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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Withdrawn; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Pioglitazone vs Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT00399204

Pharma6/701

Details and patient eligibility

About

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

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Control

Active Comparator group

Description:

Metformin

Treatment:

Drug: Pioglitazone vs Metformin

Experimental

Experimental group

Description:

Pioglitazone

Treatment:

Drug: Pioglitazone vs Metformin