Status:
COMPLETED
Efficacy of Pioglitazone on Microcirculation in Type 2 Diabetes Patients Treated With Insulin
Lead Sponsor:
Takeda
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
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).
Detailed Description
Pioglitazone is a thiazolidinedione compound with a mode of action as a peroxisome proliferator-activated receptor gamma agonist. Activation of this receptor causes increased transcriptional activity ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00676260
Start Date
December 1 2002
End Date
August 1 2004
Last Update
February 28 2012
Active Locations (1)
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1
Exeter, United Kingdom