- Email: [email protected]
Inflammatory markers and silent myocardial ischemia in type 2 diabetes
abstract
results: After 16 weeks of treatment, similar HbA1c improvements were observed with the highest dose of each albiglutide regimen (-0.87, -0.79 and -0.87% for 30mg weekly, 50mg biweekly and 100mg monthly dosing, respectively, vs placebo -0.17%, p<0.005). Exenatide reduced HbA1c by -0.54%. Improvements in FPG were seen as early as the first assessment (2 weeks) in all albiglutide groups. Although there were similar changes in HbA1c in the highest doses of albiglutide within each dosing schedule, the 100mg monthly regimen resulted in marked fluctuations in FPG between each dose. FPG reductions remained the most consistent over time for 30mg weekly, followed by 50mg biweekly albiglutide, and PK/PD modelling showed a clear relationship between albiglutide exposure and FPG reduction. change From baseline FPG (mmol/L) Week
Placebo
Exenatide
albiglutide 30mg weekly
albiglutide 50mg biweekly
albiglutide 100mg monthly
Baseline
9.9
9.5
9.6
10.0
9.8
2
-0.2
-0.8
-1.4
-1.1
-1.6
4
-0.4
-1.1
-1.4
-1.4
-0.6
5
-0.4
-1.1
-1.5
-2.2
-2.1
7
-0.2
-1.3
-1.5
-1.9
-1.1
8
-0.4
-1.4
-1.6
-1.3
-1.3
9
-0.3
-1.5
-1.5
-1.7
-2.3
12
-0.3
-1.3
-1.9
-1.5
-1.5
15
-0.4
-1.3
-1.5
-1.7
-1.3
16
-0.1
-0.8
-1.4
-1.3
-1.2
conclusion: Albiglutide (30mg weekly, 50mg biweekly, and 100mg monthly) resulted in comparable improvements in HbA1c in patients with type 2 diabetes over 16 weeks. The 30mg weekly dose had the least FPG fluctuation, followed by the 50mg biweekly dose. The stability of the FPG profile over time appeared to be related to more consistent exposure to albiglutide in weekly/biweekly regimens compared with monthly administration, which may be of clinical relevance. Incretin therapies Conflict of interest Stock ownership: M. Bush - GlaxoSmithKline F. Yang - GlaxoSmithKline M. Stewart - GlaxoSmithKline Advisory board: J. Rosenstock - Pfizer, Roche, Sanofi-Aventis, Novo Nordisk, Eli Lilly, Mannkind, GlaxoSmithKline, Takeda, Daiichi Sankyo, Centocor, Johnson & Johnson, Emisphere, Novartis and Amylin. Employee: M. Bush - GlaxoSmithKline F. Yang GlaxoSmithKline M. Stewart - GlaxoSmithKline Commercially-sponsored research: J. Reusch - GlaxoSmithKline, Takeda, Merck, Mannkind Other substantive relationships: J. Reusch - GlaxoSmithKline, Takeda, Amylin, Merck J. Rosenstock - Merck, Pfizer, Sanofi-Aventis, Novo Nordisk, BristolMyers Squibb, Eli Lilly, GlaxoSmithKline, Takeda, Novartis, AstraZeneca, Amylin, Johnson & Johnson, Daiichi Sankyo and Mannkind. P-1417 cream intake induces socs-3 and tLr-4: relevance to pathogenesis of inflammation and insulin resistance R. Deopurkar1, H. Ghanim1, P. Viswanathan1, S. Abuaysheh1, C.L. Sia1, P. Dandona1 1 Millard Fillmore Health System, Endocrinology, Buffalo, USA We have previously shown that the intake of macronutrients induces oxidative and inflammatory stress. Since the suppressor of cytokine signaling (SOCS-3) and toll like receptors 2 and 4 (TLR-2 and TLR-4) are induced by inflammation and since they also lead to interference with insulin signal transduction, we have now investigated whether the intake of cream, which has previously been shown to induce oxidative stress, also leads to the induction of SOCS-3 and TLR-4 along with inflammatory stress. Ten fasting normal subjects were given 33g of cream or water to ingest in 2 separate visits and blood samples were collected at 0, 1, 3 and 5h. Mononuclear cells (MNC) were prepared. Intranuclear NFkB binding (EMSA), SOCS-3 and TLR-4 mRNA and protein expression were measured by RT-PCR and western blots. There was a significant increase in NFkB binding by 57±18% at 3hr following
cream intake. In addition, TNFa and IL-1b mRNA expression in MNC increased significantly following cream intake (by 51±10% and 182±34%, respectively) while there was no change in IL-6 expression. SOCS-3 and TLR-4 mRNA increased significantly by 119±22% and 43±16% (P<0.05), respectively, at 3hr following cream intake while there was no change in SOCS-1 and SOCS-7 or in TLR-2. Consistent with the changes at the mRNA level, cream intake induced a significant increase in SOCS-3 and TLR4 proteins in MNC by 39±16% at 3 hours and by 39±16% at 3 hours, respectively (P<0.05). Water intake caused no change in NFkB binding, SOCS-3 or TLRs expression. Thus, the intake of cream not only induces oxidative stress and inflammation but also induces at two proteins key in the pathogenesis of insulin resistance. Repeated intake of saturated fat potentially contributes not only to atherogenesis but also to insulin resistance. Table 1: Change from baseline (100%) in inflammatory mediators following the intake of Cream (300 Calorie) in 10 normal weight healthy subjects. P*= P value with RMANOVA for within the same treatment comparisons; P# = P value with 2-way RMANOVA compared to water. 1
3
5
P*
P#
NFkB DNA binding
Marker/Hours
140±16
157±18
141±12
0.026
0.036
TNFa mRNA
120±11
151±10
132±13
0.036
0.031
IL-1b mRNA
225±50
282±34
238±31
0.006
0.015
SOCS-3 mRNA
155±10
219±22
174±18
0.012
0.018
SOCS-3 protein
135±17
143±21
122±15
0.037
0.043
TLR-4 mRNA
127±14
143±16
142±14
0.036
0.04
TLR-4 protein
114±8
139±16
131±14
0.039
0.044
Complications - cardiovascular disease No conflict of interest P-1422 Inflammatory markers and silent myocardial ischemia in type 2 diabetes J. Escobedo1, L.V. Buitron1, L.F. Zárate2, F.A. Morales3, E. Espinoza4, A. Méndez4, R. Garcia4, M. Cruz4 1 IMSS, Clinical Research Center, Mexico City, Mexico 2 IMSS, Epidemiology, Ensenada, Mexico 3 IMSS, Cardiology, Mexico City, Mexico 4 IMSS, Biochemisty Research Center, Mexico City, Mexico aims: To measure the strength of association between serum biomarkers of inflammation and silent myocardial ischemia in type 2 diabetes. Methods: The authors have started a screening program for silent myocardial ischemia in asymptomatic subjects with type 2 diabetes. in Mexico. A family medical unit from the Mexican Institute of the Social Security has been selected and all diabetics with no symptoms of coronary heart disease have been invited to participate. A graded exercise test was performed according to the Bruce protocol, following the American College of Cardiology/American Heart Association guidelines. Horizontal or descending ST-segment depression of at least 0.1 mV measured 80 ms after de J-point in 3 consecutive cycles was considered a significant sign of ischemia.To date 152 subjects with silent myocardial ischemia have been identified. In a case-control design they were compared with 371 controls. Controls were randomly selected from the same source population. Fasting venous blood was tested for glucose, total, high and low-density lipoprotein cholesterol, triglycerides, glycosylated hemoglobin and inflammatory markers: intercellular adhesion molecule-1 (I-CAM), vascular cell adhesion molecule-1 (V-CAM), E-selectine, resistin, interferon-gamma, interleukin-6 (IL-6), interleukin-10 (IL-10) and high sensitivity C reactive protein. MannWhitney U was used to compare median values between groups and odds ratio (OR) with 95% confidence intervals (95% CI) were estimated while classifying inflammatory markers into tertiles. A logistic regression model was employed to control for potential confounders.
| 293
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CANADIAN JOURNAL OF DIABETES
results: Median values of I-CAM, V-CAM, E-selectine, resistin, interferon-gamma and IL-6 were significantly higher in cases. In the logistic regression model, adjusting by age, sex and duration of diabetes, an increased risk was observed in the highest serum values tertile of V-CAM (OR 11.31; 95%CI 5.6–22.9) E-selectin (OR 2.90; 95%CI 1.5–5.4), IL-6 (OR 8.11; 95%CI 3.6–18.4) and resistin (OR 1.85; 95%CI 1.0–3.5). A dose–response effect was observed with these inflammatory markers. No relation was observed between silent myocardial ischemia and metabolic control parameters. Discussion: Inflammation plays a major role in atherosclerosis and coronary heart disease, particularly in the context of diabetes. The appreciation of the role of inflammation in silent myocardial ischemia in diabetes, provides insights into its pathogenesis, and offers opportunities for diagnosis and prediction of this subclinical and early manifestation of coronary artery disease, a major complication in type 2 diabetes. Inflammation and diabetes No conflict of interest P-1425 Patient treatment satisfaction after switching to biphasic insulin aspart 30 in the IMProVE™ study M. Brod , P. Valensi , J. Shaban , T. Christensen The Brod Group, Health Outcomes, Mill Valley, USA 2 Jean Verdier Hospital Paris Nord University, Endocrinology Diabetology Nutrition, Paris, France 3 Windsor Regional Hospital, Medicine, Windsor, Canada 4 Novo Nordisk A/S, Market Access, Copenhagen, Denmark 1
2
3
4
1
aims: Treatment satisfaction (TS) is a key patient-reported outcome that may differ between treatments and impacts patient adherence, treatment costs and self-management behaviors. The effect of switching to biphasic insulin aspart 30 (BIAsp 30, NovoMix® 30) and likely confounding factors on TS was examined using data from the IMPROVE study, a multinational, 26-week, open labeled, observational study of the safety and effectiveness of BIAsp 30 for the treatment of type 2 diabetes in routine practice. Methods: Data from 52,419 patients were available, and 18,823 patients (previously on oral agents or on basal or biphasic human insulin) with both baseline and end of study TS observations were included in the analysis. TS was assessed with the validated DiabMedSat questionnaire which examines efficacy, relief of burden, relief of symptoms and overall TS. Independent ANOVAs were performed to examine the influence on TS of pre-treatment factors (age, gender, country, duration of diabetes, prior treatment, diabetes-related comorbidities) and current treatment factors (reaching HbA1c goal, weight gain, hypoglycemic events). results: Patients previously on oral therapy had a mean baseline HbA1c of 9.2% and mean time since diagnosis of 7.4 years; after 26 weeks of BIAsp 30 therapy mean HbA1c dropped to 7.1% (p<0.01) and all TS domains improved (p<0.001). Patients previously on insulin had a mean baseline HbA1c of 9.3% and a mean time since diagnosis of 10.4 years; after 26 weeks mean HbA1c dropped to 7.3% (p<0.01) and all TS domains improved (p<0.001). Although the magnitude of improvement differed by country, patients in all countries had significantly improved TS. Examination of the effect of pre-treatment factors found that higher age was associated with greater levels of satisfaction for overall TS (p<0.001), efficacy (p<0.01) and relief of burden (p<0.001). Patients with a longer duration of diabetes reported greater burden relief (p<0.01), and those with diabetes-related comorbidities had greater TS for relief of symptoms (p<0.001) and burden (p<0.05). Analysis of the impact of side effects and reaching HbA1c goal found that weight gain and minor hypoglycemic events were associated with lower TS in all domains (p<0.001), and of patients who reached their HbA1c goal, 98% also reported relief of burden (p<0.05) and symptoms (p<0.01). Discussion: This analysis shows that BIAsp 30 significantly improved
TS, even in patients previously on oral agents, suggesting that improved management of HbA1c with insulin compared with oral therapy may alleviate the perceived treatment burden of daily insulin use. In addition, treatment side effects should be considered when choosing the preferred insulin as these events significantly impact patient TS. Living with diabetes Conflict of interest Advisory board: M Brod, Novo Nordisk Employee: T Christensen, Novo Nordisk A/S P-1426 Positive impact of biphasic insulin aspart 30/70 (bIasp 30) on physician resources: insights from the IMProVE™ study J. Shaban1, J.G. Gumprecht2, V.K. Knudsen on behalf of the IMPROVE study group expert panel3 1 Windsor Regional Hospital, Department of Medicine Endocrinology and Metabolism, Windsor, Canada 2 Medical University of Silesia, Department of Internal Medicine Diabetology and Nephrology, Zabrze, Poland 3 Novo Nordisk, Department of Statistics, Bagsvaerd, Denmark aims: Regimens that are straightforward to teach and easy for patients to learn offer benefits to physicians, especially where time and resources are limited; this analysis aims to quantify the impact on physician resources of initiating insulin with, or switching patients onto, biphasic insulin aspart 30/70 (BIAsp 30). Methods: IMPROVETM is an international, open-label, 26-week observational study designed to evaluate the safety and effectiveness of use of BIAsp30 in everyday clinical care. Patients with type 2 diabetes on a variety of regimens (n=52,419) were recruited and prescribed BIAsp 30 at the discretion of their physician, and in accordance with local practice. In addition to recording standard clinical endpoints, physicians were also given a series of resource utilisation questions, designed to explore their perceptions and time investment when starting patients on BIAsp30 using cartridges or a prefilled pen. This abstract reports data comprising physicians’ evaluation for each patient initiated onto BIAsp 30. results: The majority of physicians (>80%) found it easy or very easy to introduce BIAsp 30 into their patients’ regimen, with most (88%) being satisfied or very satisfied that BIAsp30 enabled them to achieve their preferred HbA1c target. Most physicians were confident or very confident that patients would continue to maintain good glycaemic control, including post-prandial blood glucose control (89% and 90% respectively). The majority of physicians (97%) stated that they would continue to treat patients in the study with BIAsp30 following its conclusion and overall most (96%) preferred or strongly preferred BIAsp 30 to other insulins. When insulin-naïve patients were considered as a separate subgroup (n=42,368), nurses, physicians and other healthcare practitioners were still able to teach patients to self-inject BIAsp 30 in 10 minutes or less (70%, 80% and 65% respectively), with most able to do so in under 5 minutes. Following this introduction, most physicians (87%) were confident that patients initiated onto insulin with BIAsp30 were able to self-inject correctly. conclusion: BIAsp 30 can be easily introduced into a regimen: explanations could be made simply, and the majority of physicians were confident that their patients were able to follow their prescribed treatment and maintain good glycaemic control. Most patients were initiated onto insulin without the need for formal referral to a diabetes education clinic, thus saving time and expense. These data suggest that BIAsp30 use may support the management of insulin therapy where time and resources are limited, as in primary care practice. Diabetes education delivery Conflict of interest Paid lecturing: JG Gumprecht, speaker’s honoraria from Novo Nordisk Employee: VK Knudsen, employee Novo Nordisk
results: After 16 weeks of treatment, similar HbA1c improvements were observed with the highest dose of each albiglutide regimen (-0.87, -0.79 and -0.87% for 30mg weekly, 50mg biweekly and 100mg monthly dosing, respectively, vs placebo -0.17%, p<0.005). Exenatide reduced HbA1c by -0.54%. Improvements in FPG were seen as early as the first assessment (2 weeks) in all albiglutide groups. Although there were similar changes in HbA1c in the highest doses of albiglutide within each dosing schedule, the 100mg monthly regimen resulted in marked fluctuations in FPG between each dose. FPG reductions remained the most consistent over time for 30mg weekly, followed by 50mg biweekly albiglutide, and PK/PD modelling showed a clear relationship between albiglutide exposure and FPG reduction. change From baseline FPG (mmol/L) Week
Placebo
Exenatide
albiglutide 30mg weekly
albiglutide 50mg biweekly
albiglutide 100mg monthly
Baseline
9.9
9.5
9.6
10.0
9.8
2
-0.2
-0.8
-1.4
-1.1
-1.6
4
-0.4
-1.1
-1.4
-1.4
-0.6
5
-0.4
-1.1
-1.5
-2.2
-2.1
7
-0.2
-1.3
-1.5
-1.9
-1.1
8
-0.4
-1.4
-1.6
-1.3
-1.3
9
-0.3
-1.5
-1.5
-1.7
-2.3
12
-0.3
-1.3
-1.9
-1.5
-1.5
15
-0.4
-1.3
-1.5
-1.7
-1.3
16
-0.1
-0.8
-1.4
-1.3
-1.2
conclusion: Albiglutide (30mg weekly, 50mg biweekly, and 100mg monthly) resulted in comparable improvements in HbA1c in patients with type 2 diabetes over 16 weeks. The 30mg weekly dose had the least FPG fluctuation, followed by the 50mg biweekly dose. The stability of the FPG profile over time appeared to be related to more consistent exposure to albiglutide in weekly/biweekly regimens compared with monthly administration, which may be of clinical relevance. Incretin therapies Conflict of interest Stock ownership: M. Bush - GlaxoSmithKline F. Yang - GlaxoSmithKline M. Stewart - GlaxoSmithKline Advisory board: J. Rosenstock - Pfizer, Roche, Sanofi-Aventis, Novo Nordisk, Eli Lilly, Mannkind, GlaxoSmithKline, Takeda, Daiichi Sankyo, Centocor, Johnson & Johnson, Emisphere, Novartis and Amylin. Employee: M. Bush - GlaxoSmithKline F. Yang GlaxoSmithKline M. Stewart - GlaxoSmithKline Commercially-sponsored research: J. Reusch - GlaxoSmithKline, Takeda, Merck, Mannkind Other substantive relationships: J. Reusch - GlaxoSmithKline, Takeda, Amylin, Merck J. Rosenstock - Merck, Pfizer, Sanofi-Aventis, Novo Nordisk, BristolMyers Squibb, Eli Lilly, GlaxoSmithKline, Takeda, Novartis, AstraZeneca, Amylin, Johnson & Johnson, Daiichi Sankyo and Mannkind. P-1417 cream intake induces socs-3 and tLr-4: relevance to pathogenesis of inflammation and insulin resistance R. Deopurkar1, H. Ghanim1, P. Viswanathan1, S. Abuaysheh1, C.L. Sia1, P. Dandona1 1 Millard Fillmore Health System, Endocrinology, Buffalo, USA We have previously shown that the intake of macronutrients induces oxidative and inflammatory stress. Since the suppressor of cytokine signaling (SOCS-3) and toll like receptors 2 and 4 (TLR-2 and TLR-4) are induced by inflammation and since they also lead to interference with insulin signal transduction, we have now investigated whether the intake of cream, which has previously been shown to induce oxidative stress, also leads to the induction of SOCS-3 and TLR-4 along with inflammatory stress. Ten fasting normal subjects were given 33g of cream or water to ingest in 2 separate visits and blood samples were collected at 0, 1, 3 and 5h. Mononuclear cells (MNC) were prepared. Intranuclear NFkB binding (EMSA), SOCS-3 and TLR-4 mRNA and protein expression were measured by RT-PCR and western blots. There was a significant increase in NFkB binding by 57±18% at 3hr following
cream intake. In addition, TNFa and IL-1b mRNA expression in MNC increased significantly following cream intake (by 51±10% and 182±34%, respectively) while there was no change in IL-6 expression. SOCS-3 and TLR-4 mRNA increased significantly by 119±22% and 43±16% (P<0.05), respectively, at 3hr following cream intake while there was no change in SOCS-1 and SOCS-7 or in TLR-2. Consistent with the changes at the mRNA level, cream intake induced a significant increase in SOCS-3 and TLR4 proteins in MNC by 39±16% at 3 hours and by 39±16% at 3 hours, respectively (P<0.05). Water intake caused no change in NFkB binding, SOCS-3 or TLRs expression. Thus, the intake of cream not only induces oxidative stress and inflammation but also induces at two proteins key in the pathogenesis of insulin resistance. Repeated intake of saturated fat potentially contributes not only to atherogenesis but also to insulin resistance. Table 1: Change from baseline (100%) in inflammatory mediators following the intake of Cream (300 Calorie) in 10 normal weight healthy subjects. P*= P value with RMANOVA for within the same treatment comparisons; P# = P value with 2-way RMANOVA compared to water. 1
3
5
P*
P#
NFkB DNA binding
Marker/Hours
140±16
157±18
141±12
0.026
0.036
TNFa mRNA
120±11
151±10
132±13
0.036
0.031
IL-1b mRNA
225±50
282±34
238±31
0.006
0.015
SOCS-3 mRNA
155±10
219±22
174±18
0.012
0.018
SOCS-3 protein
135±17
143±21
122±15
0.037
0.043
TLR-4 mRNA
127±14
143±16
142±14
0.036
0.04
TLR-4 protein
114±8
139±16
131±14
0.039
0.044
Complications - cardiovascular disease No conflict of interest P-1422 Inflammatory markers and silent myocardial ischemia in type 2 diabetes J. Escobedo1, L.V. Buitron1, L.F. Zárate2, F.A. Morales3, E. Espinoza4, A. Méndez4, R. Garcia4, M. Cruz4 1 IMSS, Clinical Research Center, Mexico City, Mexico 2 IMSS, Epidemiology, Ensenada, Mexico 3 IMSS, Cardiology, Mexico City, Mexico 4 IMSS, Biochemisty Research Center, Mexico City, Mexico aims: To measure the strength of association between serum biomarkers of inflammation and silent myocardial ischemia in type 2 diabetes. Methods: The authors have started a screening program for silent myocardial ischemia in asymptomatic subjects with type 2 diabetes. in Mexico. A family medical unit from the Mexican Institute of the Social Security has been selected and all diabetics with no symptoms of coronary heart disease have been invited to participate. A graded exercise test was performed according to the Bruce protocol, following the American College of Cardiology/American Heart Association guidelines. Horizontal or descending ST-segment depression of at least 0.1 mV measured 80 ms after de J-point in 3 consecutive cycles was considered a significant sign of ischemia.To date 152 subjects with silent myocardial ischemia have been identified. In a case-control design they were compared with 371 controls. Controls were randomly selected from the same source population. Fasting venous blood was tested for glucose, total, high and low-density lipoprotein cholesterol, triglycerides, glycosylated hemoglobin and inflammatory markers: intercellular adhesion molecule-1 (I-CAM), vascular cell adhesion molecule-1 (V-CAM), E-selectine, resistin, interferon-gamma, interleukin-6 (IL-6), interleukin-10 (IL-10) and high sensitivity C reactive protein. MannWhitney U was used to compare median values between groups and odds ratio (OR) with 95% confidence intervals (95% CI) were estimated while classifying inflammatory markers into tertiles. A logistic regression model was employed to control for potential confounders.
| 293
294 |
CANADIAN JOURNAL OF DIABETES
results: Median values of I-CAM, V-CAM, E-selectine, resistin, interferon-gamma and IL-6 were significantly higher in cases. In the logistic regression model, adjusting by age, sex and duration of diabetes, an increased risk was observed in the highest serum values tertile of V-CAM (OR 11.31; 95%CI 5.6–22.9) E-selectin (OR 2.90; 95%CI 1.5–5.4), IL-6 (OR 8.11; 95%CI 3.6–18.4) and resistin (OR 1.85; 95%CI 1.0–3.5). A dose–response effect was observed with these inflammatory markers. No relation was observed between silent myocardial ischemia and metabolic control parameters. Discussion: Inflammation plays a major role in atherosclerosis and coronary heart disease, particularly in the context of diabetes. The appreciation of the role of inflammation in silent myocardial ischemia in diabetes, provides insights into its pathogenesis, and offers opportunities for diagnosis and prediction of this subclinical and early manifestation of coronary artery disease, a major complication in type 2 diabetes. Inflammation and diabetes No conflict of interest P-1425 Patient treatment satisfaction after switching to biphasic insulin aspart 30 in the IMProVE™ study M. Brod , P. Valensi , J. Shaban , T. Christensen The Brod Group, Health Outcomes, Mill Valley, USA 2 Jean Verdier Hospital Paris Nord University, Endocrinology Diabetology Nutrition, Paris, France 3 Windsor Regional Hospital, Medicine, Windsor, Canada 4 Novo Nordisk A/S, Market Access, Copenhagen, Denmark 1
2
3
4
1
aims: Treatment satisfaction (TS) is a key patient-reported outcome that may differ between treatments and impacts patient adherence, treatment costs and self-management behaviors. The effect of switching to biphasic insulin aspart 30 (BIAsp 30, NovoMix® 30) and likely confounding factors on TS was examined using data from the IMPROVE study, a multinational, 26-week, open labeled, observational study of the safety and effectiveness of BIAsp 30 for the treatment of type 2 diabetes in routine practice. Methods: Data from 52,419 patients were available, and 18,823 patients (previously on oral agents or on basal or biphasic human insulin) with both baseline and end of study TS observations were included in the analysis. TS was assessed with the validated DiabMedSat questionnaire which examines efficacy, relief of burden, relief of symptoms and overall TS. Independent ANOVAs were performed to examine the influence on TS of pre-treatment factors (age, gender, country, duration of diabetes, prior treatment, diabetes-related comorbidities) and current treatment factors (reaching HbA1c goal, weight gain, hypoglycemic events). results: Patients previously on oral therapy had a mean baseline HbA1c of 9.2% and mean time since diagnosis of 7.4 years; after 26 weeks of BIAsp 30 therapy mean HbA1c dropped to 7.1% (p<0.01) and all TS domains improved (p<0.001). Patients previously on insulin had a mean baseline HbA1c of 9.3% and a mean time since diagnosis of 10.4 years; after 26 weeks mean HbA1c dropped to 7.3% (p<0.01) and all TS domains improved (p<0.001). Although the magnitude of improvement differed by country, patients in all countries had significantly improved TS. Examination of the effect of pre-treatment factors found that higher age was associated with greater levels of satisfaction for overall TS (p<0.001), efficacy (p<0.01) and relief of burden (p<0.001). Patients with a longer duration of diabetes reported greater burden relief (p<0.01), and those with diabetes-related comorbidities had greater TS for relief of symptoms (p<0.001) and burden (p<0.05). Analysis of the impact of side effects and reaching HbA1c goal found that weight gain and minor hypoglycemic events were associated with lower TS in all domains (p<0.001), and of patients who reached their HbA1c goal, 98% also reported relief of burden (p<0.05) and symptoms (p<0.01). Discussion: This analysis shows that BIAsp 30 significantly improved
TS, even in patients previously on oral agents, suggesting that improved management of HbA1c with insulin compared with oral therapy may alleviate the perceived treatment burden of daily insulin use. In addition, treatment side effects should be considered when choosing the preferred insulin as these events significantly impact patient TS. Living with diabetes Conflict of interest Advisory board: M Brod, Novo Nordisk Employee: T Christensen, Novo Nordisk A/S P-1426 Positive impact of biphasic insulin aspart 30/70 (bIasp 30) on physician resources: insights from the IMProVE™ study J. Shaban1, J.G. Gumprecht2, V.K. Knudsen on behalf of the IMPROVE study group expert panel3 1 Windsor Regional Hospital, Department of Medicine Endocrinology and Metabolism, Windsor, Canada 2 Medical University of Silesia, Department of Internal Medicine Diabetology and Nephrology, Zabrze, Poland 3 Novo Nordisk, Department of Statistics, Bagsvaerd, Denmark aims: Regimens that are straightforward to teach and easy for patients to learn offer benefits to physicians, especially where time and resources are limited; this analysis aims to quantify the impact on physician resources of initiating insulin with, or switching patients onto, biphasic insulin aspart 30/70 (BIAsp 30). Methods: IMPROVETM is an international, open-label, 26-week observational study designed to evaluate the safety and effectiveness of use of BIAsp30 in everyday clinical care. Patients with type 2 diabetes on a variety of regimens (n=52,419) were recruited and prescribed BIAsp 30 at the discretion of their physician, and in accordance with local practice. In addition to recording standard clinical endpoints, physicians were also given a series of resource utilisation questions, designed to explore their perceptions and time investment when starting patients on BIAsp30 using cartridges or a prefilled pen. This abstract reports data comprising physicians’ evaluation for each patient initiated onto BIAsp 30. results: The majority of physicians (>80%) found it easy or very easy to introduce BIAsp 30 into their patients’ regimen, with most (88%) being satisfied or very satisfied that BIAsp30 enabled them to achieve their preferred HbA1c target. Most physicians were confident or very confident that patients would continue to maintain good glycaemic control, including post-prandial blood glucose control (89% and 90% respectively). The majority of physicians (97%) stated that they would continue to treat patients in the study with BIAsp30 following its conclusion and overall most (96%) preferred or strongly preferred BIAsp 30 to other insulins. When insulin-naïve patients were considered as a separate subgroup (n=42,368), nurses, physicians and other healthcare practitioners were still able to teach patients to self-inject BIAsp 30 in 10 minutes or less (70%, 80% and 65% respectively), with most able to do so in under 5 minutes. Following this introduction, most physicians (87%) were confident that patients initiated onto insulin with BIAsp30 were able to self-inject correctly. conclusion: BIAsp 30 can be easily introduced into a regimen: explanations could be made simply, and the majority of physicians were confident that their patients were able to follow their prescribed treatment and maintain good glycaemic control. Most patients were initiated onto insulin without the need for formal referral to a diabetes education clinic, thus saving time and expense. These data suggest that BIAsp30 use may support the management of insulin therapy where time and resources are limited, as in primary care practice. Diabetes education delivery Conflict of interest Paid lecturing: JG Gumprecht, speaker’s honoraria from Novo Nordisk Employee: VK Knudsen, employee Novo Nordisk