NCT03794518

Brief Summary

The prevalence of type 2 diabetes mellitus (T2DM) in Qatar and nations worldwide has increased in recent decades into epidemic proportions. Cardiovascular (CVD) disease is the leading cause of death in T2DM patients. Approximately 80% of T2DM patients will die because of CV cause. Congestive heart failure (CHF) is a major cause of CV death in T2DM, and it also is responsible for significant morbidity and health care expenditure due to high rate of hospitalization for heart failure.

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
648

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2019

Typical duration for phase_3

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

August 1, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 7, 2019

Status Verified

July 1, 2018

Enrollment Period

2.5 years

First QC Date

August 1, 2018

Last Update Submit

January 4, 2019

Conditions

Risk Reduction

Outcome Measures

Primary Outcomes (1)

  • Time to first hospitalization for heart failure after starting intervention

    Hospitalization for heart failure will be defined as a hospitalization \>24 hours requiring intravenous diuretic infusion.

    3 years

Secondary Outcomes (1)

  • Number of all cause mortality

    3 years

Study Arms (2)

Pioglitazone Plus dapaglifliozin

EXPERIMENTAL

Pioglitazone 15mg and dapaglifliozin 10mg together in T2DM patients having HF and HFpEF conditions

Drug: Pioglitazone Plus dapaglifliozin

Placebo

PLACEBO COMPARATOR

Beta blockers, ACEI, ARB, and aldosterone

Drug: Placebo

Interventions

Pioglitazone Plus dapaglifliozinDRUG

Pioglitazone Plus dapaglifliozin

Pioglitazone Plus dapaglifliozin
PlaceboDRUG

(Beta blockers, ACEI, ARB, and aldosterone )

Placebo

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of type 2 diabetes according to the ADA criteria.
  • Drug naïve or on stable dose of antidiabetic therapy (oral agents and/or insulin) for 3 months preceding recruitment.
  • Hospitalized for HFpEF (defined as hospitalization require intravenous diuresis) in the 6 months preceding recruitment.
  • eGFR \>60 ml/min
  • LVEF \>50%
  • Presence of LV diastolic dysfunction in echocardiography

You may not qualify if:

  • Treatment with pioglitazone or SGLT2 inhibitor in the 3 months prior to recruitment.
  • eGFR \< 60 ml/min
  • LVEF \<50%;
  • Valvular heart disease, ASD, VSD
  • Chronic lung disease
  • Cancer
  • diabetes mellitus type 1
  • patients with acute coronary syndrome, stroke or transient ischemic attack in the preceding 6 months
  • pregnancy or lactation period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Hospital, Hamad Medical Coorporation

Doha, 3050, Qatar

Location

Related Publications (16)

  • Alharbi NS, Almutari R, Jones S, Al-Daghri N, Khunti K, de Lusignan S. Trends in the prevalence of type 2 diabetes mellitus and obesity in the Arabian Gulf States: systematic review and meta-analysis. Diabetes Res Clin Pract. 2014 Nov;106(2):e30-3. doi: 10.1016/j.diabres.2014.08.019. Epub 2014 Sep 6.

    PMID: 25241351RESULT

  • Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.

    PMID: 19896746RESULT

  • American Diabetes Association. 9. Cardiovascular Disease and Risk Management. Diabetes Care. 2017 Jan;40(Suppl 1):S75-S87. doi: 10.2337/dc17-S012. No abstract available.

    PMID: 27979896RESULT

  • Bahrami H, Bluemke DA, Kronmal R, Bertoni AG, Lloyd-Jones DM, Shahar E, Szklo M, Lima JA. Novel metabolic risk factors for incident heart failure and their relationship with obesity: the MESA (Multi-Ethnic Study of Atherosclerosis) study. J Am Coll Cardiol. 2008 May 6;51(18):1775-83. doi: 10.1016/j.jacc.2007.12.048.

    PMID: 18452784RESULT

  • Kannel WB, Hjortland M, Castelli WP. Role of diabetes in congestive heart failure: the Framingham study. Am J Cardiol. 1974 Jul;34(1):29-34. doi: 10.1016/0002-9149(74)90089-7. No abstract available.

    PMID: 4835750RESULT

  • Nichols GA, Gullion CM, Koro CE, Ephross SA, Brown JB. The incidence of congestive heart failure in type 2 diabetes: an update. Diabetes Care. 2004 Aug;27(8):1879-84. doi: 10.2337/diacare.27.8.1879.

    PMID: 15277411RESULT

  • Gustafsson I, Brendorp B, Seibaek M, Burchardt H, Hildebrandt P, Kober L, Torp-Pedersen C; Danish Investigatord of Arrhythmia and Mortality on Dofetilde Study Group. Influence of diabetes and diabetes-gender interaction on the risk of death in patients hospitalized with congestive heart failure. J Am Coll Cardiol. 2004 Mar 3;43(5):771-7. doi: 10.1016/j.jacc.2003.11.024.

    PMID: 14998615RESULT

  • Pfeffer MA, Braunwald E, Moye LA, Basta L, Brown EJ Jr, Cuddy TE, Davis BR, Geltman EM, Goldman S, Flaker GC, et al. Effect of captopril on mortality and morbidity in patients with left ventricular dysfunction after myocardial infarction. Results of the survival and ventricular enlargement trial. The SAVE Investigators. N Engl J Med. 1992 Sep 3;327(10):669-77. doi: 10.1056/NEJM199209033271001.

    PMID: 1386652RESULT

  • Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006 Jul 20;355(3):251-9. doi: 10.1056/NEJMoa052256.

    PMID: 16855265RESULT

  • Shah SJ, Katz DH, Selvaraj S, Burke MA, Yancy CW, Gheorghiade M, Bonow RO, Huang CC, Deo RC. Phenomapping for novel classification of heart failure with preserved ejection fraction. Circulation. 2015 Jan 20;131(3):269-79. doi: 10.1161/CIRCULATIONAHA.114.010637. Epub 2014 Nov 14.

    PMID: 25398313RESULT

  • Johnsson K, Johnsson E, Mansfield TA, Yavin Y, Ptaszynska A, Parikh SJ. Osmotic diuresis with SGLT2 inhibition: analysis of events related to volume reduction in dapagliflozin clinical trials. Postgrad Med. 2016 May;128(4):346-55. doi: 10.1080/00325481.2016.1153941. Epub 2016 Mar 2.

    PMID: 26878357RESULT

  • Liu C, Liu T, Li G. Pioglitazone may offer therapeutic advantages in diabetes-related atrial fibrillation. Int J Cardiol. 2013 Sep 30;168(2):1603-5. doi: 10.1016/j.ijcard.2013.01.037. Epub 2013 Feb 12. No abstract available.

    PMID: 23414743RESULT

  • Liu B, Wang J, Wang G. Beneficial effects of pioglitazone on retardation of persistent atrial fibrillation progression in diabetes mellitus patients. Int Heart J. 2014;55(6):499-505. doi: 10.1536/ihj.14-107. Epub 2014 Oct 14.

    PMID: 25310928RESULT

  • 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

MeSH Terms

Conditions

Risk Reduction Behavior

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Nidal Asaad, MD

    Heart Hospital, HMC, Doha, Qatar

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nidal Asaad, MD

CONTACT

44395578nasaad@hamad.qa

Rajvir Singh, Ph.D

CONTACT

44390442rsingh@hamad.qa

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Random process
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Pioglitazone (15 mg) and dapagliflozin (10mg) vs Placebo
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2018

First Posted

January 7, 2019

Study Start

March 1, 2019

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

January 7, 2019

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

QA(1)