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

Phase 1

• Conditions: Type 2 diabetes mellitus; MedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-001594-40-GB
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-08
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1.Male and postmenopausal female participants aged between 30-70 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 (6.5 - 10%)
5.eGFR=60ml/min/1.73m2
6.BMI = 25kg/m2
7.Able and willing to give informed consent
8.Able to understand English.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

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 <29 years and >70 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified