Extrait

The primary objective of this study, in suboptimally-controlled insulin-naïve individuals with type 2 diabetes, is to demonstrate that a simple approach for adding HIIP to oral antihyperglycemic medication can achieve, within 6 months, glycemic control similar to a more aggressive approach. The two treatment regimens algorithms (Algorithm A versus Algorithm B) will be compared with respect to mean change in HbA1c from baseline to endpoint (6 months). Noninferiority with respect to HbA1c will be concluded if the upper limit of the 95% confidence interval for the treatment difference (Algorithm A – Algorithm B) is less than 0.4%.

Critère d'inclusion

• Male or non pregnant female nonsmoking patients, 18 years of age or older: have had type 2 diabetes mellitus for at least 6 months, and have been treated with one or more oral antihyperglycemic medications for at least 6 weeks (12 weeks for thiazolidinediones [TZDs]), and are insulin-naïve as defined in the protocol, have HbA1c >7.0% and ≤10.5%, and FEV1 and DLCO >70% of predicted value

Liens

• ictrp
• euctr
• ictrp
• euctr
• euctr
• ictrp