Trial Outcomes & Findings for Reducing Risk of Type 2 Diabetes: Hydroxychloroquine Use in Pre-Diabetes (NCT NCT01326533)

NCT ID: NCT01326533

Last Updated: 2016-02-26

Results Overview

Change from baseline in the insulin sensitivity index (Si)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 32 participants
• Primary outcome timeframe: 13 weeks after baseline measurement
• Results posted on: 2016-02-26

Participant Flow

Participant milestones

Measure	Hydroxychloroquine 13 weeks of hydroxychloroquine sulfate PO 400 mg/day	Placebo 13 weeks of placebo PO
Overall Study STARTED	17	15
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Measure	Hydroxychloroquine 13 weeks of hydroxychloroquine sulfate PO 400 mg/day	Placebo 13 weeks of placebo PO
Overall Study Lost to Follow-up	2	0
Overall Study Withdrawal by Subject	1	0
Overall Study Adverse Event	1	0

Baseline Characteristics

Reducing Risk of Type 2 Diabetes: Hydroxychloroquine Use in Pre-Diabetes

Baseline characteristics by cohort

Measure	Hydroxychloroquine n=17 Participants Hydroxychloroquine sulfate PO 400 mg daily	Placebo n=15 Participants Placebo daily	Total n=32 Participants Total of all reporting groups
Age, Continuous	50.1 years STANDARD_DEVIATION 14.5 • n=93 Participants	44.9 years STANDARD_DEVIATION 16.8 • n=4 Participants	47.6 years STANDARD_DEVIATION 15.7 • n=27 Participants
Sex: Female, Male Female	15 Participants n=93 Participants	9 Participants n=4 Participants	24 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	6 Participants n=4 Participants	8 Participants n=27 Participants
Insulin sensitivity (Si)	0.52 10^-4 / pmol*l / min STANDARD_DEVIATION 0.27 • n=93 Participants	0.58 10^-4 / pmol*l / min STANDARD_DEVIATION 0.42 • n=4 Participants	0.55 10^-4 / pmol*l / min STANDARD_DEVIATION 0.34 • n=27 Participants
Beta cell function (disposition index)	1721 arbitrary units STANDARD_DEVIATION 2014 • n=93 Participants	1214 arbitrary units STANDARD_DEVIATION 691 • n=4 Participants	1483 arbitrary units STANDARD_DEVIATION 1540 • n=27 Participants

PRIMARY outcome

Timeframe: 13 weeks after baseline measurement

Population: all randomized with last observation carried forward for missing data

Change from baseline in the insulin sensitivity index (Si)

Outcome measures

Measure	Hydroxychloroquine n=17 Participants 400 mg PO daily for 13 weeks	Placebo n=15 Participants PO daily for 13 weeks
Insulin Sensitivity	0.08 10^-4/pmol*l/min Standard Error 0.03	-0.11 10^-4/pmol*l/min Standard Error 0.04

SECONDARY outcome

Timeframe: 13 weeks after baseline measurement

Population: all randomized with last observation carried forward for missing data

Change from baseline in the disposition index (DI)

Outcome measures

Measure	Hydroxychloroquine n=17 Participants 400 mg PO daily for 13 weeks	Placebo n=15 Participants PO daily for 13 weeks
Beta Cell Function	352 arbitrary units Standard Error 143	-218 arbitrary units Standard Error 158

Adverse Events

Hydroxychloroquine

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Hydroxychloroquine n=17 participants at risk Hydroxychloroquine sulfate PO 400mg/day	Placebo n=15 participants at risk Placebo PO
General disorders Unusual or vivid dreams	11.8% 2/17 • Number of events 2 • During 13 weeks of treatment	6.7% 1/15 • Number of events 1 • During 13 weeks of treatment
Gastrointestinal disorders Dyspepsia or GI discomfort	17.6% 3/17 • Number of events 3 • During 13 weeks of treatment	20.0% 3/15 • Number of events 3 • During 13 weeks of treatment
General disorders Headache	11.8% 2/17 • Number of events 2 • During 13 weeks of treatment	0.00% 0/15 • During 13 weeks of treatment

Additional Information

Frederico Toledo

University of Pittsburgh

Phone: 412-692-2848

Email: .toledofs@upmc.edu

Results disclosure agreements

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