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NCT00399204 Clinical Trial

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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00399204
Other study ID # Pharma6/701
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date January 2006
Est. completion date December 2012

Study information
Verified date March 2019
Source Postgraduate Institute of Medical Education and Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 25 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pioglitazone vs Metformin

Locations
Country Name City State
India PGIMER Chandigarh

Sponsors (2)
Lead Sponsor Collaborator
Postgraduate Institute of Medical Education and Research Council of Scientific and Industrial Research, India

Country where clinical trial is conducted

India, 

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