Trial Outcomes & Findings for Amlexanox for Type 2 Diabetes and Obesity (NCT NCT01842282)

NCT ID: NCT01842282

Last Updated: 2024-05-07

Results Overview

Change in HbA1c from baseline to 12 weeks as shown by mean increase or decrease of HbA1c where decreased values represent better health

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2024-05-07

Participant Flow

Participant milestones

Measure	Amlexanox Amlexanox
Overall Study STARTED	7
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Amlexanox for Type 2 Diabetes and Obesity

Baseline characteristics by cohort

Measure	Amlexanox n=7 Participants Amlexanox
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	3 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	1 Participants n=5 Participants
Race (NIH/OMB) White	6 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	7 participants n=5 Participants
A1C	7.9 percent of total hemoglobin n=5 Participants
Weight	97.6 kg n=5 Participants
Hepatic Steatosis by MRI	7.5 percentage of fat in liver n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Change in HbA1c from baseline to 12 weeks as shown by mean increase or decrease of HbA1c where decreased values represent better health

Outcome measures

Measure	Amlexanox n=6 Participants Amlexanox
HbA1c	0 percentage of total hemoglobin Interval -0.6 to 0.6

PRIMARY outcome

Timeframe: 12 weeks

change in hepatic steatosis from baseline to 12 weeks: MRI Liver fat percentage as shown by mean difference

Outcome measures

Measure	Amlexanox n=6 Participants Amlexanox
Hepatic Steatosis by MRI	-2.2 percentage of liver mass Interval -5.9 to 0.3

SECONDARY outcome

Timeframe: 12 weeks

Change in weight (Kg) from baseline to 12 weeks as shown by mean difference, where lower weights represent healthier outcomes

Outcome measures

Measure	Amlexanox n=6 Participants Amlexanox
Weight	-2.2 kg Interval -5.7 to -0.1

Adverse Events

Amlexanox

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Amlexanox n=7 participants at risk Amlexanox
Blood and lymphatic system disorders elevated triglycerides	14.3% 1/7 • 16 weeks (12 weeks of treatment and 4 of followup)
Gastrointestinal disorders nausea	14.3% 1/7 • 16 weeks (12 weeks of treatment and 4 of followup)
Infections and infestations upper respiratory infection	28.6% 2/7 • 16 weeks (12 weeks of treatment and 4 of followup)
Nervous system disorders restless legs	14.3% 1/7 • 16 weeks (12 weeks of treatment and 4 of followup)
Renal and urinary disorders polyuria	14.3% 1/7 • 16 weeks (12 weeks of treatment and 4 of followup)
Skin and subcutaneous tissue disorders Subcutaneous nodule at biopsy site	14.3% 1/7 • 16 weeks (12 weeks of treatment and 4 of followup)
Skin and subcutaneous tissue disorders breast abscess	14.3% 1/7 • 16 weeks (12 weeks of treatment and 4 of followup)
Skin and subcutaneous tissue disorders rash	28.6% 2/7 • 16 weeks (12 weeks of treatment and 4 of followup)

Additional Information

Elif Oral

University of Michigan

Phone: 734-615-7271

Email: eliforal@med.umich.edu

Results disclosure agreements

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