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

NCT02798744 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2020-01-30

No results posted yet for this study

Summary

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™).

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Empagliflozin

25mg once daily to be taken orally for the duration of the study (24 weeks)

BEHAVIORAL

Diet

Daily energy restriction diet to be followed for the duration of the study (24 weeks)

DRUG

Placebo

Placebo once daily for the duration of the study (24 weeks)

Sponsors & Collaborators

  • Loughborough University

    collaborator OTHER

  • University Hospitals, Leicester

    collaborator OTHER

  • University of Leicester

    lead OTHER

Principal Investigators

  • Melanie J Davies, MBBS MD FRCP · University of Leicester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2019-07-30
Completion
2019-07-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02798744 on ClinicalTrials.gov