Abstract

Background: Insulin Degludec/Aspart is a novel insulin co-formulation launched in Pakistan in 2018 containing Insulin Degludec and aspart in 70/30 ratio that can be give once daily or twice daily with similar efficacy to other pre-mix insulin and lesser hypoglycaemic risk. Aim: The Aim of this study was to look at the efficacy and safety of Insulin Degludec/Aspart in real-life Pakistani population with Type 2 Diabetes mellitus in secondary care setting in Islamabad, Pakistan. Method: A 12-week multi-centric observational cohort study was performed at different hospitals of Islamabad, Pakistan with 105 patients enrolled in 10 months who were prescribed with Insulin Degludec/Aspart. The data was collected from patients having HbA1C ≥ 7.0% and aged between 40-70 years diagnosed with type II diabetes. The primary end point of the study was decrease in HbA1C from base line and secondary end point includes change in body weight, fasting plasma glucose level, postprandial glucose level, hypoglycaemic episodes and adherence to the treatment. Morisky Green Levine test was used to measure the adherence to the treatment. The statistical analysis was carried out through paired T test. Results: Baseline HbA1c, fasting glucose, post-prandial glucose and weight was 8.48±1.27%, 201.05±44.41 mg/dl, 266.67±58.45 mg/dl and 79.18±17.69 kg respectively. At the end of 12 weeks, there was a mean reduction in HbA1c by 1.79% to 6.69±0.52%, fasting glucose reading by 78 mg/dl to 123.33±24.68 mg/dl and post-prandial glucose by 95 mg/dl to 171.62±30.73 mg/dl. Surprisingly, there was a minimal weight loss as well with weight coming down by a mean of 1.62 kg to 77.56±16.13 kg though there was a wide confidence interval. There was only 1 patient who experienced hypoglycaemia with Insulin Degludec/Aspart. Similarly, All the participants were well adhere to their treatments throughout the study duration as per Morisky Green Levine test. Discussion: This real-life observational study on the use of Insulin Degludec/Aspart in a Pakistani population with Type 2 Diabetes mellitus have shown that once or twice daily Insulin/Aspart is significantly more effective in hyperglycaemia management and adherence effective with a mean HbA1c reduction of 1.79%. This is associated with significantly less hypoglycaemic episode and minimal weight loss of 1.62 kg. Thus Insulin Degludec/Aspart can be safely prescribed in people with uncontrolled Type 2 Diabetes mellitus in a Pakistani setting.

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