NCT01124656

Brief Summary

The purpose of this study is to determine the safety and tolerability of pioglitazone-azilsartan, once daily (QD), in patients with type 2 diabetes mellitus.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_3 diabetes-mellitus-type-2

Status
terminated

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

September 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2010

Completed
Last Updated

May 21, 2012

Status Verified

May 1, 2012

Enrollment Period

8 months

First QC Date

May 13, 2010

Last Update Submit

May 18, 2012

Conditions

Diabetes Mellitus, Type 2

Keywords

angiotensin II receptor blockerthiazolidinedionescombinationActosHbA1cType 2 diabetesDrug TherapyHypertension

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events.

    The Incidence of Treatment-Emergent Adverse Events, with an incidence \> 5%.

    On Occurrence (up to 52 Weeks).

Secondary Outcomes (1)

  • Change from Baseline for Glycosylated Hemoglobin.

    Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48 and 52.

Study Arms (1)

Pioglitazone-Azilsartan QD

EXPERIMENTAL

(Dependent on glycosylated hemoglobin level at screening)

Drug: Pioglitazone-Azilsartan

Interventions

Pioglitazone-AzilsartanDRUG

Pioglitazone-Azilsartan (30 mg + 20 mg) or (45 mg + 20 mg), tablets, orally, once daily for up to 52 weeks.

Also known as: Pioglitazone, Actos, Azilsartan, AD-4833, TAK-536
Pioglitazone-Azilsartan QD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has type 2 diabetes with glycosylated hemoglobin ≥7.0 % to ≤ 11.0% at Screening.
  • Has been on a stable diabetic diet/exercise program.
  • If receiving anti-glycemic therapy, he/she must be on ≤ two (2) anti-glycemic agents and be on a stable regimen for a minimum of 8 weeks prior to Screening.
  • A female subject of childbearing potential who is sexually active agrees to use adequate contraception from screening throughout the duration of the study.

You may not qualify if:

  • Currently taking or is expected to take thiazolidinediones within 12 weeks of Screening.
  • Hypersensitive to thiazolidinediones.
  • Hypertension with diastolic blood pressure \>100 mm Hg and/or systolic blood pressure \>170 mm Hg at Screening and/or Visit 2 (Day 1).
  • Currently taking an angiotensin II-receptor blocker (ARB) and is not willing to discontinue therapy at Visit 2 (day 1) and remain off for the duration of the study.
  • Hypersensitive to angiotensin II-receptor blocker.
  • Unstable angina or heart failure of any etiology with New York Heart Association functional class III or IV.
  • History of myocardial infarction, cerebrovascular accident , percutaneous coronary intervention, coronary artery bypass graft or transient ischemic attack within the previous six months.
  • Clinically significant cardiac conduction defects
  • Body mass index \>45 kg/m2 at Screening.
  • Moderate to severe renal dysfunction
  • Anemia
  • Hematuria (\>1+ blood) at Screening.
  • Triglycerides \>600 mg/dL at Screening.
  • Hyperkalemia, defined as serum potassium level of greater than the upper limit of normal, per the central laboratory at Screening.
  • Alanine aminotransferase or aspartate aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at Screening.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hypertension

Interventions

Pioglitazoneazilsartan

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • VP, Clinical Science

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2010

First Posted

May 17, 2010

Study Start

September 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

May 21, 2012

Record last verified: 2012-05