Avandamet (rosiglitazone/metformin) / GSK - LARVOL DELTA

63% of American Caregivers Believe in Link Between Inflammation In Alzheimer’s Disease (Times of San Diego) - "Our survey shows nearly half of caregivers (43%) would guess there are at least 3-4 drugs targeting inflammation with 16% of respondents guessing that there are 5 or more of these drugs in development. This, however, is wrong. According to an article by Jeffrey Cummings that looked at all Alzheimer's clinical trials underway...31 Alzheimer's agents in Phase 3, NE3107 is the only drug candidate addressing inflammation."

Media quote

The impact of obesity and obesity treatments on breast cancer (clinicaltrials.gov) - P1, N=24; Active, not recruiting; Completion date: Jul '12 -> Jul '13

Completion date • Breast Cancer • Renal Cell Carcinoma

Rosiglitazone versus rosiglitazone and metformin versus rosiglitazone and losartan in the treatment of nonalcoholic steatohepatitis (NASH): A 12 month-randomized, prospective, open- label trial (Hepatology) - P=NA, N=137; 108 subjects completed trial; 48 weeks of combination therapy with rosiglitazone & metformin or rosiglitazone & losartan confers no greater benefit than rosiglitazone alone w.r.t histopathology

Clinical data • Diabetes

A clinical trial to maintain glycemic control in youth with type 2 diabetes (New Eng J Med) - P3, N=699; TODAY; Rates of failure were 51.7% (120 of 232 pts), 38.6% (90 of 233), and 46.6% (109 of 234) for metformin alone, metformin plus rosiglitazone, and metformin plus lifestyle intervention, respectively; Metformin plus rosiglitazone was superior to metformin alone (p=0.006)

P3 data • Diabetes

Effects of RSG/MET FDC on glycaemic control and BMD after 80 weeks of treatment in drug-naïve type 2 diabetes mellitus subjects (EASD 2010) - N=688; RSG/MET (-1.9%) was superior to MET (-1.4%) with respect to mean change from baseline A1c at Week 80 (-0.50%, p<0.0001); RSG/MET showed significant improvements in insulin sensitivity (HOMA-%S) at 80 weeks compared to MET alone (% treatment difference: 31.1%, p<0.0001);

P4 data • Diabetes