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

NCT ID: NCT00399204

Last Updated: 2019-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2012-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control

Metformin

Group Type ACTIVE_COMPARATOR

Pioglitazone vs Metformin

Intervention Type DRUG

Experimental

Pioglitazone

Group Type EXPERIMENTAL

Pioglitazone vs Metformin

Intervention Type DRUG

Interventions

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Pioglitazone vs Metformin

Intervention Type DRUG

Eligibility Criteria

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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 -
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Council of Scientific and Industrial Research, India

OTHER_GOV

Sponsor Role collaborator

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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SHotra

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Promila Pandhi

Role: STUDY_CHAIR

Post Graduate Institute of Medical Education and Research, Chandigarh

Nusrat Shafiq, MD,DM

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Anil Bhansali, MD,DM

Role: STUDY_DIRECTOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

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PGIMER

Chandigarh, , India

Site Status

Countries

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India

Other Identifiers

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Pharma6/701

Identifier Type: -

Identifier Source: org_study_id

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