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

• Status: Completed
• Trial end date: 2019-07-30
• Target enrollment: 0
• Participant gender: All

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™).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leicester
• Collaborators: Loughborough University; University Hospitals, Leicester
• Treatments: Empagliflozin

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)