The main objective of this trial is to determine the effectiveness and durability of a combined group of drugs (exenatide [Byetta], pioglitazone [Actos] and metformin [Glucophage]) compared to standard treatment in type 2 diabetes. The main outcome to be measured will be the change in HbA1c (average blood glucose over 3 months).
The details
The standard treatment for type 2 diabetes involves combining a number of therapies used to treat high blood sugar levels. This can include metformin as the initial treatment, with the addition of other therapies (such as exenatide and pioglitazone used in this trial) if the initial treatment does not work. Many patients eventually need to start insulin therapy.
The aim of this study is to determine whether a combination of metformin, exenatide, and pioglitazone is more effective at controlling blood sugar levels compared to standard treatment (insulin and metformin). The main outcome to be measured is the change in average blood glucose levels.
Who are they looking for?
This study will recruit 600 patients who have had type 2 diabetes confirmed within the last 2 years. Participants must be over the age of 18 years to be eligible for this trial. Patients who have not received treatment yet or who have been on metformin for the past 3 months will be considered for this trial.
Patients who have long-standing diabetes of more than 2 years will not be eligible for this trial. Patients who have received treatment for diabetes or those who have been on metformin for more than 3 months will not be eligible for this trial.
How will it work
Patients will be split into two groups. Group 1 will receive the triple combination therapy. They will receive 1000 mg of metformin, 15 mg of pioglitazone and 5 micrograms of exenatide
Group 2 will receive treatment with a conventional diabetes treatment. This will include 500 mg of metformin, up to 5 mg of glyburide (Glynase) and basal (long-lasting) insulin.
Patients will be monitored for 3 years and HbA1c levels will be compared to determine the more effective treatment.
