Efficacy of Amlexanox vs. Placebo in Type 2 Diabetic Patients

NCT01975935 | Completed Phase 2 Results DMC

• 1 other identifier: HUM00079381
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

diabetes mellitus type 2; non-alcoholic fatt liver disease; obesity

Outcome Measures

Primary Outcomes (1)

• Difference in Hemoglobin A1c Values

  Difference in hemoglobin A1c as measured at baseline and week 12 visits

  12 weeks (measured at baseline and 12 weeks)

Secondary Outcomes (2)

• Hepatic Steatosis as Measured by MRI

  12 weeks

• Change in Weight

  12 week

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks

Drug: Placebo

Amlexanox

EXPERIMENTAL

Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks

Drug: Amlexanox

Interventions

Amlexanox DRUG

25 mg amlexanox tablets blinded by encapsulation

Also known as: Solfa tablets

Amlexanox

Placebo DRUG

placebo sham blinded by encapsulation in the same capsules as the study drug arm

Placebo

Eligibility Criteria

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

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

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

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.

Results Point of Contact

• Title: Dr. Elif Oral
• Organization: University of Michigan

eliforal@med.umich.edu

7346157271

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Internal Medicine

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 5, 2013
• Study Start: January 1, 2014
• Primary Completion: April 25, 2016
• Study Completion: August 18, 2017
• Last Updated: November 7, 2018
• Results First Posted: May 9, 2017

Record last verified: 2018-10

Locations

US (1)