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.
10.35460/2546-1621.2019-0010
- Author:
Leilani B MERCADO-ASIS
1
;
Mary Jane TANCHEE-NGO
2
;
Erick S MENDOZA
2
;
Ashish MANE
3
;
Anand VASAM
3
;
Agam SHAH
3
;
Rishi JAIN
3
Author Information
1. Faculty of Medicine and Surgery, University of Santo Tomas, Manila, Philippines
2. Hospital of Infant Jesus, Laong Laan St., Sampaloc, Manila, Philippines
3. Medical Affairs, Wockhardt Limited, India
- Publication Type:Journal Article
- Keywords:
Insulin Glulisine;
Filipino population
- MeSH:
Insulin, Isophane;
Insulin;
Diabetes Mellitus, Type 2
- From:
Journal of Medicine University of Santo Tomas
2019;3(1):260-269
- CountryPhilippines
- Language:English
-
Abstract:
Background:The high prevalence of type 2 diabetes mellitus (T2DM) in the Philippines has burdened the health care system. Therefore, we compared the
standard of care Insulin 30/70 + Insulin Glulisine
(Arm B) to a traditional insulin regimen NPH Insulin
+ Regular Insulin (Arm A) to test the concept that
both insulin regimens provide comparable effectiveness and safety in real-world practice.
Methods :This is a ‘proof-of-concept,’ prospective,
randomized, open label pragmatic study of 40
consecutive Filipino T2DM patients from October
2015 to June 2016. The primary endpoint was a
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 :Patients in treatment arm A showed 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 (AE) (8 vs. 8 patients).
Conclusion :The traditional combination of NPH
Insulin + Regular Insulin offers comparable glycemic control and tolerance as the standard of care
without any new safety signals in the Filipino T2DM
population. With a lower price, it can be one of the
strategies to reduce the fi nancial burden of antidiabetic treatment.
- Full text:1 JMUST 2.pdf
