Arun, R (2022) A Prospective, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog Glargine Plus Glulisine with Premixed Insulin in Adult Patients with Type 2 Diabetes Mellitus. Doctoral thesis, The Tamil Nadu Dr. M.G.R. Medical University, Chennai.
Full text not available from this repository.Abstract
AIM OF THE STUDY: The study aims to assess the effectiveness of the combination of Glargine + Glulisine while initiating insulin therapy in comparison with Premixed insulin analogue in insulin naïve Type 2 Diabetes (T2D) patients with increased fasting and postprandial plasma glucose. METHOD: We randomised 200 (116 men 84 women) insulin naïve T2D patients visiting the hospital with inadequate glycemic control who were on two or more oral hypoglycemic agents. Mean age of the recruited patients was 52.4 ± 8.8 years and mean body mass index was 26.3 ± 4.3 kg/m2. The patients were randomised into two groups. Group 1 was initiated with insulin Glargine + Glulisine (n = 101), and Group 2 was treated with Premixed insulin analogue (n = 99). The primary outcome measure was to compare the change in glycated haemoglobin A1c (HbA1c) by initiating the use of Glargine + Glulisine or Premixed insulin analogue in insulin naïve patients with T2D from baseline to week 24. RESULTS: Among the 101 patients randomised to Glargine + Glulisine group, 7.9 % required one dose/day, and 83.2 % required additional Glulisine injection at night due to poor glycemic control. Among the 99 persons who were randomised to premixed insulin analogue group, 3.0 % required one dose/day, and 88.9 % required additional premixed insulin analogue injection at night. The percentage of patients requiring an additional shot of insulin in both groups was similar. At the end of the study, there were 9.5 % dropouts. The decrease in HbA1c was significant in the Glargine + Glulisine group. The reduction in the Glargine + Glulisine group at 12 weeks (0.7 ± 0.1, p < 0.0001) and 24 weeks (0.8 ± 0.2, p < 0.0001) were significant compared with the baseline values. There was a non-significant reduction of HbA1c in the Premixed Insulin analogue group from baseline. The percentage of patients having good glycemic control (HbA1c ≤ 7.0%) at the end of the study was similar in both the groups (18.5 % in the Glargine + Glulisine group and 14.3 % in the Premixed insulin analogue group). There was a significant reduction in fasting plasma glucose (FBG) and postprandial plasma glucose (PBG) in both the groups till 24 weeks. The initial prescribed dose was 12 units/day of Glargine, 4 units of Glulisine and 16 units of Premixed insulin analogue. The dose at the end of the study was 46 units for Glargine, 46 units for Glulisine and 50 units for Premixed insulin analogue. Significant increase in body mass index was observed in the Glargine rgine + Glulisine (0.4 ± 0.1 kg/m2, P < 0.05) and Premixed Insulin analogue group (0.3 ± 0.1 kg/m2, P < 0.05) at the end of the study compared with baseline value. This increase in body mass index was not clinically significant. Adverse events: The number of episodes of hypoglycemia was more in Premixed insulin analogue BD group compared to Glargine + Glulisine BD group. The incidence rate for symptomatic hypoglycemia was 0.13 events/ person-year in the Glargine + Glulisine BD group when compared to the Premixed insulin analogue BD group (0.12 / person-year). The overall incidence rate for symptomatic hypoglycemia was 0.24 events/ person-year in Glargine + Glulisine group when compared with the Premixed insulin analogue group (0.12 / person-year). CONCLUSION: Among the subjects initiated on Glargine + Glulisine (basal plus regimen of insulin) there was a significant reduction in HbA1c from baseline. The overall episodes of symptomatic hypoglycemia were less compared with the Premixed insulin analogue group. There was no clinically significant change in body mass index in both groups.
| Item Type: | Thesis (Doctoral) |
|---|---|
| Additional Information: | 54299/2013 |
| Uncontrolled Keywords: | Prospective, Randomized, Open Label Comparison, Long Acting Basal Insulin Analog, Glargine Plus Glulisine, Premixed Insulin, Adult Patients, Type 2 Diabetes Mellitus. |
| Subjects: | Respiratory Medicine > Diabtology > Respiratory Medicine > Diabtology |
| Depositing User: | Subramani R |
| Date Deposited: | 25 Dec 2022 14:39 |
| Last Modified: | 22 Jan 2023 03:10 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/21057 |
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