Comparison of Cardiovascular Outcomes of Pioglitazone and... | NCT00399204

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

NCT00399204

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Status

Withdrawn

Last Update Posted

Mar 20, 2019Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Type 2 Diabetes

Interventions

Pioglitazone vs Metformin

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of funding

Expanded Access Info

Start Date

Jan 2006Estimated

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Nov 13, 2006

First Submission Date that Met QC Criteria

Nov 13, 2006

First Posted Date

Nov 14, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2019

Last Update Posted Date

Mar 20, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

SHotra, professor, Post Graduate Institute of Medical Education and Research, ChandigarhPrincipal Investigator

Lead Sponsor

Post Graduate Institute of Medical Education and Research, ChandigarhOTHER

Collaborators

Name	Class
Council of Scientific and Industrial Research, India	OTHER_GOV

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator	Metformin	Drug: Pioglitazone vs Metformin
Experimental	Experimental	Pioglitazone	Drug: Pioglitazone vs Metformin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pioglitazone vs Metformin	Drug		Control Experimental

Eligibility Module

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 -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Promila Pandhi	Post Graduate Institute of Medical Education and Research, Chandigarh	Study Chair
Nusrat Shafiq, MD,DM	Post Graduate Institute of Medical Education and Research, Chandigarh	Principal Investigator
Anil Bhansali, MD,DM	Post Graduate Institute of Medical Education and Research, Chandigarh	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PGIMER		Chandigarh		160012	India

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided