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Comparison of an Insulin Analog, Insulin Aspart, and Regular Human Insulin with No Insulin in Gestational Diabetes Mellitus

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Comparison of an Insulin Analog, Insulin Aspart, and Regular Human Insulin with No Insulin in Gestational Diabetes Mellitus Pathophysiology/Complications ORIGINAL ARTICLE Comparison of an Insulin Analog, Insulin Aspart, and Regular Human Insulin With No Insulin in Gestational Diabetes Mellitus 1 2 DAVID J. PETTITT, MD JERZEY W. KOLACZYNSKI, MD, PHD tion measured after eating has been 1 1 PAULINA OSPINA, MHS LOIS JOVANOVIC, MD recommended because of fear of hypogly- cemia due to the peak action of human regular insulin. Because the peak post- prandial glucose concentration is 1 h after eating (11), a rapid-acting insulin analog OBJECTIVE — To assess the short-term efficacy of insulin aspart in comparison with regular that reaches peak concentration at about human insulin in women with gestational diabetes mellitus (GDM) during standardized meal 1 h after injection would be ideal. Data on tests. nonpregnant diabetic patients document that the rapid-acting insulin analog, insu- RESEARCH DESIGN AND METHODS — The study included 15 women with GDM who had inadequate diabetes control with diet alone. On 3 consecutive days, breakfast meal tests lin aspart, peaks at 40 to 60 min after in- were performed—the first with no exogenous insulin and the other two after the injection of jection and thus can be used to blunt the either regular insulin or insulin aspart. peak postprandial glucose concentrations (15). Before insulin aspart can be pre- RESULTS — The peak insulin concentration was higher and the peak glucose and C-peptide scribed in pregnancy, the safety and effi- concentrations were lower with both insulin preparations than with no exogenous insulin. cacy of this insulin analog will need to be Glucose areas under the curve above baseline were significantly lower with insulin aspart (180- studied. The aim of this article is to doc- ⅐ ⅐ –1 ϭ ⅐ ⅐ –1 ϭ min area, 7.1 mg h dl ; P 0.018), but not with regular insulin (30.2 mg h dl ; P 0.997), ument the short-term efficacy of insulin ⅐ ⅐ –1 than with no insulin (29.4 mg h dl ). aspart in pregnant women during a stan- dardized meal. CONCLUSIONS — This study demonstrates that effective postprandial glycemic control in women with GDM who required insulin was brought about by insulin aspart through higher insulin peak and lower demand on endogenous insulin secretion. RESEARCH DESIGN AND METHODS — Women with GDM Diabetes Care 26:183–186, 2003 who had been unable to control their glu- cose concentrations with diet and exer- cise, and were therefore candidates for estational diabetes mellitus (GDM), cation clearly associated with GDM is insulin therapy, were recruited to partic- defined as “carbohydrate intoler- macrosomia (5), which occurs at rates as ipate in a randomized trial of either insu- ance of varying degrees of severity high as 40% of neonates in untreated lin aspart or regular human insulin (Table G 1). Before insulinization, three 4-h break- with onset or first recognition during GDM (6). In addition, neonatal macroso- pregnancy” (1,2), occurs in nearly 4% of mia is associated with the metabolic syn- fast meal tests were administered, when- all pregnancies in the U.S., but the actual drome of hyperinsulinemia and ever possible, on 3 consecutive days. The prevalence differs with ethnicity and ma- deposition of fat in the visceral cavity (7). Table 1—Characteristics of study partici- ؍ ternal age (3). Women with high blood The literature suggests that the risk of glucose concentrations experience greater macrosomia rises as maternal glycemia in- pants (n 15) risk of adverse maternal and fetal out- creases (8–10). Specifically, the risk of comes, including preeclampsia, cesarean macrosomia appears to increase with in- Mean Ϯ SE Range delivery, macrosomia, congenital anoma- creasing postprandial glucose concentra- Ϯ lies, and increased risk for future devel- tions (11–13). Traditionally, in the Age at enrollment 31.9 1.9 20.4–46.5 (years) opment of type 2 diabetes (4). The most guidelines for care of nonpregnant dia- Ϯ common and significant neonatal compli- betic patients (14), a glucose concentra- Height (cm) 156.1 1.6 149.0–173.5 Prepregnancy 65.5 Ϯ 3.9 51.8–102.3 ●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●● weight (kg)* 2 Ϯ From the 1Sansum Medical Research Institute, Santa Barbara, California; and 2Novo Nordisk Pharmaceuti- BMI (kg/m ) 26.8 1.5 21.4–41.2 cals, Inc., Princeton, New Jersey. Fasting plasma 93.5 Ϯ 3.4 76.0–120.0 Address correspondence and reprint requests to David J. Pettitt, MD, Sansum Medical Research Institute, glucose† 2219 Bath St., Santa Barbara, CA 93105. E-mail: [email protected]. Gravity 2.8 Ϯ 0.4 1–7 Received for publication 17 May 2002 and accepted in revised form 26 September 2002. Ϯ Abbreviations: AUC, area under the curve; GDM, gestational diabetes mellitus. Parity 1.7 0.4 0–6 A table elsewhere in this issue shows conventional and Syste`me International (SI) units and conversion *Data missing for one participant. †At baseline meal factors for many substances. test. DIABETES CARE, VOLUME 26, NUMBER 1, JANUARY 2003 183 Insulin aspart in GDM Table 2 —Glucose, insulin, and C-peptide during three meal tests No exogenous insulin Regular insulin Insulin aspart Time Glucose Insulin C-peptide Glucose Insulin C-peptide Glucose Insulin C-peptide (min) (mg/dl) (␮U/ml) (ng/ml) (mg/dl) (␮U/ml) (ng/ml) (mg/dl) (␮U/ml) (ng/ml) Ϫ30 93.7 Ϯ 3.1 14.4 Ϯ 3.6 2.5 Ϯ 0.4 93.0 Ϯ 2.5 16.7 Ϯ 3.1 2.3 Ϯ 0.2 94.3 Ϯ 2.7 15.2 Ϯ 2.9 2.6 Ϯ 0.4 0 93.5 Ϯ 3.4 14.6 Ϯ 3.3 2.5 Ϯ 0.4 89.6 Ϯ 2.5 18.2 Ϯ 3.8* 2.5 Ϯ 0.4 93.0 Ϯ 2.6 14.6 Ϯ 3.1† 2.6 Ϯ 0.4 15 91.7 Ϯ 2.7 16.0 Ϯ 2.8 2.5 Ϯ 0.3 87.3 Ϯ 3.0‡ 28.1 Ϯ 6.9‡ 2.5 Ϯ 0.4 90.5 Ϯ 2.6 20.0 Ϯ 2.9‡ 2.6 Ϯ 0.3 30 101.7 Ϯ 2.9 37.4 Ϯ 3.9 4.0 Ϯ 0.4 101.8 Ϯ 2.9 51.5 Ϯ 7.4‡ 4.2 Ϯ 0.4 102.2 Ϯ 3.8 56.1 Ϯ 6.5* 4.2 Ϯ 0.4 60 122.8 Ϯ 3.0 72.3 Ϯ 9.7 6.8 Ϯ 0.7 115.8 Ϯ 2.9‡ 84.7 Ϯ 10.8‡ 5.8 Ϯ 0.4 111.6 Ϯ 3.9* 95.9 Ϯ 10.9* 5.5 Ϯ 0.3‡ 90 112.8 Ϯ 2.8 53.9 Ϯ 8.6 6.2 Ϯ 0.6 108.4 Ϯ 2.6‡ 68.2 Ϯ 10.4‡ 5.8 Ϯ 0.5 103.3 Ϯ 4.3‡ 77.4 Ϯ 8.8* 5.4 Ϯ 0.5 120 102.5 Ϯ 2.5 35.6 Ϯ 6.2 5.4 Ϯ 0.7 100.6 Ϯ 2.5 55.2 Ϯ 9.4* 5.4 Ϯ 0.6 93.1 Ϯ 3.5* 51.7 Ϯ 9.8* 4.8 Ϯ 0.7 180 85.1 Ϯ 2.1 20.0 Ϯ 4.1 3.9 Ϯ 0.5 79.9 Ϯ 2.6‡ 26.9 Ϯ 4.5‡ 3.1 Ϯ 0.4 72.5 Ϯ 3.4*† 24.6 Ϯ 4.6 2.7 Ϯ 0.4*† 240 74.7 Ϯ 1.7 11.2 Ϯ 3.0 2.6 Ϯ 0.5 66.7 Ϯ 2.0* 18.8 Ϯ 3.3* 1.8 Ϯ 0.4* 65.5 Ϯ 2.0* 15.4 Ϯ 1.9‡ 1.5 Ϯ 0.2*† Data are means Ϯ SE. *P ϭ 0.01; †P Ͻ 0.05 vs. meal using regular human insulin; ‡P Ͻ 0.05 vs. meal with no exogenous insulin. meal, which was plain yogurt (Alta Dena, lated at 120, 180, and 240 min. Paired t ing each of the three meal tests and was City of Industry, CA), contained 11 g fat, tests were used to compare the insulin significantly lower during the meal in 19 g carbohydrate, and 12 g protein per and glucose areas and the glucose, insu- which no exogenous insulin was admin- cup (227 g) and was topped with one-half lin, and C-peptide concentrations at each istered (72.6 Ϯ 9.7 ␮U/ml [mean Ϯ SE]) sliced banana. This meal comprised time point. than with either regular insulin (84.7 Ϯ ϳ40% carbohydrate, 20% protein, and Fifteen women who met the criteria 10.8 ␮U/ml; t ϭ 2.35, P ϭ 0.034 com- 40% fat and was calculated to provide for inclusion in the study participated in pared with no insulin) or insulin aspart 20% of the woman’s daily caloric require- all three meal tests. During one meal test, (95.9 Ϯ 10.9 ␮U/ml; t ϭ 3.6, P ϭ 0.009). ment. The same volume of yogurt was the intravenous catheter ceased to func- The insulin concentrations are plotted in given for each of the three meal tests. On tion after the 60-min sample was col- Fig. 1. In contrast, serum C-peptide peak day 1, a baseline meal was consumed lected, and subsequent phlebotomy by and overall response were lower after in- without any exogenous insulin. On day 2, venipuncture was unsuccessful. Conse- jection of insulin aspart (5.5 ng/ml) than each woman was randomly assigned to quently, blood was not obtained from one after no insulin (6.8 ng/ml; t ϭ 2.40, P ϭ take either regular human insulin or insu- woman for glucose measurements after 0.031).
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