drugset / Trial / NCT01396564

Pioglitazone and Metformin in Diabetic Children

NCT01396564

Phase 1/2 Completed 56 enrolled Coordinación de Investigación en Salud, Mexico
RandomizedParallel-groupTriple-blindTreatment

Summary

HYPOTHESIS: Treatment with pioglitazone is more effective in reducing resistin concentrations and insulin resistance than metformin in children with Type 2 Diabetes (T2D). MATERIAL AND METHODS: Pediatric patients aged 8-17 with T2D as defined by the American Diabetes Association (ADA) were included, not under treatment or who had been treated exclusively with diet and exercise or who only received an anti-diabetic agent, as well as those with a history of insulin use who had not applied insulin within 1 month before the initial visit. History of T2D, hypertension, exercise, diet, age, gender and somatometry are recorded. A Blood sample is taken to determine HbA1c, glucose, insulin and resistin. STATISTICAL ANALYSIS: The percentual change over 4 weeks is analyzed for concentrations of resistin, insulin resistance. Changes are noted for weeks 12, 24, 36 and 48 for resistin concentrations, HbA1c and HOMA values. Baseline and final values are compared with a paired t test. Lineal or logarithmic regression analysis is used to evaluate the relationship between homeostasis model assessment of insulin resistance (HOMA-IR) and resistin concentrations. The statistical significance between variables is determined using ANOVA. The effect of confounding variables is analyzed with a test of co-variance analysis. Statistical significance is considered as p \<0.05.

Timeline

Start
2005-10
Primary completion
2006-10
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 1700 mg
Comparator Pioglitazone Small molecule 60 mg