Efficacy of Pioglitazone on Microcirculation in Type 2 Diabetes Patients Treated With Insulin

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.