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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06149793
Other study ID # MED-2023-31645
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date December 30, 2023
Est. completion date December 31, 2025

Study information

Verified date February 2024
Source University of Minnesota
Contact Amir Moheet, MBBS
Phone 612-625-2153
Email mohee002@umn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This will be a placebo-controlled, randomized, double blind, crossover study with a 4 week wash out period. Collect pilot data on the safety, tolerability, and feasibility of empagliflozin therapy in overweight/obese patients with CFRD to support a future larger randomized controlled trial.


Description:

The overall goal of this proposal is to collect pilot data for safety and feasibility metrics to support a future larger randomized controlled trial. In this study, we will examine the safety and tolerability of Sodium glucose co-transporter 2 inhibitor (SGLT2i) empagliflozin as an add-on therapy to insulin for overweight/obese adult patients with CFRD. We hypothesize that empagliflozin will be safe, well tolerated and will improve glycemic control in overweight/obese adult patients with CFRD. Specific Aim 1: Collect pilot data on the safety, tolerability, and feasibility of empagliflozin therapy in overweight/obese patients with CFRD to support a future larger randomized controlled trial. Hypothesis 1: Empagliflozin will be safe and well tolerated, with no evidence for electrolyte abnormalities, metabolic acidosis, ketosis or increased risk of severe hypoglycemia in overweight/obese adults people with CFRD. Specific Aim 2: Collect preliminary data to evaluate the effect of empagliflozin on glycemic outcomes. Hypothesis 2: Treatment with empagliflozin will improve glycemic control as indicated by glucose levels as measured by oral glucose tolerance test (OGTT), and on glycemic outcomes as measured by continuous glucose monitoring (CGM).


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult subjects 18 years or older with CFRD and on insulin treatment - BMI >25 kg/m2 - A participant who is capable of becoming pregnant must agree to take precautions that are effective in preventing pregnancy throughout this study. These methods could include one of the following 1. Complete abstinence from sexual intercourse; 2. Tubal ligation; 3. Use combination of two forms of contraception during the study including, oral, injectable, or implanted hormonal contraceptives, intrauterine device or barrier method. Exclusion Criteria: - acute pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks prior to baseline study procedures - less than 12 weeks since start of a new CFTR corrector/modulator therapy - type 1 diabetes - Positive GAD 65 antibody or low fasting C-peptide (below the normal reference range of the lab) - A history of diabetic ketoacidosis - history of recurrent genital or urinary tract infections - pregnancy or lactation - prior solid organ transplant - Chronic liver disease (based on problem list in medical records or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times elevated above the upper limit of normal. - chronic kidney disease (eGFR < 60mL/min/1.73 m2) - Hypersensitivity to empagliflozin or any excipients of Jardiance - History of eating disorder - Non-English speakers and those unable to read in English • Diminished capacity to consent (study staff will utilize the MacCAT-CR for assessment)

Study Design


Intervention

Drug:
Empagliflozin
Sodium glucose co-transporter 2 inhibitor
Other:
Placebo Control
Placebo Control

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Amir Moheet

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility, safety, tolerability The primary outcomes are related to feasibility, including safety and treatment tolerability. Safety will be evaluated as the proportion (in %) of participants who experience a serious adverse event during the study. Tolerability will be evaluated as the proportion (in %) of participants who discontinue their assigned treatment due to side effects. Duration of anticipated participation for an individual participant's would be around 15 weeks.Duration anticipated to complete all study procedures, including any long-term follow-up, and data analysis is 24 months.
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