Efficacy and Safety of Pioglitazone in Treating Subjects With Vascular Complications Associated With Type 2 Diabetes Mellitus.

NCT00770835 | Completed Phase 4

• 3 other identifiers: IT-PIO-1092007-003077-44U1111-1114-3045
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the efficacy of pioglitazone compared to glibenclamide, once daily (QD), taken together with metformin and lifestyle modification in type 2 diabetic subjects with cardiovascular disease.

Conditions

Diabetes Mellitus

Keywords

Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus, Lipoatrophic; Dyslipidemia; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Increase from Baseline in the number of Endothelial Progenitor Cells (CD34+KDR+).

  Baseline and Final Visit.

Secondary Outcomes (11)

• Change from Baseline in Circulating Progenitor Cells Integrated Markers of cardiovascular risk (CD34+).

  Baseline and Weeks 12 and 24.

• Change from Baseline in Flow Mediated Dilation Integrated Markers of cardiovascular risk.

  Baseline and Final Visit.

• Modulation of Endothelial Progenitor Cell recruitment (vascular endothelial growth factor, erythropoietin and stromal cell-derived factor-1).

  Weeks: 4, 12 and 24.

• Measure of Glucose Control (glycosylated hemoglobin and fasting plasma glucose).

  Weeks: 4, 12 and 24.

• Measure of Lipid Parameters (total lipids, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, apolipoprotein B and apolipoprotein A1).

  Weeks: 4, 12 and 24.

Study Arms (2)

Pioglitazone and Metformin QD

EXPERIMENTAL

(along with lifestyle modification)

Drug: Pioglitazone and Metformin

Glibenclamide and Metformin QD

ACTIVE COMPARATOR

(along with lifestyle modification)

Drug: Glibenclamide and Metformin

Interventions

Pioglitazone and Metformin DRUG

Pioglitazone 30 mg, tablets, orally, once daily, metformin stable dose and lifestyle modification for up to 24 weeks.

Also known as: ACTOS®, AD-4833

Pioglitazone and Metformin QD

Glibenclamide and Metformin DRUG

Glibenclamide 10 mg, tablets, orally, once daily and metformin stable dose and lifestyle modification for up to 24 weeks.

Also known as: Diabeta, Glynase, Micronase, Daonil, Semi-Daonil, Euglucon

Glibenclamide and Metformin QD

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females must be non-pregnant, non-lactating and post-menopausal.
• A glycosylated hemoglobin level greater than 7.5% and less than 10%.
• Has an age of onset of Type 2 Diabetes greater than 35 years of age.
• Is on metformin monotherapy up to the maximum tolerated daily dose.
• Has a normal or only slightly impaired renal function (a modification of diet in renal disease estimated glomerular filtration rate greater than 60 ml/min/1.73m2.
• Antihypertensives, statins and any other hypolipidemic medications have been initiated at least three months prior to enrollment; no dose modifications are allowed during the study.
• Has one or more cardiovascular comorbidities as follows:
• stable angina pectoris
• previous (greater than three months) transient ischemic attack, cerebrovascular accident or carotid atherosclerosis as assessed by bilateral carotid artery ultrasonography
• peripheral vascular complications documented by a history of claudication or rest pain, ultrasonography or angiography.
• and/or two or more of the following major cardiovascular risk factors:
• hypertension (blood pressure \>130/80 mmHg or treatment)
• dyslipidemia (low-density lipoprotein-cholesterol \>100 mg/dl or treatment and/or high-density lipoprotein-cholesterol \<40 mg/dl in men and \<45 mg/dl in women or treatment)
• smoking (\>10 cigarettes/day)

You may not qualify if:

• Has Type 1 Diabetes.
• Is on insulin therapy.
• Is severely obese defined as a body mass index greater than or equal to 40mg/m2
• Has diabetic retinopathy.
• Has evidence of hepatic dysfunction including liver transaminase greater than three times the upper limit of normal.
• Is unable to remain on a stable dose of the following class of medications 30 days prior to randomization and throughout the six months of the study:
• antihypertensives
• statins
• other hypolipidemic and antiplatelet drugs
• Has a history of alcohol or other drug abuse.
• Has had a new diagnosis of cancer or recurrent cancer within five years of screening.
• Has a need for chronic (greater than two weeks) immunosuppressive therapy.
• Has had heart failure based on the New York Heart Association Functional Class I through IV.
• 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:
• Other antidiabetic drugs (except metformin)

Sponsors & Collaborators

• Takeda: lead

Study Sites (2)

Unknown Facility

Padua, Italy

Location

Unknown Facility

Pisa, Italy

Location

Related Links

• ACTOS® Package Insert

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus, Lipoatrophic; Dyslipidemias

Interventions

Pioglitazone; Metformin; Glyburide

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines; Sulfonylurea Compounds; Urea; Amides; Sulfones

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 10, 2008
• Study Start: March 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 12, 2011

Record last verified: 2011-07

Locations

IT (2)