Empagliflozin in Adolescent Diabetes

NCT04917692 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: Empad
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Empagliflozin, an inhibitor of the sodium glucose co-transporter 2 (SGLT2), reduces post-prandial glucose levels in adults with both type 2 and type 1 diabetes and importantly reduces both cardiovascular and renal complications in type 2 diabetes. In adults with type 1 diabetes empagliflozin improves endothelial function and vascular stiffness when used in conjunction with insulin. There is clear evidence that complications in type 1 diabetes have their origins during adolescents thus to reduce diabetic complications with adjunctive therapy, this age group must be studied. These studies will need to focus on the effects of these adjunctive agents on functional biomarkers for development of complications. This study is designed to develop pilot and feasibility data for a large scale trial of low dose empagliflozin, 2.5 mg daily, on biomarkers for the development of cardiovascular and renal complications in adolescents between 12 and 18 years of age. The investigators will specifically study the effects of 8 weeks of empagliflozin on:

1. 1.Pre-and post-prandial inflammatory markers using high carbohydrate and high fat meals. Inflammatory markers to be measured include interleukin-6 (IL-6), tissue necrosing factor α (TNF-α), complement component C3 concentrations and skin advanced glycosylation endproducts (AGE).
2. 2.Pre-and post-prandial vascular function including forearm vascular resistance, endothelial function and pulse wave velocity.
3. 3.Microalbuminuria and pre- and post-prandial glomerular hyperfiltration, tubular injury and renal inflammation.

Conditions

type1diabetes

Keywords

type 1 diabetes; adolescents; cardiovascular risk; inflammation; complement; endothelial function; empagliflozin

Outcome Measures

Primary Outcomes (4)

• Interleukin 6

  IL6 levels will be measured before and after high carbohydrate meal at the beginning and end of the 8 weeks

  8 weeks

• Glomerular filtration rate

  Cystatin C levels will be used to calculate GFR before and after high carbohydrate meal at the beginning and end of the 8 weeks

  8 weeks

• Endothelial function

  Percentage change in forearm vascular resistance following 5 min of arterial occlusion.

  8 weeks

• Number of episodes of diabetic ketoacidosis per patient

  Frequency of diabetic ketoacidosis will be assessed through the 8 weeks

  8 weeks

Secondary Outcomes (4)

• Complement

  8 weeks

• Lipids

  8 weeks

• Pulse wave velocity

  8 weeks

• Number of episodes of hypoglycemia per patient

  8 weeks

Study Arms (1)

empagliflozin

EXPERIMENTAL

empagliflozin 2.5 mg daily

Drug: Empagliflozin

Interventions

Empagliflozin DRUG

2.5 mg daily

Also known as: Jardiance

empagliflozin

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age: 12-18 years
• Clinical diagnosis of type 1 diabetes
• Duration of diabetes \> 1 r
• Multiple daily injections or continuous subcutaneous insulin infusion.
• Home glucose testing 4 times per day or continuous glucose monitor.
• Hemoglobin A1c levels will be ≤ 10.5%
• History of adherence to insulin administration, carbohydrate counting.

You may not qualify if:

• Duration of type 1 diabetes for less than 1 year
• Medical conditions other than type 1 diabetes or treated hypothyroidism
• Medications other than insulin, levothyroxine or oral contraceptives for birth control
• Antihypertensive medications, lipid lowering medications, or anti-hyperglycemic agents other than insulin.
• Hospital admission for diabetic ketoacidosis in the last year

Sponsors & Collaborators

• Ohio State University: lead
• Diacomp: collaborator

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Inflammation

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single arm, open label intervention study

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: June 8, 2021
• Study Start: July 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: October 1, 2022
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)