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Improve glycaemic control and weight management in patients with Type II diabetes

A study to investigate the effects of an injectable drug compared with placebo and open-label semaglutide in patients with Type II diabetes.

This is a 16-week, phase II, randomised, parallel group study to investigate the effects of the injectable study drug BI 456906 compared with placebo and open-label semaglutide in patients with Type II diabetes mellitus. 


BI 456906 is a dual acting agonist of glucagon-like peptide 1 (GLP-1) and glucagon receptors. In patients with Type II diabetes, overweight and obesity, BI 456906 is expected to result in improved HbA1c and body weight loss. 


Participants will be randomly allocated to a dose of BI 456906 or placebo once or twice weekly or semaglutide which is weekly. Participants will attend visits at the Charles Perkins Centre, Royal Prince Alfred clinic once or twice weekly for eight weeks and then monthly for the following two months.

Those in the BI 456906 groups or placebo will be blinded so neither the researchers nor the participants know what dose regime of medication has been allocated to each participant. The semaglutide group will be open label, meaning both the researchers and the participant will be aware of what they are taking.

This study is being sponsored by Boehringer Ingelheim Pharmaceuticals, Inc and conducted at Boden Collaboration, The University of Sydney at the Charles Perkins Centre.

Eligibility

You may be eligible to participate in this study if you:

  • are 18 to 75 years old
  • have a diagnosis of Type II diabetes 
  • have HbA1c 7% - 10% 
  • are currently taking Metformin ≥ 1000mg/day 
  • have a BMI: 25 kg/m2 – 50kg/m2

How to participate

If you are interested in assisting with this important and exciting area of research, please contact the study facilitator: 8627 0101 or clinicaltrials.boden@sydney.edu.au