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GLP-1 Receptor Agonist and SGLT2 Inhibitor Combination
Empagliflozin 25 MG + Liraglutide 1.8 MG for Diabetes (NATRIURETIC Trial)
Phase 2
Recruiting
Led By David ZI Cherney, MD PhD FRCPC
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up outcome will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks)
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 10 Other Conditions
Summary
This trial studies how two diabetes treatments affect heart health in people with type 2 diabetes without heart failure.
Eligible Conditions
- Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ glomerular filtration rate (gfr, based on plasma iohexol clearance) will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~glomerular filtration rate (gfr, based on plasma iohexol clearance) will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proximal tubular natriuresis
Secondary study objectives
Arterial stiffness
Body weight
Glomerular Filtration Rate
+4 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
2Treatment groups
Experimental Treatment
Group I: LiraglutideExperimental Treatment2 Interventions
Liraglutide Subcutaneous Total Dose 1.8mg daily for 6 weeks
Group II: EmpagliflozinExperimental Treatment2 Interventions
Empagliflozin Tablets Total Dose 25mg daily for 6 weeks
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Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,523 Previous Clinical Trials
503,302 Total Patients Enrolled
10 Trials studying Diabetes
2,688 Patients Enrolled for Diabetes
David ZI Cherney, MD PhD FRCPCPrincipal InvestigatorUniversity Health Network, Toronto General Hospital
1 Previous Clinical Trials
50 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of a condition called gastroparesis, where your stomach takes longer than usual to empty its contents.You have a history of not being able to sense when your blood sugar levels are too low.You have a known intolerance or negative reaction to SGLT2i or GLP-1RA medications.Your body weight is within a certain range, called Body Mass Index (BMI), which goes from 18.5 to 40.0 kg/m2.You have recently had a heart condition like a heart attack, heart procedure, or surgery.You had weight loss surgery or other surgeries that affect how your body absorbs nutrients within the past year.You have been taking weight loss medication or following a strict diet for the past three months, and your weight has been changing a lot during that time.You are currently taking corticosteroid medications.You have had pancreatitis in the past.You or your family has a history of a specific type of thyroid cancer called medullary thyroid cancer or a condition called MEN2B.
Research Study Groups:
This trial has the following groups:- Group 1: Liraglutide
- Group 2: Empagliflozin
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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