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WithdrawnNCT00399204Updated Mar 20, 2019

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

A Phase 4 interventional study of Pioglitazone vs Metformin in Type 2 Diabetes, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Withdrawn at 1 site in India. Open to participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-03-20.

Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Phase 4, Interventional, and Health services research

Why this study was withdrawn
lack of funding
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
25 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Type 2 Diabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

Browse Diabetes Mellitus studies →

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 290 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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 -
05

Study design

Phase
Phase 4
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Control

    Metformin

    Drug: Pioglitazone vs Metformin

  • Experimental
    Experimental

    Pioglitazone

    Drug: Pioglitazone vs Metformin

Interventions

  • DrugPioglitazone vs Metformin
06

Study locations

1 site
  • PGIMER
    Chandigarh, 160012, India
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00399204
Lead sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Collaborators
Council of Scientific and Industrial Research, India
Responsible party
SHotra (professor, Post Graduate Institute of Medical Education and Research, Chandigarh) — Principal investigator
First posted
Nov 14, 2006
Start date
Jan 2006 (estimated)
Primary completion
Dec 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Mar 20, 2019

Study contacts

Promila Pandhi
study chair · Post Graduate Institute of Medical Education and Research, Chandigarh
Nusrat Shafiq, MD,DM
principal investigator · Post Graduate Institute of Medical Education and Research, Chandigarh
Anil Bhansali, MD,DM
study director · Post Graduate Institute of Medical Education and Research, Chandigarh
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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