Fatty Liver Study in Patients With Type II Diabetes

NCT02365233 | Terminated Phase 4 Results DMC

• 1 other identifier: 13-021
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to measure changes in hepatic lipid content using three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.

Conditions

Type II Diabetes; Nonalcoholic Fatty Liver

Keywords

Type II Diabetes; Nonalcoholic fatty liver

Outcome Measures

Primary Outcomes (1)

• Change in Hepatic Lipid Content From Baseline Visit to Six Month Follow up Visit

  Comparison of the hepatic lipid content measurement taken by MRI at baseline with the measurement taken by MRI at the 6 month follow up visit.

  Hepatic lipid content measurement will be taken on Day #1 ( the day of randomization) and at the 6 month follow up visit.

Study Arms (3)

Thiazolidinedione

ACTIVE COMPARATOR

(Pioglitazone, 15 mg/day)

Drug: Pioglitazone

Lantus Insulin

ACTIVE COMPARATOR

0.35 U per kg body weight once daily

Drug: Lantus insulin

DPP4 inhibitor

ACTIVE COMPARATOR

Sitagliptin, 100 mg/day or Saxagliptin, 5 mg/day

Drug: DPP4 inhibitor

Interventions

DPP4 inhibitor DRUG

Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.

Also known as: sitagliptin100 mg daily, saxagliptin 5 mg daily

DPP4 inhibitor

Pioglitazone DRUG

Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.

Also known as: Pioglitazone 15 mg daily

Thiazolidinedione

Lantus insulin DRUG

Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.

Also known as: Lantus insulin (0.35U/kg of body weight once daily)

Lantus Insulin

Eligibility Criteria

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

You may qualify if:

• Subject has provided informed consent in a manner approved by the Institutional Review Board (IRB) and is willing and able to comply with the trial procedures.
• Adults at least 18 years of age at the time of consent.
• Have type 2 diabetes mellitus.
• Be on a stable medication with metformin (2000 mg/day) for at least 3 months prior to study enrollment.
• Have blood A1c \>7.6% and \< 8.5% within 3 months prior to study enrollment.
• Have fatty liver, which is diagnosed by ultrasonographic findings of "bright liver" within 1 year of study enrollment.
• Stable medication for lipid lowering, blood pressure control, dietary supplements, including vitamins, for at least 3 months.
• Women of Childbearing Potential must be willing and able to use acceptable forms of birth control while on the study.

You may not qualify if:

• Currently taking medication that can affect glucose metabolism other than Metformin.
• History of Kidney diseases that, in the opinion of the investigator , would place the subject at increased risk of participation or plasma levels of creatinine \> 1.4 for women and \> 1.5 for men.
• History of Cirrhosis of liver, hepatitis, or other liver diseases that, in the opinion of the investigator, would place the subject at increased risk of participation.
• Current alcohol consumption more than12 to 15 g of alcohol a day, or \>12 oz of beer, 5 oz of wine, or 1.5 oz of distilled spirits.
• History of heart failure.
• Concurrent participation on another research study
• Use of an investigational agent in the 30 days prior to signing informed consent.
• History of prior non-compliance or the presence or history of psychiatric conditions (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
• Females who are pregnant or lactating
• Current Diagnosis or History of Bladder Cancer

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch -Galveston

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

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

Interventions

Dipeptidyl-Peptidase IV Inhibitors; saxagliptin; Pioglitazone; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Inadequate documentation and lack of funding resulted in no usable data. IRB withheld the data.

Results Point of Contact

• Title: Nicola Abate, MD - Professor and Director of Endocrinology Division
• Organization: University of Texas Medical Branch

niabate@utmb.edu

409 772 1922

Study Officials

• Nicola Abate, MD

  University of Texas Medical Branch-Galveston

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: February 18, 2015
• Study Start: May 1, 2013
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: July 31, 2018
• Results First Posted: July 31, 2018

Record last verified: 2018-04

Locations

US (1)