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Randomized Controlled Clinical Trial of Glargine Versus Ultralente Insulin in the Treatment of Type 1 Diabetes

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Randomized Controlled Clinical Trial of Glargine Versus Ultralente Insulin in the Treatment of Type 1 Diabetes Clinical Care/Education/Nutrition ORIGINAL ARTICLE Randomized Controlled Clinical Trial of Glargine Versus Ultralente Insulin in the Treatment of Type 1 Diabetes 1 1 YOGISH C. KUDVA, MD, MBBS JULIE A. GEBEL, RN poglycemia (1). In the past, ultralente or 1 2 ANANDA BASU, MD DEBRA A. VOGELSANG, NP NPH insulin were commonly used to pro- 1 1 GREGORY D. JENKINS, MS STEVEN A. SMITH, MD vide basal insulin concentrations (2). 2 1 GUILLERMO M. PONS, MD ROBERT A. RIZZA, MD 1 1 More recently, glargine has been LORI L. QUANDT, RN WILLIAM L. ISLEY, MD shown to be an effective basal insulin preparation. Several studies have shown that when compared with NPH insulin, use of glargine as a basal insulin prepara- OBJECTIVE — Multiple daily insulin injection programs are commonly accompanied by tion results in comparable or lower HbA considerable glycemic variation and hypoglycemia. We conducted a randomized crossover 1c design clinical trial to compare glargine with ultralente insulin as a basal insulin in type 1 concentrations and lower frequency of diabetes. nocturnal hypoglycemia (3). However, the observation that nocturnal hypoglyce- RESEARCH DESIGN AND METHODS — To determine whether the use of glargine mia was lower with glargine than NPH insulin as a basal insulin would result in a comparable HbA1c and less glycemic variation and insulin is not particularly surprising since hypoglycemia than ultralente insulin, 22 individuals (aged 44 Ϯ 14 years [ϮSD], 55% men) with insulin concentrations peak 6–8 h after type 1 diabetes who were experienced with multiple daily insulin injections and had an HbA1c Ͻ injection (i.e., in the middle of the night) of 7.8% were randomized in a crossover design to receive either glargine or ultralente as the when NPH insulin is injected at bedtime. basal insulin for 4 months. Aspart insulin was used as the prandial insulin. Physicians providing insulin dose adjustment advice were masked to the type of basal insulin. Ultralente has also been used as a basal insulin preparation (4). While beef- Ϯ Ϯ pork ultralente is essentially peakless and RESULTS — Treatment with glargine resulted in lower mean HbA1c (6.82 0.13 vs. 7.02 0.13, difference: 0.2 Ϯ 0.08, P ϭ 0.026), less nocturnal variability (plasma glucose 49.06 Ϯ 4.74 lasts at least 24 h, (5), human ultralente vs. 62.36 Ϯ 5.21 mg/dl, P ϭ 0.04), and less hypoglycemia (24.5 Ϯ 2.99 vs. 31.3 Ϯ 4.04 events, peaks at 12–16 h (6) and has been re- P ϭ 0.05), primarily due to less daytime hypoglycemia (P ϭ 0.002). On the other hand, serious ported to be more variable than glargine hypoglycemia and average glucose concentration measured with continuous subcutaneous glu- (7). Therefore, use of glargine as a basal cose monitoring did not differ. insulin for people with type 1 diabetes CONCLUSIONS — We conclude that while use of either ultralente or glargine as a basal may result in better glycemic control, less insulin can result in excellent glycemic control, treatment with glargine is associated with slightly glycemic variability, and a lower fre- quency of hypoglycemia. If so, glargine is but significantly lower HbA1c and less nocturnal glycemic variability and hypoglycemia. a better basal insulin than ultralente. If Diabetes Care 28:10–14, 2005 not, since ultralente is considerably less expensive than glargine, its continued use to treat type 1 diabetes may be a reason- ype 1 diabetes is characterized by slowly absorbed “basal” insulin prepara- able option. The present experiments ad- severe insulin deficiency. Injection tion can lower HbA1c to values that are dressed these questions. T of rapidly absorbed insulin before close to those observed in nondiabetic in- each meal and intraprandial and noctur- dividuals. However, near normalization nal coverage with a continuous subcuta- of HbA1c is accompanied by a substantial RESEARCH DESIGN AND neous insulin infusion or injection of a increase in the prevalence of serious hy- METHODS — The Mayo Institutional ●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●● Review Board approved all procedures. Twenty-four subjects with type 1 diabetes 1 2 From the Division of Endocrinology, Mayo Clinic, Rochester, Minnesota; and the Division of Endocrinol- participated in the study. Subjects were ogy, Immanuel St. Joseph’s Clinic, Mayo Health Care System, Mankato, Minnesota. Address correspondence and reprint requests to Yogish C. Kudva, MD, MBBS, W18A, Division of Endo- aged 18 years or older, with HbA1c crinology, Diabetes, Nutrition & Metabolism, Mayo Clinic, 200 First St., SW Rochester, MN 55905. E-mail: Ͻ7.8% and fasting C-peptide concentra- [email protected]. tion Ͻ200 pmol/l. All subjects were using Received for publication 4 August 2004 and accepted in revised form 8 October 2004. a multiple daily injection insulin pro- Y.C.K. has received grant/research support from Aventis and Medtronic. R.A.R. has received honoraria/ consulting fees from and has been on an advisory panel for Aventis and Novo Nordisk. gram, with glargine or ultralente as the Abbreviations: CGMS, continuous subcutaneous glucose monitoring. basal insulin preparation and a rapid- A table elsewhere in this issue shows conventional and Syste`me International (SI) units and conversion acting insulin at the time of enrollment. factors for many substances. All were in good health and had been pre- © 2005 by the American Diabetes Association. The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby viously instructed in the principles of in- marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact. sulin dose adjustment. 10 DIABETES CARE, VOLUME 28, NUMBER 1, JANUARY 2005 Kudva and Associates Table 1—Demographics and disease vari- ables at baseline of patients enrolled in trial Variables Values Demographics Men 10% (45.5) Women 12% (54.6) Age (years) 43 (24–72) BMI (kg/m2) 25.9 (21.0–36.5) Figure 1—Flow of patients through the trial. Diabetes history Duration of diabetes 16 (3–54) (years) Age at onset (years) 24 Ϯ 2.8 acting and basal insulin preparations and trations on seven occasions in a 24-h Metabolic control at supplementation of short-acting insulin. period at the end of every month. In ad- baseline Following randomization, endocri- dition, CGMS was used to measure glu- Ϯ nologists, blinded to the patients’ treat- HbA1c (%) 6.94 0.14 cose concentrations every 5 min over a Data are means Ϯ SE, n (%), or median (range). ment allocation, assisted patients in 72-h period at the start of the study and at titrating the dose of the basal insulin to the end of each 4-month period. The ac- achieve fasting, premeal, and bedtime curacy of CGMS was confirmed by inde- Blinding glucose values of 80–120 mg/dl. The ti- pendently measuring plasma glucose tration period was continued until ade- The study was designed as a randomized, using the patient’s meter every 6 h. Using quate (in the investigator’s judgment) partially blind, crossover clinical trial. the software MiniMed Solutions version glycemic control had been achieved. Sub- The primary end point was end-of- 2.0B, all measurements analyzed had a jects continued on the same basal insulin treatment-period HbA . At enrollment, correlation between the meter and sensor 1c for a total of 16 weeks in each arm. Then all patients started on aspart insulin as the Ն patients crossed over, followed the same readings of 0.79, with absolute differ- prandial insulin. All enrolled subjects Յ titration procedure, and used the other ences 28%. The time interval from were randomized at a central location to basal insulin agent for 16 weeks. 11:00 P.M. to 6:00 A.M. constituted the treatment with glargine or ultralente as nocturnal period. the basal insulin. Subjects were given the Hypoglycemia. Hypoglycemia was de- insulin preparations by a trial coordina- Data analyses fined as symptoms suggestive of hypo- tor. Investigators involved in insulin dose Glycemic control and variability. HbA1c glycemia with simultaneous capillary adjustment were blinded to patient allo- was measured in a central reference labo- blood glucose Ͻ60 mg/dl during self- cation to the treatment arms. Conversion ratory by high-performance liquid chro- monitoring of blood glucose. Serious from the prior basal insulin was made on matography (Biorad, Hercules, CA) by hypoglycemia was defined as symptoms a unit-by-unit basis. Basal insulin was personnel blinded to allocation. Fasting consistent with severe hypoglycemia given at bedtime. Before randomization, and preprandial meal glucose measure- requiring third-party assistance with cap- subjects underwent 3 days of continuous ments were downloaded from memory Ͻ subcutaneous glucose monitoring glucometers. Variability in glucose mea- illary blood glucose 50 mg/dl. Hypogly- (CGMS; Medtronic, MiniMed, North- surements was assessed by two different cemia-related quality of life was assessed ridge, CA). A certified diabetes educator techniques. We used the method that Ser- using the Fear of Hypoglycemia Ques- reviewed the principles of self-moni- vice et al. (8) described to quantify glyce- tionnaire at the start and end of the study toring of blood glucose and provided mic variability termed mean amplitude (9). This questionnaire quantifies fear of guidelines for dose adjustments of short- glycemic variation using glucose concen- hypoglycemia in type 1 diabetes. Table 2—Glycemic end points during trial On glargine On ultralente Glargine-ultralente P Mean glycemia* 154.11 Ϯ 9.97 145.54 Ϯ 8.24 8.57 Ϯ 6.76 0.2309 Fasting glucose* 155.28 Ϯ 13.99 190.99 Ϯ 23.25 Ϫ35.70 Ϯ 15.97 0.0471 Preevening meal glucose* 167.56 Ϯ 16.82 146.28 Ϯ 11.83 21.28 Ϯ 10.88 0.0763 The mean amplitude glycemic variation 110.49 Ϯ 7.26 113.02 Ϯ 9.19 Ϫ2.53 Ϯ 9.31 0.7885 (7-point glucose readings) CGMS mean values 138.36 Ϯ 5.84 148.21 Ϯ 6.07 Ϫ9.85 Ϯ 6.64 0.1530 CGMS (ϮSD) 59.05 Ϯ 3.66 66.07 Ϯ 3.99 Ϫ7.02 Ϯ 3.67 0.0695 CGMS nocturnal values (ϮSD) 49.06 Ϯ 4.74 62.36 Ϯ 5.21 Ϫ13.29 Ϯ 5.91 0.0360 Data are means Ϯ SE, unless otherwise indicated.
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