An Observational Study of Patient Cohorts Who Previously Received Long-term Treatment With Pioglitazone or Placebo in Addition to Existing Antidiabetic Medications

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

An Observational Study of Patient Cohorts Who Previously Received Long-term Treatment With Pioglitazone or Placebo in Addition to Existing Antidiabetic Medications.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02678676
• Other study ID #: AD-4833/EC445
• Status: Completed
• Phase: Phase 4
• First received: February 7, 2016
• Last updated: February 7, 2016
• Start date: November 2004
• Est. completion date: November 2011

Study information

• Verified date: February 2016
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyBelgium: Federal Agency for Medicinal Products and Health ProductsBulgaria: Bulgarian Drug AgencyCroatia:Agency for medicinal products and medical devices of CroatiaCyprus:Ministry of Health - Pharmaceutical ServicesCzech Republic: State Institute for Drug ControlDenmark: Danish Health and Medicines AuthorityEstonia:State Agency of MedicinesFinland: Finnish Medicines AgencyFrance:National Agency for the Safety of Medicine and Health ProductsGermany: Federal Institute for Drugs and Medical DevicesGreece:National Organization for MedicinesHungary: National Institute of PharmacyIceland:Icelandic Medicines AgencyIreland:Health Products Regulatory Authority (HPRA)Italy:Italian Medicines AgencyLatvia: State Agency of MedicinesLiechtenstein:Office of Health / Department of PharmaceuticalsLithuania: State Medicines Control AgencyLuxembourg:Ministry of HealthMalta: Medicines AuthorityNetherlands:Healthcare InspectorateNorway: Norwegian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal:National Authority of Medicines and Health ProductsRomania: National Medicines AgencySlovakia: State Institute for Drug ControlSlovenia:Agency for Medicinal Products and Medical Devices of the Republic of SloveniaSpain:Spanish Agency for Medicines and Health ProductsSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyEuropion Union: European Medicines Agency
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study was to investigate the mortality and macrovascular morbidity as well as the incidence of malignancies over time, in high-risk diabetic participants who previously received long-term treatment with either pioglitazone or placebo in combination with their usual medication for glycaemic management.

Description:

This was a European,multicenter,observational study of participants who were previously treated with pioglitazone or placebo in addition to their existing anti diabetic medication. This 10-year observational study was conducted as a follow-up of PROactive study (NCT00174993) to investigate the CV and macrovascular effects observed with pioglitazone over time during PROactive.In this study,high risk T2DM patients previously enrolled in PROactive were analyzed for long-term incidence,nature, and pattern of all malignancies in pioglitazone and placebo-treated groups.This study enrolled 3599 participants.No treatment was prescribed by this protocol and participants will be managed in accordance with normal medical practice.The planned total duration of the study was 10 years,with data being analyzed and reported every 2 years.Participants were assessed at nominal visits every 6 months and every effort was made to obtain as much of the required information as possible.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3599
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 36 Years to 75 Years

Eligibility

Inclusion Criteria:

• Completion of the final visit of the PROactive Study (NCT00174993).

• Willingness and ability to give written informed consent for the observational study.

Exclusion Criteria:

• There were no exclusion criteria.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Other:
• No Intervention
Participants who previously received Pioglitazone in the PROactive study (NCT00174993).
• No Intervention
Participants who previously received pioglitazone-matching placebo in the PROactive study (NCT00174993).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

References & Publications (1)

Erdmann E, Harding S, Lam H, Perez A. Ten-year observational follow-up of PROactive: a randomized cardiovascular outcomes trial evaluating pioglitazone in type 2 diabetes. Diabetes Obes Metab. 2016 Mar;18(3):266-73. doi: 10.1111/dom.12608. Epub 2016 Jan 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Occurrence of First Macro-vascular Event or Death	The composite macro-vascular event included all-cause mortality, non-fatal myocardial infarction, cardiac intervention, stroke, major leg amputation (above the ankle), bypass surgery or revascularization in the leg. Kaplan-Meier method was to be used for calculating survival curves for pioglitazone and placebo.	Year 1 up to Year 10	Yes