BP Exhibitor Poster Display (1-5

BP-1

RELATIVE CONTRIBUTION OF BASAL AND POST-PRANDIAL HYPERLGYCEMIA STRATIFIED BY A1C CATEGORIES BEFORE AND AFTER TREATMENT INTENSIFICATION WITH DULAGLUTIDE

1GUILLERMO UMPIERREZ, 2KEVIN M. PANTALONE, 3CHARLES ATISSO, 3LAURA FERNÁNDEZ LANDÓ, 3HIREN PATEL, 3THOMAS LEW (NON-AUTHOR PRESENTER)

1Department of Medicine, Emory University, Atlanta, GA, USA; 2Cleveland Clinic, Cleveland, OH, USA; 3Lilly USA, Indianapolis, IN, USA

Dulaglutide (DU) has demonstrated non-inferiority vs. liraglutide (LIR) and superiority vs. exenatide BID (EXE) in A1c reduction. No data are available on how GLP-1RAs affect the relative contribution of basal hyperglycemia (BHG) and post-prandial hyperglycemia (PPHG) to overall hyperglycemia (OHG) across A1c categories.

Data from five phase 3 studies (N = 673) were pooled to assess the change in relative contributions of BHG and PPHG to diurnal OHG across different A1c categories after 6 months of patients . BHG and PPHG were calculated using the area under the curve of the 7-point SMPG

At baseline, relative contributions of BHG increased and PPHG decreased with increasing A1c levels which was maintained after 6 months of treatment with DU despite 1.3% overall mean A1c reduction. At 6 months, the relative contribution of BHG and PPHG were similar between LIR and DU. Relative contribution of BHG was 66.7% (DU) and 66.0% (LIR) at baseline and 55.2% (DU) and 55.9% (LIR) at 6 months. Relative contribution of PPHG was 33.3% (DU) and 34% (LIR) at baseline and 44.8% (DU) and 44.1% (LIR) at 6 months. However, DU had lower BHG but higher PPHG contribution than EXE. Relative contribution of BHG was 63.3 (DU) and 63.1 (EXE) at baseline and 44.7% (DU) and 56.5% (EXE) at 6 months (p <0.001). Relative contribution of PPHG was 36.7% (DU) and 36.9% (EXE) at baseline and 55.3% (DU) and at 43.5% (EXE) at 6 months.

The trend of relative contribution of PPHG and BHG across A1c categories is similar before and

BP-2

EVALUATION OF CHARACTERISTICS OF DULAGLUTIDE-INDUCED GASTROINTESTINAL ADVERSE EVENTSIN CHINESE PATIENTS WITH TYPE 2 DIABETES MELLITUS

1ZHIGUANG ZHOU, 2LIYING DU; 2JIANING HOU, 3THOMAS LEW (NON-AUTHOR PRESENTER)

1Institute of Metabolism and Endocrinology, The Second Xiangya Hospital, Key Laboratory of Diabetes Immunology, Ministry of Education, Central South University, National Clinical Research Center for Metabolic Diseases, Changsha, Hunan, China; 2Lilly Suzhou Pharmaceutical Company, Ltd., Shanghai, China; 3Lilly USA, Indianapolis, IN, USA

Objective: A post hoc analysis to investigate the characteristics of gastrointestinal adverse events (GI AE) in Chinese type 2 diabetes mellitus (T2DM) patients treated with once-weekly dulaglutide in two phase 3 clinical studies.

Methods: In two IMCT phase 3 clinical studies (a glimepiride-controlled monotherapy study NCT01644500 and an insulin glargine-controlled combination therapy study with oral antihyperglycemic drugs NCT01648582), dulaglutide was administered to patients with T2DM at a dose of 1.5 mg or 0.75 mg once weekly. The characteristics (incidence, severity, onset, duration and etc.) of GI AE reported through 26 weeks in Chinese subpopulation in these two studies were investigated.

Results: A total of 787 Chinese patients comprised of the safety analysis subpopulation who had received at least one dose of 1.5 mg or 0.75 mg dulaglutide in the two studies. The most commonly reported GI AEs are diarrhea, nausea, abdominal distension and vomiting, with incidence of 13.1% (103 pt), 6.6% (52 pt), 6.4% (50 pt) and 3.0% (24 pt), respectively. Among patients who experienced diarrhea, nausea, abdominal distension and vomiting during treatment, most of them had mild to moderate symptoms with proportions of 92% (95/103 pt), 88% (46/52 pt), 94% (47/50 pt) and 83% (20/24 pt), respectively. A total of 1.5% (12/787 pt) patients in dulaglutide groups discontinued the dulaglutide treatment and then declined rapidly, and stayed low until week 26. The median durations of diarrhea, nausea, abdominal distension and vomiting in patients treated with dulaglutide were 4.0 days, 5.0 days, 12.5 days, 4.0 days, respectively.

Conclusions: The most commonly reported dulaglutide-induced GI AE were diarrhea, nausea, abdominal distension and vomiting in Chinese population. They are mostly mild to moderate in severity, and very few patients discontinued treatment. The median duration of dulaglutide-induced

BP-3

STATIN TREATMENT ADHERENCE AND ITS PREDICTING FACTORS IN TAIWAN DIABETES PATIENTS

1LIN TC, 2SHAU WY, 1YANG KAO YH

1National Cheng Kung University, Tainan, Taiwan; 2

OBJECTIVES: To investigate the level, trend and predictors of statin treatment adherence in Taiwan incident diabetes patients. METHODS: aged above 40 years from the Taiwan Longitudinal Cohort of Diabetes Patients database between year end of database in 2012. Statin treatment adherence was measured every 3-month using medication and treatment-stop (MPR = 0%). Multinomial logistic regression with repeated measures was used to explore both baseline and time-varying predictors on non-adherence and treatment-stop. RESULTS: There were 273,461 statin initiators after diabetes diagnoses, and 63% of them were adherent in the study follow at 11 years. On the other hand, 50% of patients stopped statin treatment after one year, and increased to 56% at end of second year than remained to last study follow up. In multinomial logistic regression analysis, we found baseline covariates, including age, gender, comorbid diseases were associated with adherence or stop significantly, however the strength of associations were at marginal 10% increase or decrease of risk. Indicated by adjusted odds ratio (aOR), time-varying covariates were associated stronger with non-adherence and stop: aOR for more frequent lipid level tests were 0.81 and 0.47; for prescribed in Medical center compared to General Clinics were 0.57 and 0.43, respectively. CONCLUSIONS: The long-term statin adherence was suboptimal in diabetes patients in Taiwan. Analysis of time-varying factors implicates the importance of close watching on patients’ treatment adherence. The results of our study could be applied for developing strategy to improve treatment adherence in diabetes patients needs long-term follow up.

BP-4

THE IMPACTS OF STATIN ADHERENCE ON ATHEROSCLEROTIC CARDIOVASCULAR DISEASE (ASCVD) IN TAIWAN DIABETES PATIENTS

1LIN TC, 2SHAU WY, 1YANG KAO YH

1National Cheng Kung University, Tainan, Taiwan; 2

OBJECTIVES: To investigate the risk of ASCVD associated with non-adherent or stopped statin treatments among Taiwan diabetes patients. METHODS: of incident diabetes patients aged above 40 years, who received statin treatments from Taiwan prescription after diabetes diagnosis (the index date) to ASCVD, death, or the end of the study (2013/12/31). Time-varying adherence and covariates were assessed every 3-month. Adherence was adherent (MPR < 80%) and stop in each period. Marginal structure models with stabilized weights were used to adjust for baseline and time-varying confounders to assess the associations between risk of outcomes and non-adherence/stop. RESULTS: There were 273,461 statin initiators after diabetes diagnosis, percentage of adherent decreased from 63% to 30%, non-adherence changing between 40% to 15%, and stop treatment increased to 56% during the follow up. Adherent patients were more likely to receive lipid level tests, treated at higher tiers of medical facilities, and lived in higher urbanization cities during the follow-up. After stabilizing both baseline and time-varying confounders, the Hazard ratio, HR (95%CI) of ASCVD increased when patient non-adherent, 2.27 (2.15-2.38) or stop treatment, 2.41 (2.29-2.55). We also found traditional methods included only baseline confounders may underestimate the association with HR for non-adherent 1.84 (1.78-1.91); for stop 1.27 (1.231.30). CONCLUSIONS: After adjusting for both baseline and time-varying confounders, we found diabetes patients non-adherent or stop their statin treatments may increase their risk for ASCVD more than two-folds, as compared with adherent patients.

BP-5

BASELINE CHARACTERISTICS IN TAIWAN IN THE VERIFY STUDY — A RANDOMISED TRIAL ASSESSING THE DURABILITY OF GLYCAEMIC CONTROL WITH EARLY VILDAGLIPTIN-METFORMIN COMBINATION IN NEWLY DIAGNOSED TYPE 2 DIABETES

1WAYNE H.-H. SHEU, 2,3,4D.R. MATTHEWS, 5P.M. PALDÁNIUS, 5P. PROOT, 6J.E. FOLEY, 7M. STUMVOLL, 8S.D. PRATO

1Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital 2Oxford Centre for Diabetes Endocrinology and Metabolism, 3National Institute for Health Research (NIHR), Oxford Biomedical Research Centre, 4Harris Manchester College, Oxford, UK, 5Novartis Pharma AG, Basel, Switzerland, 6*Novartis Pharmaceutical Cooperation, East Hanover, NJ, USA, 7Divisions of Endocrinology and Diabetes, University Hospital Leipzig, Germany, 8Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Pisa, Italy *employee at the time of manuscript preparation.

Background / aim: Durable glycaemic control can delay diabetic complications and lead to improved quality of life in people with type 2 diabetes mellitus (T2DM). The ongoing VERIFY trial is vildagliptin and metformin versus metformin monotherapy in drug-naïve people with T2DM. Here we report the baseline characteristics of the subjects enrolled in the ongoing VERIFY study in Taiwan.

Methods: We randomised 21 participants among the global (n = 2001) multi-ethnic population, aged 18–70 years, having glycated haemoglobin (HbA1c) levels 48–58 mmol/mol (6.5–7.5%) and body mass index (BMI) 22–40 kg/m2. Baseline data included HbA1c, fasting plasma glucose (FPG) secretion rate relative to glucose (ISR/G), and oral glucose insulin sensitivity (OGIS) were assessed on the global level only.

Results: Out of 21 screened, data were collected from the 21 eligible participants (43% women). disease duration was 6.3 months; mean ( ± SD) age 52.8 ± 7.15 years; weight 71.9 kg, and BMI 26.4. 23.8 % of participants were smokers. Baseline HbA1c was 6.9 % and FPG was 7.8 mmol/L. The those undertaking meal-tests, the global mean ISR/G was 2 ± 12 pmol/min/m2/mmol/L and OGIS 353 ± 57mL/min/m2 .

Conclusions: also the characteristic presence of early insulin resistance in subjects with increased demand for insulin associated with obesity in our country. The VERIFY study will provide unique evidence in characterising therapeutic intervention in a diverse population with hyperglycaemia, focusing on durability of early glycaemic control.