None listed
Conditions
Brief summary
In the majority of people with newly-diagnosed type 2 diabetes, the standard medical treatment starts with metformin, followed by the addition of other medications if blood glucose levels remain elevated. The purpose of this study is to evaluate the possible risks and the effectiveness of using three different tablets together to normalise blood glucose levels in adults with newly-diagnosed type 2 diabetes, compared with starting treatment with one tablet, and adding the other two tablets sequentially if blood glucose levels remain above normal. All of the tablets are already available for the treatment of type 2 diabetes, but the use of all 3 together in newly diagnosed diabetes has not been studied. Participants will be randomly assigned by a computer to receive treatment with metformin, saxagliptin and dapagliflozin together at the onset of the study, or to commence treatment with metformin, and add saxagliptin and dapagliflozin sequentially if their blood glucose levels remain above normal. Approximately 20 volunteers will be recruited to participate in the study. Participants’ involvement in the study will last 12 months, and include 5 study visits at the research site. Participants will have an initial medical assessment, and receive information about blood glucose self-monitoring, diet and lifestyle habits. They will then be randomly assigned to receive metformin 2000mg daily, saxagliptin 5mg daily and dapagliflozin 10mg daily either concurrently, or sequentially over 12 months. Participants will visit the research site every 4 months during the treatment period for monitoring. During these visits, participants will be weighed, have their blood pressure checked and blood glucose readings reviewed, and have a fasting blood and a urine test. At the beginning and end of the 12 month treatment period, participants will be also be asked to undergo testing of their blood glucose levels in response to a meal. Once all participants have completed the study, the study results will be analysed and released.
Interventions
Metformin XR - 7 days at 500mg followed by 7 days at 1000mg, followed by 7 days at 1500mg and then to a total daily dose of 2000mg for a duration of 12 months.
Saxagliptin - oral tablet at a total daily dose of 5mg for a duration of 12 months.
Dapagliflozin - oral tablet at a total daily dose of 10mg for a duration of 12 months.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- newly diagnosed patients with type 2 diabetes and HbA1c > 6.5%. - age between 40 and 75 years - BMI > 25 - community dwelling - able to visit the Repatriation Hospital - has a general practitioner
Exclusion criteria
- estimated glomerular filtration rate (eGFR) < 60ml/min/1.73m2 - active drug or heavy alcohol use - type 1 diabetes - pregnancy or breastfeeding - BMI<25 - previous history of bladder cancer excluded because of unacceptable risk of adverse events from study treatment - active malignancy - use of warfarin, alpha – glucosidase inhibitors, gliptins, orlistat, opioids, corticosteroids excluded because confounding factors would make outcomes difficult to interpret
Outcome results
None listed