Effects of Single Doses of Liraglutide and Dapagliflozin on Ketogenesis in Type 1 Diabetes

Part of paid clinical trials in Buffalo, New York.

Sponsor
University at Buffalo
Study ID
NCT02777073
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Victoza — DRUG
    Single dose of Liraglutide
  • Placebo — DRUG
    Single dose of generic placebo
  • Dapagliflozin 10mg Tab — DRUG
    single dose of 10 mg dapagliflozin

Study Details

1. To compare levels of ketone bodies (beta-hydroxybutyrate and acetoacetate) in plasma and urine following a single dose treatment of either liraglutide 1.8mg, dapagliflozin 10mg or placebo in insulinopenic state. 2. To compare plasma levels of free fatty acid, glucagon, hs-CRP, Ll-6 and IL-1 before and after administration of liraglutide/placebo.

Key Dates

Start date
Mar 1, 2016
Status verified
Feb 2024
Primary completion
Dec 1, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
43 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: liraglutide 1.8 mg
    single dose of Victoza ( liraglutide) 1.8 mg
  • Placebo Comparator: Placebo
    Single dose of placebo
  • Active Comparator: Dapagliflozin
    Single dose of Dapagliflozin 10 mg oral tablet

Primary Outcome Measure

Difference in Ketone Bodies Formation After Single Dose of Liraglutide and Dapagliflozin [ Time Frame: 8 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
ECMC Ambulatory Center, 3rd FloorBuffaloNew York14215-

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