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


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