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Assessing Treatment Success of Diabetes Therapies.pdf

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of 0.34 mg/kg/week; and showed a median height of 110.0cms (-2.5 SDS (Tanner)) at baseline. Likewise, girls reached a median height of 117.1cms (-1.9 SDS (Tanner)) at the end of the first year and 122.5cms (-1.6 SDS (Tanner)) at the end of the second year; which represents an improvement of over 20% growth compared to girls with TS without GH therapy. CONCLUSIONS: Due to an earlier initiation of treatment in Colombian girls compared to global reported data (at 9.7 years), GH achieved at the end of first year height increments of 8.6cm for the Colombian cohort vsersus 7.2cm in global cohort. PDB14 ASSESSING TREATMENT SUCCESS OF DIABETES THERAPIES - NUMBER NEEDED TO TREAT TO REACH A CLINICALLY RELEVANT COMPOSITE ENDPOINT: USING A META-ANALYSIS OF THE LIRAGLUTIDE CLINICAL TRIAL PROGRAM Langer J 1 , Bouchard JR 1 , Ploug UJ 2 1 Novo Nordisk, Inc., Princeton, NJ, USA, 2 Novo Nordisk A/S, Søborg, Denmark OBJECTIVES: The ADA/EASD Consensus Panel recommends an individualized treatment approach for patients with type 2 diabetes (T2DM) based on efficacy, safety, tolerability, and ease of use. A challenge in the management of T2DM is to maximize glycemic control while minimizing side effects, such as weight gain and hypoglycemia. A clinically relevant composite endpoint of HbA1c 7%, no weight gain, and no hypoglycemia may be useful for evaluation of diabetes treatments. The objective is to estimate the Number Needed to Treat (NNT), using this com- posite endpoint, across all seven RCTs in T2DM patients in the liraglutide clinical trial program. METHODS: The findings of a recently conducted meta-analysis (Zin- man et al. 2012) from seven trials (N 4625) at week 26 in the liraglutide clinical trial program were used to calculate the NNT to achieve the composite endpoint of HbA1c 7%, no weight gain and no hypoglycemia for liraglutide vs. comparator therapies and placebo. Logistic regression on the intent-to-treat population using the last observation carried forward was used. The NNT was calculated as 1/Abso- lute Risk Reduction (ARR), with ARR being the difference in the percentage of pa- tients achieving the composite endpoint with liraglutide vs. the comparator ther- apy or placebo. RESULTS: The calculated NNT values for liraglutide 1.2 mg ranged from 3.8 (vs. rosiglitazone) to 4.8 (vs. sitagliptin) and from 2.9 (vs. rosiglitazone) to 6.7 (vs. exenatide) for liraglutide 1.8 mg. The NNT across all comparators for lira- glutide 1.2 mg was 3.8 vs. rosiglitazone, 4.2 vs. glimepiride, 4.2 vs. placebo and 4.8 vs. sitagliptin. For liraglutide 1.8 mg the NNT was 2.9 vs. rosiglitazone, 3.1 vs. glimepiride, 3.1 vs. placebo, 3.4 vs. sitagliptin, 4.0 vs. insulin glargine and 6.7 vs. exenatide. CONCLUSIONS: Across the seven phase 3 trials in the liraglutide clinical trial program, the calculated NNT suggests that liraglutide provides clinically meaningful benefits in T2DM.
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