Initial Combination Therapy with Metformin/Pioglitazone/Exenatide is More Effective Than Sequential Add-On Therapy in Subjects with New Onset Diabetes. Results from the Efficacy and Durability of Initial Combination Therapy for Type 2 Diabetes (EDICT): A Randomized Trial Muhammad A Abdul-Ghani1, Curtiss Puckett1, Curtis Triplitt1, David Maggs2, John Adams1, Eugenio Cersosimo1, and Ralph A DeFronzo1 1

Diabetes Division, University of Texas Health Science Center at San Antonio

2

GI Dynamics, One Maguire Road, Lexington MA

Key Words: Combination therapy, conventional therapy, glycemic control, durability Address correspondence to: Ralph A DeFronzo, M.D. Diabetes Division, UTHSCSA 7703 Floyd Curl Dr San Antonio, TX, 78229 Phone (210) 567-6691 Fax (210) 567- 6554 [email protected] DISCLOSURES: MAA, CP, CT, DM, JA, EC have nothing to disclose; RAD –Speakers Bureau: Bristol Myers Squibb /Astra Zeneca, Novo Nordisk; Grants: Bristol Myers Squibb, Takeda, Amylin, VeroScience, Xeris; Advisory Board: Bristol Myers Squibb/Astra Zeneca, Takeda, Novo-Nordisk, Janssen, Lexicon ABSTRACT Background: ADA and EASD recommend lowering HbA1c in T2DM individuals to as close to normal as possible while avoiding hypoglycemia. We hypothesized that initiating therapy with a combination of agents known to improve insulin secretion and insulin sensitivity in subjects with new onset diabetes would produce greater, more durable HbA1c reduction while avoiding hypoglycemia and weight compared to sequential addition of agents that lower plasma glucose but do not correct established pathophysiologic abnormalities. This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/dom.12417

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Research Design and Methods: Drug naïve, recently diagnosed T2DM subjects were randomized in an open fashion design in a single center study to metformin/pioglitazone/exenatide (Triple Therapy) (n=106) or escalating dose of metformin followed by sequential addition of sulfonylurea and glargine insulin (Conventional Therapy) (n=115) to maintain HbA1c< 6.5 for 2 years. Results: Subjects receiving Triple Therapy experienced a significantly greater reduction in HbA1c versus Conventional Therapy (5.95% vs 6.50 %, p

Initial combination therapy with metformin, pioglitazone and exenatide is more effective than sequential add-on therapy in subjects with new-onset diabetes. Results from the Efficacy and Durability of Initial Combination Therapy for Type 2 Diabetes (EDICT): a randomized trial.

To test our hypothesis that initiating therapy with a combination of agents known to improve insulin secretion and insulin sensitivity in subjects wit...
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