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ABSTRACT: To evaluate treatment patterns associated with diabetes medication regimen changes after hospitalization on the basis on preadmission hemoglobin A1c levels.
In this retrospective database analysis, patients with a diabetes diagnosis, hospitalization, and documented hemoglobin A1c level within the 90 days leading up to hospital admission were identified in an administrative claims database. Treatment regimens were assessed before and after hospitalization. The proportion of patients who had progression, reduction, or no change in therapy was compared across hemoglobin A1c subgroups: hemoglobin A1c <7.0%, hemoglobin A1c 7.0%-7.9%, and hemoglobin A1c ≥8.0%.
Four hundred patients were included (192 in hemoglobin A1c <7.0% group, 94 in hemoglobin A1c 7.0%-7.9% group, and 114 in hemoglobin A1c ≥8.0% group). Demographically, hemoglobin A1c subgroups did not differ significantly (mean age, 57 years; 47.5% male). With respect to therapeutic regimen overall, 28%, 24%, and 48% of patients experienced progression, reduction, and no change, respectively. Across hemoglobin A1c subgroups, 37.7% of patients in the hemoglobin A1c ≥8.0% subgroup had therapy progression compared with 26% and 20.2% in the hemoglobin A1c <7.0% and hemoglobin A1c 7.0%-7.9% subgroups, respectively (P = .032 and P = .006, respectively). Within the progression category, progression via insulin initiation was significantly higher in the hemoglobin A1c ≥8.0% subgroup (55.8%) than in the hemoglobin A1c <7.0% subgroup (16%, P<.001), but not significantly higher than in the hemoglobin A1c 7.0%-7.9% subgroup (36.8%, P = .084). In the hemoglobin A1c ≥8.0% subgroup, a lower percentage of patients, 35.1%, experienced no therapy change than in both the hemoglobin A1c <7.0% subgroup (52.6%) and the hemoglobin A1c 7.0%-7.9% subgroup (54.3%) (P = .003 and P = .006, respectively). There was no difference between subgroups in reduction of therapy.
A higher proportion of patients with a hemoglobin A1c level ≥8.0% had progression of their antidiabetes therapy after hospitalization and fewer patients had no change in therapy than those in lower hemoglobin A1c subgroups. These data suggest that clinicians may be using hemoglobin A1c measurements to guide discharge planning treatment decisions.
Endocrine Practice 05/2012; 18(3):371-5. · 2.49 Impact Factor
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ABSTRACT: Endpoint HbA(1c) <7.0% was achieved by 80 (73.4%) lispro mix 25 (LM25)-treated patients and 67 (60.9%) glargine-treated patients (p=0.027) with baseline 1,5 anhydroglucitol (1,5AG) below median and 75 (70.8%) LM25-treated patients and 72 (63.7%) glargine-treated patients (p=0.238) with 1,5AG≥median, suggesting, 1,5AG may offer therapeutic insight when starting insulin therapy.
Diabetes research and clinical practice 03/2012; 96(3):e66-9. · 2.16 Impact Factor
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ABSTRACT: To compare outcomes in patients with type 2 diabetes initiating insulin lispro mix 75/25 (75% insulin lispro protamine suspension and 25% lispro) or insulin glargine therapy, stratified by baseline oral antihyperglycemic agent (OHA) use.
We performed a post hoc analysis of 6-month data from the DURABLE clinical trial, which enrolled patients with hemoglobin A1c (A1C) levels >7.0% treated with 2 or more OHAs (metformin, sulfonylurea, and thiazolidinedione), and randomly assigned them to treatment with twice-daily insulin lispro 75/25 or once-daily glargine.
In both insulin treatment groups, metformin/thiazolidinedione-treated patients had significantly greater improvement in A1C levels (-2.19% to -2.36%), lower end point A1C values, and lower rates of occurrence of hypoglycemia in comparison with metformin/sulfonylurea-treated patients (all P<.05). Patients treated with sulfonylurea/thiazolidinedione or metformin/sulfonylurea/thiazolidinedione did not differ significantly from metformin/sulfonylurea-treated patients in A1C change (-1.56% to -1.84%) or rates of occurrence of hypoglycemia.
In these post hoc analyses, patients with type 2 diabetes initiating premixed or basal insulin therapy and treated concomitantly with the OHA combination of metformin/thiazolidinedione at baseline demonstrated significantly greater A1C improvement with less hypoglycemia in comparison with patients treated with metformin/sulfonylurea.
Endocrine Practice 05/2011; 17(4):563-7. · 2.49 Impact Factor
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ABSTRACT: This study compared the durability of glycemic control of twice-daily insulin lispro mix 75/25 (LM75/25: 75% insulin lispro protamine suspension/25% lispro) and once-daily insulin glargine, added to oral antihyperglycemic drugs in type 2 diabetes patients.
During the initiation phase, patients were randomized to LM75/25 or glargine. After 6 months, patients with A1C ≤ 7.0% advanced to the maintenance phase for ≤ 24 months. The primary objective was the between-group comparison of duration of maintaining the A1C goal.
Of 900 patients receiving LM75/25 and 918 patients receiving glargine who completed initiation, 473 and 419, respectively, had A1C ≤ 7.0% and continued into maintenance. Baseline characteristics except age were similar in this group. Median time of maintaining the A1C goal was 16.8 months for LM75/25 (95% CI 14.0-19.7) and 14.4 months for glargine (95% CI 13.4-16.8; P = 0.040). A1C goal was maintained in 202 LM75/25-treated patients (43%) and in 147 glargine-treated patients (35%; P = 0.006). No differences were observed in overall, nocturnal, or severe hypoglycemia. LM75/25 patients had higher total daily insulin dose (0.45 ± 0.21 vs. 0.37 ± 0.21 units/kg/day) and more weight gain (5.4 ± 5.8 vs. 3.7 ± 5.6 kg) from baseline. Patients taking LM75/25 and glargine with lower baseline A1C levels were more likely to maintain the A1C goal (P = 0.043 and P < 0.001, respectively).
A modestly longer durability of glycemic control was achieved with LM75/25 compared with glargine. Patients with lower baseline A1C levels were more likely to maintain the goal, supporting the concept of earlier insulin initiation.
Diabetes care 02/2011; 34(2):249-55. · 8.09 Impact Factor
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ABSTRACT: To examine changes in patient-reported outcome (PRO) measures in patients with type 2 diabetes (T2DM) on oral agents who initiated insulin (insulin lispro mix 25/75 [LM25] or insulin glargine) in the DURABLE trial (n=580).
Subjects completed generic and diabetes-specific health-related quality-of-life measures (RAND-36 and Diabetes-39) and a symptom assessment measure (DSC-Revised) at baseline and 6 months post insulin initiation. Mean score change was evaluated. Effect size (ES; Cohen's d) and analysis of covariance were used to examine extent and significance of change both within and between treatment groups.
Subject characteristics were mean age 57 years, males 59%, duration of diabetes 9.6 years, and baseline HbA1c 8.9%. In the total sample, significant (P<0.01) improvements (with small ES) were observed in four of eight RAND-36 subscales (ES range: 0.13-0.24), three of five Diabetes-39 subscales (ES range: 0.09-0.34), and five of eight DSC-Revised subscales (ES range: 0.15-0.38). While significance of within-group changes varied by treatment, only one subscale (physical functioning for LM25) showed deterioration. The changes were not significantly different (P>0.01) between regimens for any subscales.
Our findings suggest that insulin initiation improves selective PRO in patients with poorly controlled T2DM.
Diabetes research and clinical practice 08/2010; 89(2):157-66. · 2.16 Impact Factor
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ABSTRACT: Insulin glargine and lispro mix 75/25 (75% insulin lispro protamine suspension and 25% insulin lispro injection [LM75/25]) represent 2 common starter insulin regimen classes: basal and premixed. After initiation of starter insulin therapy, if patients with type 2 diabetes mellitus (DM) are unable to achieve a glycosylated hemoglobin (HbA1c) level <7.0%, insulin intensification may be indicated. The DURABLE (Assessing Durability of Basal Versus Lispro Mix 75/25 Insulin Efficacy) trial was designed to compare initiating insulin therapy with analogue basal insulin versus premixed analogue insulin in patients unable to achieve good glycemic control while taking multiple oral antihyperglycemic drugs (OADs).
To provide objective information about insulin intensification, the DURABLE trial also included a substudy evaluating a systematic approach to advancing insulin therapy in those patients who did not achieve glycemic control with their initial insulin regimen. This substudy, the results of which are reported here, tested the hypothesis that advancing insulin therapy with premixed insulin is noninferior to basal-bolus therapy (BBT) in patients with type 2 DM unable to achieve an HbA1c level < or = 7.0% after 6 months of starter insulin therapy.
In the main DURABLE study, 2091 patients (age range, 30-80 years) with type 2 DM and HbA1c values >7.0% receiving > or = 2 OADs were randomized to receive insulin glargine (n = 1046) or LM75/25 (n = 1045), both in combination with prestudy OADs. After 6 months, patients with HbA1c levels >7.0% could enter this intensification substudy; OADs except sulfonylureas were continued. Patients originally receiving insulin glargine were enrolled in intensification arm A and were randomized to receive BBT (insulin glargine once daily plus mealtime insulin lispro TID) or LM75/25 BID. Patients originally receiving LM75/25 were enrolled in intensification arm B and randomized to receive BBT or mealtime 50% insulin lispro protamine suspension and 50% insulin lispro injection (LM50/50) TID. Insulin doses were adjusted based on preprandial plasma glucose levels. The primary end point was noninferiority of premixed therapy versus BBT with respect to end-point HbA1c. Secondary end points included change in HbA1c and weight, percentage of patients reaching HbA1c target levels, total daily insulin dose, and rates of hypoglycemia. The safety profile was also assessed.
Of the 475 patients in the insulin glargine + OAD arm of the main study who had HbA1c levels >7.0% at 6 months, 399 (84%) entered intensification arm A. The mean age was 57 years, 53% of the patients were male, and mean (SD) HbA1c was 8.0% (1.0%) at baseline. Of those patients, 199 were randomly assigned to receive BBT and 200 were assigned to receive LM75/25. Of the 411 patients in the LM75/25 + OAD arm of the main study who had an HbA1c level >7.0% at 6 months, 345 (84%) entered intensification arm B. The mean age was 55 years, 51% of the patients were male, and mean (SD) HbA1c was 8.0% (0.9%) at baseline. Of those patients, 171 were randomly assigned to receive BBT and 174 were assigned to receive LM50/50. At end point, noninferiority of LM75/25 or LM50/50 to BBT was supported, with a 95% CI of -0.10 to 0.37 and -0.25 to 0.25, respectively. At 6 months, HbA1c did not differ significantly from baseline in any group. Regardless of treatment group, <20% of patients achieved an HbA1c level <7.0%. There were no significant differences between groups in total daily insulin dose, weight gain, incidence or rate of hypoglycemia, or incidence of serious adverse events.
No group had significant improvement from baseline in HbA1c. Our study results suggest that premixed therapy, dosed 2 times per day (LM75/25) or 3 times per day (LM50/50), was noninferior to BBT (4 injections/d) in this population of adult patients with type 2 DM previously uncontrolled with OADs plus basal insulin or twice-daily premixed insulin. Clinical-Trials.gov identifier: NCT00279201.
Clinical Therapeutics 05/2010; 32(5):896-908. · 2.32 Impact Factor
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ABSTRACT: In non-critical care settings, patients with hyperglycemia experience increased morbidity and mortality. Despite an increased recognition of the importance of treating inpatient hyperglycemia, many patients are still not adequately controlled. Insulin offers flexibility to address varying glucose levels and therefore is the preferred therapy to achieve recommended targets and manage hyperglycemia. Traditional sliding-scale insulin regimens often ineffectively control blood glucose levels as they are unable to mimic physiologic insulin secretion. Basal-bolus insulin regimens are recognized as a more effective way to correct hyperglycemia in non-critical care settings and a systematic glycemic control program is necessary to address hyperglycemia while minimizing hypoglycemia. Critical components of these programs include addressing barriers to glycemic control, understanding varying needs of different types of patients, and developing standardized subcutaneous insulin orders to achieve target glucose levels. This article provides strategies for using insulin in non-critical care settings to facilitate glycemic control.
Postgraduate Medicine 01/2010; 122(1):153-62. · 1.78 Impact Factor
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ABSTRACT: To compare the ability of two starter insulin regimens to achieve glycemic control in a large, ethnically diverse population with type 2 diabetes.
During the initiation phase of the DURABLE trial, patients were randomized to a twice-daily lispro mix 75/25 (LM75/25; 75% lispro protamine suspension, 25% lispro) (n = 1,045) or daily glargine (GL) (n = 1,046) with continuation of prestudy oral antihyperglycemic drugs.
Baseline A1C was similar (LM75/25: 9.1 +/- 1.3%; GL: 9.0 +/- 1.2%; P = 0.414). At 24 weeks, LM75/25 patients had lower A1C than GL patients (7.2 +/- 1.1 vs. 7.3 +/- 1.1%, P = 0.005), greater A1C reduction (-1.8 +/- 1.3 vs. -1.7 +/- 1.3%, P = 0.005), and higher percentage reaching A1C target <7.0% (47.5 vs. 40.3%, P < 0.001). LM75/25 was associated with higher insulin dose (0.47 +/- 0.23 vs. 0.40 +/- 0.23 units x kg(-1) x day(-1), P < 0.001) and more weight gain (3.6 +/- 4.0 vs. 2.5 +/- 4.0 kg, P < 0.0001). LM75/25 patients had a higher overall hypoglycemia rate than GL patients (28.0 +/- 41.6 vs. 23.1 +/- 40.7 episodes x pt(-1) x year(-1), P = 0.007) but lower nocturnal hypoglycemia rate (8.9 +/- 19.3 vs. 11.4 +/- 25.3 episodes x pt(-1) x year(-1), P = 0.009). Severe hypoglycemia rates were low in both groups (LM75/25: 0.10 +/- 1.6 vs. GL: 0.03 +/- 0.3 episodes x pt(-1) x year(-1), P = 0.167).
Compared with GL, LM75/25 resulted in slightly lower A1C at 24 weeks and a moderately higher percentage reaching A1C target <7.0%. Patients receiving LM75/25 experienced more weight gain and higher rates of overall hypoglycemia but lower rates of nocturnal hypoglycemia. Durability of regimens will be evaluated in the following 2-year maintenance phase.
Diabetes care 03/2009; 32(6):1007-13. · 8.09 Impact Factor
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ABSTRACT: Recent studies have reported hemoglobin A(1c) (A1c) differences across racial/ethnic groups. Our diverse population allows for further investigation of potential differences in measurements of glycemia.
Our objectives were to describe and explore baseline racial/ethnic differences in self-monitored plasma glucose profiles, A1c, and 1,5-anhydroglucitol (1,5-AG) in patients with type 2 diabetes enrolled in the Assessing DURAbility of Basal vs. Lispro Mix 75/25 Insulin Efficacy trial.
The trial enrolled 2094 patients with type 2 diabetes, ages 30-80 yr, from 11 countries.
Estimated mean plasma glucose (MPG), A1c, and 1,5-AG were compared among racial/ethnic groups before and after adjusting for factors affecting glycemia: age, sex, duration of diabetes, body mass index, and MPG.
Baseline estimated MPG +/- sd was 220.0 +/- 82.0 mg/dl, mean A1c was 9.0 +/- 1.3%, and 1,5-AG was 5.0 +/- 4.1microg/ml. Estimated MPG did not differ between Caucasian and non-Caucasian groups. A1c was higher in Hispanics (9.4 +/- 1.4%; P < 0.001), Asians (9.2 +/- 1.4%; P < 0.01), and patients of other racial/ethnic groups (9.7 +/- 1.5%; P < 0.001) compared with Caucasians (8.9 +/- 1.2%). Paradoxically, 1,5-AG was higher for Asian (5.7 +/- 4.6 microg/ml) and African patients (6.2 +/- 5.4 microg/ml) vs. Caucasians (4.9 +/- 3.9 microg/ml) (P < 0.01). After adjusting for factors affecting glycemia, A1c was higher (all P <or= 0.002) in Hispanics, Asians, Africans, and patients of other racial/ethnic groups, and 1,5-AG was higher in Asian and African patients (P < 0.001) vs. Caucasians.
There were differences in A1c and 1,5-AG, but not MPG, among racial/ethnic groups. Comparisons of glycemia across racial/ethnic groups using these parameters may be problematic due to inherent biological variability and methodological issues.
The Journal of clinical endocrinology and metabolism 03/2009; 94(5):1689-94. · 6.50 Impact Factor
