Target HbA1c Value Research Articles

Sitagliptin: A novel agent for the management of type 2 diabetes mellitus

The pharmacologic, pharmacokinetic, safety, clinical efficacy, and role of sitagliptin in the management of type 2 diabetes mellitus are reviewed. Sitagliptin is a dipeptidyl-peptidase IV (DPP4) inhibitor that increases insulin release and decreases glucagon levels by preventing the activation of incretin hormones--glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide. The clinical trials reviewed provide evidence that sitagliptin, either alone or in combination with metformin or thiazolidinediones, is effective in reducing glycosylated hemoglobin (HbA(1c)), fasting plasma glucose, and two-hour postprandial glucose levels in patients with type 2 diabetes. Specifically, sitagliptin has a role in patients who have been compliant with their oral hypoglycemic agents but unable to attain target HbA(1c) values with monotherapy and lifestyle modifications. Sitagliptin is generally well tolerated, with the frequency of adverse events being similar to placebo and a low frequency of hypoglycemia. Sitagliptin does not appear to alter the pharmacokinetics of metformin, rosiglitazone, glyburide, simvastatin, warfarin, or oral contraceptives. The addition of sitagliptin to a patient's oral antidiabetic regimen would necessitate close monitoring for adverse events and possible drug interactions. The sitagliptin dosage recommended by the manufacturer is 100 mg once daily as monotherapy or in combination with metformin or a thiazolidinedione. No formal pharmacoeconomic evaluations of sitagliptin therapy have been conducted. Sitagliptin, a DPP4 inhibitor, offers a novel treatment option for patients with type 2 diabetes mellitus.

Glycemic control over 3 years in a young adult clinic for patients with type 1 diabetes

ObjectiveTo evaluate the effect of specialized young adult diabetes clinic (YAC) on glycemic control in a young adult patients with type 1 diabetes (DM1) transitioning from pediatric to adult diabetes care. Research design and methodsHbA1c was retrospectively analyzed through 3 years in 15–25 y/o DM1 patients entering a YAC, and compared to similar patients entering general endocrine clinics (GEC) in a university diabetes center. ResultsNinety-six patients were seen in the YAC, compared to 153 patients in the GEC. No difference in HbA1c was seen at entry (YAC 9.0±2.3% versus 8.8±2.3%). HbA1c did not change over time in either clinic (mean 3-year HbA1c 8.6±2.1% in YAC versus 8.4±2.3% in GEC). When the HbA1c values were divided into tertiles, no differences in distribution of baseline HbA1c were seen. Within the highest tertile, the YAC had a greater fall in HbA1c, compared to the GEC. Pump users from both clinics had HbA1c values 1% lower at each time point. ConclusionsYoung adults with DM1 continue to have difficulty achieving target HbA1c values. Earlier use of pump therapy and a specialized YAC for those with the worst glycemic control will benefit this population.

Prevalence of Cardiovascular Risk Factors in Middle-Aged Type 2 Diabetic Automobile Employees Assessed at the Workplace—The Praeford Study

The purpose of this study was to provide contemporary data on the prevalence of cardiovascular risk factors in middle-aged diabetic employees in Germany. Cardiovascular risk factors were assessed at the workplace in employees of the automobile industry who identified themselves as having type 2 diabetes mellitus. The proportion of subjects reaching the target values for hemoglobin A1c (HbA1c), systolic blood pressure, and low-density lipoprotein (LDL) cholesterol was analyzed. Among 4234 employees, 91 employees with diabetes were identified (mean age, 52 years). Only 7 of 91 (8%) diabetic employees achieved all three recommended target values. Blood pressure targets were achieved by 26%, HbA1c target value by 54%, and LDL target value by 31% of employees. Only a negligible proportion of working people with diabetes achieve the recommended target values. This sobering result questions current management modalities and calls for new treatment and monitoring strategies for working people with diabetes.

Improvement in Glycemic Excursions With a Transcutaneous, Real-Time Continuous Glucose Sensor

Hypoglycemia and wide glucose excursions continue to be major obstacles to achieving target HbA(1c) values and the associated reductions in long-term complications (and economic costs) in people with insulin-treated diabetes. In this study we evaluated the accuracy, safety, and clinical effectiveness of a continuous glucose-sensing device. A total of 91 insulin-requiring patients with type 1 (n = 75) and type 2 (n = 16) diabetes were enrolled in this multicenter randomized study. Subjects wore a transcutaneous, 3-day, continuous glucose-sensing system for three consecutive 72-h periods. Subjects were randomly assigned (1:1 ratio) to either a control group (continuous glucose data not provided) or a display group (continuous glucose data not provided during period 1 but displayed during periods 2 and 3). During periods 2 and 3, patients in the display group had real-time access to sensor glucose values, could review glucose trends over the preceding 1, 3, and 9 h, and were provided with high (> or = 200 mg/dl) and low (< or = 80 mg/dl) alerts and a low (< or = 55 mg/dl) alarm. Sensors were inserted by patients, and both groups used (or wore) the system during daily activities. Device accuracy was assessed by comparing continuous glucose values to paired self-monitoring of blood glucose (SMBG) meter readings. Clinical effectiveness was evaluated by analyzing between-group (control vs. display, periods 2 and 3) and within-group (display, period 1 vs. period 3) differences in time spent in high, low, and target (81-140 mg/dl) glucose zones. When prospective, real-time sensor values were compared with SMBG values, 95.4% of 6,767 paired glucose values fell within Clarke error grid A and B zones. Pearson's correlation coefficient was 0.88, and mean and median absolute relative differences were 21.2 and 15.9%, respectively. No systematic bias was detected at any of the prespecified glucose levels (50, 80, 100, 150, and 200 mg/dl). When compared with control subjects, the display group spent 21% less time as hypoglycemic (<55 mg/dl), 23% less time as hyperglycemic (> or = 240 mg/dl), and 26% more time in the target (81-140 mg/dl) glucose range (P < 0.001 for each comparison). Nocturnal (10:00 p.m. to 6:00 a.m.) hypoglycemia, as assessed at two thresholds, was also reduced by 38% (<55 mg/dl; P < 0.001) and 33% (55-80 mg/dl; P < 0.001) in the display group compared with control subjects. We conclude that real-time continuous glucose monitoring for periods up to 72 h is accurate and safe in insulin-requiring subjects with type 1 and type 2 diabetes. This study demonstrates that availability of real-time, continuously measured glucose levels can significantly improve glycemic excursions by reducing exposure to hyperglycemia without increasing the risk of hypoglycemia, which may reduce long-term diabetes complications and their associated economic costs.

Consensus statement on diabetes control in preparation for pregnancy

The Medical Journal of Australia ISSN: 0025729X 20 September 2004 181 6 326-326 ©The Medical Journal of Australia 2004 www.mja.com.au Consensus statement in February 2004) on diabetes control for wome or type 2 diabetes who are preparing for pregnan Women planning pregnancy should aim t a target HbA1c value of <7% (where t limit of the normal range for people diabetes is <6%) (If the normal range for people without d specified otherwise, the target HbA level he (N in T National Diabetes in Pregnancy Advisory Committee DIPAC) is a multidisciplinary committee established November 2000 by the Commonwealth Department of Health and Aged Care as part of the National Diabetes Strategy. On behalf of the NDIPAC, we present the first Australian consensus statement (endorsed by the Committee n with type 1 cy: o achieve he upper without

Initiating Insulin Therapy in Type 2 Diabetes

Safety and efficacy of biphasic insulin aspart 70/30 (BIAsp 70/30, prebreakfast and presupper) were compared with once-daily insulin glargine in type 2 diabetic subjects inadequately controlled on oral antidiabetic drugs (OADs). This 28-week parallel-group study randomized 233 insulin-naive patients with HbA(1c) values >/=8.0% on >1,000 mg/day metformin alone or in combination with other OADs. Metformin was adjusted up to 2,550 mg/day before insulin therapy was initiated with 5-6 units BIAsp 70/30 twice daily or 10-12 units glargine at bedtime and titrated to target blood glucose (80-110 mg/dl) by algorithm-directed titration. A total of 209 subjects completed the study. At study end, the mean HbA(1c) value was lower in the BIAsp 70/30 group than in the glargine group (6.91 +/- 1.17 vs. 7.41 +/- 1.24%, P < 0.01). The HbA(1c) reduction was greater in the BIAsp 70/30 group than in the glargine group (-2.79 +/- 0.11 vs. -2.36 +/- 0.11%, respectively; P < 0.01), especially for subjects with baseline HbA(1c) >8.5% (-3.13 +/- 1.63 vs. -2.60 +/- 1.50%, respectively; P < 0.05). More BIAsp 70/30-treated subjects reached target HbA(1c) values than glargine-treated subjects (HbA(1c) </=6.5%: 42 vs. 28%, P < 0.05; HbA(1c) <7.0%: 66 vs. 40%, P < 0.001). Minor hypoglycemia (episodes/year) was greater in the BIAsp 70/30 group than in the glargine group (3.4 +/- 6.6 and 0.7 +/- 2.0, respectively; P < 0.05). Weight gain and daily insulin dose at study end were greater for BIAsp 70/30-treated subjects than for glargine-treated subjects (weight gain: 5.4 +/- 4.8 vs. 3.5 +/- 4.5 kg, P < 0.01; insulin dose: 78.5 +/- 39.5 and 51.3 +/- 26.7 units/day, respectively). In subjects with type 2 diabetes poorly controlled on OADs, initiating insulin therapy with twice-daily BIAsp 70/30 was more effective in achieving HbA(1c) targets than once-daily glargine, especially in subjects with HbA(1c) >8.5%.

Consensus statement on diabetes control in preparation for pregnancy

The Medical Journal of Australia ISSN: 0025729X 20 September 2004 181 6 326-326 ©The Medical Journal of Australia 2004 www.mja.com.au Consensus statement in February 2004) on diabetes control for wome or type 2 diabetes who are preparing for pregnan Women planning pregnancy should aim t a target HbA1c value of <7% (where t limit of the normal range for people diabetes is <6%) (If the normal range for people without d specified otherwise, the target HbA level he (N in T National Diabetes in Pregnancy Advisory Committee DIPAC) is a multidisciplinary committee established November 2000 by the Commonwealth Department of Health and Aged Care as part of the National Diabetes Strategy. On behalf of the NDIPAC, we present the first Australian consensus statement (endorsed by the Committee n with type 1 cy: o achieve he upper without

Beneficial Effects of Continuous Subcutaneous Insulin Infusion and Flexible Multiple Daily Insulin Regimen Using Insulin Glargine in Type 1 Diabetes

The aim of this study was to evaluate the metabolic effects of continuous subcutaneous insulin infusion (CSII) with flexible multiple daily insulin (FMDI; premeal lispro + bedtime glargine) therapy as determined by glycosylated hemoglobin (HbA1c), body mass index (BMI), and hypoglycemic episodes in a group of patients who made the transition from multiple daily insulin (premeal lispro + bid ultralente) to either CSII or FMDI therapy. Data from 40 (27 female and 13 male) patients (10.1-17.8 years of age) who were on CSII and 40 age- and gender-matched (27 female and 13 male) patients (10.3-17.3 years of age) who were on FMDI were collected during regularly scheduled visits at a similar frequency over a 1-year period. The total daily insulin dose did not change in CSII (0.97 +/- 0.24 vs 0.91 +/- 0.22 U/kg) and FMDI (0.98 +/- 0.21 vs 0.97 +/- 0.21 U/kg) patients, whereas the bolus:basal insulin ratio was significantly increased in both CSII (1.01 +/- 0.43 vs 1.32 +/- 0.52) and FMDI (1.07 +/- 0.0.41 vs 1.29 +/- 0.47) patients. The total cohort of CSII patients showed a decrease in HbA1c from 8.4 +/- 1.0% to 7.8 +/- 0.8%, whereas the FMDI cohort did not show a significant change in HbA1c (8.5 +/- 1.1% to 8.2 +/- 0.9%). However, 40% of the CSII group and 22.5% of the FMDI group showed > or =1.0% improvement in HbA1c. Also, a similar number of patients in CSII (52.5%; 8.0 +/- 1.1 to 7.2 +/- 0.5%) and FMDI (47.5%; 8.0 +/- 0.5% to 7.5 +/- 0.4%) maintained or achieved target HbA1c values <8.0%. The BMI increased significantly in the CSII group (21.6 +/- 3.2 vs 23.0 +/- 3.0 kg/m2) but did not change in the FMDI group (21.9 +/- 3.9 vs 22.6 +/- 3.8 kg/m2). There was a significant reduction in the rate of severe hypoglycemia (events/100 patient-years) in both cohorts: 20.6 to 8.2 in the CSII and 18.8 to 7.5 in the FMDI. Similarly, the rate of moderate hypoglycemia decreased in both CSII (68.3-35.4) and FMDI (56.3-30.4). CSII therapy resulted in a significant improvement in HbA 1c in the entire group, whereas FMDI therapy improved HbA1c in only a subgroup of patients. However, almost half of the patients in each of the treatment groups maintained or achieved target glycemic control. Both CSII and FMDI treatment groups demonstrated a decreased rate of hypoglycemia without an abnormal increase in BMI. Although the design of this study does not allow direct comparison of the metabolic effects of CSII and FMDI therapies, both regimens seem to be superior to basal ultralente and lispro multiple daily insulin regimen and offer desirable therapeutic alternatives in pediatric diabetes care.

Field test of a group education program for type 2 diabetes: measures and predictors of success on individual and group levels

We performed field testing of a previously described group education program for type 2 diabetes. HbA 1c levels at start, 6 and 12 months were collected and demographic factors examined to identify predictors of long-term glycemic control on individual and group levels. “Glycemic success” comprised of (1) achieving target values of HbA 1c≤6.5% and/or (2) decreasing HbA 1c progressively, depending on initial values. Groups in the field test and previous pilot-study ( N=105) decreased their mean HbA 1c significantly after 6 months, implying that diabetes mass education led by pharmacists could be possible in the future. Target HbA 1c≤6.5% was seen in 51% at start and 63% after 12 months ( P=0.023). Initial HbA 1c and BMI were the most important success predictors; age, sex, duration, and civil status showed no effects. Overweight individuals relapsed after initially decreasing their HbA 1c, emphasizing the need for long-term support in weight management. Experienced loneliness affected outcomes, indicating interaction between diet self-care and social relations.

Assessment of glycaemic control in stable type 2 black South African diabetics attending a peri-urban clinic

Glycaemic control was assessed in type 2 black diabetics attending the diabetic clinic at a peri-urban hospital. Baseline glycosylated haemoglobin levels were measured and a subsequent estimation was carried out...