NCT00399204

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2006

Longer than P75 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

6.9 years

First QC Date

November 13, 2006

Last Update Submit

March 18, 2019

Conditions

Type 2 Diabetes

Study Arms (2)

Control

ACTIVE COMPARATOR

Metformin

Drug: Pioglitazone vs Metformin

Experimental

EXPERIMENTAL

Pioglitazone

Drug: Pioglitazone vs Metformin

Interventions

Pioglitazone vs MetforminDRUG
ControlExperimental

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIMER

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • 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
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 13, 2006

First Posted

November 14, 2006

Study Start

January 1, 2006

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 20, 2019

Record last verified: 2019-03

Locations

IN(1)