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 — DRUG
    Dapagliflozin or Farxiga is a SGLT-2 inhibitor
  • Insulin — DRUG
  • Liraglutide — DRUG
    Victoza(Liraglutide) is a GLP-1 agent.
  • Dapagliflozin placebo — DRUG
    Dapagliflozin 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: Placebo
    12 weeks of treatment with Insulin, Liraglutide and "Dapagliflozin Placebo"
  • Active Comparator: Active drugs
    12 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)

FacilityCityStateZIPSite coordinators
ECMC Ambulatory Center, 3rd FloorBuffaloNew York14215-

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