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P021

Peptide 021, GLXC-21260

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Studies 37
Trials 57
Terminated PHASE4 INTERVENTIONAL NCT02365233

Fatty Liver Study in Patients With Type II Diabetes

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Detailed Description

In patients with type 2 diabetes whose glycemic control is not accomplished with Metformin alone, there are several options for additional hypoglycemic agent. As per recent National guidelines at least three "second line" agents can be added to metformin: thiazolidinediones, Lantus insulin, and DPP4 inhibitors. All three approaches have been proven to help accomplishing goals of therapy for glycemic control (HbA1c\<7%) in clinical trials. Whether one approach is superior to the other in improving associated non-glycemic metabolic abnormalities and risk for future morbidity and mortality in patients with type 2 diabetes remains a matter of intense debate. Among these abnormalities, excessive triglyceride content in the liver (fatty liver or liver steatosis) is a major predictor of risk for non-alcoholic steato-hepatitis (NASH) and liver cirrhosis. Fatty liver is highly prevalent in patients with type 2 diabetes. There are no clinical studies done to determine if any of these three therapeutic options is superior at reducing the liver triglyceride content in patients with type 2 diabetes and fatty Liver. Therefore, in this study we propose to measure and compare the effects on liver triglyceride content when either pioglitazone, lantus insulin, or DPP4 inhibitors are added to metformin in patients with poorly controlled type 2 diabetes (HbA1c\>7.6%) and fatty liver (presence of "bright" liver in abdominal ultrasound). 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.

Interventions

Name: DPP4 inhibitor
Type: DRUG
Description: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.
Name: Pioglitazone
Type: DRUG
Description: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.
Name: Lantus insulin
Type: DRUG
Description: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.

Primary Outcomes

Measure: Change in Hepatic Lipid Content From Baseline Visit to Six Month Follow up Visit
TimeFrame: Hepatic lipid content measurement will be taken on Day #1 ( the day of randomization) and at the 6 month follow up visit.
Description: 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.

Trial Information

NCT ID

NCT02365233

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

The University of Texas Medical Branch, Galveston

Last Updated

December 15, 2025