MedTrace Logo

Amitriptyline in Treating Hypoglycemia

NCT03591458 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-07-22

Study results available
· View outcomes & findings →

Summary

Patients with type 1 diabetes mellitus (T1DM) commonly experience hypoglycemia and develop impaired awareness of hypoglycemia. Many patients using continuous glucose monitoring (CGM) system to mitigate these complications, but continue to spend a significant amount of time in hypoglycemia. The long-term goal is to develop novel and readily available therapeutic approaches to improve hypoglycemia course and awareness in T1DM patients. The objective of this study is to determine whether amitriptyline will improve hypoglycemia course and the ability to recognize hypoglycemic events in T1DM patients who are using CGM.

Conditions

  • Type1 Diabetes Mellitus
  • Hypoglycemia Unawareness

Interventions

DRUG

Amitriptyline

Participants will receive a supply of Amitriptyline capsules for titration, intervention, and taper periods.

DRUG

Placebo

Participants will receive a supply of Placebo capsules, matching those of Amitriptyline, for the titration, intervention, and taper periods

Sponsors & Collaborators

Principal Investigators

  • Yu Kuei Lin, M.D. · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2019-06-03
Completion
2019-06-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03591458 on ClinicalTrials.gov