7 Diabetes Clinical Trials (Plus ONE!) Recruiting Right Now…

elixir-1312949-639x468When we participate in clinical trials, we help move our research ahead faster… and that means timelines for better devices, drugs, and services for diabetes management are shorter.

I know a lot of people complain (and rightly so!) that trials don’t happen near where they live. Here are some trials that have a lot of locations and others that may only have one or two, but need our community’s help.

If you’re interested in participating in a clinical trial or learning more about it, click on the title of the study which will bring you to clinicaltrials.gov – you can get details on inclusion/exclusion criteria and who to contact to enroll in the trial or get further information. 

Unified Safety System (USS) Virginia Closed-Loop Versus Sensor Augmented Pump Therapy for Hypoglycemia Reduction in Type 1 Diabetes

This is a randomized, controlled trial of Unified Safety System (USS) Virginia closed-loop versus sensor-augmented pump (SAP) therapy for hypoglycemia prevention in subjects with type 1 diabetes and hypoglycemia unawareness and/or risk for hypoglycemia.

Device: Diabetes Assistant (DiAs) (Unified Safety System (USS) Virginia)

Subject will participate in (2) 24-hour study insulin pump and DiAs training session. At the conclusion of each training session, subject will wear the equipment at home for a total of 5 weeks.
The purpose of this study is to evaluate the effectiveness of the control system in reducing hypoglycemia by comparing, in a randomized study, 24 hour control with USS Virginia versus sensor augmented pump (SAP) therapy in subjects with type 1 diabetes and hypoglycemia unawareness and/or risk for hypoglycemia.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02302963
Locations: Stanford University in CA and University of Virginia in VA

Afrezza Safety and Pharmacokinetics Study in Pediatric Patients

This study is to assess the safety and tolerability of Afrezza (inhaled insulin) in children ages 4 to 17 years with type 1 diabetes mellitus (T1DM). In addition to safety and tolerability, they will assess:

  • To assess the ability to titrate the prandial and supplemental doses of Afrezza at each meal.
  • To assess pharmacokinetics (PK) following a prandial dose of Afrezza in children ages 4 to 17 years with T1DM.

The trial locations are in Aurora, Colorado (site # 80045) and Gainesville, Florida (840002).

Contact: For site information, send an email with site number to Contact-Us@sanofi.com

Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes (DEPICT 1)

The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes. Phase III trial is for Farxiga (the brand name), which is currently being used by people with Type 2 diabetes.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02268214

Study is all over the US: AR, CA, CO, FL, ID, IA, KY, LA, ME, MD, MI, MN, MO, NV, NY, PA, TN, TX, UT, WA and in other countries, too!

Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy (inTandem1)

This Phase 3 study is intended to demonstrate superiority of either Sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult patients with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy. SGLT1, SGLT2

Please refer to this study by its ClinicalTrials.gov identifier: NCT02384941

Study is all over the US: AL, AR, CA, CO, FL, GA, HI, IL, KS, KY, ME, MD, MI, MO, NE, NV, NY, NC, OH, OK, SC, SD, TN, TX, VA, WA, WI and all across Canada, too!

Contact: Lisa Sherman (281)863-3228 lsherman@lexpharma.com

Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT)

The primary objective of the study is to determine if RT CGM (Real Time-Continuous Glucose Monitoring) can improve glycemic control in women with T1D who are pregnant or planning pregnancy without substantially increasing the rate of hypoglycemia.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01788527

Studies are currently accepting enrollments across Canada and Europe. The only U.S. location is California. 

Contact: Sonya Mergler, BSc 416-480-5627 conceptt@sunnybrook.ca
Contact: Asma Qureshi, MPH 416-480-5629 conceptt@sunnybrook.ca

A Euglycemic Insulin Clamp Study in Type 1 Diabetic Patients With Oral Insulin (ORAMED)

ORAMED has developed an oral insulin that, in preliminary studies, has shown promise. In the present study investigators will perform a pharmacodynamic/pharmacokinetic study to evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients.

Each subject will be studied on three occasions with an interval of 3 days to 4 weeks between each study. During each study subjects will receive: (i) two 8 mg ORAMED capsule containing insulin; (ii) three 8 mg ORAMED capsules containing insulin; (iii) one 16 mg ORAMED capsule containing insulin. If the fasting plasma glucose is >200mg/dl on the procedure day, the procedure will be rescheduled.

Please review the detailed information as this is an intensive trial.

This study is being done at The University of Texas Health Science Center at San Antonio, TX.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02535715

Contact: Ralph A DeFronzo, MD 210-567-6691 defronzo@uthscsa.edu  
Contact: Monica Palomo, BS 210-567-6710 palomom@uthscsa.edu

A Study to Evaluate the Effect of Camicinal on Gastroparesis Symptoms in Type 1 and 2 Diabetic Subjects With Gastroparesis

This study is a randomized, double-blind, placebo controlled trial designed to confirm the symptomatic effects of camicinal treatment vs. placebo, on gastroparesis symptoms in type 1 and 2 diabetic subjects with gastroparesis. The primary purpose of this study is to determine if a low-dose of camicinal (25 milligram[mg]) for 12 weeks of repeat administration improves gastroparesis symptoms.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02210000

Locations include: AZ, CA, FL, GA, MD, MA, MI, NV, NM, NY, NC, OH, SC, SD, TN, TX, UT, VA.

Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com  

Plus One More…

I am putting this here because fertility can be impacted by diabetes and this may help our male diabetes community members.

Atrasentan Spermatogenesis and Testicular Function

This study is being conducted to evaluate the effects of Atrasentan on sperm production and the function of the testicles in male subjects with Type 1 or 2 Diabetes and Nephropathy.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02118714

Locations: CA, IL, LA, NY, OH, PA

Contact: Melissa Wigderson, MD 847-393-5607 melissa.wigderson@abbvie.com
Contact: Ioanna Mantika Ioanna.Mantika@abbvie.com


7 Noteworthy Diabetes Clinical Trials Recruiting NOW…

elixir-1312949-639x468Clinical trials are the only way that we are going to get better treatments, better devices, and better…cures.

Here are seven noteworthy diabetes clinical trials recruiting now that you might want to look into and see if you (or anyone you know) might be eligible to volunteer.

Click on the titles of each trial to get more info straight from the ClinicalTrials.gov website. 

(Remember… some clinical trials may have you take a placebo in lieu of the investigational drug. Some clinical trials may require extra visits, invasive testing, and travel. You need to think about what the benefits and risks are for trial participation. That being said… nothing ventured, nothing gained.)

Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes

The purpose of this study is to see if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect on Type 1 diabetes. Published Phase I data on repeat BCG vaccinations in long term diabetics showed specific death of some of the disease causing bad white blood cells and also showed a short and small pancreas effect of restored insulin secretion. In this Phase II study, the investigators will attempt to vaccinate more frequently to see if these desirable effects can be more sustained.

Eligible volunteers will either be vaccinated with BCG in a repeat fashion over a period of four years or receive a placebo treatment. The investigators hypothesize that each BCG vaccination will eliminate more and more of the disease causing white blood cells that could offer relief to the pancreas for increased survival and restoration of insulin secretion from the pancreas.

If you’re interested and meet the criteria (and the location, as the trial is being conducted in Boston and requires weekly injections for the first year… don’t know if you can do this at home…), you should send an email to: diabetestrial@partners.org

This is Dr. Denise Faustman’s lab and website. Check out the details and what she’s doing.

Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes (DIaMonD)

Evaluate if addition and use of real time continuous glucose monitoring (RT-CGM) improves glycemic outcome of patients using multiple daily injections (MDI) and self monitoring blood glucose (SMBG) testing, who are not at target glycemic control.

If you are on multiple daily injections, this might be a great opportunity to participate in a really interesting study if you are willing to wear a continuous glucose monitor (CGM) and possibly a pump. Check out the inclusion/exclusion criteria and locations, then send an email or call to either:

Eileen Casal, RN, MSN 858-875-9774 ecasal@dexcom.com
 David Price, MD 858-875-9525 dprice@dexcom.com

A Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Type 1 Diabetes (REPLACE-BG)

The primary objective of the study is to determine whether the routine use of Continuous Glucose Monitoring (CGM) without Blood Glucose Monitoring (BGM) confirmation is as safe and effective as CGM used as an adjunct to BGM.

This study will determine if we can actually make treatment decisions based on our CGM alone when we feel it is accurate, not verifying it with a finger-stick blood glucose check.

This. Is. Huge.

Why? Because one of the reasons why Medicare, Medicaid, and some insurance companies refuse to pay for a continuous glucose monitor, claiming it’s just an adjunct to a blood glucose meter and we still have to check to make treatment decisions. (And we know better, don’t we?) This trial has a lot of inclusion and exclusion criteria, but seriously… if you can do this, you will help the entire T1 diabetes community get access to this device.

Contact either person for more info:

 Katrina Ruedy, MSPH 813-975-8690 kruedy@jaeb.org
 Nhung “Leena” Nguyen, MPH, CCRP 813-975-8690 nnguyen@jaeb.org

Glucose Variability Pilot Study for the Abbott Sensor Based Glucose Monitoring System-Professional

This is to trial the Abbot Libre system, which is a sensor with “flash monitoring” for individuals with Type 2 diabetes. How cool is that? They currently need participants in the following locations: San Diego, Detroit, Kansas City, MO and Pearland, TX. If you meet the criteria, shoot Dr. Karinka an email for more info and get enrolled.

Shridhara Alva Karinka, Ph.D. 510-749-6393 shridhara.alva@abbott.com

A Study To Assess The Safety Of PF-06342674 In Adults With Type 1 Diabetes

If you are a newly diagnosed (within the last two years) adult (over 18), you can participate in a Phase 1 clinical trial for a biological drug, examining safety issues. Again, look at the criteria and locations, then if you are interested, call:

Pfizer CT.gov Call Center 1-800-718-1021

Please refer to this study by its ClinicalTrials.gov identifier: NCT02038764

In-Clinic Evaluation of the Predictive Low Glucose Management (PLGM) System in Adult and Pediatric Insulin Requiring Patients With Diabetes Using the Enlite 3 Sensor

This is a Medtronic study for their next step in the artificial pancreas technology pathway. (And hello… “Enlite 3 sensor!”)

All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

The more patients willing to participate in artificial pancreas technology trials, the faster this technology will become available! Take a look at the locations and criteria and if you’re able to do this trial, contact:

Julie Sekella (818) 576-5171 julie.sekella@medtronic.com

Along those same lines…

Hybrid Closed Loop Pivotal Trial in Type 1 Diabetes

This is a BIG. DEAL. for people with diabetes in the United States. If on this trial, you get to wear the MMT-670G insulin pump, using it with the closed loop algorithm.

Closed Loop. Closed Loop. Need we say more?

Contact: Thomas P Troub(818) 576-3142 thomas.troub@medtronic.com to get involved.

There are so many studies out there that need our help. We help ourselves AND all people with diabetes. Do what you can. If you can’t participate, share this post with someone who might be able to volunteer.

Patient Centricity at #DIA2015

I have the honor and the privilege of speaking on a panel at the Drug Information Association today about patient centricity in clinical trials.

What? What does that have to do with diabetes?


Did you know that less than 1% of the global population participates in clinical trials, but that clinical trials are what provides us with new drugs and treatments? Without them, we wouldn’t have new drugs and devices?

Clinical trials often have issues recruiting patients and getting patients to stay in studies through to completion. Reasons for recruitment and drop out rates can include: issues with traveling to a clinical trial site, exclusions due to age or lab results, and the complexity of the trial (including invasive procedures). What if these issues were minimized because the clinical trial was patient-centric?

What is patient-centric?

We’ve heard the term “patient-friendly” bandied about when discussing organizations that speak on a level that patients can understand. These are the companies who share disease education in an easily digestible way (infographics overload sometimes!) and provide ways to contact the company if further information is needed. When you apply the term “patient-friendly” in clinical trials, it means, in my opinion, the clinical trial personnel can talk to the patient without sounding too… well… clinical. And here’s the difference between “patient-friendly” and “patient-centric” – Patient-centricity means listening to the patient, talking with the patient, and sharing with the patient at every point in the clinical trial timeline.

Patients Aren’t Stupid

We’re not. We understand that without new drugs and devices, our care is the same as it ever was. However, many of us don’t know what’s involved with a clinical trial and the role that we play in helping to get new drugs and devices to market. If we slog through clinicaltrials.gov and read the gobbledygook that is all clinical and zero layman, we’re still left to reach out on our own to get more information and see if we qualify. Most people don’t bother to go that far. And the opportunity to help, to get access to investigational drugs and treatments from the get go, to be a part of the future of healthcare is wasted.

What Needs To Happen

A successful clinical trial, much like everything else, needs clear, understandable, two-way communication between patients and the key people running the trial at every stage. It’s no longer acceptable to bring a token patient to help recruit for a trial. That’s not “patient-centric.” Patients actively participating in developing trial protocols, patients sharing thoughts and potential issues surrounding adherence to a trial – or what might prevent people from participating – and having those who run the trial listen and make changes based on the feedback given – that is “patient-centric.” Understanding the patient (and we aren’t just one patient – all of us are unique, so having “one patient speak for all” isn’t good enough) and incorporating that understanding goes a long way.

Patients want to help. Patients want to be at every table that may help their health or the health of a loved one. Patients need to know if trials are available that they can easily participate in and have an understanding of what is needed and wanted from them – and why they should participate. Communication is key.

Have you thought about participating in a clinical trial?

Take your time to look through the available clinical trials available worldwide. (There are many available for Type 1 and Type 2 diabetes.) Some involve taking investigational drugs. Others involve using a device. All will have a list of “thank you for your interest, but you don’t fit what we’re looking for…” criteria, but take the first step. Be the patient and step into this world. Get involved and while the study may not help you, it may help someone else.

For me, I want to be at the table from the very beginning to the very end. Why? Because at the end of a trial, I’m the patient… hopefully being able to use the new drug or device that I helped bring to life. I want to be patient-centric to other patients.

BBK Worldwide and the Michael J. Fox Foundation will be sharing their thoughts this afternoon on stage alongside me. Grateful for the opportunity. Grateful to speak from the patient perspective.

Grateful to those who participated in clinical trials so that I can wear an insulin pump and a CGM. I’m just trying to pay it forward.

Disclosure: BBK Worldwide paid for my travel and lodging to speak at DIA 2015. My thoughts and words are my own. Always. Like you could shut me up.