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Title: Hypoglycemia in Type 2 Diabetes Patients Substituted with Insulin Degludec Aspart from Premixed Insulin Therapy: a Quasi Experimental Study
Authors: Komal Mumtaz Malik, Sadia Zafar, Shabana Ali, Mudassir Noor, Noaman Ishaq
Journal: Pakistan Armed Forces Medical Journal (PAFMJ)
Publisher: Army Medical College, Rawalpindi.
Country: Pakistan
Year: 2024
Volume: 74
Issue: 2
Language: English
Keywords: Type 2 diabetes mellitusBiphasic Insulin AspartGlycemic ControlInsulin Degludec Aspart
Objective: To determine whether Insulin Degludec Aspart is associated with a reduced risk of hypoglycemia as compared to premixed Insulin aspart therapy in type-2 diabetes mellitus patients.
Study Design: Quasi-experimental study
Place and Duration of Study: Department of Pharmacology, Army Medical College, National University of Medical Sciences, Rawalpindi and Department of Medicine, Pak Emirates Military Hospital, Rawalpindi Pakistan, from Sep to Dec 2021.
Methodology: One hundred twenty participants with documented type 2 diabetes, taking premixed Insulin Aspart therapy, were enrolled in the study. The participants were divided into two groups. Group-A participants were continued on Premixed Insulin Aspart therapy, and Group-B participants were substituted with Insulin Degludec Aspart. The symptomatic hypoglycemic episodes were recorded for 12 weeks as confirmed hypoglycemia, nocturnal hypoglycemia, and severe hypoglycemia.
Results: Among the Premixed Insulin Aspart-Group, 49(81.6%) participants and in the Insulin Degludec Aspart-Group, 26(43.3%) participants reported 160 and 40 episodes of confirmed total hypoglycemia, respectively (p-value<0.001). 43(71.6%) participants in the Premixed Insulin Aspart-Group and 11(18.3%) participants in the Insulin Degludec Aspart-Group reported 73 and 12 episodes of confirmed nocturnal hypoglycemia, respectively (p-value<0.001). No severe hypoglycemic episodes were recorded in both groups after 12 weeks.
Conclusion: The use of Degludec Aspart is associated with a reduced incidence of hypoglycemia, offering improved treatment compliance among the Pakistani population with type 2 diabetes.
To determine whether Insulin Degludec Aspart is associated with a reduced risk of hypoglycemia as compared to premixed Insulin aspart therapy in type-2 diabetes mellitus patients.
Quasi-experimental study involving 120 participants with type 2 diabetes on premixed Insulin Aspart therapy. Participants were divided into two groups: Group-A continued premixed Insulin Aspart, and Group-B was substituted with Insulin Degludec Aspart. Symptomatic, confirmed, nocturnal, and severe hypoglycemic episodes were recorded for 12 weeks. Data was analyzed using SPSS version 26.0, with Chi-square test and Independent sample t-test applied.
graph TD
A["Enroll 120 Type 2 Diabetes Patients on Premixed Insulin Aspart"] --> B["Divide into Two Groups"];
B --> C["Group A: Continue Premixed Insulin Aspart"];
B --> D["Group B: Substitute with Insulin Degludec Aspart"];
C --> E["Record Hypoglycemic Episodes for 12 Weeks"];
D --> E;
E --> F["Analyze Data using SPSS"];
F --> G["Compare Hypoglycemic Episodes Between Groups"];
G --> H["Draw Conclusions"];
The study found that switching to Insulin Degludec Aspart therapy resulted in a statistically significant reduction in both total and nocturnal hypoglycemic episodes compared to continuing premixed Insulin Aspart. This is attributed to the pharmacokinetic properties of Insulin Degludec Aspart, with its rapid-acting Insulin Aspart component for post-meal control and ultra-long-acting Insulin Degludec component for basal control. The findings align with international studies, suggesting that Insulin Degludec Aspart offers improved safety and efficacy in managing type 2 diabetes, potentially leading to better treatment compliance in the Pakistani population.
- In the Premixed Insulin Aspart-Group, 81.6% of participants reported 160 episodes of confirmed total hypoglycemia, while in the Insulin Degludec Aspart-Group, 43.3% reported 40 episodes (p<0.001).
- 71.6% of participants in the Premixed Insulin Aspart-Group reported 73 episodes of confirmed nocturnal hypoglycemia, compared to 18.3% reporting 12 episodes in the Insulin Degludec Aspart-Group (p<0.001).
- No severe hypoglycemic episodes were recorded in either group after 12 weeks.
The use of Insulin Degludec Aspart is associated with a reduced incidence of hypoglycemia in type 2 diabetes patients compared to conventional premixed Insulin Aspart therapy, suggesting improved treatment compliance.
- Study duration: September to December 2021. (Confirmed)
- Number of participants: 120. (Confirmed)
- p-value for confirmed total hypoglycemia difference: <0.001. (Confirmed)
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