Trial Outcomes & Findings for Hydroxychloroquine Versus Pioglitazone in Combination Treatment for Type 2 Diabetes Mellitus (NCT NCT02303405)

Results Overview

Glycemic control

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

4 months

Results posted on

2022-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	Hydroxychloroquine Treatment with hydroxychloroquine 400 mg (2 x 200 mg tablets) po once daily x 4 months Hydroxychloroquine: Anti-inflammatory and anti-malarial agent	Pioglitazone Treatment with pioglitazone 45 mg po (1 tablet) once daily x 4 months Pioglitazone: Anti-hyperglycemic agent
Overall Study STARTED	15	7
Overall Study COMPLETED	15	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hydroxychloroquine Versus Pioglitazone in Combination Treatment for Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hydroxychloroquine n=15 Participants Treatment with hydroxychloroquine 400 mg (2 x 200 mg tablets) po once daily x 4 months Hydroxychloroquine: Anti-inflammatory and anti-malarial agent	Pioglitazone n=7 Participants Treatment with pioglitazone 45 mg po (1 tablet) once daily x 4 months Pioglitazone: Anti-hyperglycemic agent	Total n=22 Participants Total of all reporting groups
Age, Continuous	53 years STANDARD_DEVIATION 10 • n=5 Participants	57 years STANDARD_DEVIATION 13 • n=7 Participants	54 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Latino	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Diabetes Duration	5.1 years STANDARD_DEVIATION 3.1 • n=5 Participants	7.8 years STANDARD_DEVIATION 4.3 • n=7 Participants	6.0 years STANDARD_DEVIATION 3.6 • n=5 Participants
Weight	85.7 kg STANDARD_DEVIATION 14.3 • n=5 Participants	83.7 kg STANDARD_DEVIATION 18.2 • n=7 Participants	85.0 kg STANDARD_DEVIATION 15.2 • n=5 Participants
Hemoglobin A1c	8.6 % STANDARD_DEVIATION 1.0 • n=5 Participants	9.1 % STANDARD_DEVIATION 0.7 • n=7 Participants	8.7 % STANDARD_DEVIATION 0.9 • n=5 Participants
Fasting Plasma Glucose	179 mg/dL STANDARD_DEVIATION 53 • n=5 Participants	170 mg/dL STANDARD_DEVIATION 50 • n=7 Participants	176 mg/dL STANDARD_DEVIATION 51 • n=5 Participants
Body Mass Index	35.3 kg per meter squared STANDARD_DEVIATION 5.7 • n=5 Participants	34.1 kg per meter squared STANDARD_DEVIATION 5.2 • n=7 Participants	34.9 kg per meter squared STANDARD_DEVIATION 5.4 • n=5 Participants
hs-CRP	6.2 mg/L STANDARD_DEVIATION 6.7 • n=5 Participants	8.8 mg/L STANDARD_DEVIATION 7.2 • n=7 Participants	7.0 mg/L STANDARD_DEVIATION 6.8 • n=5 Participants
Leucocyte Count	8.4 x 10^9 cells/L STANDARD_DEVIATION 1.6 • n=5 Participants	7.8 x 10^9 cells/L STANDARD_DEVIATION 1.4 • n=7 Participants	8.2 x 10^9 cells/L STANDARD_DEVIATION 1.5 • n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Glycemic control

Outcome measures

Outcome measures
Measure	Hydroxychloroquine n=15 Participants Treatment with hydroxychloroquine 400 mg (2 x 200 mg tablets) po once daily x 4 months Hydroxychloroquine: Anti-inflammatory and anti-malarial agent	Pioglitazone n=7 Participants Treatment with pioglitazone 45 mg po (1 tablet) once daily x 4 months Pioglitazone: Anti-hyperglycemic agent
Hemoglobin A1c	7.4 % of hemoglobin Standard Deviation 0.9	6.3 % of hemoglobin Standard Deviation 0.2

SECONDARY outcome

Timeframe: 4 months

Fasting glucose level

Outcome measures

Outcome measures
Measure	Hydroxychloroquine n=15 Participants Treatment with hydroxychloroquine 400 mg (2 x 200 mg tablets) po once daily x 4 months Hydroxychloroquine: Anti-inflammatory and anti-malarial agent	Pioglitazone n=7 Participants Treatment with pioglitazone 45 mg po (1 tablet) once daily x 4 months Pioglitazone: Anti-hyperglycemic agent
Fasting Plasma Glucose	147 mg/dL Standard Deviation 33	105 mg/dL Standard Deviation 21

SECONDARY outcome

Timeframe: 4 months

Percent of subjects achieving a HbA1c level \< 7.5%

Outcome measures

Outcome measures
Measure	Hydroxychloroquine n=15 Participants Treatment with hydroxychloroquine 400 mg (2 x 200 mg tablets) po once daily x 4 months Hydroxychloroquine: Anti-inflammatory and anti-malarial agent	Pioglitazone n=7 Participants Treatment with pioglitazone 45 mg po (1 tablet) once daily x 4 months Pioglitazone: Anti-hyperglycemic agent
Percent of Subjects Achieving HbA1c < 7.5%	10 Participants	7 Participants

SECONDARY outcome

Timeframe: 4 months

Body weight

Outcome measures

Outcome measures
Measure	Hydroxychloroquine n=15 Participants Treatment with hydroxychloroquine 400 mg (2 x 200 mg tablets) po once daily x 4 months Hydroxychloroquine: Anti-inflammatory and anti-malarial agent	Pioglitazone n=7 Participants Treatment with pioglitazone 45 mg po (1 tablet) once daily x 4 months Pioglitazone: Anti-hyperglycemic agent
Weight	85.4 kilograms Standard Deviation 14.5	87.0 kilograms Standard Deviation 17.9

SECONDARY outcome

Timeframe: 4 months

Body mass index (BMI)

Outcome measures

Outcome measures
Measure	Hydroxychloroquine n=15 Participants Treatment with hydroxychloroquine 400 mg (2 x 200 mg tablets) po once daily x 4 months Hydroxychloroquine: Anti-inflammatory and anti-malarial agent	Pioglitazone n=7 Participants Treatment with pioglitazone 45 mg po (1 tablet) once daily x 4 months Pioglitazone: Anti-hyperglycemic agent
Body Mass Index	35.2 kg per square meter Standard Deviation 6.0	35.5 kg per square meter Standard Deviation 5.4

SECONDARY outcome

Timeframe: 4 months

Insulin resistance by the HOMA model

Outcome measures

Outcome measures
Measure	Hydroxychloroquine n=15 Participants Treatment with hydroxychloroquine 400 mg (2 x 200 mg tablets) po once daily x 4 months Hydroxychloroquine: Anti-inflammatory and anti-malarial agent	Pioglitazone n=7 Participants Treatment with pioglitazone 45 mg po (1 tablet) once daily x 4 months Pioglitazone: Anti-hyperglycemic agent
HOMA-IR	3.91 uU/mL*mg/dL Standard Deviation 2.92	1.48 uU/mL*mg/dL Standard Deviation 0.79

SECONDARY outcome

Timeframe: 4 months

Insulin resistance by the QUICKI model

Outcome measures

Outcome measures
Measure	Hydroxychloroquine n=15 Participants Treatment with hydroxychloroquine 400 mg (2 x 200 mg tablets) po once daily x 4 months Hydroxychloroquine: Anti-inflammatory and anti-malarial agent	Pioglitazone n=7 Participants Treatment with pioglitazone 45 mg po (1 tablet) once daily x 4 months Pioglitazone: Anti-hyperglycemic agent
QUICKI	0.32 (Log(uU/dL)+Log(mg/dL))^-1 Standard Deviation 0.03	0.38 (Log(uU/dL)+Log(mg/dL))^-1 Standard Deviation 0.05

SECONDARY outcome

Timeframe: 4 months

Highly-sensitive C-reactive protein (inflammatory marker)

Outcome measures

Outcome measures
Measure	Hydroxychloroquine n=15 Participants Treatment with hydroxychloroquine 400 mg (2 x 200 mg tablets) po once daily x 4 months Hydroxychloroquine: Anti-inflammatory and anti-malarial agent	Pioglitazone n=7 Participants Treatment with pioglitazone 45 mg po (1 tablet) once daily x 4 months Pioglitazone: Anti-hyperglycemic agent
Hs-CRP	4.2 mg/L Standard Deviation 3.8	3.3 mg/L Standard Deviation 3.7

SECONDARY outcome

Timeframe: 4 months

White cell count (surrogate marker of inflammation)

Outcome measures

Outcome measures
Measure	Hydroxychloroquine n=15 Participants Treatment with hydroxychloroquine 400 mg (2 x 200 mg tablets) po once daily x 4 months Hydroxychloroquine: Anti-inflammatory and anti-malarial agent	Pioglitazone n=7 Participants Treatment with pioglitazone 45 mg po (1 tablet) once daily x 4 months Pioglitazone: Anti-hyperglycemic agent
Leucocyte Count	7.7 x 10^9 cells/ L Standard Deviation 1.9	6.8 x 10^9 cells/ L Standard Deviation 1.7

SECONDARY outcome

Timeframe: 4 months

Number of hypoglycemic events

Outcome measures

Outcome measures
Measure	Hydroxychloroquine n=15 Participants Treatment with hydroxychloroquine 400 mg (2 x 200 mg tablets) po once daily x 4 months Hydroxychloroquine: Anti-inflammatory and anti-malarial agent	Pioglitazone n=7 Participants Treatment with pioglitazone 45 mg po (1 tablet) once daily x 4 months Pioglitazone: Anti-hyperglycemic agent
Hypoglycemic Events	0 Events	6.0 Events

SECONDARY outcome

Timeframe: 4 months

All other adverse events other than hypoglycemia

Outcome measures

Outcome measures
Measure	Hydroxychloroquine n=15 Participants Treatment with hydroxychloroquine 400 mg (2 x 200 mg tablets) po once daily x 4 months Hydroxychloroquine: Anti-inflammatory and anti-malarial agent	Pioglitazone n=7 Participants Treatment with pioglitazone 45 mg po (1 tablet) once daily x 4 months Pioglitazone: Anti-hyperglycemic agent
Adverse Events	0 Events	1.0 Events

Adverse Events

Hydroxychloroquine

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Pioglitazone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Hydroxychloroquine n=15 participants at risk Treatment with hydroxychloroquine 400 mg (2 x 200 mg tablets) po once daily x 4 months Hydroxychloroquine: Anti-inflammatory and anti-malarial agent	Pioglitazone n=7 participants at risk Treatment with pioglitazone 45 mg po (1 tablet) once daily x 4 months Pioglitazone: Anti-hyperglycemic agent
Vascular disorders Transient Ischemic Attack	6.7% 1/15 • Number of events 1 • 4 months	0.00% 0/7 • 4 months

Other adverse events

Other adverse events
Measure	Hydroxychloroquine n=15 participants at risk Treatment with hydroxychloroquine 400 mg (2 x 200 mg tablets) po once daily x 4 months Hydroxychloroquine: Anti-inflammatory and anti-malarial agent	Pioglitazone n=7 participants at risk Treatment with pioglitazone 45 mg po (1 tablet) once daily x 4 months Pioglitazone: Anti-hyperglycemic agent
Vascular disorders Pedal Edema	0.00% 0/15 • 4 months	14.3% 1/7 • Number of events 1 • 4 months

Additional Information

Stanley H. Hsia, MD

Charles R. Drew University of Medicine and Science

Phone: 323-357-3633

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place