Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01530178 · ClinicalTrials.gov registry record · Phase 4
Sitagliptin Dose Determination Study
A Phase 4 study of Diabetes Mellitus, Type 1, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT01530178 is a Phase 4 study of Diabetes Mellitus, Type 1 that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 8 participants, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01530178, a Phase 4 study of Diabetes Mellitus, Type 1, has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
There are many recent advances in insulin treatment of type 1 diabetes, 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 glucoses (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 test mixed meal and its effects on insulin, other hormones that affect blood glucose as well as your sugar will be measured by a series of blood tests. Insulin dose will be reduced by 20-50% to prevent low 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) 3 different times in 25 mg, 50 mg and 100mg dosages. You and the researchers will not know which dose you are taking at any single visit. A total of 30 people in which some will be children aged 13- 17 and others will be adults aged 18-30 will participate. Some will have had diabetes for over a year, others will be within 3 months of having been found to have type 1 diabetes. Furthermore, only 18-30 year people who are diagnosed with type 1 diabetes for a year or more will be studied initially (4 subjects) to establish safety data before younger subjects are enrolled into the study.
Conditions Studied
Interventions
- DRUG Sitagliptin
- DRUG Placebo Oral Tablet
Study Locations (1)
New York
- Albert Einstein College of Medicine CRC - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2011-11 |
| Est. Completion | 2015-03 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01530178
The ClinicalTrials.gov registry entry for NCT01530178 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (99% lower). The listed sponsor is Albert Einstein College of Medicine, which has 175 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 2 interventions - of which Sitagliptin is the first listed.
NCT01530178 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01530178 about?
NCT01530178 is a clinical study titled "Sitagliptin Dose Determination Study". There are many recent advances in insulin treatment of type 1 diabetes, 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 glucoses (sugars) after meals. This study is going to t...
What is the current status of trial NCT01530178?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2011-11. Estimated completion is 2015-03.
What conditions does trial NCT01530178 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT01530178?
The interventions under investigation include: Sitagliptin (DRUG), Placebo Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT01530178?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01530178 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Teplizumab in Pediatric Stage 2 Type 1 Diabetes
ACTIVE NOT RECRUITING · Phase 4
-
Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus
ACTIVE NOT RECRUITING · Phase 4
-
Afrezza® Dosing Optimization Study
COMPLETED · Phase 4
-
Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones.
COMPLETED · Phase 4
-
NovoLog Observation Trial in Subjects With Type 1 and Type 2 Diabetes
COMPLETED · Phase 4
-
Comparison of Glycemic Control Achieved With 2 Different Needles
COMPLETED · Phase 4
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.