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 failurehypoglycemic 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
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