NCT02003014

Brief Summary

To investigate the safety and efficacy of long-term treatment with pioglitazone (Actos tablets) in combination with biguanides (for 12 months after the start of pioglitazone tablets treatment) in patients with type 2 diabetes mellitus.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
899

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

Typical duration for all trials

Status
completed

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

February 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

November 10, 2016

Completed
Last Updated

November 10, 2016

Status Verified

September 1, 2016

Enrollment Period

2.9 years

First QC Date

December 1, 2013

Results QC Date

December 7, 2015

Last Update Submit

September 21, 2016

Conditions

Type 2 Diabetes Mellitus

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (2)

  • Number of Participants Reporting One or More Adverse Drug Reactions

    Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.

    Baseline up to 12 months

  • Number of Participants Reporting One or More Serious Adverse Drug Reactions

    Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

    Baseline up to 12 months

Secondary Outcomes (5)

  • Change From Baseline in Glycosylated Hemoglobin (HbA1c)

    Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)

  • Change From Baseline in Fasting Blood Glucose

    Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)

  • Change From Baseline in Body Weight

    Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)

  • Change From Baseline in Immunoreactive Insulin (IRI)

    Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)

  • Change From Baseline Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)

Study Arms (1)

Pioglitazone 15 mg to 30 mg

administered orally once daily

Drug: Pioglitazone

Interventions

PioglitazoneDRUG

Pioglitazone Tablets

Also known as: Actos
Pioglitazone 15 mg to 30 mg

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 2 diabetes mellitus

You may qualify if:

  • Patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy
  • Patients with available HbA1c data within the 1 month prior to the start of Actos Tablets treatment
  • Patients likely to be available for a 12-month observation after the start of Actos Tablets treatment

You may not qualify if:

  • Patients who have received Actos Tablets within the past 3 months.
  • Patients who started treatment with biguanides and Actos Tablets simultaneously
  • Patients who discontinued biguanides and switched to Actos Tablets treatment.
  • Patients who received additional biguanides after the start of Actos Tablets treatment
  • Patients with contraindications to Actos Tablets treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Medical Director
Organization
Takeda
trialdisclosures@takeda.com
+1-877-825-3327

Study Officials

  • Postmarketing Group Manager

    Takeda

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2013

First Posted

December 6, 2013

Study Start

February 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

November 10, 2016

Results First Posted

November 10, 2016

Record last verified: 2016-09