Boehringer Ingelheim (BI) has made clinical study data and other clinical study-related documents more widely accessible for approved products or after termination of a drug development programme.
Researchers will be granted access after approval of their study proposal by an independent external review panel and based on a data-sharing agreement, which will include obligations such as the commitment to use the data only for the purpose of the study proposal, to not attempt to identify study participants and to not misuse the data.
Documents and data to be shared will be redacted by BI to protect personal data of study participants, study personnel and BI employees, and to protect BI’s commercial confidential information, in particular intellectual property rights.
Data and documents relating to studies initiated since 1998 will be made available.
In addition, BI confirmed its commitment to publish the scientific results from all sponsored studies in peer-reviewed journals and at scientific meetings, regardless of study outcome.
Reports and other clinical documents can be requested via trials.boehringer-ingelheim.com/trial_results.html.
VOKANAMET® approved by the European Commission
Janssen-Cilag International NV (Janssen) announced in April this year that the European Commission has approved VOKANAMET for the treatment of adults with T2D to improve glycaemic control in the European Union (EU).
VOKANAMET is a fixed-dose therapy combining canagliflozin (a sodium–glucose cotransporter 2 inhibitor) and immediate-release metformin hydrochloride in a single tablet prescribed to be taken twice a day.
Canagliflozin as a single agent was approved as INVOKANA® in the EU in November 2013.
Eperzan® treatment receives European authorisation
In March 2014, the European Commission granted authorisation for GlaxoSmithKline plc (GSK) to market its once-weekly diabetes treatment Eperzan (albiglutide).
The European Medicines Agency’s authorisation of albiglutide is based on the results of the comprehensive Harmony programme, comprising eight Phase III studies with over 5000 participants.
Albiglutide is a glucagon-like peptide-1 receptor agonist, and Eperzan is indicated for the treatment of T2D in adults, to improve glucose control as a monotherapy or as an add-on combination therapy.
GSK expects to launch albiglutide in several countries in Europe at the end of 2014 with additional launches to follow thereafter. Albiglutide was also approved for use by the US Food and Drug Administration in April 2014.
Becton, Dickinson and Company launches pen needle
Becton, Dickinson and Company (BD), has launched the BD Micro-Fine Ultra™ with Pentapoint™ 4 mm pen needle with five-bevel needle technology in the UK and Ireland.
The BD Micro-Fine Ultra with Pentapoint needle tip is specially designed with five-bevelled edges to create a flatter, thinner surface to penetrate the skin and has been clinically demonstrated to improve injection comfort for people with diabetes.
The BD Micro-Fine Ultra with Pentapoint is proven to be as effective as longer needles for people with diabetes of all body types, and provides equivalent glucose control by effectively delivering the insulin dose to subcutaneous tissue, and reducing the risk of injecting into muscle.
Sanofi Diabetes launches JuniorSTAR®
Sanofi Diabetes has launched JuniorSTAR, a new and award-winning half‑unit insulin reusable pen device that can be used with Lantus® (insulin glargine), Apidra® (insulin glulisine) or Insuman® (recombinant human insulin).
The pen allows for half-unit dose increments to be administered, which helps to provide flexibility. The lightweight pen can deliver between 1 and 30 units per injection and contains a large dose display and a single-step dial back with no insulin leakage.
JuniorSTAR has been tested by young people with T1D (6–18 years of age), parents and nurses in a non-comparative survey with 167 insulin pen users from five European countries. The study showed that 93% of survey participants agreed that it was easy to use.
Attempts to achieve remission, or at least a substantial improvement in glycaemic control, should be the initial focus at type 2 diabetes diagnosis.
9 May 2024