Trial · NCT01975935

Efficacy of Amlexanox vs. Placebo in Type 2 Diabetic Patients

NCT01975935, Phase 2, Completed, University of Michigan; results first posted 2017-05-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy of Amlexanox vs. Placebo in Type 2 Diabetic Patients. Trials, record NCT01975935. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01975935

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy of Amlexanox vs. Placebo in Type 2 Diabetic Patients
NCT number: NCT01975935
Status: Completed
Phases: Phase 2
Enrollment: 42 participants, actual
Lead sponsor: University of Michigan
Conditions: Diabetes Mellitus Type 2, Non-alcoholic Fatty Liver Disease, Obesity
Interventions: Amlexanox, Placebo
First posted: 2013-11-05
Last updated: 2018-11-07
Results first posted: 2017-05-09
Limitations and caveats: Optimal drug dose is yet to be defined. The dose and the treatment duration may not have been sufficient to reveal all the positive as well as negative effects of the drug. Effects of combination with other anti-diabetics is also unknown.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Difference in Hemoglobin A1c Values	12 weeks (measured at baseline and 12 weeks)	Difference in hemoglobin A1c as measured at baseline and week 12 visits
Secondary	Hepatic Steatosis as Measured by MRI	12 weeks	Improvement in hepatic steatosis by MRI is shown by a decrease in percent fat from baseline to week 12 visit.
Secondary	Change in Weight	12 week	Change in weight (kilograms) as measured at baseline and week 12 visits.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Difference in Hemoglobin A1c Values	12 weeks (measured at baseline and 12 weeks)	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.	percentage of hemoglobin glycated	MEAN
SECONDARY	Hepatic Steatosis as Measured by MRI	12 weeks	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.	% fat	MEAN
SECONDARY	Change in Weight	12 week	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.	kilograms	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Difference in Hemoglobin A1c Values	Placebo	Baseline	7.77	Standard Deviation 1.07	percentage of hemoglobin glycated
Difference in Hemoglobin A1c Values	Amlexanox	Baseline	7.68	Standard Deviation 0.97	percentage of hemoglobin glycated
Difference in Hemoglobin A1c Values	Placebo	Week 12	7.76	Standard Deviation 1.23	percentage of hemoglobin glycated
Difference in Hemoglobin A1c Values	Amlexanox	Week 12	7.44	Standard Deviation 0.95	percentage of hemoglobin glycated
Hepatic Steatosis as Measured by MRI	Placebo	Baseline	12.82	Standard Deviation 7.82	% fat
Hepatic Steatosis as Measured by MRI	Amlexanox	Baseline	18	Standard Deviation 9.67	% fat
Hepatic Steatosis as Measured by MRI	Placebo	Week 12	12.88	Standard Deviation 8.66	% fat
Hepatic Steatosis as Measured by MRI	Amlexanox	Week 12	16.22	Standard Deviation 9.86	% fat
Change in Weight	Placebo	Baseline	100.24	Standard Deviation 19.77	kilograms
Change in Weight	Amlexanox	Baseline	100.95	Standard Deviation 15.18	kilograms

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	21
Overall Study	STARTED	Amlexanox	21
Overall Study	COMPLETED	Placebo	18
Overall Study	COMPLETED	Amlexanox	20
Overall Study	NOT COMPLETED	Placebo	3
Overall Study	NOT COMPLETED	Amlexanox	1

Source ClinicalTrials.gov

Adverse events28

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhea	Gastrointestinal disorders	Placebo	2	21	2
other	Diarrhea	Gastrointestinal disorders	Amlexanox	1	21	2
other	Head cold	Immune system disorders	Placebo	4	21	4
other	Head cold	Immune system disorders	Amlexanox	0	21	0
other	Skin rash	Skin and subcutaneous tissue disorders	Placebo	3	21	3
other	Skin rash	Skin and subcutaneous tissue disorders	Amlexanox	4	21	5
other	Indigestion	Gastrointestinal disorders	Placebo	2	21	2
other	Indigestion	Gastrointestinal disorders	Amlexanox	0	21	0
other	Worsening neuropathy	Nervous system disorders	Placebo	2	21	2
other	Worsening neuropathy	Nervous system disorders	Amlexanox	0	21	0

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	21
Total, all-cause mortality	Amlexanox	0	21
Total, other adverse events	Placebo	16	21
Total, other adverse events	Amlexanox	15	21
Total, serious adverse events	Placebo	1	21
Total, serious adverse events	Amlexanox	1	21

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Amlexanox vs Placebo: deaths from any cause	Trial comparisons
Amlexanox vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01975935

GET https://conductscience.org/api/trials/v1/NCT01975935/events?page=2

API reference For AI assistants