NCT00449553

Brief Summary

The purpose of this study is to asses changes in glycosylated hemoglobin, fasting blood lipids and genetic polymorphism's in peroxisomal proliferator activated receptors--gamma receptor after 6 months of pioglitazone, once daily (QD), treatment.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
326

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2001

Typical duration for all trials

Geographic Reach
4 countries

4 active sites

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

June 1, 2001

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2007

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 20, 2007

Completed
Last Updated

February 28, 2012

Status Verified

February 1, 2012

Enrollment Period

2.3 years

First QC Date

March 1, 2007

Last Update Submit

February 27, 2012

Conditions

Diabetes Mellitus

Keywords

Glucose Metabolism DisorderDysmetabolic SyndromeType II DiabetesDiabetes Mellitus, LipoatrophicDyslipidemiaDrug Therapy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in glycosylated hemoglobin.

    6 months

Secondary Outcomes (6)

  • Change from baseline in Clinical Laboratory Tests (alanine transaminase, hematocrit and hemoglobin).

    End of Treatment

  • Change from baseline in Body Weight.

    End of Treatment

  • Percentage of treatment responders defined as a patient with 0.6% decrease in HbA1C from baseline visit to final visit or accomplishment of a HbA1c value at or below 6.5%.

    End of Treatment

  • Change from baseline in beta-cell function (Homeostasis model assessment).

    End of Treatment

  • Change from baseline in insulin resistance (Homeostasis model assessment).

    End of Treatment

  • +1 more secondary outcomes

Study Arms (4)

Pioglitazone 15 mg QD + Sulphonylurea

Drug: Pioglitazone and sulphonylurea

Pioglitazone 30 mg QD + Sulphonylurea

Drug: Pioglitazone and sulphonylurea

Pioglitazone 15 mg QD + Metformin

Drug: Pioglitazone and metformin

Pioglitazone 30 mg QD + Metformin

Drug: Pioglitazone and metformin

Interventions

Pioglitazone and sulphonylureaDRUG

Pioglitazone 15 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months.

Also known as: ACTOS®, AD4833
Pioglitazone 15 mg QD + Sulphonylurea
Pioglitazone and metforminDRUG

Pioglitazone 15 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months.

Also known as: ACTOS®, AD4833
Pioglitazone 15 mg QD + Metformin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving pioglitazone therapy.

You may qualify if:

  • Fulfills all requirements for treatment with pioglitazone.
  • Willing to start treatment with pioglitazone.

You may not qualify if:

  • Has previously participated in this study.
  • Is currently taking or have taken oral antidiabetic medications other than sulfonylurea or metformin within the last 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Multiple, Denmark

Location

Unknown Facility

Multiple, Iceland

Location

Unknown Facility

Multiple, Norway

Location

Unknown Facility

Multiple, Sweden

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood for DNA-analyses

MeSH Terms

Conditions

Diabetes MellitusGlucose Metabolism DisordersDiabetes Mellitus, Type 2Diabetes Mellitus, LipoatrophicDyslipidemias

Interventions

PioglitazoneSulfonylurea CompoundsMetformin

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsUreaAmidesSulfonesBiguanidesGuanidinesAmidines

Study Officials

  • VP Clinical Science Strategy

    Takeda Global Research and Developmnet Center Inc

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 1, 2007

First Posted

March 20, 2007

Study Start

June 1, 2001

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

February 28, 2012

Record last verified: 2012-02

Locations

NO(1)IC(1)DK(1)SE(1)