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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by Postgraduate Institute of Medical Education and Research.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Council of Scientific and Industrial Research, India
Information provided by:
Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT00399204
First received: November 13, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 PGIMER
Principal Investigator: Nusrat Shafiq, MD,DM PGIMER
Study Director: Anil Bhansali, MD,DM PGIMER
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00399204     History of Changes
Other Study ID Numbers: Pharma6/701
Study First Received: November 13, 2006
Last Updated: November 13, 2006
Health Authority: India: Ministry of Health

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

ClinicalTrials.gov processed this record on October 23, 2014