The Results of Open-Label, Multicenter, Non-Randomized Study on the Efficacy and Safety of Insulins: Insuman Basal®, Insuman Comb 25®, Insuman Rapid® in Patients with Diabetes Mellitus Type 2 Who Underwent Basic Training in Diabetes Schools (SPIRIT)
The objective of this study was to evaluate the level of glycated hemoglobin (HbA1c) reduction after 6 months of treatment with Insuman® insulin in patients with diabetes mellitus type 2 (DM-2),
who were not treated with insulin previously and did not achieve glycemic control with oral antidiabetic drugs (OADs). Also, we have studied the effectiveness of teaching in the schools of diabetes self-management, specified the average dose of insulin by the end of the study, the incidence of hypoglycemia and overall safety of the treatment.
Design. IV phase, open-label, multicenter, non-randomized interventional study with duration of 6 months (Clinical Trials. Gov: NCT01630369). The study was conducted in 11 centers in Ukraine.
Population. Patients with DM-2, who were not treated with insulin previously, men and women aged over 18 years, with an index HbA1c > 7.5 %, were divided into three treatment groups according do doctor’s decision: n = 341 in group 1 (Insuman Basal®), n = 173 in group 2 (Insuman Comb 25®), n = 36 in group 3 (Insuman Rapid®).
Treatment. Patients received one of three types of Insuman® insulin for 24 weeks, according to the group of distribution and titration scheme by protocol. Study suggested 4 visits, during which we have collected patient’s data from the medical records: achieving target HbA1c < 7.5 % by the sixth month, the distribution of patients according to HbA1c dynamics (a decrease of 1 % or more) to the sixth month, Δ FPG (fasting plasma glucose) (before treatment — during 2nd — 3rd visits — on sixth month). Between the first and second visit, all patients had to undergo a course of five lessons in the school of diabetes self-management and take a test assessing the level of knowledge.
Results. We have treated 550 patients included in the analysis. The average age of the patients was 59.57 ± 9.53 years, 231 patients were males (42 %), 319 — females (58 %). The total number of patients with macrovascular complications in three groups was equal to 419 (75.6 %), with microvascular complications — 525 (96.4 %). A statistically significant difference between three groups was observed in baseline parameters of DM duration, HbA1c and FPG. The average duration of DM (years) in group 1 was 8.7 ± 5.0, in group 2 — 7.7 ± 5.5, and in group 3 — 9.9 ± 6.8. The average HbA1c (%) level before treatment in group 1 was 10.4 ± 1.9, in group 2 — 11.0 ± ± 1.9, and in group 3 — 10.1 ± 1.5. Median FPG before treatment was 10.7 ± 2.2 mmol/l in group 1, 11.3 ± 2.7 mmol/l in group 2, and 10.4 ± 2.6 mmol/l in group 3. It was shown that 43.9 % of all treated patients achieved the target values of HbA1c: 49.8 % in group 1, 33.3 % in group 2, and 32.3 % in group 3. The most significant decrease in HbA1c level by the sixth month of treatment was observed in group 1 (Δ = –2.61 %) and in group 2 (Δ = –2.81 %). Overall assessment of the effectiveness in groups (N patients with a reduction in HbA1c > 1 %) n/N (%) was 430/539 (79.7 %). The positive dynamics of Δ FPG index was statistically significant (p < 0.001) in all groups. The improvement in the effectiveness of treatment in patients, who have successfully completed a training course at diabetes self-management schools, hasn’t been observed. In 16.5 % of 550 patients, symptomatic hypoglycemia developed: 14.9 % in group 1, 19.6 % in group 2, and 16.6 % in group 3. A total of 10.1 % of patients reported documented hypoglycemia episodes (≤ 3.9 mmol/l) and 3.4 % — nocturnal hypoglycemia. No cases of severe hypoglycemia were reported. One serious adverse event resulted in death of the patient, in the general population 8 adverse events were observed during the study.
Conclusions. Treatment with Insuman® insulins of patients with DM-2, who were not compensated while taking OADs, was associated with improved glycemic control without an increase in the incidence of severe hypoglycemia. There was no statistically significant increase in the effectiveness of therapy in patients, who have successfully completed a training program at diabetes school, compared with evaluation of overall efficiency. The state of young studied population of patients with inadequate control at baseline, and those who had developed cardiovascular complications associated with DM, improved in most cases in terms of glycemic control, and, at that, episodes of severe hypoglycemia were not detected. This may be due to the positive influence of training in diabetes school.
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