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

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ClinicalTrials.gov Identifier: NCT00399204
Recruitment Status : Unknown
Verified November 2006 by Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Recruiting
First Posted : November 14, 2006
Last Update Posted : November 14, 2006
Sponsor:
Collaborator:
Council of Scientific and Industrial Research, India
Information provided by:
Postgraduate Institute of Medical Education and Research

Brief 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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Pioglitazone vs Metformin Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
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
Study Start Date : January 2006

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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 -

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

ClinicalTrials.gov Identifier: NCT00399204     History of Changes
Other Study ID Numbers: Pharma6/701
First Posted: November 14, 2006    Key Record Dates
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