A study comparing insulin lispro mix 25 with glargine plus lispro therapy in patients with Type2 diabetes who have inadequate glycaemic control on oral anti-hyperglycaemic medication: results of the PARADIGM study
Diabetic Medicine, 08/20/2012
Bowering K et al. – For patients with Type 2 diabetes inadequately controlled with oral anti–hyperglycaemic medications, glycaemic control when initiating and intensifying with LM25 therapy was found to be non–inferior to treatment with glargine + insulin lispro therapy.Methods
- In this randomized, non-inferiority (margin of 0.4%), parallel, prospective, multi-country, 48-week, open-label study, patients (n = 426) with Type 2 diabetes inadequately controlled with oral anti-hyperglycaemic medications were assigned to either initiating therapy with one daily LM25 injection, progressing up to three daily injections (full analysis set n = 211; per protocol set n = 177) or initiating therapy with one daily glargine injection and progressing up to three daily insulin lispro injections (full analysis set n = 212; per protocol set n = 184).
- LM25 therapy was found to be non-inferior to glargine + insulin lispro therapy by study end (upper limit of 95% CI < 0.4), with a least-squares mean difference (95% CI) in HbA1c (LM25 minus glargine + insulin lispro) of -0.4 mmol/mol (95% CI -2.7 to 1.9); -0.04% (95% CI -0.25 to 0.17).
- No statistically significant differences between treatment groups were found in the percentage of patients achieving HbA1c targets or postprandial blood glucose levels.
- The increase in insulin dose, number of injections and weight change during the course of the study were similar in both groups.
- Patients in both groups experienced similar hypoglycaemia rates and safety profile.