Trial Outcomes & Findings for Examination of the Anti-inflammatory and Insulin Sensitizing Properties of Doxycycline in Humans (NCT NCT01375491)

Results Overview

MMP activity is measured using a charge-changing peptide substrate for MMP-2 and MMP-9.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

39 participants

Primary outcome timeframe

Baseline (Day 1)

Results posted on

2020-01-13

Participant Flow

The study included non-type 2 diabetics controls (n = 15), and type two diabetics subjects randomized to placebo (n = 13) or doxycycline 100 mg twice daily (n = 11).

Participant milestones

Participant milestones
Measure	Doxycycline Participants with DM2 receiving doxycycline 100mg BID Doxycycline : generic doxycycline 100mg twice daily	Placebo Pills prepared identical to doxycycline. Placebo : Placebo comparator to doxycycline	Control non- type two diabetics to serve as a control
Overall Study STARTED	11	13	15
Overall Study COMPLETED	9	12	15
Overall Study NOT COMPLETED	2	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Examination of the Anti-inflammatory and Insulin Sensitizing Properties of Doxycycline in Humans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Doxycycline n=11 Participants Participants with DM2 receiving doxycycline 100mg BID Doxycycline : generic doxycycline 100mg twice daily	Placebo n=13 Participants Pills prepared identical to doxycycline. Placebo : Placebo comparator to doxycycline	Control n=15 Participants Participants enrolled without type 2 diabetes to serve as a control	Total n=39 Participants Total of all reporting groups
Age, Continuous	55.3 years STANDARD_DEVIATION 1.9 • n=5 Participants	54.5 years STANDARD_DEVIATION 1.7 • n=7 Participants	48.7 years STANDARD_DEVIATION 3.1 • n=5 Participants	54.9 years STANDARD_DEVIATION 1.8 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1)

MMP activity is measured using a charge-changing peptide substrate for MMP-2 and MMP-9.

Outcome measures

Outcome measures
Measure	Doxycycline n=9 Participants Participants with DM2 receiving doxycycline 100mg BID Doxycycline : generic doxycycline 100mg twice daily	Placebo n=12 Participants Pills prepared identical to doxycycline. Placebo : Placebo comparator to doxycycline	Control Arm n=15 Participants The study included non-DM2 controls (n = 15), but the non DM2 controls were not evaluated on day 84.
MMP Activity	56.8 uM 5-FAM/h-ug protein Standard Error 13.3	43.8 uM 5-FAM/h-ug protein Standard Error 4	47.2 uM 5-FAM/h-ug protein Standard Error 3.2

PRIMARY outcome

Timeframe: Day 84

Population: Only the Doxycycline and Placebo arms are reported because the control group was not evaluated at Day 84.

MMP activity is measured using a charge-changing peptide substrate for MMP-2 and MMP-9. Only the Doxycycline and Placebo arms are reported because the control group was not evaluated at Day 84.

Outcome measures

Outcome measures
Measure	Doxycycline n=9 Participants Participants with DM2 receiving doxycycline 100mg BID Doxycycline : generic doxycycline 100mg twice daily	Placebo n=12 Participants Pills prepared identical to doxycycline. Placebo : Placebo comparator to doxycycline	Control Arm The study included non-DM2 controls (n = 15), but the non DM2 controls were not evaluated on day 84.
MMP Activity	59.7 uM 5-FAM/h-ug protein Standard Error 4.3	56.6 uM 5-FAM/h-ug protein Standard Error 10.1	—

SECONDARY outcome

Timeframe: Baseline (Day 1)

Measure of global inflammation.

Outcome measures

Outcome measures
Measure	Doxycycline n=9 Participants Participants with DM2 receiving doxycycline 100mg BID Doxycycline : generic doxycycline 100mg twice daily	Placebo n=11 Participants Pills prepared identical to doxycycline. Placebo : Placebo comparator to doxycycline	Control Arm n=15 Participants The study included non-DM2 controls (n = 15), but the non DM2 controls were not evaluated on day 84.
CRP	7.4 microgram/ml Standard Error 3.3	5.9 microgram/ml Standard Error 1.8	1.9 microgram/ml Standard Error .8

SECONDARY outcome

Timeframe: Day 84

Population: Only the Doxycycline and Placebo arms are reported because the control group was not evaluated at Day 84.

Measure of global inflammation. Only the Doxycycline and Placebo arms are reported because the control group was not evaluated at Day 84.

Outcome measures

Outcome measures
Measure	Doxycycline n=9 Participants Participants with DM2 receiving doxycycline 100mg BID Doxycycline : generic doxycycline 100mg twice daily	Placebo n=11 Participants Pills prepared identical to doxycycline. Placebo : Placebo comparator to doxycycline	Control Arm The study included non-DM2 controls (n = 15), but the non DM2 controls were not evaluated on day 84.
CRP	2.3 microgram/ml Standard Error 0.4	6.2 microgram/ml Standard Error 1.8	—

Adverse Events

Doxycycline

Serious events: 0 serious events

Other events: 0 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

Adverse event data not reported

Additional Information

Dr. Karen Louise Herbst

University of California, San Diego

Phone: 858-552-8585

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place