Trial Outcomes & Findings for A Randomized Double Blinded Study to Examine the Use of N-acetyl Cysteine for the Prevention and Treatment of HAAF in Patients With Type 1 Diabetes (NCT NCT02206152)

NCT ID: NCT02206152

Last Updated: 2020-01-31

Results Overview

Epinephrine secretion during hypoglycemia is assessed by collecting blood samples for measurement of epinephrine concentrations at baseline and every 15 minutes during the period of hypoglycemia (starting at point where blood glucose is first \< 55 mg/dl) in the clamp studies done in the mornings of days 1 and 2 of both parts 1 and 2. .

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 22 participants
• Primary outcome timeframe: 8-10 weeks
• Results posted on: 2020-01-31

Participant Flow

Crossover design

Participant milestones

Measure	All Participants Crossover design: All participants included in baseline data.
Pre-Randomization STARTED	22
Pre-Randomization COMPLETED	20
Pre-Randomization NOT COMPLETED	2
Placebo, Then NAC STARTED	10
Placebo, Then NAC COMPLETED	10
Placebo, Then NAC NOT COMPLETED	0
NAC, Then Placebo STARTED	10
NAC, Then Placebo COMPLETED	10
NAC, Then Placebo NOT COMPLETED	0

Reasons for withdrawal

Measure	All Participants Crossover design: All participants included in baseline data.
Pre-Randomization Withdrawal by Subject	2

Baseline Characteristics

A Randomized Double Blinded Study to Examine the Use of N-acetyl Cysteine for the Prevention and Treatment of HAAF in Patients With Type 1 Diabetes

Baseline characteristics by cohort

Measure	All Subjects n=20 Participants All participants at baseline
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	37.7 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 8-10 weeks

Epinephrine secretion during hypoglycemia is assessed by collecting blood samples for measurement of epinephrine concentrations at baseline and every 15 minutes during the period of hypoglycemia (starting at point where blood glucose is first < 55 mg/dl) in the clamp studies done in the mornings of days 1 and 2 of both parts 1 and 2. .

Outcome measures

Measure	Placebo n=20 Participants Normal Saline IV infusion given during a controlled hyperinsulinemic hypoglycemic insulin clamp Placebo	Treatment With N-Acetyl Cysteine n=20 Participants N-acetyl cysteine IV infusion given as a 150 mg/kg loading dose over the first hour and then follow that with a 50 mg/kg maintenance dose infused over the next 4 hours during a controlled hyperinsulinemic hypoglycemic insulin clamp N-acetyl cysteine: N-acetyl cysteine (or saline) IV infusion given as a 150 mg/kg loading dose over the first hour and then follow that with a 50 mg/kg maintenance dose infused over the next 4 hours during a controlled hyperinsulinemic hypoglycemic insulin clamp
Difference in Epinephrine Secretion During the Morning Episodes of Hypoglycemia on Days One and Two Under the Two Treatment Conditions	622.8 ug/ml Standard Deviation 334.1	867 ug/ml Standard Deviation 675.9

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment With N-Acetyl Cysteine

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=20 participants at risk Normal Saline IV infusion given during a controlled hyperinsulinemic hypoglycemic insulin clamp Placebo	Treatment With N-Acetyl Cysteine n=20 participants at risk N-acetyl cysteine IV infusion given as a 150 mg/kg loading dose over the first hour and then follow that with a 50 mg/kg maintenance dose infused over the next 4 hours during a controlled hyperinsulinemic hypoglycemic insulin clamp N-acetyl cysteine: N-acetyl cysteine (or saline) IV infusion given as a 150 mg/kg loading dose over the first hour and then follow that with a 50 mg/kg maintenance dose infused over the next 4 hours during a controlled hyperinsulinemic hypoglycemic insulin clamp
Skin and subcutaneous tissue disorders Pruritis	0.00% 0/20 • 8 weeks	35.0% 7/20 • 8 weeks
Gastrointestinal disorders Nausea	0.00% 0/20 • 8 weeks	10.0% 2/20 • 8 weeks

Additional Information

Elizabeth Seaquist, MD

University of Minenesota

Phone: 612-624-9176

Email: chape044@umn.edu

Results disclosure agreements

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