| Outcome Measures: |
Primary: Change in HbA1c, 12 weeks|Safety and tolerability as assessed by incidence of adverse events, 12 weeks|Safety and tolerability as assessed by change in medication use, vital signs, physical examination findings, mental well-being questionnaires, laboratory evaluations, and electrocardiogram results, 12 weeks | Secondary: Change in body weight, 12 weeks|Change in fasting plasma glucose, 12 weeks|Change in insulin, 12 weeks|Change in C-peptide, 12 weeks|Change in proinsulin, 12 weeks|Change in glucagon, 12 weeks|Proportion of subjects achieving HbA1c <7% and ≤6.5%, 12 weeks|Change in beta-cell function, 12 weeks|Change in insulin sensitivity, 12 weeks|Change in preprandial and postprandial glycemic parameters as assessed by a mixed meal tolerance test in a subset of subjects, 12 weeks|Change in waist and hip circumference, 12 weeks|Change in biomarkers relevant to obesity and/or type 2 diabetes, 12 weeks|Change in patient reported outcomes measures, 12 weeks
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| Locations: |
Coffs Harbour GP SuperClinic, Coffs Harbour, New South Wales, 2450, Australia|Northside Health, Coffs Harbour, New South Wales, 2450, Australia|The Aim Centre, Merewether, New South Wales, 2291, Australia|The Boden Institute, Sydney, New South Wales, 2006, Australia|Holdsworth House Medical Practice, Sydney, New South Wales, 2010, Australia|Pendlebury Research, Sydney, New South Wales, 2289, Australia|Q-Pharm, Herston, Queensland, 4006, Australia|Griffith University, Gold Coast Campus, Southport, Queensland, 4222, Australia|Southern Adelaide Diabetes & Endocrine Services, Daw Park, South Australia, 5041, Australia|Eastern Clinical Research Unit (ECRU), Box Hill, Victoria, 3128, Australia|Barwon Health, Geelong, Victoria, 3218, Australia|Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia|Optimal Clinical Trials, Auckland, 1021, New Zealand|Middlemore Hospital, Auckland, 2025, New Zealand|Christchurch Diabetes Centre, Christchurch, 8011, New Zealand|Southern Clinical Trials, Christchurch, 8024, New Zealand|Lipid and Diabetes Research Group, Christchurch, 8140, New Zealand|Clinical Trials New Zealand Ltd, Hamilton, 3206, New Zealand|P3 Research Hawkes Bay, Hastings, 4130, New Zealand|P3 Research Wellington, Newtown, 6021, New Zealand|Lakeland Clinical Trials, Rotorua, 3010, New Zealand|P3 Research Tauranga, Tauranga, 3110, New Zealand|Wellington Hospital, Wellington, 6021, New Zealand
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