Efficacy of Amlexanox vs. Placebo in Type 2 Diabetic Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Elif Oral, University of Michigan
ClinicalTrials.gov Identifier:
NCT01975935
First received: October 29, 2013
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

This study involves research about an investigational medicine called Amlexanox. The reason for this study is to find out how Amlexanox can improve type 2 diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). In this study, Amlexanox is considered to be investigational (not approved by the Food and Drug Administration [FDA]) for type 2 diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). This is a placebo controlled study. There is a 50-50 chance that the patient may either receive the study drug, Amlexanox, or a placebo (sugar pill). Neither the patient or the study doctors will know if the patient is receiving the study drug or placebo.


Condition Intervention Phase
Diabetes Mellitus Type 2
Non-alcoholic Fatty Liver Disease
Obesity
Drug: Amlexanox
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Protocol to Investigate the Efficacy of Amlexanox vs. Placebo for Treatment of Glucose and Lipid Abnormalities in Obese Type 2 Diabetics

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    improvement in HbA1c

  • hepatic steatosis by MRI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    improvement in hepatic steatosis by MRI


Secondary Outcome Measures:
  • Weight [ Time Frame: 12 week ] [ Designated as safety issue: No ]
    weight decrease


Estimated Enrollment: 40
Study Start Date: January 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks
Experimental: Amlexanox
Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks
Drug: Amlexanox
Other Name: Solfa tablets

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 years old at baseline.
  • 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.
  • BMI ≥27 and <45 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, or other injectables for treatment of Type 2 diabetes.
  • Unable to conduct home based glucose monitoring.
  • HbA1c <6.5% and >10.0% (set to achieve uniformity in the study population).
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01975935

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Adam Neidert, MS    734-615-0539    aneidert@med.umich.edu   
Contact: Elif Oral, MD    734-615-7271    eliforal@med.umich.edu   
Principal Investigator: Elif A Oral, MD, MS         
Sub-Investigator: Nevin A Ajluni, MD         
Sub-Investigator: Evgenia Korytnaya, MD         
Sub-Investigator: Alan Saltiel, PhD         
Sub-Investigator: Thomas Chenevert, PhD         
Sub-Investigator: Laura Butz, MD         
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

Responsible Party: Elif Oral, Associate Professor, Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT01975935     History of Changes
Other Study ID Numbers: HUM00079381
Study First Received: October 29, 2013
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan:
diabetes mellitus type 2
non-alcoholic fatt liver disease
obesity

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Liver Diseases
Fatty Liver
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Digestive System Diseases
Amlexanox
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014