Randomized Trial Comparing Sitagliptin to Placebo in Closed Loop
Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
There are many recent advances in insulin treatment of type 1 Diabetes Mellitus (T1DM),
however after a meal sugars are always a concern. There is a drug sitagliptin (Januvia) which
is FDA approved to treat people with type 2 diabetes which helps correct their glucose
(sugars) after meals. This study is going to test whether this drug can improve the after
meal sugars in people with type 1 diabetes. To test this, you will be given a mixed meal and
its effects on insulin levels. The hormones that affect blood glucose as well as your sugar
levels will be measured by a series of blood tests. We will also look for high blood sugars
which might occur because of food staying longer in the stomach than usual or due to the
suppression of a hormone called glucagon which increases blood sugar. If you qualify, you
will be given sitagliptin (Januvia) 50 mg and 100 mg dosages. You and the researchers will
not know which dose you are taking at any single visit. We will first enroll 10 subjects with
established type 1 Diabetes Mellitus for at least 1 year, between the ages of 18-30 years
old. The first 10 patients will be evaluated for safety parameters such as ability to keep
blood sugars < 70 mg/dl for at least 70% of the time, no episode of severe hypoglycemia (low
blood sugars) and so on. After this safety criteria is established, we will then recruit
subjects between the ages of 14-19 yrs for the next phase of the study. A total of 17
subjects were enrolled into the study.
Phase:
Phase 1
Details
Lead Sponsor:
Albert Einstein College of Medicine Albert Einstein College of Medicine of Yeshiva University