Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes
Part of paid clinical trials in Buffalo, New York.
- Sponsor
- University at Buffalo
- Study ID
- NCT02518945
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dapagliflozin — DRUGDapagliflozin or Farxiga is a SGLT-2 inhibitor
- Insulin — DRUG
- Liraglutide — DRUGVictoza(Liraglutide) is a GLP-1 agent.
- Dapagliflozin placebo — DRUGDapagliflozin placebo looking similar to active drug Dapagliflozin in external appearance but not containing active ingredient dapagliflozin
Study Details
This is a single center, prospective, randomized, double blinded placebo controlled study conducted I patients with type 1 diabetes.The aim of this study is to examine the additive effects of GLP-1 agonist and SGLT2 inhibitor in patients with type 1 diabetes in terms of possible improved glycemic control, reduced glycemic variability, reduced insulin dosages, additional effects of weight loss and blood pressure reduction.
Key Dates
- Start date
- Aug 31, 2015
- Status verified
- Dec 2023
- Primary completion
- Dec 31, 2015
- Completion
- Apr 30, 2016
Study Design
- Enrollment
- 26 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Placebo12 weeks of treatment with Insulin, Liraglutide and "Dapagliflozin Placebo"
- Active Comparator: Active drugs12 weeks of treatment with Insulin, Liraglutide and "Active Dapagliflozin Drug"
Primary Outcome Measure
Absolute Change After 12 Weeks From Baseline in Mean HbA1c With Addition of Dapagliflozin Compared to Placebo. [ Time Frame: 12 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| ECMC Ambulatory Center, 3rd Floor | Buffalo | New York | 14215 | - |
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