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Tricyclic Antidepressant
Amitriptyline in Treating Hypoglycemia
Phase 2
Waitlist Available
Led By Yu Kuei Lin, M.D.
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
Approved for 20 Other Conditions
All Individual Drugs Already Approved
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.
Eligible Conditions
- Low blood sugar awareness
- Type 1 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Glucose Area Under the Curve (AUC): Values < 54 mg/dL
Glucose Area Under the Curve (AUC): Values < 70 mg/dL
Ratio of Self-Reported Hypoglycemic Episodes to Total Hypoglycemic Episodes
Secondary study objectives
Average Hypoglycemia Duration With Blood Glucose < 54 mg/dL
Average Hypoglycemia Duration With Blood Glucose < 70 mg/dL
Hypoglycemia Awareness Score by Clarke Questionnaire
+6 moreAwards & Highlights
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AmitriptylineExperimental Treatment1 Intervention
Participants will be initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose will be increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline will be reduced to 25 mg daily during the two week Taper Period.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose will be changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose will be changed back to the Placebo capsule matching the 25 mg Amitriptyline during the two week Taper period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amitriptyline
FDA approved
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,147 Previous Clinical Trials
1,699,078 Total Patients Enrolled
Yu Kuei Lin, M.D.Principal InvestigatorUniversity of Utah