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Comparative Effectiveness of Two Initial Combination Therapies in Patients with New Onset Diabetes

Award Number: R01DK097554
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Comparative Effectiveness of Two Initial Combination Therapies in Patients with New Onset Diabetes - Project Summary/Abstract The current ADA/EASD recommendation for glucose control in newly diagnosed T2DM patients who are free from CVD and renal disease is to start on metformin and sequentially add other glucose lowering agents upon metformin failure to maintain HbA1c <7.0%. The recently completed GRADE study, which had tested the efficacy of 4 glucose lowering agents (sitagliptin, glimepiride, liraglutide and glargine insulin) in maintaining the treatment goal in metformin failing T2DM patients, has demonstrated that the vast majority (67-75%) failed to maintain the treatment goal at 5 years, suggesting of inability of sequential add on approach on maintaining durable reduction in the HbA1c. Initial combination therapy is an alternative therapeutic approach for glucose control in T2DM patients. The VERIFY study has demonstrated that subjects initiated on combination of metformin plus vildagliptin had 26% lower failure rate than subjects started on metformin and had vildagliptin added in metformin-failing subjects. Nonetheless, 43% of subjects receiving initial combination of metformin plus vildagliptin failed to maintain HbA1c <7.0% at 5 years. We have demonstrated in EDICT study that, initial combination therapy with agents that correct known pathophysiologic defects present in T2DM will produce durable reduction in the HbA1c. Initial combination with pioglitazone plus exenatide BID produced long lasting reduction in the HbA1c in patients with T2DM and 68% of subjects maintained HbA1c <6.5% at 6 years. Nonetheless, this combination had some limitations. Approximately, one third of subjects failed to maintain the treatment goal and bone mineral density has decreased in women > 50 years. These limitations can be avoided by using dual GLP-1 /GIP agonist in combination with pioglitazone. Thus, the present study is a comparative effectiveness study comparing the efficacy and durability of HbA1c reduction by two initial combination therapies, one therapy (pioglitazone plus tirzepatide) is based on the principle of correcting the underlying metabolic defects in T2DM versus a second therapy (metformin plus sitagliptin) which focuses on lowering the plasma glucose concentration.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $616,424 )
2025	2025	THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO	7703 FLOYD CURL DR	SAN ANTONIO	TX	78229	BEXAR	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	12	2/24/2025	NON-COMPETING CONTINUATION	$616,424
														Subtotal = $616,424

Issue Date FY: 2024 ( Subtotal = $684,914 )
2024	2024	THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO	7703 FLOYD CURL DR	SAN ANTONIO	TX	78229	BEXAR	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	11	4/12/2024	COMPETING CONTINUATION	$684,914
														Subtotal = $684,914

Issue Date FY: 2023 ( Subtotal = -$2,087 )
2023	2021	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER OF SAN ANTONIO	7703 FLOYD CURL DR	SAN ANTONIO	TX	78229	BEXAR	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	10	3/30/2023	NON-COMPETING CONTINUATION	-$2,087
														Subtotal = -$2,087

Issue Date FY: 2021 ( Subtotal = $604,444 )
2021	2021	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER OF SAN ANTONIO	7703 FLOYD CURL DR	SAN ANTONIO	TX	78229	BEXAR	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	10	8/2/2021	NON-COMPETING CONTINUATION	$604,444
														Subtotal = $604,444

Issue Date FY: 2020 ( Subtotal = $601,089 )
2020	2020	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER OF SAN ANTONIO	7703 FLOYD CURL DR	SAN ANTONIO	TX	78229	BEXAR	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	9	7/16/2020	NON-COMPETING CONTINUATION	$601,089
														Subtotal = $601,089

Issue Date FY: 2019 ( Subtotal = $601,089 )
2019	2019	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER OF SAN ANTONIO	7703 FLOYD CURL DR	SAN ANTONIO	TX	78229	BEXAR	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	7/5/2019	NON-COMPETING CONTINUATION	$601,089
														Subtotal = $601,089

Issue Date FY: 2018 ( Subtotal = $601,089 )
2018	2018	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER OF SAN ANTONIO	7703 FLOYD CURL DR	SAN ANTONIO	TX	78229	BEXAR	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	7	7/16/2018	NON-COMPETING CONTINUATION	$601,089
2018	2017	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER OF SAN ANTONIO	7703 FLOYD CURL DR	SAN ANTONIO	TX	78229	BEXAR	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	6	1/4/2018	COMPETING CONTINUATION	$8,919
2018	2016	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER OF SAN ANTONIO	7703 FLOYD CURL DR	SAN ANTONIO	TX	78229	BEXAR	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	1/4/2018	EXTENSION WITH OR WITHOUT FUNDS	-$8,919
														Subtotal = $601,089

Issue Date FY: 2017 ( Subtotal = $601,089 )
2017	2017	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER OF SAN ANTONIO	7703 FLOYD CURL DR	SAN ANTONIO	TX	78229	BEXAR	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	6	9/4/2017	COMPETING CONTINUATION	$601,089
2017	2016	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER OF SAN ANTONIO	7703 FLOYD CURL DR	SAN ANTONIO	TX	78229	BEXAR	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	5	2/10/2017	EXTENSION WITH OR WITHOUT FUNDS	$37
2017	2015	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER OF SAN ANTONIO	7703 FLOYD CURL DR	SAN ANTONIO	TX	78229	BEXAR	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	2/10/2017	NON-COMPETING CONTINUATION	-$37
														Subtotal = $601,089

Issue Date FY: 2016 ( Subtotal = $325,163 )
2016	2016	UNIVERSITY OF TEXAS HEALTH SCIENCE CTR AT SAN ANTONIO	7703 FLOYD CURL DRIVE	SAN ANTONIO	TX	78229	BEXAR	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	7/20/2016	EXTENSION WITH OR WITHOUT FUNDS	$325,163
														Subtotal = $325,163

Issue Date FY: 2015 ( Subtotal = $325,163 )
2015	2015	UNIVERSITY OF TEXAS HEALTH SCIENCE CTR AT SAN ANTONIO	7703 FLOYD CURL DRIVE	SAN ANTONIO	TX	78229	BEXAR	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	7/23/2015	NON-COMPETING CONTINUATION	$325,163
														Subtotal = $325,163

Issue Date FY: 2014 ( Subtotal = $325,163 )
2014	2014	UNIVERSITY OF TEXAS HEALTH SCIENCE CTR AT SAN ANTONIO	7703 FLOYD CURL DRIVE	SAN ANTONIO	TX	78229	BEXAR	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	7/15/2014	NON-COMPETING CONTINUATION	$325,163
														Subtotal = $325,163

Issue Date FY: 2013 ( Subtotal = $313,783 )
2013	2013	UNIVERSITY OF TEXAS HEALTH SCIENCE CTR AT SAN ANTONIO	7703 FLOYD CURL DRIVE	SAN ANTONIO	TX	78229	BEXAR	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	7/19/2013	NON-COMPETING CONTINUATION	$313,783
														Subtotal = $313,783

Issue Date FY: 2012 ( Subtotal = $325,163 )
2012	2012	UNIVERSITY OF TEXAS HEALTH SCIENCE CTR AT SAN ANTONIO	7703 FLOYD CURL DRIVE	SAN ANTONIO	TX	78229	BEXAR	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/21/2012	NEW	$325,163
														Subtotal = $325,163

Grand Total All Awards = $5,922,486

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Comparative Effectiveness of Two Initial Combination Therapies in Patients with New Onset Diabetes

Award Number: R01DK097554

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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