Nateglinide reduces mean glycemia in diet- and previously treated type 2 diabetic patients

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Poster Session I

P334 Nateglinide Reduces Mean Glycemia in Diet- And Previously ‘Skated +Qpe 2 Diibetic Patients M. HOYER, S. Mallows, S. Dickinson, S. Shen, C. Guitard, M. Gatlin. Novartis Phanna AG Basel,; CH and Novartis Pharmaceuticals, NJ, United States of America Background and Aims: Nateglinide (NAT) is a rapid and short acting insulin stimulator which reduces post-meal glucose spikes by enhancing early insulin secretion. NAT when taken orally immediately before meals is safe and effective in the treatment of type 2 diabetes. This analysis was conducted to assess the utility of NAT monotherapy in patients on diet and exercise but untreated with oral antidiabetic therapy (OAD) at 3 months prior to randomization, as compared to patients in whom OAD therapy was discontinued 3 months before randomization. Materials and Methods: Efficacy data from 2 similarly designed, blinded placebo controlled trials of 24-week duration were pooled to analyze change from baseline (BL) in HbAi, in function of previous exposure to OAD treatment. Results: NAT 120 mg produced similar reductions in HbAi, vs placebo in both groups. Previously treated patients on placebo deteriorated further (increase in HbAi, of 0.62%) as compared to untreated patients on placebo who remained stable throughout the study.

Unrreared Baseline HbAtc Mean change (SD) Mean change vs plsccbo(SE) Trpnted until 3 months before mndomization Baseline HbAt, Mean change (SD) Mean change vs placebo(SE)

Nateglinide 120 mg

Placebo

N= 228 8.08% -0.61 (1.09) -0.76% (0.10)

N=222 8.02% 0.15 (1.07)

N=llO 8.43% -0.12(1.21) -0.74% (0.17)

N=106 8.38% 0.62 (1.28)

Conclusions: NAT caused a clinically relevant reduction in HbAi, in patients with type 2 diabets mellitus not controlled by diet and exercise alone and stabilized patients whose previous OAD treatment was discontinued 3 months before randomization.

P335 Metabolic Control with Repaglinide and Rating Patterns of Patients with Qpe 2 Diabetes Compared to Prior Therapy RUDIGER LANDGRAF’, Christiane Bauer’, Komelius Selenka’, Markus Leyck Dieken2. ’ Medizinische Klinik Innenstadt, Miinchen, Germany; 2 Novo Nordisk, Mainz, Germany Purpose: Conventional insulin secretagogues require meals at regular intervals to avoid hypoglycaemia. Treatment with repaglinide (Repa) allows patients to vary the timing of, or skip, meals and snacks while the fast rise in insulin secretion reduces postprandial hyperglycaemia and thus improves metabolic control. This open, large-scale survey analyses the impact on glycaemia and eating patterns with Repa and the effects on weight control. Methods: HbAi, and home blood glucose profiles were measured in 5985 patients receiving Repa (mean 46 days), who were also questioned about their perceptions regarding the meal-related aspects of diabetes care. 64% of patients had previously received oral hypoglycaemic agents (OHAs); 72% of these discontinued their previous therapy on commencing Repa. Results: HbAi, decreased from 8.6% (f1.48) to 7.6% (f1.21) in patients switched from OHAs to Repa. Postprandial blood glucose (pp-BG) fell from 220 (f54) to 156 mg/dl (f41) when switching from SU to Repa, from 220 (+53) to 148 mg/dl (f32) from acarbose to Repa and from 209 (f52) to 153 mg/dl (f45) from metformin to Repa. Before switching 41% of the patients on SU admitted to eating when not hungry for fear of hypoglycaemia, but only 10% continued this behaviour. Overall the proportion of patients reporting lifestyle restrictions as a result of fixed mealtimes declined from 32% to 8%. and patients took fewer snacks. Repa-treated patients achieved

a weight reduction of 1.0 kg with individuals > 110 kg losing 2.0 kg (medians). Conclusions: Repa improves metabolic control and favours weight reduction as a consequence of reduced food intake and flexible meal timing. The switch to a flexible, meal-based treatment is regarded as liberating.

P336 Assessment of Switching to Nateglinide in Diabetic Patients Who Were Moderately Controlled by Small Doses of Sulfonylurea Drugs TAKAICHI MIYAKAWA ’ , Mizuho Takei ‘, Tadasumi Nakano *, Atsushi 0ono3, Akio Uekis. ’ TachikawaSougo General Hospital; 2 TokyoTama Geriatric Hospital; 3 Hachioji Medical Center, Tokyo Medical University,Tokyo,Japan Objective: To determine whether switching from small doses of sulfonylurea (SU) drugs to the novel ultrashort-acting hypoglycemic agent nateglinide (NAT) was effective in SU-controlled diabetic patients, NAT was administered alone or in combination with an cr-glucosidase inhibitor (ol-GI) in such patients. Subjects and Methods: A total of 50 type2 diabetic patients (33 men and 17 women; age, 66.2f12.4 years) were enrolled in this study. Patients receiving small doses of SU drugs (average dose of 4.2 mg of glibenclamide [n=8], 30 mg of gliclazide [n=ll], 230 mg of tolbutamide [n=S]) were switched to NAT (previously SU treated group: SU group). The remaining 23 patients had been controlling their diabetes using only dietary therapy [n=19], or in combination with (x-G1 ]n=4] prior to the start of the NAT therapy (non-SU treated group: NSU group). The daily dose of NAT was 180 mg in 9 patients and 270 mg in 41 patients. Various diabetic indicators were compared in the SU group and the NSU group. Results: HbAlc levels improved significantly after NAT therapy in the NSU group (6.6*1.3% on Month 2, compared with a baseline of 7.8f1.5%) (p
P337 Single- and Multiple-Dose Phannacoktnetics of Repaglhdde in Patients with Type 2 Diabetes and Renal Impairment SABINE SCHUMACHER ’ , Isabelle Abbasi ’ , Dagmar Weise ’ , Kristin Sattlerz, Markus Leyck Dieken’, Christoph Hasslacher ’ i Abteilung Innere Medizin, St Josefskrankenhaus. Heidelberg, Germany; 2 Novo Nordisk, Mainz, Germany The pharmacokinetic and safety profiles of the prandial glucose regulator repaglinide were evaluated using single and multiple dosing in patients with Type 2 diabetes with varying degrees of renal impairment. The