Trial Outcomes & Findings for Efficacy of Amlexanox vs. Placebo in Type 2 Diabetic Patients (NCT NCT01975935)
NCT ID: NCT01975935
Last Updated: 2018-11-07
Results Overview
Difference in hemoglobin A1c as measured at baseline and week 12 visits
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
12 weeks (measured at baseline and 12 weeks)
Results posted on
2018-11-07
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks
Placebo
|
Amlexanox
Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks
Amlexanox
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Amlexanox vs. Placebo in Type 2 Diabetic Patients
Baseline characteristics by cohort
| Measure |
Placebo
n=21 Participants
Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks
Placebo
|
Amlexanox
n=21 Participants
Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks
Amlexanox
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
59.24 years
STANDARD_DEVIATION 7.65 • n=5 Participants
|
55.81 years
STANDARD_DEVIATION 9.52 • n=7 Participants
|
57.52 years
STANDARD_DEVIATION 8.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Decline to Answer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks (measured at baseline and 12 weeks)Population: The number of participants analyzed at week 12 differs from the overall number analyzed at baseline because 1 treatment group and 3 placebo group participants dropped from the study before their week 12 visit.
Difference in hemoglobin A1c as measured at baseline and week 12 visits
Outcome measures
| Measure |
Placebo
n=21 Participants
Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks
Placebo
|
Amlexanox
n=21 Participants
Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks
Amlexanox
|
|---|---|---|
|
Difference in Hemoglobin A1c Values
Baseline
|
7.77 percentage of hemoglobin glycated
Standard Deviation 1.07
|
7.68 percentage of hemoglobin glycated
Standard Deviation 0.97
|
|
Difference in Hemoglobin A1c Values
Week 12
|
7.76 percentage of hemoglobin glycated
Standard Deviation 1.23
|
7.44 percentage of hemoglobin glycated
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: One placebo patient was an early termination and did not have an MRI scan done at the 12 week visit. A total of 20 patients received MRI scans due to funding limitations.
Improvement in hepatic steatosis by MRI is shown by a decrease in percent fat from baseline to week 12 visit.
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks
Placebo
|
Amlexanox
n=11 Participants
Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks
Amlexanox
|
|---|---|---|
|
Hepatic Steatosis as Measured by MRI
Baseline
|
12.82 % fat
Standard Deviation 7.82
|
18 % fat
Standard Deviation 9.67
|
|
Hepatic Steatosis as Measured by MRI
Week 12
|
12.88 % fat
Standard Deviation 8.66
|
16.22 % fat
Standard Deviation 9.86
|
SECONDARY outcome
Timeframe: 12 weekPopulation: The number of participants analyzed at week 12 differs from the overall number analyzed at baseline because 1 treatment group and 3 placebo group participants dropped from the study before their week 12 visit.
Change in weight (kilograms) as measured at baseline and week 12 visits.
Outcome measures
| Measure |
Placebo
n=21 Participants
Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks
Placebo
|
Amlexanox
n=21 Participants
Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks
Amlexanox
|
|---|---|---|
|
Change in Weight
Baseline
|
100.24 kilograms
Standard Deviation 19.77
|
100.95 kilograms
Standard Deviation 15.18
|
|
Change in Weight
Week 12
|
97.94 kilograms
Standard Deviation 18.83
|
100.81 kilograms
Standard Deviation 14.03
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Amlexanox
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=21 participants at risk
Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks
Placebo
|
Amlexanox
n=21 participants at risk
Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks
Amlexanox
|
|---|---|---|
|
Cardiac disorders
NSTEMI
|
4.8%
1/21 • Number of events 1 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
0.00%
0/21 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
|
Musculoskeletal and connective tissue disorders
Injured left leg playing football
|
0.00%
0/21 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
4.8%
1/21 • Number of events 1 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
Other adverse events
| Measure |
Placebo
n=21 participants at risk
Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks
Placebo
|
Amlexanox
n=21 participants at risk
Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks
Amlexanox
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
9.5%
2/21 • Number of events 2 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
4.8%
1/21 • Number of events 2 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
|
Immune system disorders
Head cold
|
19.0%
4/21 • Number of events 4 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
0.00%
0/21 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
14.3%
3/21 • Number of events 3 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
19.0%
4/21 • Number of events 5 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
|
Gastrointestinal disorders
Indigestion
|
9.5%
2/21 • Number of events 2 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
0.00%
0/21 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
|
Nervous system disorders
Worsening neuropathy
|
9.5%
2/21 • Number of events 2 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
0.00%
0/21 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
23.8%
5/21 • Number of events 5 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
0.00%
0/21 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
|
Nervous system disorders
Headache
|
9.5%
2/21 • Number of events 2 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
0.00%
0/21 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
|
Blood and lymphatic system disorders
Ankle edema
|
0.00%
0/21 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
9.5%
2/21 • Number of events 2 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
|
General disorders
Fatigue
|
0.00%
0/21 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
9.5%
2/21 • Number of events 2 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
|
Musculoskeletal and connective tissue disorders
Elevated CK
|
0.00%
0/21 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
9.5%
2/21 • Number of events 2 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
0.00%
0/21 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
14.3%
3/21 • Number of events 3 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
|
Skin and subcutaneous tissue disorders
Itchy skin
|
0.00%
0/21 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
9.5%
2/21 • Number of events 2 • March 31, 2014-May 25, 2017. 2 years, 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place