| Trial ID: | L3595 |
| Source ID: | NCT02328040
|
| Associated Drug: |
Placebo And Insulin Monotherapy Via Cl
|
| Title: |
Randomized Trial Comparing Sitagliptin to Placebo in Closed Loop
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02328040/results
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Placebo and Insulin monotherapy via CL|DRUG: Sitagliptin and insulin/novolog via CL
|
| Outcome Measures: |
Primary: Blood Glucose Measures in Subjects Treated With Sitagliptin, Compared to the Placebo, Better targeted blood glucose levels in the CL setting in the treatment arm, Sitagliptin, compared to placebo (insulin monotherapy), 18 Months | Secondary: Measure of Glucagon Concentration in Subjects Treated With Sitagliptin, Compared to Placebo, Serum glucagon concentrations were measured in the CL setting in the treatment arm, sitagliptin, compared to the placebo (Insulin monotherapy), 18 months
|
| Sponsor/Collaborators: |
Sponsor: Albert Einstein College of Medicine | Collaborators: Medtronic
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
17
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-09
|
| Completion Date: |
2016-01
|
| Results First Posted: |
2018-08-07
|
| Last Update Posted: |
2018-08-07
|
| Locations: |
Albert Einstein College of Medicine CRC, Bronx, New York, 10461, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02328040
|
