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NCT02328040 · ClinicalTrials.gov registry record · Phase 1
Randomized Trial Comparing Sitagliptin to Placebo in Closed Loop
A Phase 1 study, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT02328040 is a Phase 1 study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 17 participants.
The verdict
NCT02328040, a Phase 1 study, has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo and Insulin monotherapy via CL
- DRUG Sitagliptin and insulin/novolog via CL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2014-09 |
| Est. Completion | 2016-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02328040
The ClinicalTrials.gov registry entry for NCT02328040 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Einstein College of Medicine, which has 175 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo and Insulin monotherapy via CL is the first listed.
NCT02328040 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02328040 about?
NCT02328040 is a clinical study titled "Randomized Trial Comparing Sitagliptin to Placebo in Closed Loop". 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 stud...
What is the current status of trial NCT02328040?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2014-09. Estimated completion is 2016-01.
What interventions are being tested in trial NCT02328040?
The interventions under investigation include: Placebo and Insulin monotherapy via CL (DRUG), Sitagliptin and insulin/novolog via CL (DRUG).
Who is sponsoring clinical trial NCT02328040?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
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