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CD2-1 Efficacy and safety of sitagliptin or rosiglitazone when added to ongoing metformin therapy in patients with Type 2diabetes
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DIABETES RESEARCH A N D CLINICAL PRACTICE
CD1-4 Increasing fruit and vegetable consumption – a multipronged intervention (“Fresh for Less” campaign) Amanda Dunlop 1 , Rob McNeill 2 , Sarah Appleton 2 , Brandon Orr-Walker 1 1 ”Let’s Beat Diabetes”, Counties Manukau District Health Board, 2 School of Population Health, University of Auckland, Auckland, New Zealand Introduction: Fruit and vegetable consumption is positively linked with good health, and has been encouraged in public health promotion (“5 + A Day”). Findings from the Let’s Beat Diabetes baseline survey (2007) were that people knew fruit and vegetables were good for their health but weren’t eating daily recommended amounts. Price, time required to prepare or cook vegetables and knowing how to prepare and cook vegetables were identified as key barriers. The 8 week Fresh for Less campaign was designed specifically to address these barriers via pricing incentives, promotion and health education by health providers (via in-store cooking demonstrations and recipe cards). Detailed sales data from intervention supermarkets, customer and stakeholder interviews will be used to evaluate the effectiveness of the campaign. Aims: To assess whether pricing incentives, promotion and health education (via in-store cooking demonstrations and recipe cards) results in increased fresh fruit and vegetable consumption. To assess whether supermarket stores are viable settings for health promotion and education activity. Method: Sales data from intervention supermarkets in the Counties Manukau district will be compared with comparative control supermarkets. Sales volumes 8 weeks prior to the intervention, the 8 weeks of the intervention, and 8 weeks following the intervention will be collated. Pricing incentives, promotions and health education is staggered for specific vegetables and fruit over four fortnightly intervals. Comparison of data prior and during the intervention and between intervention and control supermarkets will be made. Consumption patterns after the intervention will also be analysed. Structured interviews with customers will be undertaken to attain qualitative information in regards to intervention, and its impact on their shopping behaviour. Structured interviews with key stakeholders will also be undertaken to attain qualitative information on intervention process and outcomes. Results: the analysis will compare differences between the pre-intervention measures and intervention measures and between the intervention and control supermarkets including sales volumes generally, and specifically for the fruit and vegetables featured during the intervention. Any long-term effects will be assessed in the post-intervention period. Qualitative findings from the interviews will be presented, including impact of the intervention on behaviour and perceptions on the value of health education provision within supermarkets.
CD2-1 Efficacy and safety of sitagliptin or rosiglitazone when added to ongoing metformin therapy in patients with Type 2 diabetes Russell Scott, Tom Loeys, Michael J. Davies, Samuel S. Engel Lipid and Diabetes Research Group, Christchurch Hospital, Christchurch, New Zealand, Merck Research Laboratories, Rahway, NJ, USA Background and aims: The addition of sitagliptin, a dipeptidyl peptidase-4 inhibitor, or rosiglitazone, a PPARγ agonist, to ongoing metformin therapy was assessed in patients with Type 2 diabetes who were inadequately controlled (HbA1c ≥7% and ≤11%) on metformin monotherapy.
79 (2008) S1 – S127
Material and methods: After a screening diet/exercise run-in, a metformin dose titration/stabilization period, and a 2-week, single-blind, placebo run-in, 272 patients receiving ongoing metformin (≥1500 mg/day) were randomized to receive the addition of once-daily placebo, sitagliptin 100 mg, or rosiglitazone 8 mg in a 1:1:1 ratio for 18 weeks. The efficacy analysis was based on an all-patients-treated population using an ANCOVA with change in HbA1c from baseline as the primary endpoint. Results: The mean baseline HbA1c was 7.7% in these patients. After 18 weeks, both active add-on therapies led to significant reductions from baseline in HbA1c : -0.73% for sitagliptin and -0.79% for rosiglitazone compared with a -0.22% reduction from baseline for placebo (p<0.001; difference between the sitagliptin and rosiglitazone groups = 0.06% [95% CI: -0.14, 0.25]). The proportion of patients achieving an HbA1c <7% was significantly (p<0.01) greater in the sitagliptin (55%) and rosiglitazone (63%) groups compared to the placebo group (38%). Treatment with sitagliptin or rosiglitazone produced a significant change from baseline in fasting plasma glucose (FPG) relative to placebo (difference from placebo of -1.0 mmol/L and -1.7 mmol/L, respectively, p<0.001; difference between the sitagliptin and rosiglitazone groups = 0.7 mmol/L [95% CI: 0.2, 1.3]). Following a standard meal, treatment with sitagliptin or rosiglitazone significantly reduced the 2-hour postprandial glucose (PPG) from baseline relative to placebo (difference from placebo of -1.7 mmol/L and -2.6 mmol/L, respectively, p<0.001; difference between sitagliptin and rosiglitazone groups = 0.9 mg/dL [95% CI: 0.02, 1.8]). The incremental increase in 2-hour PPG was also significantly different for sitagliptin or rosiglitazone relative to placebo (p<0.05; difference between sitagliptin and rosiglitazone groups = 0.1 mg/dL [95% CI: -0.5, 0.7]). The change in body weight from baseline was significantly (p<0.001) less with sitagliptin (-0.4 kg) and placebo (-0.9 kg) groups relative to the rosiglitazone (+1.5 kg) group. Sitagliptin provided a reduction relative to placebo in LDL-C (-5.3%, p = NS), while rosiglitazone led to an increase in LDL-C relative to placebo (+9.5%, p<0.05), for a difference between sitagliptin and rosiglitazone of -14.8% (95% CI: -23.9, -5.7). Both active treatments were generally well tolerated, with no increased risk of hypoglycemia or gastrointestinal adverse events compared to placebo. Conclusion: In this 18-week study, the addition of sitagliptin was effective and well-tolerated in patients with Type 2 diabetes who had inadequate glycemic control on metformin monotherapy, and also produced similar reductions in HbA1c without weight gain compared to rosiglitazone.
CD2-2 Efficacy and safety of repaglinide in combination with metformin in Type 2 diabetes inadequately controlled with oral anti-diabetic drugs Guang-wei Li 1 , Wei-ping Jia 2 , Chang-yu Pan 3 , Xiao-hui Guo 4 , Da-jin Zou 5 1 Department of Endocrinology, Peking China-Japan Friendship Hospital, Beijing, China, 2 Department of Endocrinology, Shanghai No.6 People Hospital, Shanghai, China, 3 Department of Endocrinology, Chinese PLA General Hospital, Beijing, China, 4 Department of Endocrinology, Peking University First Hospital, Beijing, China, 5 Department of Endocrinology, Shanghai Changhai Hospital, Shanghai, China Background and aims: Patients with Type 2 diabetes often fail to achieve adequate glycemic control with monotherapy of oral anti-diabetic drugs (OADs). One treatment option for patients who fail on monotherapy is combination therapy of OADs. This study examined the efficacy and safety of repaglinide at different dose levels in combination with metformin in Chinese patients with Type 2 diabetes. Materials and methods: Patients with Type 2 diabetes mellitus inadequately controlled with OADs and without initiation of
DIABETES RESEARCH A N D CLINICAL PRACTICE
CD1-4 Increasing fruit and vegetable consumption – a multipronged intervention (“Fresh for Less” campaign) Amanda Dunlop 1 , Rob McNeill 2 , Sarah Appleton 2 , Brandon Orr-Walker 1 1 ”Let’s Beat Diabetes”, Counties Manukau District Health Board, 2 School of Population Health, University of Auckland, Auckland, New Zealand Introduction: Fruit and vegetable consumption is positively linked with good health, and has been encouraged in public health promotion (“5 + A Day”). Findings from the Let’s Beat Diabetes baseline survey (2007) were that people knew fruit and vegetables were good for their health but weren’t eating daily recommended amounts. Price, time required to prepare or cook vegetables and knowing how to prepare and cook vegetables were identified as key barriers. The 8 week Fresh for Less campaign was designed specifically to address these barriers via pricing incentives, promotion and health education by health providers (via in-store cooking demonstrations and recipe cards). Detailed sales data from intervention supermarkets, customer and stakeholder interviews will be used to evaluate the effectiveness of the campaign. Aims: To assess whether pricing incentives, promotion and health education (via in-store cooking demonstrations and recipe cards) results in increased fresh fruit and vegetable consumption. To assess whether supermarket stores are viable settings for health promotion and education activity. Method: Sales data from intervention supermarkets in the Counties Manukau district will be compared with comparative control supermarkets. Sales volumes 8 weeks prior to the intervention, the 8 weeks of the intervention, and 8 weeks following the intervention will be collated. Pricing incentives, promotions and health education is staggered for specific vegetables and fruit over four fortnightly intervals. Comparison of data prior and during the intervention and between intervention and control supermarkets will be made. Consumption patterns after the intervention will also be analysed. Structured interviews with customers will be undertaken to attain qualitative information in regards to intervention, and its impact on their shopping behaviour. Structured interviews with key stakeholders will also be undertaken to attain qualitative information on intervention process and outcomes. Results: the analysis will compare differences between the pre-intervention measures and intervention measures and between the intervention and control supermarkets including sales volumes generally, and specifically for the fruit and vegetables featured during the intervention. Any long-term effects will be assessed in the post-intervention period. Qualitative findings from the interviews will be presented, including impact of the intervention on behaviour and perceptions on the value of health education provision within supermarkets.
CD2-1 Efficacy and safety of sitagliptin or rosiglitazone when added to ongoing metformin therapy in patients with Type 2 diabetes Russell Scott, Tom Loeys, Michael J. Davies, Samuel S. Engel Lipid and Diabetes Research Group, Christchurch Hospital, Christchurch, New Zealand, Merck Research Laboratories, Rahway, NJ, USA Background and aims: The addition of sitagliptin, a dipeptidyl peptidase-4 inhibitor, or rosiglitazone, a PPARγ agonist, to ongoing metformin therapy was assessed in patients with Type 2 diabetes who were inadequately controlled (HbA1c ≥7% and ≤11%) on metformin monotherapy.
79 (2008) S1 – S127
Material and methods: After a screening diet/exercise run-in, a metformin dose titration/stabilization period, and a 2-week, single-blind, placebo run-in, 272 patients receiving ongoing metformin (≥1500 mg/day) were randomized to receive the addition of once-daily placebo, sitagliptin 100 mg, or rosiglitazone 8 mg in a 1:1:1 ratio for 18 weeks. The efficacy analysis was based on an all-patients-treated population using an ANCOVA with change in HbA1c from baseline as the primary endpoint. Results: The mean baseline HbA1c was 7.7% in these patients. After 18 weeks, both active add-on therapies led to significant reductions from baseline in HbA1c : -0.73% for sitagliptin and -0.79% for rosiglitazone compared with a -0.22% reduction from baseline for placebo (p<0.001; difference between the sitagliptin and rosiglitazone groups = 0.06% [95% CI: -0.14, 0.25]). The proportion of patients achieving an HbA1c <7% was significantly (p<0.01) greater in the sitagliptin (55%) and rosiglitazone (63%) groups compared to the placebo group (38%). Treatment with sitagliptin or rosiglitazone produced a significant change from baseline in fasting plasma glucose (FPG) relative to placebo (difference from placebo of -1.0 mmol/L and -1.7 mmol/L, respectively, p<0.001; difference between the sitagliptin and rosiglitazone groups = 0.7 mmol/L [95% CI: 0.2, 1.3]). Following a standard meal, treatment with sitagliptin or rosiglitazone significantly reduced the 2-hour postprandial glucose (PPG) from baseline relative to placebo (difference from placebo of -1.7 mmol/L and -2.6 mmol/L, respectively, p<0.001; difference between sitagliptin and rosiglitazone groups = 0.9 mg/dL [95% CI: 0.02, 1.8]). The incremental increase in 2-hour PPG was also significantly different for sitagliptin or rosiglitazone relative to placebo (p<0.05; difference between sitagliptin and rosiglitazone groups = 0.1 mg/dL [95% CI: -0.5, 0.7]). The change in body weight from baseline was significantly (p<0.001) less with sitagliptin (-0.4 kg) and placebo (-0.9 kg) groups relative to the rosiglitazone (+1.5 kg) group. Sitagliptin provided a reduction relative to placebo in LDL-C (-5.3%, p = NS), while rosiglitazone led to an increase in LDL-C relative to placebo (+9.5%, p<0.05), for a difference between sitagliptin and rosiglitazone of -14.8% (95% CI: -23.9, -5.7). Both active treatments were generally well tolerated, with no increased risk of hypoglycemia or gastrointestinal adverse events compared to placebo. Conclusion: In this 18-week study, the addition of sitagliptin was effective and well-tolerated in patients with Type 2 diabetes who had inadequate glycemic control on metformin monotherapy, and also produced similar reductions in HbA1c without weight gain compared to rosiglitazone.
CD2-2 Efficacy and safety of repaglinide in combination with metformin in Type 2 diabetes inadequately controlled with oral anti-diabetic drugs Guang-wei Li 1 , Wei-ping Jia 2 , Chang-yu Pan 3 , Xiao-hui Guo 4 , Da-jin Zou 5 1 Department of Endocrinology, Peking China-Japan Friendship Hospital, Beijing, China, 2 Department of Endocrinology, Shanghai No.6 People Hospital, Shanghai, China, 3 Department of Endocrinology, Chinese PLA General Hospital, Beijing, China, 4 Department of Endocrinology, Peking University First Hospital, Beijing, China, 5 Department of Endocrinology, Shanghai Changhai Hospital, Shanghai, China Background and aims: Patients with Type 2 diabetes often fail to achieve adequate glycemic control with monotherapy of oral anti-diabetic drugs (OADs). One treatment option for patients who fail on monotherapy is combination therapy of OADs. This study examined the efficacy and safety of repaglinide at different dose levels in combination with metformin in Chinese patients with Type 2 diabetes. Materials and methods: Patients with Type 2 diabetes mellitus inadequately controlled with OADs and without initiation of