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Durability of Combination Therapy With Exenatide/Pioglitazone/Metformin vs. Conventional Therapy in New Onset T2DM

Information source: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes

Intervention: metformin\pioglitazone\exenatide (Drug); metformin, glyburide and glargine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: The University of Texas Health Science Center at San Antonio

Official(s) and/or principal investigator(s):
Ralph DeFronzo, MD, Principal Investigator, Affiliation: The University of Texas Health Science Center at San Antonio

Summary

Type 2 diabetes is a systemic metabolic disease with significant morbidity and mortality due to damaging blood vessels. Increased blood sugar level is a hallmark of diabetes and is an contributes to the development of many of its complications. Multiple defects, e. g. impaired insulin secretion and impaired insulin action, contribute to the development of the disease. The aim of this study is to test the efficacy and durability of combination of drugs which correct the defects that lead to the development of diabetes on achieving adequate and durable control of blood sugar levels. Achieving adequate and durable control of blood sugar will prevent many of diabetes complications.

Clinical Details

Official title: Durability of Early Initial Combination Therapy With Exenatide/Pioglitazone/Metformin vs Conventional Therapy in New Onset Type 2 Diabetes

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Difference in HbA1c level

Secondary outcome:

treatment failure

hypoglycemic events

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- subjects with type 2 diabetes diagnosed during the past 2 years,

- above 18 years of age,

- drug naive, or have been on metformin less than 3 months

Exclusion Criteria:

- subjects with type 1 diabetes or GAD positive subjects or subjects with long standing

diabetes (>2 years) or subjects who are not drug naive or have been on metformin more than 3 months.

Locations and Contacts

Texas Diabetes Institute, San Antonio, Texas 78229-3900, United States; Recruiting
Muhammad Abdul-Ghani, MD, PhD, Phone: 210-567-2391, Email: ABDULGHANI@UTHSCSA.EDU
Curtiss Puckett, PA, Phone: (210) 358 7200, Email: Curtiss.Puckett@uhs-sa.com
Ralph DeFronzo, MD, Principal Investigator
Additional Information

ADA Website

TDI site

university of texas web site

Starting date: January 2009
Last updated: June 10, 2015

Page last updated: August 23, 2015

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