Amlexanox for Type 2 Diabetes and Obesity

NCT01842282 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: HUM00065177
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus Type 2; Non Alcoholic Fatty Liver Disease; Obesity

Keywords

diabetes mellitus type 2; non alcoholic fatty liver disease; obesity; amlexanox

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Weight

  12 weeks

Study Arms (1)

Amlexanox

EXPERIMENTAL

Drug: Amlexanox

Interventions

Amlexanox DRUG

Also known as: Solfa tablets

Amlexanox

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease; Obesity

Interventions

amlexanox

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Elif Oral
• Organization: University of Michigan

eliforal@med.umich.edu

734-615-7271

Study Officials

• Elif A Oral, MD

  Univeristy of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: April 29, 2013
• Study Start: July 19, 2013
• Primary Completion: February 25, 2014
• Study Completion: February 25, 2014
• Last Updated: May 7, 2024
• Results First Posted: January 17, 2024

Record last verified: 2024-04

Locations

US (1)