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

Information source: Takeda
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus

Intervention: Pioglitazone (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Takeda

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Takeda

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).

Clinical Details

Official title: Effect of Pioglitazone 15 mg or 30 mg on Microcirculation in Type 2 Diabetes Patients Treated With Insulin

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Capillary filtration capacity.

Secondary outcome:

Isovolumetric venous pressure.

Capillary pressure.

Postural vasoconstriction.

Maximum blood flow.

Capillary recruitment.

24-hour ambulatory blood pressure.

Interleukin-6

C-Reactive Protein.

Vascular Endothelium Growth Factor.

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 at a number of locations that are important to carbohydrate and lipid (fat) metabolism. Insulin resistance is reversed by enhancing the action of insulin, thereby promoting glucose utilization in peripheral tissues, suppressing gluconeogenesis in the liver, and reducing lipolysis at the adipocyte. In previous studies of pioglitazone, peripheral edema (swelling in the hands, feet, and legs) was reported as an adverse event more often in pioglitazone groups and appears to be a dose dependent phenomenon with pioglitazone. The incidence of peripheral edema in monotherapy studies was 3. 2% in pioglitazone patients compared with 0. 7% placebo patients and was reported more by females than males. This incidence was higher when pioglitazone was combined with sulphonylurea or insulin (5. 9% and 15. 6%, respectively). In comparison, the incidence of edema, when sulphonylurea or insulin was combined with placebo, was 2. 1% and 7. 5%, respectively. This study is designed to identify the mechanisms underlying peripheral edema formation with pioglitazone in patients with Type 2 diabetes. Individuals who participate in this study will provide written informed consent and will be required to commit to a screening visit and approximately 4 additional visits at the study center. Study participation is anticipated to be about 10 to 12 weeks (or approximately 3 months). Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, physical examinations and electrocardiograms.

Eligibility

Minimum age: 40 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

Exeter, United Kingdom
Additional Information

ACTOS® Package Insert

FDA Safety Alerts and Recalls

Starting date: December 2002
Last updated: February 27, 2012

Page last updated: August 20, 2015

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