Study to Compare Pioglitazone and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Efficacy comparison of Pioglitazone, once daily (QD), to Rosiglitazone in participants with Type 2 Diabetes

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Collaborator: Eli Lilly and Company
• Treatments: Pioglitazone; Rosiglitazone

Criteria

Inclusion Criteria

• Type 2 diabetes mellitus according to the World Health Organization criteria and have diabetes-associated dyslipidemia (fasting triglycerides level between greater than or equal to 150 mg per dL and less than or equal to 600 mg per dL, and a fasting direct low-density lipoprotein cholesterol less than or equal to 130 mg per dL).

• Fasting serum C-peptide greater than or equal to1 ng per

• Glycosylated hemoglobin greater than or equal to 7% and less than or equal to 11% if naive to oral antihyperglycemic medications, or greater than or equal to 9.5% if previously treated with oral antihyperglycemic monotherapy

Exclusion Criteria

• Investigator site personnel and their immediate families. Immediate family defined as a spouse, parent, child or sibling, whether biological or legally adopted.

• Treatment with a drug within 30 days of Visit 1 that had not received regulatory approval.

• Treatment within 60 days of Visit 1 with any of the following:

• insulin

• systemic glucocorticoid therapy (excluding topical and inhaled preparations)

• combination glycemic therapy (two or more oral anti-diabetes medications)

• any lipid-lowering agent (including nicotinic acid, fibrates, bile acid resin binders, statins, d thyroxine or neomycin)

• any weight loss agent (prescription or over the counter)

• Pregnant, breast feeding, or intending to become pregnant during the study.

• Serum creatinine greater than or equal to 176.8 μmol per L or greater than or equal to 2 plus per dipstick.

• Proteinuria at Visit 1.

• Alanine transaminase or aspartate transaminase greater than or equal to 1.5 times the upper limit of normal at Visit 1 or had significant clinical signs or symptoms of liver disease.

• History of signs or symptoms of liver disease, such as jaundice or alanine transaminase greater than or equal to 1.5 times the upper limit of normal, while treated with any thiazolidinedione

• Hemoglobin less than 10.5 g per dL for females and less than11.5 g per dL for males at Visit 1.

• Clinically or biochemically based on thyroid stimulating hormone at Visit 1 hypothyroid or hyperthyroid.

• History of myocardial infarction, acute cardiovascular event, or heart surgery within 6 months of Visit 1.

• Functional New York Heart Association Cardiac Class III or IV disease.

• Receiving renal dialysis or has had received a renal transplant.

• Undergoing therapy for a malignancy other than basal cell or squamous cell skin cancer.

• Clinical signs or symptoms of drug or alcohol abuse.

• History of HIV infection.

• Allergy to any glitazone drug.

• Medical history or the presence of any clinically significant or unstable medical condition that made the patient unlikely to complete the study.

• Any condition or situations that precluded adherence and completion of the protocol or a precluding ability to voluntarily give informed consent.