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

NCT02678676 | Completed Results

• 1 other identifier: AD-4833/EC445
• Study Type: observational
• Target: 3,599
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With First Occurrence of Macro-vascular Event or Death

  The composite macro-vascular event or death included all-cause mortality, non-fatal myocardial infarction, cardiac intervention, stroke, major leg amputation (above the ankle), bypass surgery or revascularization in the leg. The percentage of participants in the observational study population having first occurrence of macro-vascular event or death during the 10-year observational study period was analyzed. The data were analyzed using the Cox regression with respect to time to the first occurrence of macro-vascular event or death.

  Up to Year 10

Secondary Outcomes (1)

• Incidences With Malignancies

  Up to Year 10

Study Arms (2)

Pioglitazone

Participants who previously received pioglitazone in the PROactive study (NCT00174993).

Other: No Intervention

Placebo

Participants who previously received Pioglitazone-matching placebo in the PROactive study (NCT00174993).

Other: No Intervention

Interventions

No Intervention OTHER

Participants who previously received Pioglitazone in the PROactive study (NCT00174993).

Pioglitazone

Eligibility Criteria

• Age: 36 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

High-risk T2DM participants previously treated with pioglitazone and placebo in PROactive study (NCT00174993) were included in this study.

You may qualify if:

• Completion of the final visit of the PROactive Study (NCT00174993).
• Willingness and ability to give written informed consent for the observational study.

Sponsors & Collaborators

• Takeda: lead

Related 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.

  PMID: 26592506 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

clinicaltrialregistry@tpna.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2016
• First Posted: February 10, 2016
• Study Start: November 1, 2004
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: July 7, 2016
• Results First Posted: July 7, 2016

Record last verified: 2016-05