A Prospective, Randomized, Open Label, Single-Centre Study for Assessment of Safety and Effectiveness of Recombinant Human Insulin 30/70 + Insulin Glulisine compared to Recombinant Human Insulin NPH + Regular in the Management of Type 2 Diabetes Mellitus Patients in the Philippines.
Leilani B. Mercado-Asis, Mary Jane Tanchee-Ngo, Erick S. Mendoza, Gaurav Puppalwar, Ashish Mane, Anand Vasam, Agam Shah, Rishi Jain
Apr 2019 DOI 10.35460/2546-1621.2019-0010 Access
Background The high prevalence of type 2 diabetes mellitus (T2DM) in Philippines has burdened the health care system. Therefore, we compared standard of care, Insulin30/70+ Insulin Glulisine (Arm B) to a traditional insulin regimen NPH Insulin+Regular Insulin (Arm A) to test the concept that both provide comparable efficacy and safety in real world practice.
Methods This is a ‘proof-of-concept’, prospective, randomized, open label study of 40 consecutive Filipino T2DM participants from October 2015 to June 2016. The primary endpoint was reduction in HbA1c at 12 weeks. The secondary endpoints were changes in Fasting Plasma Glucose (FPG), Post Prandial Glucose (PPG), Capillary Blood Sugar (CBS), weight and insulin dose at 12 weeks. ANCOVA and Fisher’s exact tests were used.
Results Treatment arm A reported comparable glycemic control to arm B as measured by reductions in HbA1c (2.89% vs. 2.67%; P = 0.657), FPG (65.94 vs. 46.71 mg/ dl; P = 0.57), PPG (76.49 vs. 86.96 mg/ dl; P = 0.271) and CBS (115.15 vs. 145.95 mg/ dl; P = 0.420). Both treatment arms reported similar weight gain (1.92 vs. 1.22 kg), experienced similar incidence of hypoglycemia (7 vs. 6 patients) and adverse events (8 vs. 8 patients).
Traditional combination of NPH Insulin + Regular Insulin offers comparable glycemic control and tolerance as the standard of care without any new safety signals in Filipino T2DM population. With a lower price, it can be one of the strategies to reduce financial burden of antidiabetic treatment.
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