A Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Group Study to Evaluate Changes in Fasting Glucose after a 4-Week Treatment Period with L-glutamine or Sodium Butyrate Administered by Rectal Suppository

Location:

Rochester, Minn.

Trial status:
Open for Enrollment
Why is this study being done?

The purpose of this study is to help determine if administration of L-glutamine or sodium butyrate suppositories results in a decrease in blood glucose levels.

This research study is being done to evaluate the safety and effectiveness of an investigational drug that is  being developed for the treatment of type 2 diabetes.

Who is eligible to participate?

Stable Type 2 diabetics, ages 21-75 years, inclusive, diagnosed six (6) or more months before the screening visit and with a fasting glucose (plasma) ≤ 150mg/dL at screening (while on a stable dose of metformin, a sulfonylurea, a dipeptidyl peptidase 4 inhibitors (DPP-4 inhibitors) and/or a glinide for at least 3 months) and a fasting glucose between 120 and 180mg/dL at baseline, after four (4) weeks off all glucose-lowering agents.

What is involved?

Subjects will be asked to to test their blood glucose, maintain a daily record of glucose values, eating and bowel habits and record of self-administered treatment. The treatments are given by suppository 3 times per day for a total of 4 weeks.

How long is the study?

It will take about 10 weeks to complete this research study, which includes a 4-week screening period, 4 week treatment period and a follow up phone call 2 weeks after the final study visit. During this time, subjects will make 6 study visits to the Clinical Research Unit.

IRB Number:
13-005130