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

Primary Purpose

Type 2 Diabetes

Status
Withdrawn
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Pioglitazone vs Metformin
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept 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 -

Sites / Locations

  • PGIMER

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

Metformin

Pioglitazone

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 13, 2006
Last Updated
March 18, 2019
Sponsor
Postgraduate Institute of Medical Education and Research
Collaborators
Council of Scientific and Industrial Research, India
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1. Study Identification

Unique Protocol Identification Number
NCT00399204
Brief Title
Comparison of Cardiovascular Outcomes of Pioglitazone and Metformin in Type 2 Diabetes Patients
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 Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
lack of funding
Study Start Date
January 2006 (Anticipated)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
Collaborators
Council of Scientific and Industrial Research, India

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Metformin
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Pioglitazone
Intervention Type
Drug
Intervention Name(s)
Pioglitazone vs Metformin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Ready to give written informed consent Exclusion Criteria: Presence of ketonuria Severe concurrent, infection or illness History of hypersensitivity to any study drug Impaired renal function Pulmonary insufficiency with hypoxemia Severe hepatic disease Congestive heart failure History of myocardial infarction or angina(stable/unstable) History of alcohol or drug abuse Pregnant or lactating women -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Promila Pandhi
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nusrat Shafiq, MD,DM
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anil Bhansali, MD,DM
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Study Director
Facility Information:
Facility Name
PGIMER
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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