Trial Outcomes & Findings for Amitriptyline in Treating Hypoglycemia (NCT NCT03591458)
NCT ID: NCT03591458
Last Updated: 2019-07-22
Results Overview
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.
TERMINATED
PHASE2
2 participants
2 Weeks
2019-07-22
Participant Flow
Participant milestones
| Measure |
Amitriptyline
Participants initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose was increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline was reduced to 25 mg daily during the two week Taper Period.
|
Placebo
Participants initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose was changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose was changed back to the Placebo matching the 25 mg Amitriptyline during the two week Taper Period.
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|---|---|---|
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Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Amitriptyline in Treating Hypoglycemia
Baseline characteristics by cohort
| Measure |
Amitriptyline
n=1 Participants
Participants initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose was increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline was reduced to 25 mg daily during the two week Taper Period.
|
Placebo
n=1 Participants
Participants initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose was changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose was changed back to the Placebo matching the 25 mg Amitriptyline during the two week Taper Period.
|
Total
n=2 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 WeeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 WeeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 WeeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 WeeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 WeeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 WeeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 WeeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 WeeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment
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.
Outcome measures
Outcome data not reported
Adverse Events
Amitriptyline
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amitriptyline
n=1 participants at risk
Participants initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose was increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline was reduced to 25 mg daily during the two week Taper Period.
|
Placebo
n=1 participants at risk
Participants initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose was changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose was changed back to the Placebo matching the 25 mg Amitriptyline during the two week Taper Period.
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|---|---|---|
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Gastrointestinal disorders
Dry Mouth
|
100.0%
1/1 • Number of events 1 • 10 Weeks
|
0.00%
0/1 • 10 Weeks
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place