[RESOLUTE Study in the Czech Republic: insulin glargine improves the compensation of type 2 diabetes in patients with unsatisfactory results of therapy with a combination of insulin detemir and oral antidiabetics. Results of the nonintervention RESOLUTE Project in the Czech Republic].
BACKGROUND
The RESOLUTE was a multinational, non interventional, 6 month prospective observational project evaluating in clinical practice, whether patients with type 2 diabetes mellitus (T2DM) inadequately controlled with detemir in combination with oral antidiabetic drugs (OADs) may benefit from switching to glargine. In Czech Republic 200 patients, for whom the participating physician according to their own consideration, had decided to prescribe insulin glargine in replacement of insulin detemir, were included in this project.


OBJECTIVE
The primary endpoint was to assess the change in HbA1c over the 6- month period in T2DM patients treated with insulin glargin after switch from insulin detemir. Secondary endpoints included the evaluation of the change in fasting plasma glucose, insulin dose, body weight over the 6-month period after starting insulin glargine , the evaluation of the number of hypoglycemia during the last month of therapy which each basal insulin and the frequency of adverse events (AE) during treatment with insulin glargine.


RESULTS
Insulin glargine therapy resulted in a statistically significant improvement in compensation of diabetes characterized by a mean HbA1c decrease of about 0.82 (± 0.93) % (p < 0.001) and a mean decrease of recorded fasting glycemia about 1.91 (± 2.81) mmol/ l (p < 0.001). No significant change in the mean body weight was recorded du-ring study [+0.12 (± 2.98) kg; p = NS]. The mean daily insulin glargine dose used at the end of the observation increased in comparison with last mean daily dose of insulin detemir [+2.99 (± 7.54) U; p < 0.001]. The improvement in glycemic control was accompanied by low risk of hypoglycemia. The percentage of patients with documented symptomatic (5.0%), nocturnal (2.5%) and severe (0%) hypoglycemia in the last month of glargine therapy was consistently lower compared with the last month of previous treatment with detemir (14.6%, 9.5% and 2.5%, respectively). Other adverse events were reported in 3.0% of patients on glargine therapy. No adverse events were considered as adverse event related to insulin glargin treatment. No serious adverse or no serious adverse events leading to treatment discontinuation or death were documented during the course of the study.


CONCLUSIONS
Under reallife conditions, switching from insulin detemir to once daily insulin glargine in poorly controlled T2DM patients resulted in clinically relevant improvements in glycemic control without an increase in weight and hypoglycemia risk.
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D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000032:analysis; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D057915:Drug Substitution; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D000069057:Insulin Detemir; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069057:Insulin Detemir; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting