Updated List of Practical Cure Research in Human Clinical Trials

Practical Cure projects in human trials as of June 2015 This is the semi-annual review of T1D research in human clinical trials. The review identified 361 open trials that focus on T1D and only 11 initiatives have the potential to deliver a Practical Cure. Over the three years that we have been tracking T1D projects in human trials, the story has remained more or less unchanged: there are very few Practical Cure projects. We strongly believe that more qualifying projects in human trials would significantly increase the chances of a successful outcome. Since the last update in November 2014, there has been only small changes in the Practical Cure project list. The number of qualifying initiatives has moved from 8 to 11, with the addition of two new projects and one returning. The returning project, ATG/GCSF,recently started Phase II trials, after over two years of inactivity. No project has been removed since November. The chart below lists the Practical Cure projects in human trials as of June 2015. A more detailed record of the Practical Cure research in human trials can be located on the clinicaltrials.gov website using the NCT numbers listed in the chart.

Glu : Lilly Plans to Take Locemia Solution’s Needle-free Glucagon to Market

Glu : Lilly Plans to Take Locemia Solution’s Needle-free Glucagon to Market

How we—you and T1D Exchange—played a role in advancing intranasal glucagon

We want to congratulate two of our member companies, Lilly and Locemia Solutions, on some exciting news!

Lilly has acquired Phase III Intranasal Glucagon from Locemia Solutions. Intranasal glucagon is a potential treatment for severe hypoglycemia in people with diabetes who use insulin and could be the first needle-free rescue treatment for severe hypoglycemia. (Learn more about severe hypoglycemia and intranasal glucagon below.)

This announcement highlights the important collaborations that are happening every day to improve outcomes in type 1 diabetes.

And you are part of this exciting collaboration. How? Our T1D Exchange community participated in advancing intranasal glucagon in the following ways:

Question of the Day

• In 2013, the Glu community answered a Question of the Day about the complexities of using injectable rescue glucagon and about severe hypoglycemia preparedness. Our community’s real-world experiences helped Locemia Solutions define the challenges of injectable glucagon in discussions with the FDA, which ultimately led to clinical studies of an intranasal form of glucagon.

T1D Exchange Clinic Expertise

• Locemia Solutions partnered with T1D Exchange to:
  • Design clinical protocols and conduct two multi-site clinical studies. Our highly qualified clinical investigators conducted these studies.
  • Recruit participants from the T1D Exchange Clinic Registry to participate in clinical studies.

“When you’re looking for that special population of people with diabetes, access to the expertise, and the investigators who can run the special procedures like that, T1D Exchange offers something that just is unavailable anywhere [else] in the world…” —Dr. Claude Piché, CEO of Locemia Solutions

 Collaborating for Improved Outcomes: A Case Study

The potential of bringing intranasal glucagon to market to relieve the burden of severe hypoglycemia has been a case study in partnership and collaboration, including:

• Initial funding from The Leona M. and Harry B. Helmsley Charitable Trust and Locemia Solutions
• Real-world evidence about complexities of the glucagon rescue kit from the Glu community.
• T1D Exchange works with Locemia Solutions to design and run phase III clinical studies and recruits participants from its Clinic Registry
• Lilly is now leveraging its global expertise and heritage in diabetes to bring this product to market.

Read more about this announcement from Lilly.

Background on Severe Hypo and Intranasal Glucagon

In type 1 diabetes, a severe low can cause confusion, seizures, or unconsciousness. It requires medical intervention right away from someone other than the person with T1D. It might be a spouse, parent, or friend. It can be a teacher, coach, or babysitter—most often, it’s from someone who has no medical training.

Today’s life-saving hypoglycemia rescue kit is complex. It contains a powdered form of glucagon that needs to be reconstituted into a liquid, drawn into a needle and injected in the person’s thigh. No easy task under the best of circumstances—and certainly not while a loved one or friend is seizing or unconscious.

Intranasal glucagon could be the first needle-free rescue treatment for severe hypoglycemia.

Intranasal glucagon uses a proprietary glucagon nasal powder formulation that is delivered in an emergency situation using a single-use, ready-to-use device. The caregiver presses a small plunger on the bottom of the device to release the glucagon as a puff in the nose, where the glucagon is absorbed in the nasal passages.

Congratulations to our members, Lilly and Locemia Solutions, and to the entire T1D Exchange patient community!

—Dana Ball
Co-founder and Executive Director, T1D Exchange