EUCTR2015-001594-40-GB
Active, not recruiting
Phase 1
SGLT-2 Inhibitor Empagliflozin Effects on Appetite and Weight Regulation: A randomised double-blind placebo-controlled trial (SEESAW) - SEESAW
niversity of Leicester0 sites76 target enrollmentJune 8, 2020
ConditionsType 2 diabetes mellitusMedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsJardiance
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 2 diabetes mellitus
- Sponsor
- niversity of Leicester
- Enrollment
- 76
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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