Clin. Invest. (2011) 1(6), 771–773 News Highlights from the latest news and research in Clinical Investigation Linagliptin tablets first to receive US FDA approval at one dosage strength for Type 2 diabetes treatment The US FDA has announced the approval another therapeutic option”. He con- Boehringer Ingelheim and Eli Lilly and of linagliptin tablets, developed by a col- tinues, highlighting how the approval Co., launched a diabetes alliance in January laboration between Boehringer Ingelheim could impact on ease of treatment for 2011, making this FDA approval the first an d Eli Lilly and Co., for the treatment of sufferers, “monotherapy with linagliptin regulatory milestone since its inception. Type 2 diabetes either as a monotherapy will aid compliance because of its ease of Klaus Dugi of Boehringer Ingelheim com- or in combination with other medica- use. No titration is required; the medi- ments: “Type 2 diabetes is increasing at an tions. This approval follows clinical trial cation is once daily and can be taken alarming rate and we are proud to offer results, which demonstrated linagliptin any time of day with or without meals. people in the USA a new treatment option tablets as significantly reducing hamo- Finally, it is the only DPP-4 inhibitor from our Boehringer Ingelheim research globin A1c (HbA1c or A1c) levels, an for which no dose adjustment is recom- laboratories that could potentially help indicator of blood sugar control, by an mended in patients with impaired renal the millions of patients with Type 2 dia- average of up to 0.7% when compared function and no prior testing and sub- betes whose blood sugar is not adequately with placebo. sequent monitoring of renal function controlled”. Enrique Conterno, of Lilly Linagliptin, an oral hypoglycemic that is recommended”. Diabetes, continues “Linagliptin is the falls in the subclass of dipeptidyl pepti- The clinical studies that preceded first regulatory approval of what we hope dase-4 (DPP-4) inhibitors, is the first of approval consisted of three separate will be many new treatment options this this subclass of drugs to receive regula- placebo-controlled studies involving alliance brings to the millions of people tory approval at one dosage strength, approximately 4000 adult patients with living with Type 2 diabetes” approved at 5 mg once daily. This means Type 2 diabetes and assessed linagliptin Sources: Del Prato S, Barnett AH, Huisman H that no alteration of dose need occur in as a mono therapy, as well as in combi- et al. Effect of linagliptin monotherapy on the treatment of patients with kidney or nation with common antihyperglyca- glycemic control and markers of b-cell function in patients with inadequately controlled Type 2 liver impairments. John Gerich, an expert mic therapies metformin and suphony- diabetes: a randomized controlled trial. in diabetes at the of the University of lurea [1-3]. HbA1c levels in participants Diabetes Obes. Metab. 13(3), 258–267 (2011); Rochester (NY, USA) comments exclu- were meaused as an indicator of blood- Taskinen MR, Rosenstock J, Tamminen I et al. Safety and efficacy of linagliptin as add-on sively to Clinical Investigation on the sugar control in diabetes patients tak- therapy to metformin in patients with Type 2 significance of the recent FDA decision: ing antihyperglycemic medication. As a diabetes: a randomized, double-blind, “The recent approval of linagliptin by the monotherapy, linagliptin showed an aver- placebo-controlled study. Diabetes Obes. Metab. 13(1), 65–74 (2011); Owens DR, FDA is quite important for people with age difference in HbA1c levels of up to Swallow R, Woerle HJ et al. Linagliptin improves Type 2 diabetes because it gives them 0.7%. In combination with metformin or glycemic control in Type 2 diabetes patients metformin and sulfonylurea, linagliptin inadequately controlled by metformin and sulfonylurea without weight gain and low risk of demonstrated a difference in blood lev- hypoglycemia. Presented at: The 70th American els of HbA1c 0.6% when compared with Diabetes Association Scientific Sessions. Orlando, placebo. Following on from this, in a fur- FL, USA, 25–29 June 2010; Gomis R, Espadero RM, Jones R, Woerle HJ, Dugi KA. ther study, the combination of linagliptin Efficacy and safety of initial combination and pioglitazone, another hypoglycemic therapy with linagliptin and pioglitazone in therapy, was compared with pioglitazone patients with inadequately controlled Type 2 diabetes: a randomized, double-blind, placebo administered with placebo [4]. The aver- controlled study. Diabetes Obes. Metab. 13(7), age HbA1c observed in the linagliptin and 653–661 (2011); FDA approves linagliptin pioglitazone arm was 0.5% lower than tablets for the treatment of Type 2 diabetes: www.boehringer-ingelheim.com/news/news_ that observed in the and pioglitazone releases/press_releases/2011/03_may_2011_ placebo arm. diabetes.html ISSN 2041-6792 10.4155/CLI.11.69 © 2011 Future Science Ltd 7711 News Clinical trials: (a)head in the clouds A white paper has recently been published meant, not only time and cost saving from used ‘interoperable digital identity cre- on the back of a 2010 pilot study, detail- an administrative perspective, but that dentials’, a type of software that can run ing how innovative technology such as employing a ‘paperless’ strategy, as well on devices such as computers and mobile digital signatures and ‘cloud computing’ as improving security and environ mental phones, and acts to link the (proven) iden- could accelerate the start of the clinical impact, may also improve the delivery of tity of the person using the device to the trial process, as well as lowering its costs. therapies to patients. electronic document in question, allow- The study, which highlights how modern ing digital, legally binding signatures to digital technology could aid drug devel- “The preliminary results be applied. These electronic documents opment by facilitating the clinical trial demonstrated that a reduced were then placed in the ‘cloud’, allowing process, involves scientists from industry reliance on these paper forms the researchers to gain access to them for and regulatory bodies, such as the NCI further signatures or information. meant, not only time and cost Cancer Therapy Evaluation Program, The pilot study is to expand, aiming Bristol-Myers Squibb and Sanofi. saving … but … may also improve to include other researchers in indus- The researchers used interoperable dig- the delivery of therapies try and government bodies, as well as ital identities, signatures and cloud com- to patients.” university-based academics, and could puting, a form of secure, shared storage prove to alter the landscape of clinical for digital data, to replace traditional hard The clinical trial process is typically trial administration. copy paper versions of the forms and docu- delayed owing to physical documents, Sources: Innovative paperless clinical trial study ments needed in the clinical trial process. necessitating a signature and thus having white paper now available: www. medicalnewstoday.com/articles/223622.php; The preliminary results demonstrated that to be sent through the post, by courier or White paper download: www.safe-biopharma. a reduced reliance on these paper forms fax. To counteract this, the researchers org/whitepaperform.htm Results from the Phase III ORAL Standard and ORAL Step studies demonstrate promise for tofacitinib as a treatment of rheumatoid arthritis Pfizer have announced top-line results 10 mg twice daily, adalimumab 40 mg ORAL Standard study, all primary end from two pivotal Phase III studies of its subcutaneously biweekly or placebo, each points of the ORAL Step were met, at investigational, novel oral JAK inhibitor, of which was added to stable background both the 5 and 10 mg twice-daily doses. tofacitinib. Both the ORAL Standard and MTX. All primary end points of the Tofacitinib demonstrated statistically ORAL Step studies met their primary end study were met, demonstrating statisti- significant changes versus placebo in points and demonstrated no new safety cally significant changes versus placebo reducing signs and symptoms of RA, as concerns regarding the use of tofacitinib in reducing the signs and symptoms of measured by ACR20 response rates; in in patients with active rheumatoid arthritis RA, as measured by ACR20 response improving physical function, as measured (RA). ORAL Standard and ORAL Step rates at 6 months, in improving physical by mean change in HAQ DI; and in reach- are the final two pivotal trials in a program function, as measured by mean change in ing DAS28-4(ESR) <2.6, all assessed at designed by Pfizer to study tofacitinib for HAQ DI at 3 months; and in reaching 3 months. RA. The program consists of five pivotal DAS28-4(ESR) <2.6 at 6 months. A more detailed analysis of the ORAL trials and a sixth long-term treatment The ORAL Step study was conducted Standard and ORAL Step efficacy and study, carried out at >350 locations in over a 6-month period and enrolled 399 safety data is likely to be presented at a 35 countries worldwide. patients with moderate-to-severe active scientific meeting in the near future. The 12-month ORAL Standard trial RA who had an inadequate response to Source: Pfizer announces top-line results of enrolled 717 patients with moderate-to- a TNF inhibitor. Patients were rand- final two pivotal Phase III trials of tofacitinib severe active RA who had an inadequate omized to receive tofacitinib 5 or 10 mg (CP-690550) in patients with active rheumatoid