Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and Type 2 Diabetes
It is not known whether a new diabetes drug, semaglutide, is an effective treatment for type 2 diabetes for persons with spinal cord injury (SCI), a population at higher risk for this condition. Therefore, this study looks at the effect of semaglutide on glucose levels in the body and other information about type 2 diabetes and obesity.
• Male and female subjects aged 18-70 years (inclusive) at screening
• More than one year after spinal cord injury
• Levels if injury C2-L2 with Asia Impairment Scale A, B, C or D.
• Provision of signed and dated written informed consent prior to any study specific procedures
• Diagnosed with T2DM with glucose control managed with diet and metformin monotherapy where no significant dose changes (increase or decrease ≥ 50%) have occurred in the three months prior to screening
• HbA1c 6.0-9.0% at screening
• BMI \> 22 kg/m2 at screening
• Female subjects of childbearing potential must have a negative pregnancy test at screening and randomization, and must not be lactating
• Females of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from screening and must agree to continue using such precautions through to the end of the study. It is strongly recommended for the male partner of a female subject to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.