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Effects of Rapid-Acting Insulin Analogues Insulin Glulisine And Endocrine Journal 2015, 62 (5), 411-416 ORIGINAL Effects of rapid-acting insulin analogues insulin glulisine and insulin aspart on postprandial glycemic excursion with single bout of exercise in patients with type 2 diabetes Nagaaki Tanaka and Yoshikazu Hiura Department of Diabetes, Osaka City Juso Hospital, Osaka, Japan Abstract. The analogue insulin glulisine (Glu) shows both more rapid onset and shorter duration of action compared with the other rapid-acting insulin analogues. The current study investigates these properties in regard to the occurrence of hypoglycemia related to exercise. A randomized, single-center, open-label, crossover study was conducted in 12 hospitalized type 2 diabetes patients (all male, mean ± SD age of 51.9 ± 11.3 years; BMI: 25.5 ± 3.9 kg/m2; HbA1c: 11.2 ± 2.4 %). Glu or insulin aspart (Asp) was subcutaneously administered just before breakfast. Insulin dosage was determined as the usual dose of pre-prandial rapid-acting insulin for patients treated with insulin therapy or as 0.1 unit/kg for patients treated with oral anti-hyperglycemic agents. Sixty min after the start of eating, the patients began aerobic exercise on a bicycle ergometer for 30 min at 50% of maximum heart rate. Hypoglycemic episodes (plasma glucose level < 70 mg/dL with or without symptoms) were observed more frequently in Asp group (p < 0.05). Post-exercise plasma glucose levels at 90, 120, and 150 min were significantly lower in Asp group (p < 0.05). In patients with BMI < 25 kg/m2 (n = 6), post- exercise blood glucose levels were significantly lower in Asp group (p < 0.05), while in patients with BMI ≥ 25 kg/m2 (n = 6) the difference was not significant. Glu may therefore be a suitable choice of rapid-acting insulin for patients with type 2 diabetes who are at high risk of post-exercise hypoglycemia. Key words: Glulisine, Exercise, Hypoglycemia INTENSIVE INSULIN THERAPY (IIT) is one of T2DM are encouraged to perform at least 150 min/ the important and fundamental therapeutic strategies week of moderate-intensity aerobic physical activ- for patients with type 2 diabetes mellitus (T2DM) ity (50–70% of maximum heart rate), spread over at [1]. While IIT is an established therapeutic strategy least 3 days/week with and no more than 2 consecu- to achieve target glycemia, hypoglycemia is still the tive days without exercise [1]. Physical activity may major barrier to an optimal outcome. Severe hypogly- increase the risk of hypoglycemia if medication dose cemia was associated with increased mortality in par- or supplementary carbohydrate intake is not altered in ticipants in both the standard and intensive glycemia patients with T2DM who are taking insulin and/or insu- arms of the ACCORD trial [2]. However, the rela- lin secretagogues. Accordingly, for individuals on these tionships between the achieved HbA1c and treatment therapies, supplementary carbohydrate ingestion is rec- intensity were not straightforward [3]. An associa- ommended if pre-exercise glucose levels are 100 mg/dL tion of severe hypoglycemia with increased mortality (5.6 mmol/L) or exercise is of longer duration than 30 was also found in the ADVANCE trial [4]. In addi- min. It may be difficult to avoid post-exercise hypogly- tion, an association of self-reported severe hypogly- cemia by having additional snacks or modifying insulin cemia with 5-year mortality has also been reported in dose just before exercise. Several lines of rapid-acting clinical practice [5, 6]. According to the ADA position insulin analogues have become available such as insu- statement of exercise recommendation, people with lin lispro (Lis), insulin aspart (Asp) and insulin gluli- Submitted Dec. 20, 2014; Accepted Feb. 6, 2015 as EJ14-0610 sine (Glu) that may be used to address this problem. Released online in J-STAGE as advance publication Feb. 21, 2015 Glu is a recombinant human insulin analogue in which Correspondence to: Nagaaki Tanaka, Department of Diabetes, asparagine at position B3 has been replaced by lysine, Osaka City Juso Hospital, 2-12-27, Nonakakita, Yodogawa-ku, and lysine at position B29 has been replaced by glu- Osaka, 532-0034, Japan. E-mail: [email protected] tamic acid. Because of these modifications, Glu shows ©The Japan Endocrine Society 412 Tanaka et al. Fig. 1 Study design and protocol Glu, insulin glulisine; Asp, insulin aspart both more rapid and sharp onset and somewhat shorter chased with the study grant. Insulin was injected sub- duration of action compared with the other rapid-act- cutaneously around the periumbilical region of the ing insulin analogues [7, 8]. To date, no study has been abdomen using a syringe with a needle of 30 G (BD conducted to directly assess the glucose excursions that Lo-DoseTM, Becton Dickinson, Franklin Lakes, NJ, occur during aerobic exercise sessions in the treatment USA, catalogue no. 326668) by a diabetes special- with Glu or Asp in T2DM patients. The characteris- ist. Sixty min after the breakfast, the patients began tic features of rapid onset and short duration of action aerobic exercise on a bicycle ergometer for 30 min at of Glu might reduce the occurrence of hypoglycemia 50% of maximum heart rate, and then took rest until during exercise. In the present study, we investigated the end of the study period. Exercise prescriptions the effect of Glu and Asp on hypoglycemic episodes in were provided to the patients using the Karvonen for- T2DM patients who were encouraged to perform aero- mula. Blood samples were collected intravenously at bic exercise. 0, 15, 30, 60, 90, 120, 150, 180, 210 and 240 min after the meal. Within 2 to 4 days, the same procedure was Materials and Methods repeated using the alternative insulin analogues with the same dosage (Fig. 1). Hypoglycemia was deter- A randomized, single-center, open-label, crossover mined as blood glucose level < 70 mg/dL with or with- study was conducted in 12 hospitalized male patients out symptoms. All patients gave their written informed with T2DM (the Japan Diabetes Society criteria of consent and the study protocol was approved by the 2010 [9]). Randomization was conducted according to Ethics Committee of Osaka City Juso Hospital. The the order of study attendance. Sixteen patients were results were expressed as means ± standard deviation. recruited to the study, but 4 patients could not complete Paired Student’s t-test and Chi-square test were used to the study due to the violation of the study protocol. detect the statistical significance of differences, andp < Finally, 12 patients (7 patients started with Glu and 5 0.05 was considered as statistically significant. patients started with Asp) completed the study. Glu or Asp was subcutaneously administered just before stan- Results dard Japanese-style breakfast (530 kcal: 55% carbohy- drate, 20% protein and 25% fat) in the morning. In Clinical characteristics of participants enrolled in patients with IIT, insulin dosage of each patient was the study are shown in Table 1. All patients were male, determined as the ordinary dose of pre-prandial rapid- age: 51.9 ± 11.3 years; mean duration of diabetes: 4.4 acting insulin. On the other hand, dosage of insulin ± 4.3 years; BMI: 25.5 ± 3.9 kg/m2; HbA1c: 11.2 ± 2.4 was determined as 0.1 unit/kg for patients treated with %; fasting PG: 105.6 ± 23.2 mg/dL; and fasting CPR: oral anti-hyperglycemic drugs (OADs). Vials of Glu 1.2 ± 0.7 ng/mL. Target heart rate for ergometer exer- (Apidra, Sanofi, Paris, France) and Asp (Novorapid, cise was 113.5 ± 8.9 bpm. Six patients were treated Novo-Nordisk, Copenhagen, Denmark) were pur- with intensive insulin therapy, four with OADs, one Glulisine vs aspart with exercise 413 Table 1 Characteristics of patients enrolled in the study (n = 12) Subgroups Total BMI < 25 kg/m2 BMI ≥ 25 kg/m2 N / Sex 12 / all male 6 6 Age (years) 51.9 ± 11.3 53.5 ± 9.7 50.3 ± 13.4 Duration (years) 4.4 ± 4.3 4.8 ± 4.7 3.9 ± 4.2 Height (cm) 166.9 ± 8.3 166.3 ± 6.8 167.6 ± 10.2 Weight (kg) 71.1 ± 12.5 61.4 ± 7.9 80.8 ± 7.5 BMI (kg/m2) 25.5 ± 3.9 22.1 ± 1.4* 28.8 ± 2.3 HbA1c (%) 11.2 ± 2.4 11.7 ± 2.7* 10.7 ± 2.2 Fasting PG (mg/dL) 105.6 ± 23.2 110.9 ± 29.8 100.3 ± 13.4 Fasting CPR (ng/mL) 1.2 ± 0.7 1.3 ± 1.0 1.1 ± 0.4 Insulin dose for the study (units) 6.9 ± 1.3 7.0 ± 1.7 6.8 ± 0.9 6: IIT, 4: OAD, 3: IIT, 2: OAD, 6: IIT, 2: OAD, Therapeutic regimen 1: BOT, 1:liraglutide 1: BOT 1:liraglutide Data are shown as the mean ± SD. IIT, intensive insulin therapy; OADs, oral antihyperglycemic drugs; BOT, basal insulin plus oral agents. *: p < 0.01 vs BMI ≥ 25 kg/m2. with basal insulin plus OADs and one with liraglutide. sodes was symptomatic nor considered as severe as to All the study participants were hospitalized due to their require assistance from another person. In patients with poor glycemic control. Therefore we could not start the BMI < 25 kg/m2 (n = 6), post-exercise plasma glucose study until their plasma glucose levels were stabilized. levels were significantly lower in Asp group at 90, 120 Exam 1 was started in 17.8 ± 3.3 days after admission. and 150 min than in Glu group (p < 0.05). However, in Moreover, to minimize the glycemic effect of single subjects with BMI ≥ 25 kg/m2 (n = 6) the difference was bout of exercise and to equalize the glycemic condition minimal (Fig.
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