Feasibility of Once/Daily Administered GLP/1 Receptoragonist (Lixisenatide) in Combination With Basal Insulin
Status:
Completed
Trial end date:
2015-08-01
Target enrollment:
Participant gender:
Summary
Premixed insulin-based therapy is a standard insulin treatment strategy in Austria. The
widespread use of premixed insulin is explained by high acceptance by health care
professionals and patients due to one single product and flexible number of injections (1-3
daily) which covers the demand in controlling fasting and postprandial glucose excursions of
most patients with diabetes. However, the use of pre-mixed insulin frequently leads to a high
insulin demand and consequently weight gain and an increased risk of hypoglycemia. Hence,
achieve good metabolic control in these patients remains a major challenge.
For those patients, the approach to treatment intensification without facing the typical
risks of insulin treatment (hypoglycemia and weight increase) is of major importance. One, so
far not exploited option may be the BIT-strategy: Basal insulin in combination with
incretin-based therapy.
Pathophysiologically basal insulin inhibits glucose production in the liver, decreases
hepatic insulin resistance and improves the function of beta cells in the postprandial state
by discharge of fasting insulin secretion. During further diabetes progression steadily
increasing HbA1c levels - despite good fasting blood glucose control - indicate the need for
additional intervention of meal-related glucose excursions. In this stage of type-2 diabetes
basal insulin can be combined with prandial (short-acting) insulin or prandial GLP-1 receptor
agonists. However, regarding important safety parameters: risks of hypoglycemia and weight
gain in the long-term treatment GLP-1 receptor agonists are beneficial.
Lixisenatide is a novel GLP-1 receptor agonist with a pronounced postprandial (PPG) effect
which fits with basal insulin mode of action primarily focused on fasting blood glucose
reduction.
Therefore 10 patients (both gender) under treatment with premixed insulin (2-3 times daily)
and HbA1c>7% will be switched to basal insulin glargine (Lantus, once daily) and GLP-1
receptor agonist Lixisenatide (Lyxumia, once daily). The investigators hypothesize that
switching from a therapy based on premixed insulin to a simple, once daily administered
combination of basal insulin plus a GLP-1 receptor agonist in patients with type-2 diabetes
not achieving therapeutic target (HbA1c>7%) is clinically feasable in an out patient setting