SGLT-2 Inhibitor Empagliflozin Effects on Appetite and Weight Regulation.

Sponsor
University of Leicester
Study ID
NCT02798744
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Empagliflozin — DRUG
    25mg once daily to be taken orally for the duration of the study (24 weeks)
  • Diet — BEHAVIORAL
    Daily energy restriction diet to be followed for the duration of the study (24 weeks)
  • Placebo — DRUG
    Placebo once daily for the duration of the study (24 weeks)

Study Details

The aim of this study is to investigate the cause for the discrepancy in predicted and observed weight loss with Empagliflozin (Jardiance™) by measuring appetite regulation. Major secondary objectives are to determine the effects of Empagliflozin (Jardiance™) on energy expenditure and change in total body weight and body composition. The primary outcome is change in appetite hormone concentrations (specifically total PYY) between baseline and 24 weeks: - this will be measured by sequential blood sampling during visits 1-5. Secondary outcomes, which are exploratory, are effect on appetite hormones (ghrelin and GLP-1), appetite perceptions, total body weight and fat and fat free mass, energy expenditure, appetite perception, physical activity and blood and urine biochemical parameters after Empagliflozin (Jardiance™) treatment for 24 weeks. The sample size for the study is 76 participants and the planned trial duration is 21 months, with participants receiving approximately 24 weeks of exposure to Empagliflozin (Jardiance™).

Key Dates

Start date
Dec 31, 2016
Status verified
Jan 2020
Primary completion
Jul 30, 2019
Completion
Jul 30, 2019

Study Design

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

Arms

  • Experimental: Empagliflozin 25mg once daily
    Empagliflozin (Jardiance™) 25mg once daily (orally)
  • Experimental: Empagliflozin 25mg once daily + diet
    Empagliflozin (Jardiance™) 25mg once daily (orally) + energy restriction diet
  • Placebo Comparator: Placebo once daily
    Placebo once daily (orally)
  • Active Comparator: Placebo once daily + diet
    Placebo once daily (orally) + energy restriction diet

Primary Outcome Measure

Change from baseline in Total PYY at 24 weeks [ Time Frame: Baseline and 24 weeks ]

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