Comparison of efficacy and safety of pioglitazone versus metformin for moderate-to-severe chronic plaque psoriasis in patients with prediabetes or newly-diagnosed diabetes who have never taken anti-diabetic agents: a parallel, randomized, open-label, prospective study
Not Applicable
Recruiting
- Conditions
- psoriasisprediabetesdiabetes mellitusplaquepsoriasisprediabetesdiabetes mellitus
- Registration Number
- TCTR20190724005
- Lead Sponsor
- Dermatological Society of Thailand (pending)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
-Minimum 18 Years
-Extensive chronic plaque-type psoriasis (at least 5% body surface area involvement)
-Prediabetes (fasting blood glucose 100-125 mg/dL or HbA1C 5.7-6.4%) or diabetes mellitus (fasting blood glucose > 126 mg/dL or HbA1C > 6.5)
Exclusion Criteria
-Pregnancy or lactation
-History of pioglitazone or metformin allergy
-Congestive heart failure (NYHA class III or IV) or ischemic heart disease
-History of diabetic ketoacidosis
-Impaired hepatic function (>2.5 times upper range limit)
-Impaired renal function (estimated glomerular filtration rate < 30 mL/min per 1.73 m²)
-Obesity (body mass index > 30 kg/m2)
-Alcoholism
-History of bladder cancer
-History of bony fracture
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Psoriasis Area Severity Index (PASI) week 0, 2, 4, 8, 12 PASI scores
- Secondary Outcome Measures
Name Time Method Adverse drug reactions week 0, 2, 4, 8, 12 clinical follow-up