Fixed-dose insulin glargine/lixisenatide improves HbA1c levels in patients with type 2 diabetes…
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J. Rosenstock and colleagues conducted a 24-week proof-of concept study to improve glycemic control without increasing the risk of hypoglycemia by adding LixiLan to metformin in type 2 diabetes patients. The study included 323 insulin-naïve patients (mean age, 56.7 years; mean diabetes duration, 6.7 years) with a mean baseline HbA1c of 8.0%. Patients were randomly assigned to metformin plus insulin glargine alone (n=162) or metformin plus LixiLan (n=161).
In a post-hoc analysis researchers examined whether a correlation existed between the reduction in HbA1c with LixiLan and rates of hypoglycemia. The results from the study showed that titrated LixiLan added on to metformin improved HbA1c from 8.1% at baseline to 6.3% while 84% also achieved an HbA1c lower than 7.0%. Also, 68% achieved an HbA1c lower than 7.0% with no documented hypoglycemia, 56% achieved an HbA1c lower than 7.0% with no weight gain, and 46% achieved an HbA1c lower than 7.0% with no weight gain and no documented hypoglycemia. Researchers had categorized the patients based on their HbA1c levels less than 6%, 6% to less than 6.5%, 6.5% to less than 7% and 7% or higher. They also evaluated patients according to absolute mean reduction in HbA1c from baseline to 24 weeks, including 1% or less, greater than 1% to 1.5%, greater than 1.5% to 2%, and greater than 2%.
Rosenstock concluded, “Reaching lower near-normal HbA1c levels and achieving greater HbA1c reductions with LixiLan vs. insulin glargine alone did not increase rates of hypoglycemia at any level of glucose control.”
- Approximately, 50-60% of patients with type 2 diabetes can improve glycemic targets by titrating basal insulin mainly by controlling nocturnal and fasting glucose levels.
- In the study, nausea and vomiting with LixiLan was less frequent than what was reported with the GLP-agonist class.
- No statistically significant relationship between hypoglycemia rates and HbA1c levels reached at week 24 or absolute mean reduction in HbA1c from baseline (P>.1).
Rosenstock J et al. Abstract 169-OR: Improved Glucose Control without Increased Hypoglycemia Risk at Any Level of HbA1c Reduction with Insulin Glargine/Lixisenatide Fixed-Ratio Combination (LixiLan) vs. Insulin Glargine Alone Both Added On to Metformin in Type 2 Diabetes (T2DM). Presented at: American Diabetes Association (ADA) 75th Scientific Sessions; June 5-9, 2015; Boston.