NCT03658031

Brief Summary

It is hypothesize that, because dapagliflozin will reverse the metabolic defects responsible for the development of prediabetes (i.e. insulin resistance and beta cell dysfunction) and progression from prediabetes to T2DM (beta cell dysfunction) and will cause weight loss, it will markedly reduce the progression from prediabetes to T2DM and reverse glucose tolerance to NGT in patients with prediabetes experiencing acute myocardial infarction. Further, it is hypothesized that the hemodynamic actions of dapagliflzoin will exert cardiovascular benefit in subjects with prediabetes and acute MI by reducing cardiac remodeling, preserve LV function and decrease the risk of development of heart failure and hospitalization for heart failure. Hence, aim to examine the impact of SGLT2 inhibitor on T2DM and cardiovascular risk in patients with prediabetes and cardiovascular disease. The primary objective of the study is to examine the effect of dapagliflozin (10 mg) on the progression from prediabetes to T2DM in patients with prediabetes who experience acute myocardial infarction (MI). A secondary objective is to examine the effect of dapagliflozin on a composite of CV outcome including incidence and hospitalization for heart failure in patients with prediabetes with acute MI. Other secondary outcome is the change from baseline to end of study in LD systolic and diastolic function.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
576

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

January 3, 2019

Status Verified

July 1, 2018

Enrollment Period

1.8 years

First QC Date

July 22, 2018

Last Update Submit

January 2, 2019

Conditions

PreDiabetesMyocardial InfarctionT2DM (Type 2 Diabetes Mellitus)CVD

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of T2DM

    T2DM in Myocardial patients with prediabetes

    36 months

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Dapagliflozin 10mg per/day in prediabetes cases with MI before breakfast

Drug: Dapagliflozin 10mg

Placebo

NO INTERVENTION

Antiplatelet, ACEI and Betablockers

Interventions

Dapagliflozin 10mgDRUG

Dapagliflozin 10 mg administered each morning before breakfast

Dapagliflozin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute MI according to AHA criteria 4 weeks prior to recruitment
  • eGFR \>60 ml/min
  • stable body weight (+2 kg) in the preceding 3 months
  • diagnosis of prediabetes based upon the ADA criteria (FPG=100-125 mg/dl, and/or 2-hour plasma glucose=140-199 mg/dl

You may not qualify if:

  • eGFR\<60 ml/min
  • T2DM or T1DM according to the ADA criteria
  • Subjects receiving medications known to affect glucose tolerance
  • Pregnancy or lactation
  • Major organ disease like cancer, chronic pulmonary or liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Hospital, Hamad Medical Coorporation

Doha, 3050, Qatar

Location

Related Publications (14)

  • Abdul-Ghani M, Migahid O, Megahed A, Singh R, Kamal D, DeFronzo RA, Jayyousi A. Insulin secretion predicts the response to therapy with exenatide plus pioglitazone, but not to basal/bolus insulin in poorly controlled T2DM patients: Results from the Qatar study. Diabetes Obes Metab. 2018 Apr;20(4):1075-1079. doi: 10.1111/dom.13189. Epub 2018 Jan 15.

    PMID: 29227578RESULT

  • Abdul-Ghani MA, DeFronzo RA. Pathophysiology of prediabetes. Curr Diab Rep. 2009 Jun;9(3):193-9. doi: 10.1007/s11892-009-0032-7.

    PMID: 19490820RESULT

  • Genuth S, Alberti KG, Bennett P, Buse J, Defronzo R, Kahn R, Kitzmiller J, Knowler WC, Lebovitz H, Lernmark A, Nathan D, Palmer J, Rizza R, Saudek C, Shaw J, Steffes M, Stern M, Tuomilehto J, Zimmet P; Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Follow-up report on the diagnosis of diabetes mellitus. Diabetes Care. 2003 Nov;26(11):3160-7. doi: 10.2337/diacare.26.11.3160. No abstract available.

    PMID: 14578255RESULT

  • Abdul-Ghani MA, Tripathy D, DeFronzo RA. Contributions of beta-cell dysfunction and insulin resistance to the pathogenesis of impaired glucose tolerance and impaired fasting glucose. Diabetes Care. 2006 May;29(5):1130-9. doi: 10.2337/diacare.2951130.

    PMID: 16644654RESULT

  • Dankner R, Abdul-Ghani MA, Gerber Y, Chetrit A, Wainstein J, Raz I. Predicting the 20-year diabetes incidence rate. Diabetes Metab Res Rev. 2007 Oct;23(7):551-8. doi: 10.1002/dmrr.728.

    PMID: 17315136RESULT

  • Lambers Heerspink HJ, de Zeeuw D, Wie L, Leslie B, List J. Dapagliflozin a glucose-regulating drug with diuretic properties in subjects with type 2 diabetes. Diabetes Obes Metab. 2013 Sep;15(9):853-62. doi: 10.1111/dom.12127. Epub 2013 Jun 5.

    PMID: 23668478RESULT

  • Al-Lawati JA, Sulaiman KJ, Al-Zakwani I, Alsheikh-Ali AA, Panduranga P, Al-Habib KF, Al-Suwaidi J, Al-Mahmeed W, Al-Faleh H, El-Asfar A, Al-Motarreb A, Ridha M, Bulbanat B, Al-Jarallah M, Bazargani N, Asaad N, Amin H. Systolic Blood Pressure on Admission and Mortality in Patients Hospitalized With Acute Heart Failure: Observations From the Gulf Acute Heart Failure Registry. Angiology. 2017 Aug;68(7):584-591. doi: 10.1177/0003319716672525. Epub 2016 Oct 7.

    PMID: 27814267RESULT

  • Sulaiman K, Panduranga P, Al-Zakwani I, Alsheikh-Ali AA, AlHabib KF, Al-Suwaidi J, Al-Mahmeed W, AlFaleh H, Elasfar A, Al-Motarreb A, Ridha M, Bulbanat B, Al-Jarallah M, Bazargani N, Asaad N, Amin H. Clinical characteristics, management, and outcomes of acute heart failure patients: observations from the Gulf acute heart failure registry (Gulf CARE). Eur J Heart Fail. 2015 Apr;17(4):374-84. doi: 10.1002/ejhf.245. Epub 2015 Mar 4.

    PMID: 25739882RESULT

  • Abdul-Ghani M, Migahid O, Megahed A, Adams J, Triplitt C, DeFronzo RA, Zirie M, Jayyousi A. Erratum. Combination Therapy With Exenatide Plus Pioglitazone Versus Basal/Bolus Insulin in Patients With Poorly Controlled Type 2 Diabetes on Sulfonylurea Plus Metformin: The Qatar Study. Diabetes Care 2017;40:325-331. Diabetes Care. 2017 Aug;40(8):1134. doi: 10.2337/dc17-er08d. Epub 2017 Jun 14. No abstract available.

    PMID: 28615237RESULT

  • Abdul-Ghani M, Migahid O, Megahed A, Adams J, Triplitt C, DeFronzo RA, Zirie M, Jayyousi A. Combination Therapy With Exenatide Plus Pioglitazone Versus Basal/Bolus Insulin in Patients With Poorly Controlled Type 2 Diabetes on Sulfonylurea Plus Metformin: The Qatar Study. Diabetes Care. 2017 Mar;40(3):325-331. doi: 10.2337/dc16-1738. Epub 2017 Jan 17.

    PMID: 28096223RESULT

  • Abdul-Ghani MA, Puckett C, Triplitt C, Maggs D, Adams J, Cersosimo E, DeFronzo RA. 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. Diabetes Obes Metab. 2015 Mar;17(3):268-75. doi: 10.1111/dom.12417. Epub 2015 Jan 7.

    PMID: 25425451RESULT

  • Verma S, Garg A, Yan AT, Gupta AK, Al-Omran M, Sabongui A, Teoh H, Mazer CD, Connelly KA. Effect of Empagliflozin on Left Ventricular Mass and Diastolic Function in Individuals With Diabetes: An Important Clue to the EMPA-REG OUTCOME Trial? Diabetes Care. 2016 Dec;39(12):e212-e213. doi: 10.2337/dc16-1312. Epub 2016 Sep 27. No abstract available.

    PMID: 27679584RESULT

  • Oliva RV, Bakris GL. Blood pressure effects of sodium-glucose co-transport 2 (SGLT2) inhibitors. J Am Soc Hypertens. 2014 May;8(5):330-9. doi: 10.1016/j.jash.2014.02.003. Epub 2014 Feb 12.

    PMID: 24631482RESULT

  • Al-Jobori H, Daniele G, Cersosimo E, Triplitt C, Mehta R, Norton L, DeFronzo RA, Abdul-Ghani M. Empagliflozin and Kinetics of Renal Glucose Transport in Healthy Individuals and Individuals With Type 2 Diabetes. Diabetes. 2017 Jul;66(7):1999-2006. doi: 10.2337/db17-0100. Epub 2017 Apr 20.

    PMID: 28428225RESULT

MeSH Terms

Conditions

Prediabetic StateMyocardial InfarctionDiabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Jassim Al-Suwaidi, MD

    Heart Hospital, HMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jassim Al-Suwaidi, MD

CONTACT

44395392jalsuwaidi@hotmail.com

Rajvir Singh, Ph.D.

CONTACT

44390442rsingh@hamad.qa

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: After completing baseline measurements, subjects will be randomized to receive in a double blind fashion dapaglfilozin (10 mg/day) or placebo. The drug will be administered each morning before breakfast.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2018

First Posted

September 5, 2018

Study Start

March 1, 2019

Primary Completion

December 31, 2020

Study Completion

January 31, 2021

Last Updated

January 3, 2019

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

QA(1)