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

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ClinicalTrials.gov Identifier: NCT02798744
Recruitment Status : Recruiting
First Posted : June 14, 2016
Last Update Posted : April 17, 2019
Sponsor:
Collaborators:
Loughborough University
University Hospitals, Leicester
Information provided by (Responsible Party):
University of Leicester

Brief 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™).


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Empagliflozin Behavioral: Diet Drug: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SGLT-2 Inhibitor Empagliflozin Effects on Appetite and Weight Regulation: A Randomised Double-blind Placebo-controlled Trial (The SEESAW Study)
Actual Study Start Date : December 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Empagliflozin 25mg once daily
Empagliflozin (Jardiance™) 25mg once daily (orally)
Drug: Empagliflozin
25mg once daily to be taken orally for the duration of the study (24 weeks)
Other Name: Jardiance

Experimental: Empagliflozin 25mg once daily + diet
Empagliflozin (Jardiance™) 25mg once daily (orally) + energy restriction diet
Drug: Empagliflozin
25mg once daily to be taken orally for the duration of the study (24 weeks)
Other Name: Jardiance

Behavioral: Diet
Daily energy restriction diet to be followed for the duration of the study (24 weeks)
Other Name: Energy restriction diet

Placebo Comparator: Placebo once daily
Placebo once daily (orally)
Drug: Placebo
Placebo once daily for the duration of the study (24 weeks)

Active Comparator: Placebo once daily + diet
Placebo once daily (orally) + energy restriction diet
Behavioral: Diet
Daily energy restriction diet to be followed for the duration of the study (24 weeks)
Other Name: Energy restriction diet

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




Primary Outcome Measures :
  1. Change from baseline in Total PYY at 24 weeks [ Time Frame: Baseline and 24 weeks ]
    The effect of Empagliflozin on appetite hormone 'Total PYY' concentration between baseline and 24 weeks. Measured by sequential blood sampling at study visits 1-5.


Secondary Outcome Measures :
  1. Change from baseline in Ghrelin at 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Change in appetite hormone 'Ghrelin' concentration from baseline to 24 weeks. Measured by blood sampling at study visits 1-5.

  2. Change from baseline in GLP-1 to 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Change in appetite hormone 'GLP-1' concentration from baseline to 24 weeks. Measured by blood sampling at study visits 1-5.

  3. Change from baseline in appetite perceptions to 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Change in appetite perceptions from baseline to 24 weeks. Measured by questionnaires visits 1 -5.

  4. Change in Weight (kg) from baseline to 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Change in weight (kg) from baseline to study end and between groups. This will be measured at visits 1 - 5.

  5. Change in Body composition from baseline to 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Change in body composition from baseline to study end and between groups. This will be measured by Dual Energy X-Ray Absorptiometry (DEXA) scanning at visits 1 and 5.

  6. Change in resting energy expenditure from baseline to 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Change in resting energy expenditure from baseline to study end and between groups. This will be measured by indirect calorimetry at visits 1-5.

  7. Change in objectively measured Physical Activity from baseline to 24 weeks using activity monitors [ Time Frame: Baseline and 24 weeks ]
    Change in physical activity from baseline to study end and between groups. This will be measured using physical activity monitors at visits 0, 3, 4 and 5.

  8. Change in subjectively measured Physical Activity from baseline to 24 weeks using the International Physical Activity Questionnaire (IPAQ) [ Time Frame: Baseline and 24 weeks ]
    Change in physical activity from baseline to study end and between groups. This will be measured using the international physical activity questionnaire at visits 1 - 5.

  9. Change from baseline urine glucose excretion to 24 weeks. [ Time Frame: Baseline and 24 weeks ]
    Change in urine glucose excretion to study end and between groups. This will be measured using urine sampling at visits 1-5.

  10. Change from baseline in blood appetite hormones to 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Change in in baseline blood appetite hormones to 24 weeks between groups. This will be measured using blood sampling at visits 1-5.

  11. Change from baseline in HbA1c to 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Change in in baseline HbA1c to 24 weeks between groups. This will be measured using blood sampling at visits 1-5.

  12. Change from baseline in inflammatory markers to 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Change in in baseline inflammatory markers to 24 weeks between groups. This will be measured using blood sampling at visits 1-5.

  13. Change from baseline in renal functioning to 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Change in in baseline renal functioning to 24 weeks between groups. This will be measured using blood sampling at visits 1-5.

  14. Change from baseline in liver functioning to 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Change in in baseline liver functioning to 24 weeks between groups. This will be measured using blood sampling at visits 1-5.



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Male and postmenopausal female participants aged between 30-75 years of age inclusive
  2. Type 2 diabetes on diet and lifestyle control or stable dose of metformin only for at least 3 months
  3. Stable weight (less than 5% change in body weight in last 3 months) - determined by self-reporting or documentation in clinical records
  4. HbA1c 48-86mmol/mol (6.0 - 10%)
  5. eGFR≥60ml/min/1.73m2
  6. BMI ≥ 25kg/m2
  7. Able and willing to give informed consent
  8. Able to understand English

Exclusion Criteria

  1. Females who are not postmenopausal (as menstrual cycle can affect appetite hormone concentrations) which is defined as "2 years post last menstrual period <50 years of age or 1 year post last menstrual period >50 years of age."
  2. Type 2 diabetes on any other glucose lowering treatment except metformin
  3. Patients with Type 1 diabetes
  4. Patients on loop diuretics
  5. Age <30 years and >75 years
  6. BMI <25kg/m2
  7. Not able to give informed consent
  8. Not able to understand English
  9. Moderate to severe renal impairment (eGFR<60ml/min/1.73m2)
  10. Unstable diabetes i.e. HbA1c >86mmol/mol (10%), recent hospital admission with diabetic emergency in last 3 months
  11. Patients with familial renal glycosuria
  12. Patients with recurrent balanitis, vaginal or urinary tract infections
  13. Shift workers
  14. Patients who have participated in another study of an investigational medicinal product in the last 3 months
  15. Active malignancy
  16. Serious illness with a life-expectancy of less than 1 year
  17. Hypersensitivity to Empagliflozin (Jardiance™) or to any of the excipients
  18. Patients with latent autoimmune diabetes in adults (LADA)
  19. Patients with a history of chronic pancreatitis
  20. Evidence of conditions that lead to restricted food intake or severe dehydration
  21. Patients with a history of excessive alcohol consumption
  22. Patients on a severely calorie restricted diet (i.e., ≤800 calories per day)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02798744


Contacts
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Contact: Natasha Wileman, MSc 0116 258 8929 ext 8929 natasha.wileman@uhl-tr.nhs.uk
Contact: Sudesna Chatterjee, MBBS MD FRCP 0116 258 8973 ext 8973 sudesna.chatterjee@uhl-tr.nhs.uk

Locations
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United Kingdom
Leicester Diabetes Centre Recruiting
Leicester, United Kingdom, LE5 4PW
Contact: Natasha Wileman, MSc    0116 258 8929 ext 8929    natasha.wileman@uhl-tr.nhs.uk   
Contact: Lucy Ayres    0116 258 4499 ext 4499    lucy.ayres@uhl-tr.nhs.uk   
Principal Investigator: Melanie Davies, MBBS MD FRCP         
Sponsors and Collaborators
University of Leicester
Loughborough University
University Hospitals, Leicester
Investigators
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Principal Investigator: Melanie J Davies, MBBS MD FRCP University of Leicester

Publications:
Bailey CJ. SGLT2 inhibitors:Glucuretic treatment for type 2 diabetes. British Journal of Diabetes and Vascular Disease. 2010;10:193-199

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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT02798744     History of Changes
Other Study ID Numbers: UNOLE 0526
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs