Effect of Pioglitazone HCl on the Microcirculation in Type 2 Diabetes Patients Treated With Insulin
Information source: Takeda Global Research & Development Center, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: pioglitazone HCl (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Takeda Global Research & Development Center, Inc. Official(s) and/or principal investigator(s):
Richard Urquhart, MD, Study Director, Affiliation: Takeda Europe Research & Development Centre Ltd.
Summary
This was a randomized, double-blind, parallel group, placebo controlled comparison study
designed to identify the mechanisms underlying peripheral edema formation with pioglitazone.
Clinical Details
Official title: Effect of Pioglitazone 15 mg or 30 mg on Microcirculation in Type 2 Diabetes Patients Treated With Insulin
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Capillary filtration capacity.
Secondary outcome: Isovolumetric venous pressure, capillary pressure, postural vasoconstriction, maximum blood flow, capillary recruitment, 24-hour ambulatory blood pressure, IL-6, CRP, VEGF, HbA1C and fasting plasma glucose.Triglycerides. Safety variables including vital signs, clinical laboratory tests (hematology, blood chemistry, and urinalysis), ECG, physical examination, body weight, and adverse events.
Detailed description:
The study comprised five visits over a period of 10-12 weeks, including an 8-10 week
treatment with pioglitazone HCl 15 mg QD (which could be titrated up to 30 mg QD at Week 2 or
Week 4). Study procedures included capillary filtration capacity, isovolumetric pressure,
capillary pressure, postural vasoconstriction, maximum blood flow, capillary recruitment,
24-hour ambulatory blood pressure monitoring, Interleukin-6, C-reactive protein, and vascular
endothelium growth factor, which were performed at Baseline and Week 8. Other procedures and
safety monitoring were also carried out during the course of the study.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Men or women between 40 and 80 years of age.
- Stable glycemic control in the two months prior to the study.
- Type 2 diabetes treated by diet and stable doses 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:
- Subject had Type 1 diabetes.
- Subject had an episode of hypoglycemia requiring medical assistance three months prior
to the study.
- Subject had peripheral artery disease (including Raynaud's syndrome) confirmed by an
Ankle Brachial Pressure Index less than 0. 9.
- Subject had sever chronic venous insufficiency as evidenced by venous ulceration or
subcutaneous serum deposits.
- Subject had vascular autoimmune disease, had received a renal transplant, or were
receiving dialysis.
- Subject had heart failure (NYHA I to IV), left ventricular hypertrophy evident from
the ECG, or myocardial infarction 12 months prior to start of study.
- Subject had uncontrolled hypertension or familial polyposis coli.
Locations and Contacts
Royal Devon and Exeter Hospital, Exeter, United Kingdom
Additional Information
Starting date: December 2002
Ending date: August 2004
Last updated: May 9, 2008
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