Efficacy of Pioglitazone on Microcirculation in Type 2 Diabetes Patients Treated With Insulin
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Pioglitazone 15 mg or 30 mg on Microcirculation in Type 2 Diabetes Patients Treated With Insulin|
- Capillary filtration capacity. [ Time Frame: Final Visit ]
- Isovolumetric venous pressure. [ Time Frame: Final Visit ]
- Capillary pressure. [ Time Frame: Final Visit ]
- Postural vasoconstriction. [ Time Frame: Final Visit ]
- Maximum blood flow. [ Time Frame: Final Visit ]
- Capillary recruitment. [ Time Frame: Final Visit ]
- 24-hour ambulatory blood pressure. [ Time Frame: Final Visit ]
- Interleukin-6 [ Time Frame: Final Visit ]
- C-Reactive Protein. [ Time Frame: Final Visit ]
- Vascular Endothelium Growth Factor. [ Time Frame: Final Visit ]
|Study Start Date:||December 2002|
|Study Completion Date:||August 2004|
|Primary Completion Date:||August 2004 (Final data collection date for primary outcome measure)|
|Experimental: Pioglitazone QD||
Pioglitazone 15 mg to 30 mg, tablets, orally, once daily for up to 10 weeks
|Placebo Comparator: Placebo QD||
Pioglitazone placebo-matching tablets, orally, once daily for up to 10 weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676260
|Exeter, United Kingdom|
|Study Director:||Medical Director||Takeda|