Amlexanox for Type 2 Diabetes and Obesity

Clinical Protocol to Investigate the Efficacy of Amlexanox for Treatment of Glucose and Lipid Abnormalities in Obese Type 2 Diabetics

This study involves the use of a research drug, Amlexanox, for the treatment of type 2 diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). Amlexanox is taken orally in a pill three times a day. The investigators plan to continue therapy for a period of 12 weeks followed by a follow-up 4 weeks after therapy ends. The investigators will evaluate the changes in metabolic parameters (e.g. blood cholesterol, liver function, insulin resistance) and body composition characteristics (e.g. the pattern of fat distribution in the body). Seven eligible subjects in this study will also be evaluated for a change in liver disease by a liver biopsy.

Study Overview

• Status: Terminated
• Conditions: Obesity; Diabetes Mellitus Type 2; Non Alcoholic Fatty Liver Disease
• Intervention / Treatment: Drug: Amlexanox

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥ 18 years old at baseline and <60 years of age.

• Is male, female not of childbearing potential, or meets all the following criteria if female of childbearing potential (including perimenopausal women who have had a menstrual period within one year):

  • Not breastfeeding.
  • Negative pregnancy test result (human chorionic gonadotropin, beta subunit [βhCG]) at baseline (not applicable to hysterectomized females).
  • Must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate when use consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire duration of study period.
• Has physician-confirmed diabetes mellitus with a clear diagnosis or per ADA criteria with fasting glucose>126 mg/dL or HbA1c >6.4% or 2 hour GTT >200 mg/dL or or pre-diabetes with fasting glucose >100 mg/dL (n= up to 8)
• BMI ≥27 and <36 kg/m2.
• On no medications or only on first line oral medications (such as Metformin and/or DPP IV inhibitors) for treatment of type 2 diabetes mellitus with a stable regimen for >12 weeks.
• Alcohol consumption of less than 40 grams/week.
• A liver US confirming presence of fatty infiltration of the liver.
• Is able to read, understand and sign the U of M IRBMED approved informed consent form (ICF), communicate with study physician and study team, understand and comply with protocol requirements.

Exclusion Criteria:

• On insulin, sulfonylurea or other injectables for treatment of type 2 diabetes
• Unable to conduct home based glucose monitoring
• HbA1c>9.5%
• Presence of advanced liver disease (as evidenced by abnormal synthetic function, abnormal PT or albumin).
• Evidence of other etiologies of viral hepatitis.
• Presence of hematologic, bone marrow and/or other abnormalities.
• Presence of hemoglobinopathy or other hematological abnormalities that will interfere with accurate measurement of HbA1c
• Presence of HIV infection.
• Inability to give informed consent.
• Presence of ESRD, any type of active cancer, or >class 2 congestive heart failure (New York Heart Association Functional Classification System), based on medical history and physical examination.
• Active chronic infection such as known chronic osteomyelitis or tb, etc. (may be transient).
• Creatinine >1.5 mg/dL
• Proliferative diabetic retinopathy, nonproliferative retinopathy is allowed
• Unable to ambulate
• Clinically relevant CAD: history of stent, CABG or cardiologist confirmed angina
• Any other condition in the opinion of the investigators that may impede successful data collection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amlexanox	Drug: Amlexanox; Other Names: Solfa tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Change in HbA1c from baseline to 12 weeks as shown by mean increase or decrease of HbA1c where decreased values represent better health	12 weeks
Hepatic Steatosis by MRI	change in hepatic steatosis from baseline to 12 weeks: MRI Liver fat percentage as shown by mean difference	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Change in weight (Kg) from baseline to 12 weeks as shown by mean difference, where lower weights represent healthier outcomes	12 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Elif A Oral, MD, Univeristy of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2013
• Primary Completion (Actual): February 25, 2014
• Study Completion (Actual): February 25, 2014

Study Registration Dates

• First Submitted: April 24, 2013
• First Submitted That Met QC Criteria: April 26, 2013
• First Posted (Estimated): April 29, 2013

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: obesity; diabetes mellitus type 2; non alcoholic fatty liver disease; amlexanox
• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Liver Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity; Fatty Liver; Non-alcoholic Fatty Liver Disease; Anti-Allergic Agents; Amlexanox
• Other Study ID Numbers: HUM00065177

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No