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Clinical Trial Details

Trial ID: L3413
Source ID: NCT03591458
Associated Drug: Amitriptyline
Title: Amitriptyline in Treating Hypoglycemia
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03591458/results
Conditions: Type1 Diabetes Mellitus|Hypoglycemia Unawareness
Interventions: DRUG: Amitriptyline|DRUG: Placebo
Outcome Measures: Primary: Glucose Area Under the Curve (AUC): Values < 70 mg/dL, Continuous Glucose Monitoring (CGM) data will be collected for a 2-week period at the end of the Intervention Phase. The mean AUC for glucose values \< 70 mg/dL will be compared between the Amitriptyline and Placebo arms., 2 Weeks|Glucose Area Under the Curve (AUC): Values < 54 mg/dL, Continuous Glucose Monitoring (CGM) data will be collected for a 2-week period at the end of the Intervention Phase. The mean AUC for glucose values \< 54 mg/dL will be compared between the Amitriptyline and Placebo arms., 2 Weeks|Ratio of Self-Reported Hypoglycemic Episodes to Total Hypoglycemic Episodes, Participants will complete a report of all hypoglycemic events experienced during the 2-week surveillance period at the end of the Intervention Phase. The average ratio of self-reported hypoglycemic episodes to total hypoglycemic episodes recorded by Continuous Glucose Monitoring (CGM) will be compared between the Amitriptyline and Placebo arms., 2 Weeks | Secondary: Total Count of Severe Hypoglycemic Episodes, Severe hypoglycemic episodes, defined by the need from other to administer treatments for hypoglycemia, as reported by patients will be counted and totaled during the Intervention Phase., 8 Weeks|Hypoglycemia Episode Count With Blood Glucose < 70 mg/dL, Continuous Glucose Monitoring (CGM) data will be collected for a 2-week period at the end of the Intervention Phase. The number of hypoglycemic episodes for glucose values \< 70 mg/dL will be compared between the Amitriptyline and Placebo arms., 2 weeks|Hypoglycemia Episode Count With Blood Glucose < 54 mg/dL, Continuous Glucose Monitoring (CGM) data will be collected for a 2-week period at the end of the Intervention Phase. The number of hypoglycemic episodes for glucose values \< 54 mg/dL will be compared between the Amitriptyline and Placebo arms., 2 weeks|Average Hypoglycemia Duration With Blood Glucose < 70 mg/dL, Continuous Glucose Monitoring (CGM) data will be collected for a 2-week period at the end of the Intervention Phase. The duration of hypoglycemic episodes for glucose values \< 70 mg/dL will be averaged compared between the Amitriptyline and Placebo arms., 2 weeks|Average Hypoglycemia Duration With Blood Glucose < 54 mg/dL, Continuous Glucose Monitoring (CGM) data will be collected for a 2-week period at the end of the Intervention Phase. The duration of hypoglycemic episodes for glucose values \< 54 mg/dL will be averaged compared between the Amitriptyline and Placebo arms., 2 weeks|Hypoglycemia Awareness Score by Gold Questionnaire, Participants will complete the Gold questionnaire for hypoglycemia awareness at the baseline and final Intervention Phase visit. The Gold questionnaire is comprised of one question to evaluate the hypoglycemia awareness, with scores from 1 to 7, representing from normal to minimal/no hypoglycemia awareness. The average change in Gold questionnaire score from baseline to end of treatment will be compared between the Amitriptyline and Placebo arms., 10 Weeks|Hypoglycemia Awareness Score by Clarke Questionnaire, Participants will complete the Clarke questionnaire for hypoglycemia awareness at the baseline and final Intervention Phase visit. The Clarke questionnaire is comprised of eight questions to evaluate the hypoglycemia awareness. The answer for each individual question will represent a score (0 or 1). These scores will be summed together to a final score from 0 to 7, representing from normal to minimal/no hypoglycemia awareness. The average change in Clarke questionnaire score from baseline to end of treatment will be compared between the Amitriptyline and Placebo arms., 10 Weeks|Hypoglycemia Awareness Score by Pedersen-Bjergaard Questionnaire, Participants will complete the Pedersen-Bjergaard questionnaire for hypoglycemia awareness at the baseline and final Intervention Phase visit. The Pederson-Bjergaard questionnaire is comprised of one question to evaluate the hypoglycemia awareness, with answers of "Always", "sometimes", "occasionally", "never" or "Do not know". Each answer will represent an awareness status. The change in Pedersen-Bjergaard questionnaire status from baseline to end of treatment will be compared between the Amitriptyline and Placebo arms., 10 Weeks|Hypoglycemia Fear Survey Score, Participants will complete the Hypoglycemia Fear Survey for hypoglycemia fear assessment at the baseline and final Intervention Phase visit. The Hypoglycemia Fear Survey is comprised of 33 questions to evaluate the hypoglycemia awareness. The answer for each individual question will represent a score (0 to 4). These scores will be summed together to a final score from 0 to 132, representing from normal to minimal/no hypoglycemia awareness. The average change in Hypoglycemia Fear Survey questionnaire score from baseline to end of treatment will be compared between the Amitriptyline and Placebo arms., 10 Weeks
Sponsor/Collaborators: Sponsor: University of Utah
Gender: ALL
Age: ADULT
Phases: PHASE2
Enrollment: 2
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-08-01
Completion Date: 2019-06-03
Results First Posted: 2019-07-22
Last Update Posted: 2019-07-22
Locations: University of Utah, Salt Lake City, Utah, 84132, United States
URL: https://clinicaltrials.gov/show/NCT03591458