Trial Outcomes & Findings for A Pilot Study of Moderate Hyperbilirubinemia in Type 1 Diabetes Mellitus (NCT NCT01421355)

Results Overview

The primary endpoint is the difference in the change in brachial artery diameter in response to a flow stimulus at visit 2 and 3. It is anticipated that a response will occur following atazanavir therapy compared with baseline. The principal secondary endpoints are the serum measures of oxidant stress and antioxidant capacity.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

15 participants

Primary outcome timeframe

Day 0 and Day 4

Results posted on

2014-07-21

Participant Flow

Participant milestones

Participant milestones
Measure	Atazanavir 300 mg BID Atazanavir 300 mg BID for 4 days. Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug.
Overall Study STARTED	21
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study of Moderate Hyperbilirubinemia in Type 1 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atazanavir 300 mg BID n=21 Participants Atazanavir 300 mg BID for 4 days. Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug.
Age, Continuous	44 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 and Day 4

The primary endpoint is the difference in the change in brachial artery diameter in response to a flow stimulus at visit 2 and 3. It is anticipated that a response will occur following atazanavir therapy compared with baseline. The principal secondary endpoints are the serum measures of oxidant stress and antioxidant capacity.

Outcome measures

Outcome measures
Measure	Atazanavir 300 mg BID n=15 Participants Atazanavir 300 mg BID for 4 days. Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug.
Change in Brachial Artery Diameter	-0.93 percentage of dilation Standard Deviation 2.4

Adverse Events

Atazanavir 300 mg BID

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

Joshua Beckman, MD

Brigham and Women's Hospital

Phone: 617-732-6320

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place