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rosiglitazone + pioglitazone + placebo (Solvay)
- Development stage
- Unknown
- Lead developer
- Abbott
- Modality
- Small Molecules
- Administration
- Oral
01
Overview
This refers to a Phase 1 crossover clinical trial conducted by Solvay Pharmaceuticals (later acquired by Abbott) comparing the thiazolidinedione (TZD) antidiabetic agents pioglitazone and rosiglitazone against a placebo. The study was designed as a single-center, open, randomized, 3-period crossover trial in 12 healthy male volunteers to evaluate the effects of single oral doses (45 mg pioglitazone and 8 mg rosiglitazone) on urinary sodium excretion and renal sodium handling. Both active drugs are small molecule agonists of the peroxisome proliferator-activated receptor-gamma (PPAR-gamma), which improve insulin sensitivity and glycemic control in patients with type 2 diabetes mellitus. The trial specifically investigated the methodological effects of these agents on sodium balance, addressing the clinical observation of fluid retention and edema associated with TZD therapy.
- Brand names
- AvandiaActos
- Other names
- rosiglitazone/pioglitazone/placebo
02
Targets
PPARG (Peroxisome proliferator-activated receptor gamma)PPARA (Peroxisome proliferator-activated receptor alpha)PPARD (Peroxisome proliferator–activated receptor delta)
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