NCT00225264

Brief Summary

The primary purpose of this study is to compare the effects of pioglitazone, once daily (QD), versus glimepiride on the amount of thickening of the carotid artery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
458

participants targeted

Target at P50-P75 for phase_3 diabetes-mellitus

Timeline
Completed

Started Oct 2003

Typical duration for phase_3 diabetes-mellitus

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

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

February 28, 2012

Status Verified

February 1, 2012

Enrollment Period

2.6 years

First QC Date

September 21, 2005

Last Update Submit

February 27, 2012

Conditions

Diabetes Mellitus

Keywords

Glucose Metabolism DisorderDysmetabolic SyndromeType II DiabetesDiabetes Mellitus, LipoatrophicDyslipidemiaDrug Therapy

Outcome Measures

Primary Outcomes (1)

  • Absolute change from Baseline in carotid intima-media thickness.

    Weeks 24, 48 and Final Visit.

Secondary Outcomes (5)

  • Change from Baseline in carotid intima-media thickness.

    Weeks 24, 48 and Final Visit.

  • Change from Baseline in coronary artery calcium-volume score.

    At Final Visit

  • Change from Baseline in abdominal adipose tissue content and distribution.

    At Final Visit

  • Incidence of cardiovascular events as a composite of cardiovascular mortality, nonfatal myocardial infarction and nonfatal stroke

    At each occurrence

  • Incidence of cardiovascular events as a composite of cardiovascular mortality, nonfatal MI, nonfatal stroke, coronary revascularization, carotid endarterectomy/stenting, hospitalization for unstable angina and hospitalization for CHF

    At each occurrence

Study Arms (2)

Pioglitazone QD

EXPERIMENTAL
Drug: Pioglitazone

Glimepiride QD

ACTIVE COMPARATOR
Drug: Glimepiride

Interventions

PioglitazoneDRUG

Pioglitazone 15 mg titrated up to 45 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily for up to 72 weeks.

Also known as: Actos, AD-4833
Pioglitazone QD
GlimepirideDRUG

Pioglitazone placebo-matching tablets, orally, once daily and glimepiride 1 mg titrated up to 4 mg, capsules, orally, once daily for up to 72 weeks.

Also known as: Amaryl
Glimepiride QD

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to the time of randomization.
  • Diagnosis of type 2 diabetes mellitus.
  • Has received appropriate counseling on lifestyle modification for type 2 diabetes, including diet and exercise.
  • Naïve to or not currently taking antidiabetic therapy, or is currently treated with monotherapy or combination antidiabetic therapy.
  • Glycosylated hemoglobin greater than or equal to 6.0% and less than 9% at screening if taking antidiabetic medication or glycosylated hemoglobin greater than or equal to 6.5% and less than 10% at screening if naïve to or not taking antidiabetic medication.

You may not qualify if:

  • Type 1 diabetes mellitus.
  • Taking more than 2 antidiabetic therapies at screening. For combination medications, each component is counted as 1 therapy.
  • Symptomatic coronary artery disease, cerebrovascular disease, or peripheral vascular disease at the time of screening.
  • Taking or have taken pioglitazone or other thiazolidinediones within 12 weeks of randomization or were discontinued from thiazolidinedione therapy due to lack of efficacy or clinical or laboratory signs of intolerance.
  • Was discontinued from glimepiride or other sulfonylureas due to lack of efficacy or clinical or laboratory signs of intolerance.
  • Participating in another investigational study or has participated in an investigational study within the past 30 days or is scheduled to participate in an investigational study during the time frame of this study.
  • Women who are pregnant, intend to become pregnant during the course of the study, or are lactating.
  • Men who have serum creatinine greater than or equal to 2.0 mg/dL (greater than or equal to 1.5 mg/dL if taking metformin) and women with serum creatinine greater than or equal to 1.8 mg/dL (greater than or equal to1.4 mg/dL if taking metformin).
  • Unexplained microscopic hematuria of greater than plus 1 confirmed by repeat testing.
  • History of drug abuse or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 2 years.
  • Alanine transaminase level of greater than 2.5 times the upper limit of normal, active liver disease or jaundice.
  • Weighs greater than 300 pounds or has a body mass index greater than 45 kg/m2 as calculated by weight (kg)/height (m)2 or weight (pounds)/height (inches)2 x 703.
  • Has taken excluded medications.
  • Known or suspected malignancy or recurrence of malignancy within the past 5 years, with the exception of basal cell carcinoma and Stage 1 squamous cell carcinoma of the skin.
  • Any disease where, in the opinion of the investigator, survival is expected to be less than 18 months.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Chicago, Illinois, United States

Location

Related Publications (6)

  • Mazzone T, Meyer PM, Feinstein SB, Davidson MH, Kondos GT, D'Agostino RB Sr, Perez A, Provost JC, Haffner SM. Effect of pioglitazone compared with glimepiride on carotid intima-media thickness in type 2 diabetes: a randomized trial. JAMA. 2006 Dec 6;296(21):2572-81. doi: 10.1001/jama.296.21.joc60158. Epub 2006 Nov 13.

    PMID: 17101640RESULT

  • Davidson M, Meyer PM, Haffner S, Feinstein S, D'Agostino R Sr, Kondos GT, Perez A, Chen Z, Mazzone T. Increased high-density lipoprotein cholesterol predicts the pioglitazone-mediated reduction of carotid intima-media thickness progression in patients with type 2 diabetes mellitus. Circulation. 2008 Apr 22;117(16):2123-30. doi: 10.1161/CIRCULATIONAHA.107.746610. Epub 2008 Apr 14.

    PMID: 18413496RESULT

  • Sam S, Haffner S, Davidson MH, D'Agostino RB Sr, Feinstein S, Kondos G, Perez A, Mazzone T. Relationship of abdominal visceral and subcutaneous adipose tissue with lipoprotein particle number and size in type 2 diabetes. Diabetes. 2008 Aug;57(8):2022-7. doi: 10.2337/db08-0157. Epub 2008 May 9.

    PMID: 18469202RESULT

  • Mazzone T, Meyer PM, Kondos GT, Davidson MH, Feinstein SB, D'Agostino RB Sr, Perez A, Haffner SM. Relationship of traditional and nontraditional cardiovascular risk factors to coronary artery calcium in type 2 diabetes. Diabetes. 2007 Mar;56(3):849-55. doi: 10.2337/db06-0935.

    PMID: 17327456RESULT

  • Sam S, Haffner S, Davidson MH, D'Agostino RB Sr, Feinstein S, Kondos G, Perez A, Mazzone T. Relation of abdominal fat depots to systemic markers of inflammation in type 2 diabetes. Diabetes Care. 2009 May;32(5):932-7. doi: 10.2337/dc08-1856. Epub 2009 Feb 19.

    PMID: 19228869RESULT

  • Betteridge DJ. CHICAGO, PERISCOPE and PROactive: CV risk modification in diabetes with pioglitazone. Fundam Clin Pharmacol. 2009 Dec;23(6):675-9. doi: 10.1111/j.1472-8206.2009.00741.x. Epub 2009 Sep 10.

    PMID: 19744248RESULT

Related Links

MeSH Terms

Conditions

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

Interventions

Pioglitazoneglimepiride

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • VP Clinical Science Strategy

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
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

September 21, 2005

First Posted

September 23, 2005

Study Start

October 1, 2003

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

February 28, 2012

Record last verified: 2012-02

Locations

US(1)