Randomized Trial Comparing Sitagliptin to Placebo in Closed Loop
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Placebo and Insulin monotherapy via CL; Sitagliptin and insulin/novolog via CL
Intervention description: In the control arm patient receives a placebo pill with the closed loop with insulin/novolog (placebo and insulin/novolog via CL); In the treatment arm the participant receives a single dose of sitagliptin with closed loop with insulin/novolog (Sitagliptin and insulin/novolog via CL), Part B
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Sitagliptin Phosphate; Insulin Aspart
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 14 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, Type 1; Closed loop; Artificial Pancreas; Insulin; Sitagliptin; Januvia

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age of 14 to 30 years

          2. Subjects must be otherwise healthy except for T1DM, and treated for hypothyroidism if
             present

          3. Menstruating women must have negative pregnancy test.

          4. Hemoglobin (Hb) more than 12 g/dl

        Exclusion Criteria:

          1. Having any other chronic condition except hypothyroidism stable on medications

          2. On chronic medications that may affect glucose excursions

          3. Hemoglobin less than 12 g/dl

          4. Positive pregnancy test (based on Urine)

          5. Pregnant or lactating mothers Known allergy to Januvia-