of hypoglycaemia (0-6). Global score (score range): Total Treatment Satisfaction (0-36)., From baseline (week 0) to end of treatment (week 40)|Ratio to Baseline in Leptin, Measured in ratio., From baseline (week 0) to end of treatment (week 40)|Ratio to Baseline in Soluble Leptin Receptor, Measured in ratio., From baseline (week 0) to end of treatment (week 40)|Number of Treatment Emergent Adverse Events (TEAEs), Measured as count of events., From baseline (week 0) to end of treatment +7 weeks (week 47)|Number of Clinically Significant Hypoglycaemic Episodes (level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose Meter), Measured as count of episodes., From baseline (week 0) to end of treatment +7 weeks (week 47)|Number of Clinically Significant Hypoglycaemic Episodes (level 3), Measured as count of episodes. Hypoglycaemic episodes (level 3) is hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold., From baseline (week 0) to end of treatment +7 weeks (week 47)
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| Locations: |
Valley Clinical Trials, Inc., Northridge, California, 91325, United States|Bioclinical Research Alliance, Miami, Florida, 33155, United States|Solaris Clinical Research, Meridian, Idaho, 83646, United States|Iowa Diab & Endo Res Center, West Des Moines, Iowa, 50266, United States|Alliance for Multispec Res, Newton, Kansas, 67114, United States|Elite Research Center, Flint, Michigan, 48532, United States|Palm Research Center Inc., Las Vegas, Nevada, 89128, United States|University of North Carolina, Chapel Hill, North Carolina, 27517, United States|Clinical Research Associates, Nashville, Tennessee, 37203, United States|Velocity Clinical Res-Dallas, Dallas, Texas, 75230, United States|Synergy Groups Medical, Houston, Texas, 77061, United States|PlanIt Research, PLLC, Houston, Texas, 77079, United States|Manassas Clinical Research Center, Manassas, Virginia, 20110, United States|TPMG Clinical Research, Newport News, Virginia, 23606, United States|Chinese People's Liberation Army General Hospital-Endocrinology, Beijing, Beijing, 100853, China|Huaihe Hospital of Henan University-Endocrinology, Kaifeng, Henan, 475000, China|Huaihe Hospital of Henan University, Kaifeng, Henan, 475000, China|The Second Affiliated Hospital of Nanjing Medical University-Endocrinology, Nanjing, Jiangsu, 210011, China|The Second Affiliated Hospital of Nanjing Medical University_Nanjing, Nanjing, Jiangsu, 210011, China|The Affiliated Hospital of Jiangsu University-Endocrinology, Zhenjiang, Jiangsu, 212001, China|Jinan Central Hospital, Ji'nan, Shandong, 250013, China|Manda Memorial Hospital, Sapporo-shi, Hokkaido, Hokkaido, Japan, 060-0062, Japan|Tsuruma Kaneshiro Diabetes Clinic, Yamato-shi, Kanagawa, 242-0004, Japan|Kumanomae Nishimura Internal Medical Clinic, Arakawa-ku, Tokyo, 116-0012, Japan|Akaicho Clinic, Chiba-shi, Chiba, 260-0804, Japan|Futata Tetsuhiro Clinic Meinohama, Fukuoka-shi, Fukuoka, 819-0006, Japan|Kunisaki Makoto Clinic, Fukuoka-shi, Fukuoka, 819-0168, Japan|Sasaki Internal Medicine, Hokkaido, 062-0007, Japan|Naka Kinen Clinic, Ibaraki, 311-0113, Japan|H.E.C Science Clinic, Kanagawa, 235-0045, Japan|Kyoto University Hospital, Kyoto-shi, Kyoto, 606-8507, Japan|Minami Akatsuka Clinic, Mito-shi, Ibaraki, 311-4153, Japan|Tokyo-Eki Center-building Clinic, Tokyo, 103-0027, Japan|Fukuwa Clinic, Tokyo, 104-0031, Japan|Kato Clinic of Internal Medicine, Tokyo, 125-0054, Japan|Healthcare centre Zvezdara, Belgrade, RS, 11050, Serbia|Healthcare centre Kragujevac, Kragujevac, RS, 34000, Serbia|University Clinical Centre Nis, Nis, RS, 18 000, Serbia|Healthcare centre Nis, Nis, RS, 18000, Serbia|Policlinic for diabetes, Zajecar, 19000, Serbia|MOMED, s.r.o, Kralovsky Chlmec, 077 01, Slovakia|DIA - KONTROL s.r.o., Levice, 93401, Slovakia|SIN AZUCAR s.r.o., Malacky, 901 01, Slovakia|ENRIN, s.r.o., Rimavska Sobota, 979 01, Slovakia|LUDIA, s.r.o., Spisska Nova Ves, 05201, Slovakia|Oraderumaz (Pty) Ltd, Bloemfontein, Free State, 9301, South Africa|Lenasia Clinical Trial Centre, Lenasia, Gauteng, 1827, South Africa|Prinshof Medical Campus, Pretoria, Gauteng, 0002, South Africa|Clinical Trial Systems (CTC), Pretoria, Gauteng, 0186, South Africa|Ashmed Medi-Centre, Cape Town, Western Cape, 7760, South Africa
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