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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00399204
First Posted: November 14, 2006
Last Update Posted: November 14, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Council of Scientific and Industrial Research, India
Information provided by:
Postgraduate Institute of Medical Education and Research
  Purpose
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

Condition Intervention Phase
Type 2 Diabetes Drug: Pioglitazone vs Metformin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomised Pilot Study to Compare the Effect of Pioglitazone and Metformin on Cardiovascular Morbidity and Mortality in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Estimated Enrollment: 100
Study Start Date: January 2006
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399204


Contacts
Contact: Samir Malhotra, MD, DM samirmalhotra345@yahoo.com

Locations
India
PGIMER Recruiting
Chandigarh, India, 160012
Contact: Samir Malhotra, MD, DM       samirmalhotra345@yahoo.com   
Sub-Investigator: Samir Malhotra, MD,DM         
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
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
  More Information

ClinicalTrials.gov Identifier: NCT00399204     History of Changes
Other Study ID Numbers: Pharma6/701
First Submitted: November 13, 2006
First Posted: November 14, 2006
Last Update Posted: November 14, 2006
Last Verified: November 2006

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs