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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Diabetes
Intervention	Drug: metformin\pioglitazone\exenatide Drug: metformin, glyburide and glargine
Phase	N/A
Sponsor	The University of Texas Health Science Center at San Antonio
Responsible Party	The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier	NCT01107717
First Received	April 19, 2010
Last Updated	January 17, 2013
Last verified	January 2013

Tracking Information[ + expand ][ + ]

First Received Date	April 19, 2010
Last Updated Date	January 17, 2013
Start Date	January 2009
Estimated Primary Completion Date	December 2013
Current Primary Outcome Measures	Difference in HbA1c level [Time Frame: at the end of the dtudy (3 years)] [Designated as safety issue: No]subjects will be followed for 3 years and the difference in HbA1c between the two arms at 3 years is the primary outcome of the study
Current Secondary Outcome Measures	treatment failure [Time Frame: at 6 months and 3 years] [Designated as safety issue: No]subjects with HbA1c >6.5 at 6 months and 3 years are considered treatment failure hypoglycemic events [Time Frame: during the entire study (3 years)] [Designated as safety issue: Yes]asymptomatic hypoglycemic events with documented PGC < 60 mg/dl and sympotomatic hypoglycemia

Descriptive Information[ + expand ][ + ]

Brief Title	Durability of Combination Therapy With Exenatide/Pioglitazone/Metformin vs. Conventional Therapy in New Onset T2DM
Official Title	Durability of Early Initial Combination Therapy With Exenatide/Pioglitazone/Metformin vs Conventional Therapy in New Onset Type 2 Diabetes
Brief 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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes
Intervention	Drug: metformin\pioglitazone\exenatide metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) are started and dose is up titrated to achieve HbA1c < 6.5% Drug: metformin, glyburide and glargine subjects are started on metformin 500 mg bid and dose is up titrated and glyburide (up to 5 mg) and glargine are sequentially added to maintain HbA1c < 6.5%
Study Arm (s)	Experimental: Triple Therapy initiation a combination of metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) at the time diabetes is diagnosed Active Comparator: conventional therapy sequential addition of metformin, glyburide and basal insulin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	600
Estimated Completion Date	December 2013
Estimated Primary Completion Date	December 2013
Eligibility 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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01107717
Other Study ID Numbers	DTT20080456H
Has Data Monitoring Committee	Yes
Information Provided By	The University of Texas Health Science Center at San Antonio
Study Sponsor	The University of Texas Health Science Center at San Antonio
Collaborators	American Diabetes Association Amylin Pharmaceuticals, LLC.
Investigators	Principal Investigator: Ralph DeFronzo, MD The University of Texas Health Science Center at San Antonio
Verification Date	January 2013

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