Trial Outcomes & Findings for Naltrexone and Hypoglycemia in Type 1 Diabetes (NCT NCT01053078)

NCT ID: NCT01053078

Last Updated: 2020-02-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 29 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2020-02-05

Participant Flow

Participant milestones

Measure	Naltrexone 1 month treatment; Naltrexone 25mg once daily for 5 days, then 50 mg once daily for 23 days	Placebo 1 month treatment; placebo tablet once daily for 28 days
Overall Study STARTED	14	15
Overall Study COMPLETED	10	12
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Naltrexone and Hypoglycemia in Type 1 Diabetes

Baseline characteristics by cohort

Measure	Naltrexone n=10 Participants 1 month treatment; Naltrexone 25mg once daily for 5 days, then 50 mg once daily for 23 days	Placebo n=12 Participants 1 month treatment; placebo tablet once daily for 28 days	Total n=22 Participants Total of all reporting groups
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	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	47 years STANDARD_DEVIATION 13 • n=5 Participants	39 years STANDARD_DEVIATION 10 • n=7 Participants	42 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	12 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Outcome measures

Measure	Naltrexone n=10 Participants Double blind placebo comparable Naltrexone: 1 month treatment Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28	Placebo n=12 Participants Naltrexone: 1 month treatment Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28
Cerebral Blood Flow	1.7 percentage of signal intensity change Standard Deviation 1.9	1.3 percentage of signal intensity change Standard Deviation 3.3

SECONDARY outcome

Timeframe: 1 month

Hypoglycemia symptom score is determined by a standardized 12-item questionnaire. Participants rank hypoglycemic symptoms on a Likert scale from 0 (no symptoms) to 6 (severe symptoms). Total score is a sum of the 12 items scores with a total score range from 0 to 72. Higher scores indicated increased severity of symptoms associated with hypoglycemia.

Outcome measures

Measure	Naltrexone n=10 Participants Double blind placebo comparable Naltrexone: 1 month treatment Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28	Placebo n=12 Participants Naltrexone: 1 month treatment Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28
Hypoglycemia Symptom Score	12.6 score on a scale Standard Deviation 7.5	14.5 score on a scale Standard Deviation 12.2

Adverse Events

Naltrexone

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Naltrexone n=10 participants at risk 1 month treatment; Naltrexone 25mg once daily for 5 days, then 50 mg once daily for 23 days	Placebo n=12 participants at risk 1 month treatment; placebo tablet once daily for 28 days
Nervous system disorders headache	30.0% 3/10	0.00% 0/12
Gastrointestinal disorders diarrhea	30.0% 3/10	0.00% 0/12

Additional Information

Elizabeth Seaquist

University of Minnesota

Phone: 612 624 9176

Email: seaqu001@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place