NCT00676260

Brief Summary

The purpose of this study is to measure microcirculation in type 2 diabetes patients with peripheral edema who are taking pioglitazone, once daily (QD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for phase_2 diabetes-mellitus

Timeline
Completed

Started Dec 2002

Geographic Reach
1 country

1 active site

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

December 1, 2002

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2008

Completed
Last Updated

February 28, 2012

Status Verified

February 1, 2012

Enrollment Period

1.7 years

First QC Date

May 9, 2008

Last Update Submit

February 27, 2012

Conditions

Diabetes Mellitus

Keywords

Glucose Metabolism DisorderDysmetabolic SyndromeType II DiabetesDiabetes MellitusLipoatrophicDyslipidemiaDrug Therapy

Outcome Measures

Primary Outcomes (1)

  • Capillary filtration capacity.

    Final Visit

Secondary Outcomes (9)

  • Isovolumetric venous pressure.

    Final Visit

  • Capillary pressure.

    Final Visit

  • Postural vasoconstriction.

    Final Visit

  • Maximum blood flow.

    Final Visit

  • Capillary recruitment.

    Final Visit

  • +4 more secondary outcomes

Study Arms (2)

Pioglitazone QD

EXPERIMENTAL
Drug: Pioglitazone

Placebo QD

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PioglitazoneDRUG

Pioglitazone 15 mg to 30 mg, tablets, orally, once daily for up to 10 weeks

Also known as: Actos, AD4833
Pioglitazone QD
PlaceboDRUG

Pioglitazone placebo-matching tablets, orally, once daily for up to 10 weeks

Placebo QD

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable glycemic control glycosylated hemoglobin between 6.5 and 10%) in the two months prior to the study.
  • Type 2 diabetes treated by diet and stable dose of insulin (alone or with metformin) in the three months prior to the study.
  • Female patients must have been postmenopausal, had a hysterectomy, or were surgically sterilized.

You may not qualify if:

  • Has Type 1 diabetes.
  • Has an episode of hypoglycemia requiring medical assistance three months prior to the study.
  • Has peripheral artery disease (including Raynaud's syndrome) confirmed by an Ankle Brachial Pressure Index less than 0.9.
  • Has severe chronic venous insufficiency as evidenced by venous ulceration or subcutaneous serum deposits.
  • Has vascular autoimmune disease, had received a renal transplant, or were receiving dialysis.
  • Has had heart failure (New York Heart Association I to IV), left ventricular hypertrophy evident from the ECG, or myocardial infarction 12 months prior to start of study.
  • Has Subject had uncontrolled hypertension or familial polyposis coli.
  • Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
  • Non steroidal anti-inflammatory Drugs (except for aspirin at anti-aggregant doses), oral anti-diabetic drugs (except metformin), calcium-channel blockers, and diuretics at anti-edema doses are excluded from the study.
  • Treatment with systemic corticosteroids within four weeks prior to enrolment and during the study was not allowed.
  • Patients who have taken beta-blockers are to have been on a stable dose for four weeks before entry in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Exeter, United Kingdom

Location

Related Publications (1)

  • Tooke JE, Elston LM, Gooding KM, Ball CI, Mawson DM, Piper J, Sriraman R, Urquhart R, Shore AC. The insulin sensitiser pioglitazone does not influence skin microcirculatory function in patients with type 2 diabetes treated with insulin. Diabetologia. 2006 May;49(5):1064-70. doi: 10.1007/s00125-006-0168-9. Epub 2006 Mar 1.

    PMID: 16508777RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusGlucose Metabolism DisordersDiabetes Mellitus, Type 2Dyslipidemias

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Medical Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2008

First Posted

May 13, 2008

Study Start

December 1, 2002

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

February 28, 2012

Record last verified: 2012-02

Locations

GB(1)