Humalog® Mix50™ before carbohydrate-rich meals in type 2 diabetes mellitus
Article first published online: 27 AUG 2003
Diabetes, Obesity and Metabolism
Volume 5, Issue 5, pages 311–316, September 2003
How to Cite
Roach, P., Arora, V., Campaigne, B. N., Mattoo, V., Rangwala, S. and The India Mix25/Mix50 Study Group (2003), Humalog® Mix50™ before carbohydrate-rich meals in type 2 diabetes mellitus. Diabetes, Obesity and Metabolism, 5: 311–316. doi: 10.1046/j.1463-1326.2003.00277.x
- Issue published online: 27 AUG 2003
- Article first published online: 27 AUG 2003
- Received 1 March 2002; returned for revision 1 July 2002; revised version accepted 1 March 2003
- high carbohydrate;
- insulin lispro mixtures
Aim: To compare pre-meal injection of Humalog® Mix50™ (Mix50) and Humalog® Mix25™ (Humalog® Mix75/25™ in the US; Mix25) with respect to 2 h postprandial (2 h pp) blood glucose (BG) control after a carbohydrate-rich breakfast in patients with type 2 diabetes.
Research Design and Methods: One hundred and sixteen patients were enrolled in a 16-week crossover trial and received two treatment regimens in a randomized crossover fashion: (i) Mix50 before breakfast and Mix25 before the evening meal (Mix50/Mix25) and (ii) Mix25 before both breakfast and the evening meal (Mix25 twice daily). Insulin doses were adjusted according to stated glycaemic targets. After 6 and 8 weeks of treatment, the patient's usual morning insulin dose was administered, followed immediately by a test breakfast representative of the patient's usual breakfast meal. Fasting and 2 h pp BG concentrations were measured at the time of the test meal. Haemoglobin A1c (A1C) was measured, and information regarding hypoglycaemia (symptoms) was collected at the end of each treatment period.
Results: Insulin doses were similar between treatments (morning = 31–33 U, evening = 26–28 U) at endpoint. Following the test breakfast, the 2 h pp BG was lower (10.9 ± 0.3 mmol/l vs. 12.4 ± 0.3 mmol/l, p = 0.0012) and the 2 h pp BG excursion was smaller (1.4 ± 0.28 mmol/l vs. 3.5 ± 0.28 mmol/l, p < 0.001) during treatment with Mix50/Mix25 than during treatment with Mix25 twice daily. There was no difference between the treatments with respect to fasting BG (Mix50/Mix25, 9.5 ± 0.3 mmol/l vs. Mix25 twice daily, 8.9 ± 0.3 mmol/l; p = NS), A1C (8.14% ± 1.14% vs. 8.14% ± 1.07%; p = NS) or the incidence of self-reported hypoglycaemia (34% vs. 23%; p = NS).
Conclusions: Compared with treatment with Mix25 twice daily, treatment with Mix50 before breakfast and Mix25 before the evening meal resulted in better pp glycaemic control following a carbohydrate-rich meal, and similar fasting BG, A1C and incidence of hypoglycaemia in patients with type 2 diabetes.