Comparison of Cardiovascular Outcomes of Pioglitazone and Metformin in Type 2 Diabetes Patients

March 18, 2019 updated by: SHotra, Postgraduate Institute of Medical Education and Research

A Randomised Pilot Study to Compare the Effect of Pioglitazone and Metformin on Cardiovascular Morbidity and Mortality in Patients With Type 2 Diabetes

The study aims to see if there is any significant difference in the cardiovascular outcomes in type 2 diabetes patients who are treated with pioglitazone or Metformin

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 160012
        • PGIMER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Newly diagnosed (less than six months since diagnosis and not controlled on dietary modifications) type 2 diabetic patients of both sexes aged 25-60 years.
  2. Ready to give written informed consent

Exclusion Criteria:

  1. Presence of ketonuria
  2. Severe concurrent, infection or illness
  3. History of hypersensitivity to any study drug
  4. Impaired renal function
  5. Pulmonary insufficiency with hypoxemia
  6. Severe hepatic disease
  7. Congestive heart failure
  8. History of myocardial infarction or angina(stable/unstable)
  9. History of alcohol or drug abuse
  10. Pregnant or lactating women -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Metformin
Drug: Pioglitazone vs Metformin
Experimental: Experimental
Pioglitazone
Drug: Pioglitazone vs Metformin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Collaborators

Council of Scientific and Industrial Research, India

Investigators

  • Study Chair: Promila Pandhi, Postgraduate Institute of Medical Education and Research
  • Principal Investigator: Nusrat Shafiq, MD,DM, Postgraduate Institute of Medical Education and Research
  • Study Director: Anil Bhansali, MD,DM, Postgraduate Institute of Medical Education and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2006

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

November 13, 2006

First Submitted That Met QC Criteria

November 13, 2006

First Posted (Estimate)

November 14, 2006

Study Record Updates

Last Update Posted (Actual)

March 20, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pharma6/701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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